Beauty lies.....

2011-06-22T11:15:00.000-04:00

2011-05-19T13:17:00.000-04:00

Bristol Palin Gets Sexy Hair Extensions & Plastic Surgery: Do You Like Her New Look? « Hollywood Life

2011-05-05T10:48:00.000-04:00

Bristol Palin Gets Sexy Hair Extensions & Plastic Surgery: Do You Like Her New Look? « Hollywood Life: "- Sent using Google Toolbar"

Celebrity Plastic Surgeons Agree: Looks Like Christina Aguilera Had A Breast Augmentation! « Hollywood Life

2011-02-28T10:37:00.000-05:00

Celebrity Plastic Surgeons Agree: Looks Like Christina Aguilera Had A Breast Augmentation! « Hollywood Life: "- Sent using Google Toolbar"

Heidi Montag Regrets Shocking Plastic Surgery! See Her Scars Plus Other Stars Who Went Under Knives in 2010! « Hollywood Life

2011-02-28T10:36:00.000-05:00

Heidi Montag Regrets Shocking Plastic Surgery! See Her Scars Plus Other Stars Who Went Under Knives in 2010! « Hollywood Life: "- Sent using Google Toolbar"

When Are Breast Implants Too Big?: Daily Beauty Reporter: Beauty Reporter Blog: allure.com

2011-02-28T10:33:00.000-05:00

When Are Breast Implants Too Big?: Daily Beauty Reporter: Beauty Reporter Blog: allure.com: "- Sent using Google Toolbar"

Tattoos as Permanent Makeup - Skin Deep - NYTimes.com

2011-02-24T12:36:00.000-05:00

Tattoos as Permanent Makeup - Skin Deep - NYTimes.com: "- Sent using Google Toolbar"

Lymph Node Surgery for Breast Cancer Not Always Needed, Study Says - NYTimes.com

2011-02-08T17:42:00.000-05:00

Lymph Node Surgery for Breast Cancer Not Always Needed, Study Says - NYTimes.com: "- Sent using Google Toolbar"

Heidi Montag Regrets Shocking Plastic Surgery! See Her Scars Plus Other Stars Who Went Under Knives in 2010! « Hollywood Life

2011-01-11T10:27:00.000-05:00

Heidi Montag Regrets Shocking Plastic Surgery! See Her Scars Plus Other Stars Who Went Under Knives in 2010! « Hollywood Life: "- Sent using Google Toolbar"

ASAPS: Injectables to grow in 2011 - Cosmetic Surgery Times

2011-01-07T16:06:00.000-05:00

ASAPS: Injectables to grow in 2011 - Cosmetic Surgery Times: "- Sent using Google Toolbar"

Bellevue clinic sued in liposuction death

2011-01-07T15:27:00.000-05:00

Bellevue clinic sued in liposuction death: "Marco Sobrino,

- Sent using Google Toolbar"

FDA Defends Decision on Avastin - WSJ.com

2011-01-06T19:14:00.000-05:00

FDA Defends Decision on Avastin - WSJ.com: "- Sent using Google Toolbar"

Unforeseen Costs of Bariatric Surgery - NYTimes.com

2011-01-04T12:26:00.000-05:00

Unforeseen Costs of Bariatric Surgery - NYTimes.com: "- Sent using Google Toolbar"

South Florida woman, 35, dies getting plastic surgery

2011-01-03T11:14:00.000-05:00

South Florida woman, 35, dies getting plastic surgery

Survey: Mastectomy patients prefer silicone implants over saline - Related Stories - Plastic Surgery SmartBrief

2010-11-12T13:58:00.000-05:00

Survey: Mastectomy patients prefer silicone implants over saline - Related Stories - Plastic Surgery SmartBrief

2010-11-11T10:53:00.001-05:00

Thank you to all my patients for coming to our recent events. There was one conversation that I think it's important to share. One of my old patients showed up today after about 3 years. When I asked where she had been, she admitted she had been to another physician for Botox treatments because the other physician was cheaper. He was also according to his website, the number 1 cosmetic physician in Bergen county. I know all the plastic surgeons in Bergen county and am pretty familiar with many of the dermatologists in the area. I had never heard of this physician and I found out he is a family practice physician. My patient complained about his technique, his attempts to sell every procedure/product he had, and the exorbitant bill she still got at the end of the treatment. She told me she looked horrible the two times she came out of his office. Yes, she went back a second time. Moral of the story, plastic surgery is not like Wal-Mart. Cheaper is not always better even if you think it's the same product. She was fooled by the packaging and ended up getting an inferior product which in the end was even more costly. I appreciate your trust in me and as I see so many of you time and time again I hope that you feel comfortable referring your friends so that they may have the best experience possible.

'Dr. Botch' settles in plastic surgery death of Irish woman | Irish News | IrishCentral

2010-09-17T12:48:00.000-04:00

'Dr. Botch' settles in plastic surgery death of Irish woman | Irish News | IrishCentral

All Inclusive Vacation: Breast Implants Included? | Endless Beauty

2010-09-16T09:12:00.000-04:00

All Inclusive Vacation: Breast Implants Included? | Endless Beauty

Spa Owner Charged With Nearly Killing Customer With Illegal Liposuction

2010-04-19T17:53:00.000-04:00

NEW YORK — A spa owner is being accused of performing an unlawful liposuction on a customer and then re-injecting the fat into the client's buttocks, causing serious injury.

Queens District Attorney Richard Brown says 27-year-old Barbara Nieto, of Queens, was charged with assault, reckless endangerment and unauthorized practice of medicine.

Brown says Nieto, owner of Perfect Image Stethics, performed the procedure on the victim in March and several days later the woman experienced severe pain. She was hospitalized and underwent life-saving surgery.

Nieto, who was arraigned in Queens Criminal Court on Friday, faces up to seven years in prison if convicted. She was released on her own recognizance and is due back in court on April 27.

A call to her lawyer was not immediately returned.

Awake for Breast Implants? If You Wish

2010-04-16T17:28:00.002-04:00

SOON after Jane Z. had her B-cup breasts augmented for the first time, she realized she hadn’t gone big enough. So the second time, Jane Z., who preferred to not have her last name mentioned, was thrilled that she could choose her implant size during surgery.

How? She was awake. Most women who get breast implants do so under general anesthesia. But Jane. Z.’s doctor was Dr. Robert L. True of Colleyville, Tex., one of more than 100 doctors nationwide who advocate local anesthesia and sedation for aesthetic surgeries like breast augmentations.

“They are talking to me the entire time,” Dr. True, an obstetrician and gynecologist by training, said of the 75 patients whose breasts he has enlarged in his accredited facility. Once the new implants are in, his patients are propped up on the operating table, look in a mirror and have their say. “They like that little bit of autonomy,” he said.

A lot of plastic surgeons consider it out of the question to do a breast augmentation without an anesthesiologist or nurse anesthetist on hand, partly because of the risk to the patient if something goes wrong. These doctors say they cannot do their best work — dissecting a pocket for an implant, then securing it — without total control.

But lately, a set of doctors, most of whom have not come up through plastic surgery, has been touting the awake option as a boon to patient choice and as a safer option than general anesthesia. Breast augmentation is often done in hospitals and accredited offices, but awake breast surgery is usually done in an office that might not have been vetted for safety by an accrediting organization.

“Problem is, doctors are doing large procedures on local with quote-unquote sedation to circumvent the need for accreditation,” said Dr. Lawrence S. Reed, the president of the American Association for the Accreditation of Ambulatory Surgery Facilities.

For most of surgery, Jane Z., 48, who reviews medical charts for a hospital, said she felt “pretty much out of it.” She added, “You’re technically awake, but you remember nothing.” In a more coherent moment, she did recall being asked, before Dr. True sewed her up, if her new breasts were adequate. She asked to go slightly larger, and got her wish for a DD cup.

“If you talk to 99 percent of women, they want input into what they are going to look like,” said Dr. Jeffrey Caruth, an obstetrician and gynecologist by training who now offers awake cosmetic surgery at his office in Plano, Tex. “People are not coming to me because it’s cheaper. They don’t want to be put to sleep.”

Doctors offering awake breast augmentation and awake abdominoplasty (a tummy tuck) advertise on YouTube.com and make the case for local anesthesia and sedation on their Web sites. In the last few years, marketing for awake breast augmentation has ramped up. No organization tracks how many doctors do the awake version of this surgery (or of tummy tucks).

Dr. Anil K. Gandhi, who performs both awake procedures at his office in Cerritos, Calif., said he had taught “more than 100 doctors” in two-day $7,000 seminars for the National Society of Cosmetic Physicians. His students are doctors who typically did their residencies in ob/gyn or family medicine and who take a weekend course (or two) to learn how to do aesthetic surgeries with local anesthesia and sedation.

This shortcut to practicing aesthetic surgery tends to outrage the traditionalists. After all, board-certified plastic surgeons spend five to eight years after medical school learning operations and then have their surgical skills vetted in exams.

“Two-day courses, it’s just crazy,” said Dr. William P. Adams Jr., a plastic surgeon in Dallas who teaches residents at the University of Texas Southwestern Medical Center. “It took us six years to fully train plastic surgeons to do breast augmentation.” He said it was irresponsible to let fuzzy-headed patients choose their implants. “They don’t let people drive after a six-pack of beers,” said Dr. Adams, who is an investigator for Mentor and Allergan, makers of breast implants (and a consultant for Allergan). “How well will people choose an implant size after narcotics?”

Dr. Adams and other plastic surgeons say that mid-surgery consultations can be harmful if the patient chooses implants too large for her chest. Overaugmentation can produce unsightly rippling, said Dr. Mark L. Jewell, a plastic surgeon who does breast augmentations with local anesthesia and intravenous sedation in an accredited facility in Eugene, Ore. “Decisions should be made ahead of time,” said Dr. Jewell, an investigator for Mentor and Allergan as well as a consultant for Allergan.

Several doctors said that promoting local anesthesia and sedation for aesthetic surgeries was just a gimmick that played down the risks. “Promotion of these surgeries as so easy that only local anesthesia is required, it’s intended to make someone think, ‘It’s not serious,’ “ said Dr. Douglas R. Blake, an anesthesiologist in Providence, R.I., who specializes in office-based procedures. “The promise to get by with just local anesthesia may in fact be shortchanging the patient.” Say a patient feels faint, or has a panic attack mid-surgery, “who’s there to attend to the patient?” he asked.

Practitioners of awake breast augmentation offer patients sedation and then pump in a numbing fluid. This liquid — which has been used for years in a kind of liposuction called “tumescent” — includes lidocaine, an anesthetic, and epinephrine, which controls bleeding.

Cosmetic surgeons without residencies in plastic surgery say that using local anesthesia for breast augmentation promotes a faster recovery, but plastic surgeons tend to dispute that. “No surgeon who performs awake augmentation has ever proven in an independently monitored study that their patients can be out to dinner that night and return to full normal activities in 24 hours,” said Dr. John B. Tebbetts, a plastic surgeon in Dallas.

Jane Z., who had her first breast augmentation with Dr. Tebbetts, said her recovery after that 2004 operation and the recent one with Dr. True took roughly the same time. After general anesthesia, she said, she felt woozy but not nauseated.

Aspiration — when stomach contents return to the mouth and are inhaled — is one rare complication of going under. But under sedation, Dr. Blake said, the protective reflexes in the airway may be reduced, making aspiration a possibility.

Dr. Keith J. Ruskin, an anesthesiology professor at Yale University School of Medicine, said doctors using tumescent anesthesia must avoid an overdose, which can lead to seizures and abnormal heartbeats. Dr. Caruth gives his breast augmentation patients 5 to 10 milligrams of Valium and some Ativan (anti-anxiety drugs) for minimum sedation. If a patient wants moderate sedation, she must pay $600 for an anesthesiologist. But not every doctor sedating patients for breast augmentations believes less is more. Dr. Caruth said, “I see these guys that say they do ‘awake’ and they slam the heck out of these people with drugs.”

Dr. Gandhi, who trained as a general surgeon but is not board certified, said his patients get minimal sedation. He wants them alert. “It’s more safe,” he said. “Patients can scream and you would know, I can’t be doing that, I can’t be putting my needle there,“ said Dr. Gandhi, whose office is not accredited. Later, he clarified by e-mail: “For breast augmentation the technique that I have implemented and teach for tumescent anesthesia infusion results in excellent numbness, that the patients do not feel a thing while I am operating.”

Study blasts lack of training in cosmetic surgery marketplace

2010-04-15T11:16:00.001-04:00

April 2, 2010 | 11:38 am

Cosmetic procedures like Botox, facial fillers and liposuction are big money-makers for physicians. Not surprisingly, doctors other than plastic surgeons and dermatologists also offer cosmetic treatments. According to a new study, nearly 40% of doctors offering liposuction in Southern California had no specific surgical training.

The study, published in the April issue of the journal Plastic and Reconstructive Surgery, examined 1,876 cosmetic practitioners from San Diego to Los Angeles. Only 495 of them were trained in plastic surgery. Primary care physicians made up the fourth-largest group of liposuction providers following plastic surgeons, dermatologists and otolaryngologists.

There is no law to prevent doctors from offering these services, especially in a doctor's office (doctors need to apply for privileges to perform services in hospitals). Many non-surgeons take a course or participate in some form of limited training to perform liposuction or inject fillers. But such training is not required and is often inadequate, according to the American Society of Plastic Surgeons.

Though providing Botox or facial fillers is unlikely to be dangerous, liposuction can result in serious complications, the authors state. "We feel that the provision of such a potentially hazardous treatment by physicians with no training in surgery poses a genuine threat to the safety of patients."

Further, the authors state, aesthetic franchises have sprung up that have no association with one particular provider, making it more difficult for patients to know just who is responsible for their care.

"The practices are often named after a geographic location with a cachet of affluence,such as Rodeo Drive, Beverly Hills or La Jolla. In these practices, the practitioners are employees of the owner of the clinical facility, and are pushed to produce revenue. The divorce of the practice from the name of the responsible physician has the potential to have a profound impact on the doctor-patient relationship and how patients select a provider," the authors state.

Still, the authors say more legislation is not what's needed, calling government meddling "a guest who may never leave." They suggest more effort to educate the public on who is or isn't qualified to perform various cosmetic procedures.

I vote for whichever method -- education, legislation or perhaps both -- will protect consumer health and safety regardless of professional turf wars.

-- Shari Roan

Beware the Corporate MD Shill

2010-02-02T08:40:00.002-05:00

By NATASHA SINGER
Published: January 31, 2010

In the rarefied world of fashion magazines, beauty editors have often relied on a coterie of prominent dermatologists and plastic surgeons to keep them current on advances in cosmetic medicine. This symbiotic relationship has benefited magazines eager for beauty scoops and doctors seeking visibility — and patients.

But now the Food and Drug Administration has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine.

The F.D.A. recently sent a warning letter to Dr. Leslie Baumann, a well-known dermatologist and clinical researcher in Miami Beach, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved.

Dr. Baumann’s comments in the media in 2007 violated restrictions on drug promotion, according to the letter; the agency asked Dr. Baumann to explain how she intended to prevent similar violations in the future.

Under the Obama administration, the F.D.A. has stepped up scrutiny of drug advertising, dispatching many warning letters about misleading commercials and online marketing efforts. But this is believed to be the first time the agency has warned an individual investigator — a medical researcher who oversees a clinical trial — for apparently promoting an unapproved drug.

Dr. Baumann is far from the only cosmetic doctor to have jumped the gun. Some talk show hosts and beauty editors (including this reporter in her previous job at W magazine) have often turned to clinical investigators for news of the latest cosmetic medical treatments.

Now, some industry experts say the F.D.A. warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products — or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.

“It’s a wake-up call,” said Nancy Behrman, owner of Behrman Communications, a public relations firm in Manhattan. Her firm has represented cosmetic medical companies as well as doctors. “The whole business has spiraled out of control, and we need to step back and slow it down.”

Federal rules bar drug makers and investigators on their clinical trials from promoting a drug before the agency has approved the product. Dr. Baumann violated the restrictions, the F.D.A. letter said, because she was an investigator on a clinical trial for Dysport and promoted it well before the drug’s approval in April.

“Early data shows it may last longer and kick in faster than Botox,” Dr. Baumann told the fashion magazine Allure in 2007. She made similar comments that same year to Elle magazine and during an appearance on the “Today” show on NBC in January 2009.

In response to a query from a reporter, Dr. Baumann said in a statement that she had discussed the F.D.A.’s concerns with members of the agency’s staff in a conference call last week and that the agency now considered the matter closed. Medicis Pharmaceutical, which markets Dysport in the United States as treatment for furrows between the eyebrows, was not involved in Dr. Baumann’s comments to the press, the F.D.A. letter said.

Thomas W. Abrams, director of the agency’s Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not promote any unapproved prescription drug — or an unapproved use of an already approved drug — as being safe or effective if the agency has not yet deemed it to be so, he said.

“You can’t promote a prescription drug before it is approved, whether they are diabetes drugs or heart drugs or for cosmetic uses,” Mr. Abrams said.

The federal restrictions are meant to keep drug makers and their clinical investigators from conveying misleading or unduly favorable first impressions about a drug to health care providers or the public, Mr. Abrams said.

Similar restrictions prohibit companies and investigators from promoting an unapproved medical device or the unapproved use of an approved device, the agency said.

Some magazine editors said they hoped the warning letter would not have a chilling effect on investigators, the people who have hands-on experience with experimental drugs and devices.

“There is real value in a doctor involved in a clinical trial because they know about the products in a way that other doctors are only getting by hearsay,” said Linda Wells, the editor in chief of Allure.

Allure has been particularly reliant on Dr. Baumann’s expertise. The monthly magazine quoted her in 10 articles last year and mentioned her in another, according to a Nexis search.

Dr. Baumann, a former professor of dermatology at the University of Miami medical school who recently opened a dermatology research center in Miami Beach, says she has been a clinical investigator or consultant for about 40 makers of drugs, devices or cosmetics
“I understand that as a clinical investigator for many different drugs, I am held to a higher standard than ordinary treating physicians,” Dr. Baumann wrote in a statement sent in response to a reporter’s query.

Medicis, meanwhile, said in a statement responding to a reporter’s question last week that the company “respects and observes the F.D.A.’s prohibitions on pre-approval promotion, which are designed to protect the integrity of the F.D.A.’s product approval process and to further patient safety.”

In the wake of the agency’s warning letter, some often quoted cosmetic doctors like Dr. Fredric S. Brandt, a dermatologist in Manhattan and Coral Gables, Fla., are wondering what they can and cannot say. Dr. Brandt is an investigator and consultant for Medicis; Allergan, the maker of Botox; and Ortho-Neutrogena, as well as an investigator for a dozen other makers of dermatology products.

For many years, Dr. Brandt has held an annual event for beauty editors at the Four Seasons Hotel in Manhattan. At those gatherings, he has recapped cutting-edge developments that he learned about at professional medical society meetings, and he has delivered his own reviews about unapproved products for which he was an investigator.

Dr. Brandt was also the featured guest at a Medicis dinner for beauty editors, held at Le Bernardin in Manhattan two years ago. The invitation to the event promised a discussion on “innovative products on the horizon.” These turned out to include Dysport, a product for which Dr. Brandt was an investigator.

In a phone interview last week, Dr. Brandt said he would continue to talk to journalists about products in the pipeline. But he might limit his future comments to scientific facts and published studies.

“We have been talking about new products in the pipeline for years, and I think there is nothing wrong with that,” Dr. Brandt said. “But we are going to have to keep our opinions to ourselves.”

Medicis declined to comment about the dinner at Le Bernardin.(This reporter attended the event. The New York Times paid for my filet mignon; dinner, with tip, came to $115.54. )

Ms. Wells of Allure said that it was important for her magazine to report on advances in cosmetic medicine, informing readers when products were still under F.D.A. review. Should the new warning letter muzzle clinical investigators, Allure has other resources, she said.

“We hear about products approved in Europe, Canada or South Africa a year before they are approved in the U.S.,” Ms. Wells said. “We will figure out other ways to report the story.”

But Didi Gluck, the executive beauty director at Shape magazine, said she typically waits for federal approval before she publishes information about a cosmetic medical product.

“If it’s still in clinical trials, then it’s of no benefit to the readers anyway, so wait until it is safe for them,” Ms. Gluck said. “That’s what a responsible reporter should do.”

A new way to use frequent flier miles!

2010-01-25T15:49:00.000-05:00

Nordstrom Hospital, Helsinki, Finland
www.nordstromhospital.fi
info@nordstromhospital.fi

Description
A Finnish hospital specialized entirely in plastic surgery. One of the pioneers in aesthetic and reconstructive surgery. Experience brings assurance - professor Nordström is the only internationally well-acknowledged plastic surgeon of this level in Finland, who also operates in the field of aesthetic surgery.

Use Points
Breast augmentation with the best implants and top methods, voucher value €7,950. Capsule warranty for an extra fee of €600 (brief) or €890 (extensive).

Please note, that before ordering the voucher a consultation visit to the clinic (consultation fee €95) has to be made to ensure that the client is operable.

Breast augmentation, value €7,950, valid for a year after the date of purchase.

The Nordstrom Hospital for Plastic Surgery; www.nordstromhospital.fi; info@nordstromhospital.fi; tel. +358 (9) 612 6363

This benefit can not be combined with other benefits. Valid on new reservations only

The Public Editor The Sources’ Stake in the News

2010-01-19T16:26:00.003-05:00

By CLARK HOYT
Published: January 16, 2010

WHEN The Times interviewed Michael Chertoff about airport security after the underwear bomber tried to blow up a passenger jet on Christmas Day, he said full-body scanners should be deployed at airports. Chertoff, the former secretary of homeland security, did not volunteer that he is a consultant to a company that makes such equipment, and though they spoke to him twice, reporters never asked if he had a financial stake in the matter.

Peter Galbraith, a former diplomat, wrote several Op-Ed columns a few years ago supporting a strong and independent Kurdistan. The editors who published his pieces learned only in November — from a front-page article — that Galbraith’s business ties to a Norwegian oil company operating in Kurdistan positioned him to earn millions.

Jonathan Gruber, a prominent M.I.T. health economist, wrote an Op-Ed column and was quoted frequently in other Times columns, news articles and blogs on health care reform before it came to light that he had a contract worth nearly $400,000 to analyze health proposals for the Obama administration.

Neil Sadick, a famed Manhattan dermatologist, was quoted in a Skin Deep column discussing electronic devices for the home treatment of acne, but the article did not say that Sadick has a business relationship with a company that makes one of the devices.

These examples have resulted in five embarrassing editors’ notes in the last two months — two of them last week — each of them saying readers should have been informed of the undisclosed interest. And on Thursday, the standards editor sent Times journalists a memo urging them to be “constantly alert” to the outside interests of expert sources. The cases raised timeless issues for journalists and sources about what readers have a right to know and whose responsibility it is to find it out or disclose it.

The ideal expert source is entirely independent, with no stake in an outcome. But in reality, the most informed sources often have involvements, which is why they know what they know. Readers are entitled to disclosure so they can decide if there is a conflict that would affect the credibility of the information.

But each recent Times case showed how tricky it can be to navigate the ethics of disclosure.

Chertoff, who championed full-body scanners as head of the Department of Homeland Security, long before he went into private business, said it was no secret that he had become a consultant to corporate clients through the Chertoff Group, a risk-management firm he formed in March. He said that when two Times reporters, Eric Liptonand John Schwartz, called and the subject turned to scanners, it was up to them to ask whether he had ties to that industry. “I always answer when I’m asked,” he said. “But I don’t think it is my obligation to put myself in the head of a reporter” to decide what the reporter needs to know.

Chertoff did tell NPR and CNN interviewers when they asked.

Lipton and Schwartz agreed that they should have asked Chertoff, but both expressed disappointment that he did not volunteer obviously germane information. Bob Steele, a professor at DePauw University and a journalism values scholar at the Poynter Institute, said, “I believe a source does have an affirmative obligation to reveal any competing loyalties, even if the source isn’t sure they create a direct conflict of interest.”

Interestingly, Chertoff wrote an Op-Ed article for The Washington Post, published New Year’s Day, that carried a one-sentence biography divulging that his clients included a scanner manufacturer — a note he said he volunteered.

“If I’m affirmatively getting out there,” he said, as opposed to being called by a reporter, “I make it my business to disclose.” That’s a distinction I don’t buy. What difference does it make whether a source seeks a forum or a reporter happens to call? Knowing Washington’s culture of revolving doors and news spin, the Times reporters should have asked the obvious question. But if Chertoff had a connection he thought the public needed to know in one instance, he should have made it clear in the others.

Galbraith said he regretted not telling Times editors that he had business interests in Kurdistan when he wrote Op-Ed columns published in 2005 and 2006. He did provide a vague disclosure for one in 2007. But he disputed the November editors’ note that said he could have benefited from an independent Kurdistan because he had a stake in an oil field there.

He said his support of an independent Kurdistan was against the interests of DNO International, the oil company with which he had a relationship, because it had invested $300 million in Iraq, expecting it to remain unified. “I did not promote or discuss matters of specific interest to my clients and, indeed, my generally pessimistic view of Iraq’s future was not consistent with the interests of companies trying to attract investors for projects in the country,” he said.

Galbraith asked where the line was if an Op-Ed contributor was writing about political issues in a country where he also had economic interests. Because politics and economics so often go hand in hand, I would say someone in his shoes should disclose all interests to editors and discuss whether any pose a conflict that needs to be disclosed to readers. That is what The Times requires of all Op-Ed columnists, in plain, written language.

Gruber, the health care economist, wrote an Op-Ed column in July supporting an excise tax on so-called Cadillac health plans. Not long before, he had signed a contract with the Department of Health and Human Services to analyze the economic impact of various health care proposals in Congress. He did not tell Op-Ed editors, nor was the contract mentioned on at least 12 other occasions when he was quoted in The Times after he was consulting for the administration. After a blogger reported on Gruber’s government contract on the Daily Kos Web site, Gruber did volunteer it to Steven Greenhouse, a Times reporter interviewing him for an article on the excise tax. Greenhouse said he included the fact in a draft but struck it because the article was too long. Greenhouse said that Gruber’s views on the tax were so well-known that he did not think they would be influenced by a consulting contract. But had he realized how large the contract was, Greenhouse said, “I would have stood up and paid lots more attention.”

Gruber said, “I guess it never occurred to me that the fact that I was doing technical modeling would matter.” He said he has long supported the tax and that the administration opposed it when he wrote his column, so he was hardly bending his views to a government paymaster.

Sometimes, there can be misunderstandings even when a reporter asks. Camille Sweeney, the freelancer who interviewed Sadick about acne treatments, said she asked the dermatologist a specific question: Had he been paid by any manufacturer for tests he performed on the products? He said he had not. But after the article was published, a Times editor recalled seeing an endorsement by Sadick for a hair removal product by one of the manufacturers.

What is the lesson from all this? Lipton said, “I do need to ask whenever I call a person for comment as an expert if they have any financial relationship with the topic.” He said he has posted a reminder on his computer: “Ask if hired gun.”

Botched Laser Doctor-Beware

2009-11-19T11:45:00.002-05:00

Surgery at a Spa? Buyer Beware.

2009-11-12T13:55:00.002-05:00

Béatrice de Géa
New York Times

Published: November 4, 2009

THERE is little to suggest that the TriBeCa MedSpa in Manhattan is a medical facility, at least in the traditional sense. In the waiting area, called the Tranquillity Room, a waterfall cascades down one wall. A client may have a pedicure or facial before entering a softly lighted space where a plastic surgeon performs laser Fraxel treatment or some other minimally invasive procedure that would cost twice as much in a harried doctor’s office.

TriBeCa MedSpa is one of 1,800 medical spas in the United States, hybrid facilities that offer treatments like laser hair removal and liposuction alongside massages and other traditional spa fare. In recent years, the business has become a growth industry: from July 2007 to December 2008, the number of medical spas increased 85 percent, according to the International Spa Association, far outpacing the growth of day, destination and resort spas.

The kinds of procedures performed in medical spas has also increased. At the Park Avenue Medical Spa in Armonk, N.Y., for instance, clients who have undergone chemosurgery for skin cancer, which may leave the skin pitted, can receive reconstructive surgery, a treatment that falls outside the strictly aesthetic category and may point in the direction the industry is evolving.

“It certainly seems like the wave of the future,” said Dr. Gerald Ginsberg, a cosmetic surgeon and medical director of the TriBeCa MedSpa, who noted that, increasingly, patients are becoming “customers” searching for the best deal in what he calls “today’s medical emporia.” All the more reason, in his mind, that it is important to enforce regulations “to ensure we’re offering the best care for the best price.”

In fact, despite the many well-regarded facilities like TriBeCa MedSpa, the rapidly growing industry is coming under increased scrutiny. Proposed legislation to tighten controls over the credentials of those who can own a medical spa; what procedures can be performed in such places; and how much training someone must have to perform particular procedures is making its way through several state medical boards, including those in Massachusetts, New York, Utah and Florida, where the death last month of a patient, Rohie Kah-Orukotan, is generating renewed concern.

On Sept. 25, Mrs. Kah-Orukotan, a 37-year-old nurse, entered the Weston MedSpa in Weston, Fla., for a minimally invasive liposuction procedure to remove fat from her abdomen and thighs. During the treatment, she suffered seizures and never regained consciousness.

Michael Freedland, the family’s lawyer, said she was given Lidocaine and propofol, a drug that induces sedation and is believed to have contributed to the death of Michael Jackson.

The case, which is still under investigation, raises several issues that concern experts around the country. First, should the treatment — which may actually have been, by the state’s classification, a more advanced, or Level II, liposuction procedure — have been performed at Weston MedSpa, which is licensed as an electrolysis facility, not a medical facility?

“We believe Mrs. Kah-Orukotan received more than a minimally invasive Level I liposuction procedure in a setting that was inappropriate,” Mr. Freedland said. In fact, a new rule before the state’s board of medicine would not allow any surgical procedure that requires sedation to occur outside of a registered Level II surgery facility.

And then there is the question of the experience of the doctor who performed the procedure on Mrs. Kah-Orukotan. Dr. Omar Brito Marin, a medical doctor with a specialty in occupational medicine, learned liposuction in a three-day intensive course, according to his lawyer, Brian Bieber, who said he believes no malpractice was committed in the case.

For some industry observers, the issue of training and experience is the cause for perhaps the greatest concern. Dr. Darrick Antell, a plastic surgeon in Manhattan, noted that all too frequently someone who starts out performing one procedure migrates to another with only minimal experience. “Someone may start out doing laser hair removal, and next thing you know they’re doing treatments for cellulite,” said Dr. Antell, who said that personnel in medical spas are pushing the boundaries of what is allowed.

Wendy Lewis, an aesthetic surgery consultant and author of “Plastic Makes Perfect,” said: “The incident in Florida is nothing short of tragic, and I feel for that woman’s children and family. But I say, buyer beware.”
Such sentiment applies to another popular medical spa procedure: laser hair removal. For years, complaints of second- and even third-degree burns from laser hair removal procedures have been reported. Yet in places like New York State, it is still not considered a medical procedure, despite vigorous protests from many in the medical community.

“In New York, legally, even a barber could do it, not that he would,” said Dr. David Goldberg, a cosmetic dermatologist in New Jersey, New York and Florida, as well as a law professor at Fordham University and a legal counsel to the Medical Spa Society.

In Massachusetts a medical spa task force has been set up to advise the state legislature on how best to regulate the facilities. “We are trying to set some standards here, yet make it flexible enough to accommodate rapid changes in the industry,” said Russell Aims, chief of staff of the Massachusetts Board of Registration in Medicine.

“We don’t want to say to the consumer, ‘Don’t go get these procedures done,’ or to a physician that he or she can’t profit from this potentially lucrative business, but I think it’s around the time I saw a place offering walk-in Botox shots at a mall that I became concerned,” Mr. Aims said.

“To me it’s a lot like the mortgage industry,” said Dr. Ranella Hirsch, a dermatologist in Cambridge, Mass., and an advocate for more stringent regulations of medical spas. “While it may allow more accessibility to treatments and procedures, it’s also brought a much higher level of permanent injury,” she said. Dr. Hirsch added that she thinks a system of federal regulations of medical spas would be more cohesive than the current state-by-state model but believes that is unlikely to happen, since medical and other professional boards, like nursing, electrology and aestheticians boards, are regulated and licensed by individual states.

“What is likelier to happen (and currently under way) is that national organizations like the American Society for Dermatologic Surgery, which represents member dermatologists nationwide, provide guidelines for legislative guidance state by state,” she said in an e-mail message.

Despite all the safety and regulatory controversies concerning medical spas, there are thousands of satisfied medical spa customers. Among them is Gail Fox of Palm Beach Gardens, Fla., who went to the Anushka Cosmedical Center Spa and Salon in West Palm Beach, for facial fillers that were administered by a nurse practitioner and found the experience “a pleasure.” “The service was on sale so the price was right. That’s what drew me in. The pace was slower than at my dermatologist’s office. All my questions were answered, and I didn’t feel pressured,” Ms. Fox said.

“These places can offer a wonderful opportunity for a consumer to reduce stress and get treatment for the whole body,” said Lynne McNees, president of the International Spa Association. But, she added, “just because someone is in a white coat, it doesn’t mean he or she is a qualified to perform a procedure on you.”

Both Ms. McNees and Hannelore Leavy, executive director of the International Medical Spa Association, emphasized the efforts their associations are making to educate the medical spa consumer. For instance, Ms. Leavy’s organization has a section on its Web site that pertains to current legislation affecting medical spas.

“If someone is cutting you open or injecting something into you it’s not a spa service, it’s a medical one,” Ms. McNees said. “You’re going to need to know who is performing that procedure, know their credentials and accreditations and really do your homework,” she said. “I tell everyone, ‘If you don’t know, don’t go.’ ”

The Alternative Medicine Cabinet: Arnica for Pain Relief By Anahad O'Connor

2009-09-17T12:52:00.001-04:00

What alternative remedies belong in your home medicine cabinet?

More than a third of American adults use some form of complementary or alternative medicine, according to a recent government report. Natural remedies have an obvious appeal, but how do you know which ones to choose and whether the claims are backed by science? Today, New York Times “Really?” columnist Anahad O’Connor begins a weekly series exploring the claims and the science behind alternative remedies that you may want to consider for your family medicine cabinet.

The Remedy: Arnica

The Claim: It relieves pain.

The Science: Arnica Montana, a plant native to mountainous areas of Europe and North America, has been used for centuries to treat a variety of pain. Athletes rub it on muscles to soothe soreness and strains, and arthritis sufferers rub it on joints to reduce pain and swelling. It’s believed that the plant contains derivatives of thymol, which seems to have anti-inflammatory effects.

Either way, scientists have found good evidence that it works. One randomized study published in 2007 looked at 204 people with osteoarthritis in their hands and found that an arnica gel preparation worked just as well as daily ibuprofen, and with minimal side effects. Another study of 79 people with arthritis of the knee found that when patients used arnica gel twice daily for three to six weeks, they experienced significant reductions in pain and stiffness and had improved function. Only one person experienced an allergic reaction.

The Risks: Arnica gels or creams can cause allergic reactions in some people, but it is generally safe when used topically. However, it should never be rubbed on broken or damaged skin, and it should only be ingested when in a heavily diluted, homeopathic form

New York nips facelift firm for astroturfing

2009-07-20T13:37:00.002-04:00

But they're still grinning...

By Austin Modine

Posted in Music and Media, 15th July 2009 18:35 GMT

A facelift firm is being slapped with a $300,000 fine by New York state for flooding the internet with fake positive reviews about itself.

State Attorney General Andrew Cuomo said the case is believed to be the first in the US to punish so-called "astroturf" marketing.

Under a settlement deal announced Tuesday, the cosmetic surgery outfit Lifestyle Lift agreed to cut out publishing anonymous positive reviews about the company on internet message boards and websites and pay the state $300,000 in penalties.

Lifestyle Lift, which mostly targets consumers though infomercials as a "minor one-hour" facial firming procedure, has a history of aggressively guarding its reputation online. The company has filed several lawsuits alleging trademark violations against websites that publish negative reviews or comments about the company.

Cuomo's office alleges Lifestyle Lift's president decided negative internet postings were causing a significant loss of face and ordered his employees to pose as satisfied customers on various internet message boards and websites. Internal emails discovered in the investigation show specific marching orders to engage in the illegal activity:

"Friday is going to be a slow day - I need you to devote the day to doing more postings on the web as a satisfied client," one email to employees read.

"Put your wig and skirt on and tell them about the great experience you had," stated another.

Lifestyle Lift also created stand-alone websites and blogs made to appear as if they were created by independent, satisfied customers.

"I decided to create this website because I wanted to share my story with others," one such website stated. "After my first consultation, I went online and read horror stories about Lifestyle Lift. People were trashing Lifestyle Lift, their employees, their doctors, etc...I got scared and seriously thought about canceling my procedure. I was getting cold feet. What was with all the negative posts online? Those negative stories did not ad up at at...

"I realized quickly that most of that stuff was probably made up: the reviews were using long medical terms that only a doctor would use..." it continued. "I also talked to my doctor about it.... He told me that many of the negative stories I was reading online were probably from envious doctors and just made up because he never heard any of this from his patients."

According to the settlement, Lifestyle Lift employees will no longer pose as customers on the internet. The company also agreed not to promote its services without disclosing they are responsible for the content

A Face From an Infomercial

2009-06-04T11:34:00.003-04:00

By CATHERINE SAINT LOUIS
Published: June 3, 2009

IT used to be that a cosmetic surgery patient who was tired of sagging jowls would discreetly ask for names of reputable doctors who did face-lifts. A surgeon, building a practice as word of mouth about his skills spread, became, in effect, his own brand.

But now face-lifts themselves are being branded. Certain minimally invasive procedures are marketed directly to patients in a one-size-fits-most approach. Patients pick an operation — usually after seeing it touted online, on TV or in magazines — and are referred by a national organization to a doctor.

Two procedures sold this way are the Lifestyle Lift, which an ad in Family Circle describes as “revolutionary” and a way to “remove wrinkles, frown lines and sagging skin” in about an hour; and the QuickLift, which also benefits from nationwide marketing that promotes a short recovery and only local anesthesia.

Because these procedures, priced at $4,000 and $5,900, contrast with more extensive face-lifts requiring general anesthesia and usually costing more, they have become popular: More than 100,000 patients have received the Lifestyle Lift alone since 2001, according to the company.

But some surgeons think branded face-lifts are problematic. It is not the procedures themselves that disturb critics — many plastic surgeons and otolaryngologists (head and neck surgeons) offer their own quick-recovery face-lifts. But some doctors are concerned that patients may be so persuaded by advertising that they don’t seek a second opinion or investigate the full range of options. Consumers may pick a minimally invasive procedure when the results they seek may require more complex — and expensive — intervention.

“What’s new is this is plastic surgery being marketed to the public as a widget,” said Dr. Brian Reagan, a plastic surgeon in San Diego. “People are buying, so buyer beware.”

In this new landscape, patients are encouraged to seek an advertised procedure rather than work with a surgeon to select from a menu of options. What’s more, some patients are now “looking not for the best doctor, but the one who has the magic wand,” said Dr. Reagan, who has given a lecture titled “Invasion of the Mini-Lifts ... Coming to a Clinic Near You.”

Dr. David M. Kent, an osteopath and facial plastic surgeon who founded Lifestyle Lift, said he employs nearly 100 doctors in 31 offices who are trained to do Lifestyle Lifts. (The company also has 10 doctors in private practice who license its brand.) “Every single patient gets the same basic face-lift,” he said, explaining that it consists of lifting underlying layers of muscle and connective tissue, and trimming skin. Patients also receive custom nips and tucks as needed.

The QuickLift, which roughly 10,000 patients have had since 2003, is sold differently. Doctors who offer it maintain their own practices and might also offer traditional face-lifts. A company, MDCommunications, helps those physicians market the QuickLift by placing television spots and optimizing how fast a doctor is found online.

Dr. Dominic A. Brandy, the developer of the QuickLift, coined the term to describe his adaptation of an S-lift, an operation that uses teardrop-shaped sutures to suspend sagging features. Dr. Brandy said he improved on the S-lift by pulling the face vertically instead of toward the ears.

Currently, 25 to 30 doctors receive patients through QuickLiftMd.com. The doctors attended a one-day workshop priced at $1,950 (and sometimes a few other days of training) taught by Dr. Brandy, a cosmetic surgeon with a background in emergency medicine.

Teresa Bradley, 47, found her QuickLift surgeon on the company’s site. Even before meeting him, she had decided QuickLift was for her. “I researched the procedure,” she said. “It was excellent.” But she has agonized over the results. “He lifted one side very high and left the other side hanging,” she said.

Now Ms. Bradley said she realizes the QuickLift is only as good as the surgeon doing it.

In response, Dr. Brandy said, “When you teach somebody a procedure, even if they use the basic same procedure, skill levels are so different.”

The American Society of Plastic Surgeons hasn’t taken a stand on branded procedures. But its president, Dr. John W. Canady, advised, “Go get a second opinion from someone who doesn’t have a big ad.”

Patients should be presented with a range of options, said Dr. David S. Kung, a board-certified plastic surgeon in the Washington, D.C., area. He considers deeper-plane face-lifts “the gold standard,” because they “last the longest and they can effect the maximal change,” he said. But he sees a place for middle-of-the-spectrum face-lifts, which in his opinion, include the QuickLift, Lifestyle Lift and another (nonbranded) lift, the minimal access cranial suspension.

Dr. Kent said that before patients meet a Lifestyle Lift surgeon, they see a consultant and watch a video in which the company’s medical director explains its philosophy. Then they meet with a surgeon before deciding whether to proceed.

But three Lifestyle Lift patients and Dr. Mario S. Yco, a board-certified otolaryngologist who was an employee of the company for about a year, said that patients were urged to put down a deposit before they met with a surgeon.

“The consultant sold the surgery,” said Dr. Yco, who practices in Encinitas, Calif. Often by the time he saw patients, the surgery was booked. “There were many patients I had to cancel,” he said, explaining that he didn’t deem them appropriate candidates.

In response, Dr. Kent said, “It’s never a consultant that decides whether or not a patient should have surgery.” He described the company’s consultants as “people-friendly people.” They make sure patients “understand what they are getting into, explain the things we offer, talk about the doctor,” he said.

Dr. Yco said he was amazed at the power that advertising had over Lifestyle Lift patients. “They are sold by the concept, they are not sold by the surgeon’s credentials,” he said. “Unfortunately if they are not satisfied, it’s a big drop for them.” He added, “It’s like lemmings going down a cliff.”

In May, on the job site Monster.com, the Manhattan branch of Lifestyle Lift ran an ad seeking applicants to be plastic surgery consultants. “No medical experience needed,” it said, adding that the right candidate would have an “ability to match the offerings of Lifestyle Lift with the desires of Clients.”

Sharron Bryant, a manager for Lindt Chocolates in Dallas, who got a Lifestyle Lift in 2007, said she had a “high pressure” consultation and put down a deposit before meeting a surgeon. Ms. Bryant, then 59, paid $6,100 for a Lifestyle Lift and chin liposuction. She never needed pain medication during her weeklong recovery, she said.

But she disliked the loose skin that remained on her jowls and neck. “I got nothing for the money,” she said. She later paid $8,200 for a traditional face-lift from a different surgeon.

With “every plastic surgery procedure, there’s a certain number of people afterwards that are unhappy,” Dr. Kent said. “There’s nothing wrong with them medically. They are just dissatisfied.”

On Realself.com, a Web site where patients discuss cosmetic surgery, 37 percent of the 170 people who reviewed the Lifestyle Lift said the procedure was “worth it,” while 63 percent didn’t think so.

Leigh Floyd, 46, a technical writer in Houston, is an “extremely satisfied” customer of Lifestyle Lift, which she partly attributed to her realistic expectations. “You won’t look 20” afterward, she said, “because it’s still your 40-year-old skin.”

But she was most impressed by the skill of her surgeon, Dr. Kevin R. Smith, a Houston otolaryngologist. “His sutures were so tiny,” she said. “I just know I picked the right doctor.”

Here’s some advice for those considering face-lifts.

•

Check whether your surgeon is certified by one of the boards of the American Board of Medical Specialties at abms.org. They require physicians to complete residency training in a specialty and to pass rigorous oral and written exams.

•

Before you schedule an operation, meet the surgeon to make sure you’re on the same page. “The best surgeons will give you their honest opinion whether they can achieve what you’re looking for,” said Dr. John W. Canady, the president of the American Society of Plastic Surgeons.

•

Don’t settle for a hasty consultation. The downside as well as the upside of an operation should be covered, said Dr. Robert Singer, a plastic surgeon in La Jolla, Calif.

•

You should never feel as if you’re being sold a procedure. “If you’re getting a high-pressure sales pitch for a procedure, personally that would worry me,” Dr. Canady said.

•

It never hurts to get a second opinion.

What to Know Before Going Under the Liposuction Knife

2009-05-07T10:30:00.003-04:00

By RHONDA RUNDLE

From a swank office on Beverly Hills' Rodeo Drive, Craig Alan Bittner built a busy cosmetic-surgery practice that specialized in a procedure he called liposculpture.

He spread the word through magazine ads in which he referred to himself as Dr. Lipo 90210. He sent out mailings showing before-and-after pictures of women's love handles, thighs and abdomens. Though he touted liposculpture as "an advanced technique," the procedure is essentially a marketing term for common liposuction surgery, medical experts say.

Body Sculpting

What to do before going for liposuction:

Learn about liposuction and find surgeons at asds.net and plasticsurgery.org.
Check if a doctor is certified in plastic surgery or dermatology at abms.org.
Ask how a doctor would handle a medical emergency.

Then, in December, Dr. Bittner, who is in his early 40s, shuttered his Beverly Hills Liposculpture practice. The California Medical Board is looking into patient claims that Dr. Bittner allegedly allowed unlicensed office staff to perform cosmetic surgery. Investigators from the board's enforcement arm executed a criminal search warrant of his offices in Beverly Hills and Irvine, Calif., and his Santa Monica residence in November. The warrant, signed by a state superior court judge, sought information concerning at least 15 of Dr. Bittner's patients, whose names were listed on the warrant; employment records for office staff; and "evidence tending to show the unlicensed practice of medicine."

No charges have been filed against Dr. Bittner, and it remains unclear whether he engaged in any wrongdoing pending the outcome of the California board's inquiry. "Investigations are not public record," said Candis Cohen, a board spokeswoman.

Dr. Bittner's current whereabouts couldn't be confirmed. In a farewell letter to patients left on his Web site, he wrote that he was relocating to South America to do volunteer work with a small clinic "where I can help those most in need." In a telephone interview last month, Dr. Bittner denied any wrongdoing and said he "retired" because he wasn't enjoying his work anymore. He didn't say where he was calling from, and the line went dead midconversation.

Dr. Bittner claimed that what prompted the board's scrutiny of him was an unusual element of his practice -- using his patients' harvested fat to fuel his car. Dr. Bittner publicized this unorthodox use of body fat on a now-defunct Web site, lipodiesel.org.

The field of cosmetic surgery is rife with inflated promotional claims and malpractice suits. Still, the controversy over this high-profile practitioner of liposuction, the most common form of cosmetic surgery, spotlights some lessons for patients in how to pick a doctor in this popular field.

Dr. Craig Alan Bittner promoted "liposculpture" in ads until closing his practice.

Plastic surgery has for years attracted doctors from unrelated specialties who are able to acquire a minimum level of training in cosmetic medicine by attending courses for brief periods, medical experts say. Liposuction surgeons may end up competing for patients mainly on the basis of aggressive marketing and advertising claims that tell consumers little about their medical qualifications. Fully trained plastic surgeons and dermatologists frequently complain about having to compete with newcomers who have little experience in the field.

State records show that Dr. Bittner graduated from the Johns Hopkins University School of Medicine in 1993. He is a licensed doctor with board certification in interventional radiology, a field unrelated to cosmetic medicine. In the telephone interview, he said his liposuction training came from a two-month apprenticeship with a dermatologist in South Florida, who he said is now deceased. He also said he trained with surgeons in Europe and attended programs at meetings of the American Academy of Dermatology.

Consumers seeking cosmetic surgery are able to check a doctor's credentials by going online. Details about a physician's board certification can be found at the American Board of Medical Specialties Web site (abms.org). Medical experts generally recommend choosing someone who is board certified either in plastic surgery or dermatology and has performed large numbers of liposuction surgeries. Patients also should check with a state medical agency Web site to see if any action has been taken against a physician's license.

John Canady, professor of plastic surgery at the University of Iowa and president of the American Society of Plastic Surgeons, said patients should question a surgeon about plans for handling a medical emergency. He says prospective patients should ask what the doctor's procedure is for handling events such as a heart attack during surgery, or an infection which could develop later. If doctors seem to be "dancing around" answering questions about their credentials, training or emergency procedures, "I would start to feel very uncomfortable," Dr. Canady said.

There were 456,828 liposuction procedures performed in 2007, the latest data available, an increase of 13% from a year earlier, according to the American Society for Aesthetic Plastic Surgery. To perform liposuction, a practitioner must be a doctor, but isn't required to have any special licensing or certification. In many states, a licensed physician assistant can participate in the surgery, but only under a doctor's supervision.

Cosmetic surgeons say they are seeing fewer patients because of the recession. Still, magazines, newspapers and the Internet continue to be full of ads for liposuction, many offering steep discounts.

One liposuction patient drawn by Dr. Bittner's marketing was Kelli Michael, a 35-year-old nutritional-products salesperson in Southern California. Ms. Michael said she contacted Dr. Bittner two years ago after doing an online search. "Every time I put in anything that had to do with liposuction, his name was the first to pop up," she said. "He was on Rodeo Drive, so you would think he would be good," she added.

Ms. Michael said she complained to Dr. Bittner repeatedly about the results of her surgery, which she claims left her with uneven scar tissue "as hard as a rock" above her belly button. She said Dr. Bittner dismissed her complaints. Ms. Michael said she told a medical board investigator late last year that Dr. Bittner appeared only at the end of her surgery and that most of it was performed by "a man and a woman, taking turns." She didn't recall their full names.

Ms. Michael was among the patients whose names were listed on the search warrant seeking records from Dr. Bittner's practice.

Other patients have filed malpractice suits against Dr. Bittner, claiming that he allowed unlicensed staff in his office to perform parts of their operations.

Benjamin Gluck, a Los Angeles criminal attorney representing Dr. Bittner and his practice, denied any wrongdoing by anyone in Dr. Bittner's office. "No criminal charges have been filed against him," Mr. Gluck said, adding, "We are litigating the search warrant and the manner in which it was executed." He said the investigators improperly took legal files and correspondence with attorneys.

"We believe the evidence supports our actions," said Ms. Cohen, the medical board spokeswoman, in response to Mr. Gluck's challenge of the search warrant.

Dr. Bittner said he faces four malpractice suits. "It's not surprising that after 7,000 cases, there are four lawsuits, especially in a bad economy," he said in the telephone interview. As for the criminal probe, he said that certain parts of the surgeries done at his Beverly Hills practice were lawfully performed by licensed physician assistants under his supervision. "On every single patient, I did the final work, the sculpting," Dr. Bittner said.

This isn't Dr. Bittner's first run-in with the California Medical Board. Before turning to liposuction, he operated a chain of radiology-imaging shops in California and other states. He offered magnetic resonance imaging, or MRI, that he claimed was better than mammography for detecting breast cancer. In 2003, the California board claimed this was false advertising in a civil suit it filed against him and the company he founded, HealthScan America Inc. The shops closed at about the same time. In 2004, a California state court ruled against the business and ordered it to pay $1 million in penalties. The court dismissed Dr. Bittner from the suit.

Dr. Bittner said in the telephone interview that his approach to preventive medicine using MRI to screen for breast cancer was "ahead of its time."

Annual mammograms are still the staple prescription for women at average risk of breast cancer. But the American Cancer Society in 2007 issued new guidelines recommending annual MRIs, in addition to mammograms, for women with certain genetic mutations tied to breast cancer and those whose family history signaled a significantly elevated lifetime danger of the disease, among other high-risk categories.

In promotional materials for his liposuction practice, Dr. Bittner identified himself as Alan Bittner, using his middle name. Earlier, in promotional materials for his radiology shops, he identified himself as Craig Bittner, using his first name.

Dr. Bittner defended his use of discarded body fat from his patients to fuel his car and said he received signed consents from patients who were told of the intended use. Still, "the medical board went ballistic" about this practice, he said.

Using medical waste obtained from liposuction as a biofuel "is not currently an approved alternative treatment technology," according to the California Department of Public Health. To seek approval, an individual would have to submit an application to the department for this alternative use. There is no record of Dr. Bittner filing such an application, a department spokesman said.

The practice spurred "death threats against me and my staff," Dr. Bittner said. "I thought it was a great thing to demonstrate to the world how many ways there are to solve the energy crisis."

Don’t Let Any Doctor Touch Your Skin…

2009-04-19T22:04:00.002-04:00

…until you read this. In search of a good deal, young women are getting laser hair removal from gynos and Botox from dentists—sometimes with disastrous results. Find out how to stay safe.

March 23, 2009

by Jessica Baumgardner

After saving up for months, Amy was ready to get laser treatments for acne scars on her chin. Then she saw an ad in a local paper for a doctor doing cosmetic work; the prices listed were very reasonable. “I did research and discovered he was board-certified in internal medicine, not dermatology, but I thought, Who cares?” recalls the West Coast resident. “His office was in a fancy zip code, when I met him he seemed competent, and he’d gone to a good school. So I gave myself a thirty-seventh-birthday present.” After two laser sessions, though, her skin was worse—not only did the scars on her chin appear unchanged, but three new ones had cropped up on her cheeks; they looked like red, angry cigarette burns.

Once, only dermatologists and plastic surgeons did in-office cosmetic procedures such as laser work, liposuction and lip plumping. But the booming aesthetic industry has attracted gynecologists, urologists and even oral surgeons who want a piece of this multibillion-dollar pie—and the results aren’t always beautiful.

Close to 60 percent of doctors surveyed by the American Society for Dermatologic Surgery (ASDS) have seen an increase in complications since 2005 from cosmetic work done by nonspecialist M.D.s as well as aestheticians and the like at medi-spas. Derms and plastic surgeons told Glamour about women left with second-degree burns on their pubic area after laser hair removal, lumpy lips from misguided collagen injections and droopy, over-Botoxed lids.

Women in their twenties and thirties are more at risk. Since non-derms often advertise discounted rates, “they tend to attract younger, cost-conscious patients,” notes Susan Van Dyke, M.D., a board-certified dermatologist in Paradise Valley, Arizona, who’s developed a name for herself fixing badly done cosmetic work. “They’re known as ‘derm pretenders,’” adds Kenneth Beer, M.D., a clinical instructor in dermatology at the University of Miami. “Some even list themselves in the phonebook as ‘dermatologists.’”

Statistics show that, despite the ailing economy, procedures like Botox and laser hair removal remain popular among women younger than 35. “Women still want these things,” says Dr. Van Dyke, “but now they want to find the lowest price possible. And that often means poor-quality work.”

Are so-called derm pretenders legal? In a word, yes. “Once medical students have gone through basic training and earned an M.D., they have the right to practice in whatever area of medicine they want to—but that doesn’t mean they are fully trained as specialists,” says Kevin B. Weiss, M.D., president of the American Board of Medical Specialties. Doctors who choose to specialize in one area, such as dermatology, undergo years of residency. And when new technologies crop up, they can take seminars to learn the techniques.

Non-derms who decide to offer cosmetic services may go to some of those same courses. Although laws vary by state about who can actually perform the procedures, sometimes it’s a free-for-all. “Here in Arizona,” says Dr. Van Dyke, “you could be a window washer, go take a class and start doing laser treatments.” That’s where dermatologists are said to have an edge: They typically know exactly how to treat skin complications that may arise.

The trend isn’t going away anytime soon. As insurance companies reduce payments to doctors for basic appointments, a lot of M.D.s say they need supplemental income. “When I was practicing family medicine, I was coming home at nine at night and still not making enough money to support my family,” says one doctor who now does Botox, wrinkle fillers and laser treatments at a California medi-spa. “So are there financial reasons for me to have gone into cosmetic dermatology? Absolutely. But I took many courses and practiced on friends and family before I performed on patients. And when I was on a learning curve, I’d be honest and tell them that I hadn’t done many of those procedures. And I have never had a complaint.”

Others in the medical field are also unconvinced certification in a specialty is critical. “Physicians add to their skill sets all the time with continuing education,” says Lori J. Heim, M.D., president of the American Academy of Family Physicians. “It’s not about who is doing what. The danger to patients comes from people who are not well-trained. It has less to do with what you’re board-certified in.”

Yet that remains a point of contention among top experts. “Board certification in a specialty is the only reliable measure of competence,” says Clarence Braddock III, M.D., associate dean at Stanford University School of Medicine. He also questions doctors who advertise doing cosmetic work: “Persuading patients to get procedures they don’t need raises ethical concerns.” Those ubiquitous WE OFFER LASER HAIR REMOVAL signs in ob-gyn offices can make women uncomfortable too. As Lily Hamburger, 23, a staffer at a nonprofit group in Washington, D.C., puts it, “I do not want to worry that my gynecologist is judging the way I look down there.”

With the economy in free fall, a number of reputable dermatologists are offering patients more value for their money. “Some have promotions, such as if you get your lips plumped up, the second syringe of filler may be less expensive,” says Dr. Van Dyke. But be wary of doctors who advertise rock-bottom prices or, worse, offer coupons. “I wish I hadn’t been so sold on price,” says Amy, who spent $5,000 to have a board-certified dermatologist fix her wreck of a laser job and still has to use cover-up. “You get what you pay for.”

A Cheap, Fast and Possibly Deadly Route to Beauty

2009-04-19T21:39:00.000-04:00

By ANEMONA HARTOCOLLIS and CHRISTINA DAVIDSON

Published: April 16, 2009

Like almost every woman, Fiordaliza Pichardo just wanted to look beautiful, so a few years ago, she began getting silicone injections from a woman she met through a friend in order to plump up her thighs and derriere.

Photograph provided by Mona Rivera of 1010 WINS

Fiordaliza Pichardo died a day after receiving a silicone injection.

She never expected to pay such a high price for her looks.

In March, a day after receiving an injection, Ms. Pichardo, 43, died of what the medical examiner later determined was a silicone embolism in her lungs.

The city’s health department fears that the illegal use of silicone as an alternative to cosmetic surgery is on the rise. The city’s poison control center has received three calls in the last 10 months from doctors who have treated patients injected with silicone; Ms. Pichardo’s case was not among them. In the previous two years, there were only two such cases.

Health department officials say there may be other cases that have gone unreported, since doctors are not legally obligated to report silicone poisoning or even death, and since silicone is hard to detect through X-rays or CT scans. The department was planning Thursday to send an advisory by e-mail and fax to thousands of doctors advising them to watch for silicone poisoning cases.

Nationally, reports of buttock enhancement using silicone and similar thick liquids have surfaced from the Northeast to Miami, and the Food and Drug Administration is also planning to issue a warning on the dangers of such practices, Siobhan DeLancey, a spokeswoman, said Thursday.

“This seems to be kind of an underground occurrence, so it’s difficult to get numbers of actual events and to know exactly what these people are being injected with,” Ms. DeLancey said. “It’s important to note that none of the products that are reportedly being used are approved for this purpose.”

Ms. DeLancey said silicone was not approved for injection into tissues at all, only for use in the eyes and in certain implants where it is contained and cannot leak into tissue. She said the F.D.A. had the ability to conduct criminal investigations, and would encourage victims to come forward “so that we can document the problem.”

Across the Internet, chat rooms, Web sites and blogs have sprung up discussing buttock injections.

The victims have become caught up in an underground beauty industry that uses injections of black-market, medical-grade silicone or industrial-grade silicone as a cheap, fast and easily accessible way to plump up breasts, buttocks, thighs and even wrinkles.

The injections are popular among Latina women and transgender women, who may be unable to afford conventional plastic surgery and who tap into it through unlicensed practitioners working through word of mouth, city officials said.

Although side effects are fairly rare, silicone can migrate through the bloodstream, creating potentially fatal clots in the lungs, as it did in Ms. Pichardo’s case, said Dr. Nathan M. Graber, director of environmental and occupational disease epidemiology for the New York City Department of Health and Mental Hygiene. It can also migrate through tissues, leading to ugly lumps and chronic pain.

The injections are administered at home, in motel rooms, in makeshift offices or at “pumping parties,” where the guests take turns injecting one another, officials said.

Young transgender women often seek out silicone injections because they are a quick way of making bodies more feminine, unlike hormone treatments, which may take years to work, said Dr. Nick Gorton, an emergency room doctor who treats transgender patients at the Lyon-Martin Health Services clinic in San Francisco.

“If you go to a pumping party, you can have it tonight,” Dr. Gorton said. “It’s a big temptation, especially among young people who, when you’re 20, you’re not thinking about your own mortality.”

People are often reluctant to report side effects, because they feel that they are turning in a member of their community, health officials said.

Industrial-grade silicone can be bought at a hardware store. But Dr. Graber said there have been reports of the use of substitutes like castor oil, mineral oil, petroleum jelly and even automobile transmission fluid.

Dr. Suhail Raoof, chief of pulmonary medicine at New York Methodist Hospital, treated a woman with silicone poisoning in 2007. She came in complaining of shortness of breath, chest pain and coughing, reminiscent of pneumonia, he said, and told doctors that she had been injected with about 500 milliliters of silicone in each buttock about half an hour earlier.

Because silicone is not visible on an X-ray or a CT scan, Dr. Raoof said, diagnosis is difficult without a biopsy. Doctors used deduction to diagnose the cause of the woman’s symptoms, and she survived, he said.

Ms. Pichardo was not so lucky.

Ms. Pichardo’s 19-year-old daughter, Marinés Rodriguez, said that her mother began getting silicone injections several years ago after a friend introduced her to a cosmetologist.

Ms. Rodriguez said the cosmetologist went to Ms. Pichardo’s home in the Bronx and to other clients in Manhattan and Miami. A cup of silicone cost $800, and the cosmetologist would inject half a cup to two cups in a single session, Ms. Rodriguez said. Her mother, she said, “didn’t really care about the price. It was more that she knew somebody who had this first.”

Ms. Pichardo came to trust the woman. “She felt that was her friend, nothing could go wrong,” Ms. Rodriguez said.

Ms. Pichardo was last injected on March 17, and died the next day. Doctors thought she had pneumonia, Ms. Rodriguez said, and the family never thought to mention the silicone injections — which were discovered during the autopsy — because they thought they were harmless.

The medical examiner has ruled her death a homicide because she was injected by an unlicensed nonmedical practitioner, said Ellen Borakove, a spokeswoman for the medical examiner. No charges have been filed. Paul J. Browne, a police spokesman, said, “We believe she has fled to the Dominican Republic and we are in discussions with the district attorney as to next steps.”

Ms. Rodriguez said the family was distraught, but found it hard to be angry. The day after her mother died, she said, the cosmetologist visited to pay her condolences. “We didn’t think she did it on purpose,” she said.

Botox Rival Faces Delay in FDA Marketing Approval

2009-04-14T11:51:00.001-04:00

By Catherine Larkin and Naomi Kresge

April 14 (Bloomberg) -- Competition for the Botox shot, America’s most popular cosmetic procedure, was delayed as U.S. drug regulators discuss labeling and a strategy for evaluating and mitigating risks of the new wrinkle smoother.

Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen said today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox. The delay should be a matter of weeks, according to brokerage Aurel BGC.

“We look forward to feedback from the FDA in the near term,” David Schilansky, Ipsen’s investor relations officer, said in a telephone interview. Ipsen is in talks with the FDA about a risk-mitigation plan for both aesthetic and medical use of the drug, he said.

Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Reloxin will be $160 million by 2012.

Nachman and other analysts have said they expected the FDA to delay Reloxin approval until later this year over questions about how the company plans to track use in order to minimize potential risks seen with other botulinum toxins. Yesterday was a deadline for the FDA to make a decision on Reloxin.

Medical Uses

In December, the agency delayed a decision on Dysport, Ipsen’s version of Reloxin for medical uses, to finish work on a risk-management program to ensure safe use.

Medicis, of Scottsdale, Arizona, has rights to sell Reloxin in the U.S. Approval would trigger a $75 million payment to Ipsen, which developed the drug.

U.S. regulators will decide before the end of May on the use of Dysport for medical conditions, according to a report today by brokerage Aurel BGC.

“The company indicated to us that there’s a strong probability that the FDA will give its response on the botulinum toxin for aesthetic uses once it’s reviewed the dossier for medical indications,” according to Aurel. “The decision of the FDA is thus pushed back some weeks.”

Fashionable Drug

Allergan, which got 32 percent of its revenue from Botox sales in the fourth quarter, is cutting 5 percent of its workforce this year to brace for the competition and lower demand for cosmetic procedures in the recession.

Almost 2.5 million Americans had Botox injections last year, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It quickly became fashionable among aging celebrities as a non-surgical way to appear younger.

Botox earned $1.31 billion for Allergan in 2008, split between cosmetic use and treatment of neurological disorders. Allergan estimates it has an 83 percent share of the global market for neurotoxins that paralyze certain muscles or nerves.

The FDA warned consumers in February 2008 that botulinum toxins may spread beyond the site of the injection and cause botulism, a potentially deadly muscle-weakening illness. The greatest risk was seen with high doses of the drug, used by some doctors to treat limb spasms caused by cerebral palsy, an approved use in many countries outside the U.S.

Galderma, a joint venture between Nestle SA and L’Oreal SA, has European marketing rights to a version of Dysport for aesthetic uses, called Azzalure. Medicis bought rights in 2006 to develop and sell the drug for those purposes in the U.S., Canada and Japan.

Solstice Neurosciences Inc., a closely held company in Malvern, Pennsylvania, sells a botulinum toxin called Myobloc in the U.S. for cervical dystonia, a disorder that causes the head to become twisted to one side

So Botox Isn’t Just Skin Deep

2009-04-13T11:45:00.002-04:00

Michael Falco for The New York Times

Botox is used by Dr. Andrew Blitzer to treat vocal cord problems; he injects it into the larynx.

By NATASHA SINGER

Published: April 11, 2009

Dr. Andrew Blitzer, the director of the Center for Voice and Swallowing Disorders at St. Luke’s-Roosevelt Hospital Center in Manhattan, has an antidote for speech impediments caused by vocal cord problems: he injects Botox into the larynx. DR. MARK STILLMAN, the director of the Center for Headache and Pain at the Cleveland Clinic, has a treatment for people with frequent migraines: he injects Botox around the head and neck. Dr. Fredric Brandt, a dermatologist in Manhattan and Coral Gables, Fla., has a novel procedure for oily skin and skin redness.
You guessed it: Botox.
Over the last decade, Botox has become a synonym for the eradication of wrinkles, a kind of shorthand for the entire enterprise of cosmetic medicine. But now, with the popularization of new medical uses, therapeutic applications of the drug are poised to outstrip the cosmetic treatment in both revenue and prominence.

In the hunt to discover the next blockbuster medical use for Botox, doctors have injected it experimentally into muscles and glands all over the body, making it medicine’s answer to duct tape. According to recent medical journals, physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs.

“We see it as a molecule that keeps on giving. As we understand it more, it gives us new ideas of how to use it,” says Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker.

No other therapeutic agent “has so many demonstrated uses,” he says.

But some health advocates worry that doctors are widely adopting novel uses for Botox before federal guidance and rigorous clinical studies have established safe and effective dosages for the new treatments.

“It’s trial and error with a nerve poison,” says Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group. Last year, the group petitioned the Food and Drug Administration to require a warning label for injectable toxins.

BOTOX is a purified form of botulinum toxin, a nerve poison produced by the bacteria that cause botulism, a disease that paralyzes muscles and can be fatal. Injections of Botox act like minuscule poison darts that temporarily blunt chemical nerve signals to certain muscles or glands, reducing their activity.

The F.D.A. has approved Botox to treat four problems: eye muscle disorders, neck muscle disorders, excessive sweating — and that deadly age giveaway, eyebrow furrows. But Allergan, a $14.5 billion specialty pharmaceutical company, owns or has applied for patents on more than 90 uses for the drug.

Dr. Brin of Allergan says Botox has a long safety track record — backed by 30 years of favorable research, studies on 11,000 people worldwide and 17 million treatments in the United States since 1994.

“That safety profile has enabled us to continue to explore the product in deeper parts of the body and in more novel areas,” Dr. Brin says. Allergan does not promote unapproved uses of the drug, he says.

Botox was developed in the 1970s by Dr. Alan Scott, an ophthalmologist in San Francisco who was searching for a cure for crossed eyes. He theorized that minute doses of a nerve poison used to weaken the muscles that pull crossed eyes inward could treat the malady, and he experimented with a variety of paralytic agents.

Then a biochemist who had isolated and purified a strain of botulinum toxin for potential military use as a biological weapon sent Dr. Scott a sample. It worked.

Dr. Scott named the new drug Oculinum. In 1989, the F.D.A. approved it to treat crossed eyes and twitching eyelids. Allergan bought Oculinum in 1991 for about $9 million, rebranding it Botox. When David E. I. Pyott became chief executive of the company in 1998, Botox had $90 million in annual sales. Last year, sales topped $1 billion.

“Nobody at Allergan understood how big a gold mine they were sitting on,” Mr. Pyott says.

Drug companies often rely on multiple products to fill their pipelines. But at Allergan, Botox became a virtual pipeline in and of itself after the arrival of Mr. Pyott, who recognized that it was a medication that could be serially reincarnated for other applications.

Doctors, who are permitted to use approved drugs in unapproved ways as they deem appropriate, were already using Botox off-label at the time on body parts other than eye muscles. Some physicians reported that patients had unexpected side effects — fewer headaches, for example, or smoother skin — after they had Botox.

Mr. Pyott invested heavily in expanding in-house research and encouraged doctors to formalize their anecdotal observations with published research. He also recognized that some Americans would be willing to pay handsomely for injections that tempered wrinkles. To prove the efficacy of the drug, the company sponsored clinical trials to use Botox for cosmetic medical purposes and for other muscle disorders.

Over the last nine years, the F.D.A. has approved Botox to treat neck muscle spasms and to hinder excessive sweating. The agency also approved the same drug, under the name Botox Cosmetic, to smooth forehead wrinkles.

Last year, Botox had worldwide sales of $1.3 billion, divided about equally between cosmetic and medical uses. Among botulinum toxins, Botox has an 83 percent share of the market, Allergan said.

But, with competing toxins set to enter the American market, Allergan has positioned Botox for other medical uses. Mr. Pyott says he expects therapeutic sales of the drug to soon eclipse sales of Botox Cosmetic.

Health insurers sometimes cover medical uses of Botox; a treatment for a clenched jaw might cost $1,000 every three months, for example. But for cosmetic treatments, which dipped slightly at the end of last year, consumers must pay cash.

“The therapeutic will end up being bigger than the cosmetic even if the economy recovers because there are some big unmet medical needs there,” Mr. Pyott says.

In the next few months, the company is expecting federal approval to market the drug for stroke victims suffering from limb tightness or spasms.

Later this year, Allergan plans to seek approval to market the drug for chronic migraine headaches, Mr. Pyott said. He also said the company eventually plans to seek F.D.A. approval to market Botox for benign enlarged prostate.

But many doctors are not waiting for federal sanction to inject Botox for these and other disorders. While Allergan doesn’t break down Botox sales, Gary Nachman, an analyst at Leerink Swann, an investment bank, estimates that perhaps as much as half of Botox sales already come from off-label uses.

Enlarge This Image

Michael Falco for The New York Times

Dr. Blitzer also uses the drug to treat severe jaw muscle pain.

Michael Falco for The New York Times

Allergan, Botox’s maker, owns or has applied for patents on more than 90 uses for it.

“It’s the magic bullet,” says Mr. Nachman.

BOTOX is so widely adopted in medicine — and ingrained in popular culture — that some doctors don’t think that novel uses are experiments.

Several years ago, Dr. Kamran Jafri, a facial surgeon in Manhattan, started injecting Botox just under the skin of the face, a technique that he says reduces pore size, blotchiness and oily skin.

“Dosing is by trial and error,” Dr. Jafri says. “I don’t think it’s experimental because it’s a treatment I’ve been doing a lot and it’s been working.”

Such ad hoc uses of Botox are perfectly legal for doctors. But some medical professionals are concerned that doctors are experimenting with and adopting Botox therapy before clinical trials and government approval have established safe doses for new indications — and without definitive proof that the new treatments work.

While life-threatening complications following use of Botox and other botulinum toxins are rare, a few people have died after they were treated. In some cases, the toxin has spread from the injection site, causing serious swallowing and breathing problems. For example, several children with cerebral palsy died after receiving large doses in their limbs.

“It is possible to over-inject. This is a poison,” says Dr. Frederick Burgess, the chief of anesthesia at the V.A. Medical Center in Providence, R.I. “Things can go wrong. It is rare, but it happens.”

Last year, Public Citizen petitioned the F.D.A., asking for a stronger warning on botulinum toxins that would emphasize the risk of diffusion from the injection site and the need for patients to seek immediate medical care for swallowing or breathing difficulties. The Canadian health authority instituted such a labeling change earlier this year.

Mr. Pyott of Allergan says that there have been a few serious problems following Botox injections — but not necessarily directly caused by the drug. Some patients had serious illnesses prior to treatment, he said.

“Physicians have experimented with higher and higher doses,” Mr. Pyott says. “Like any drug, if you take too much, you can have side effects.”

The F.D.A is reviewing the safety of botulinum toxins, according to an agency press release. Last year, the agency also postponed approval of a new toxin called Dysport for use in neck muscle problems. The F.D.A. asked the manufacturer to first develop a plan for communicating the risk of the drug to doctors and patients.

On Monday, the F.D.A. is due to issue a decision on the cosmetic version of Dysport, called Reloxin.

Johnson & Johnson is also developing an anti-wrinkle injection called PureTox.

But industry analysts predicted that the F.D.A. would postpone approving any new botulinum toxins until regulators have finalized a stronger warning label for all of the brands.

WHEN Mr. Pyott arrived at Allergan, it specialized in eye-care pharmaceuticals. Over the last decade, he has turned it into the house that Botox built, expanding credibility for the drug in various medical specialties by buying complementary businesses.

To solidify Allergan’s dominance in appearance medicine, for example, the company spent $3.2 billion in 2006 to acquire Inamed, a leading maker of skin-plumping injections and breast implants. In preparation for the planned introduction of Botox as a treatment for headaches, overactive bladder and enlarged prostates, the company has also established itself in neurology and urology by developing or marketing other specialty drugs, Mr. Pyott says.

The possibility of lucrative new uses for Botox has not gone unnoticed. After rumors of a possible merger with GlaxoSmithKline last month, Allergan stock rose almost 24 percent over the course of two days, to $48.95; it now trades at $47.47. Both companies declined to comment on merger rumors.

“This is a bad time to sell because they are not going to get rewarded for all of the wonderful stuff in the pipeline,” says Ronny Gal, an analyst at Sanford C. Bernstein. “I would stay independent for a couple of years.”

Mr. Gal says sales of Botox could double within the next five to seven years, provided that the F.D.A. approves new major medical uses. One million people or more might seek Botox injections for chronic headaches, while the audience for benign enlarged prostate would be “practically every man over the age of 75,” Mr. Gal says.

MR. PYOTT has a master plan, meanwhile, to expand the Botox franchise even further. The company is developing new iterations of the drug intended to treat specific targets, such as pain receptors, without weakening muscles.

Allergan also owns or has applied for patents on dozens of other uses for its toxin, a move to pre-empt competitors from marketing their products for expanded uses.

“I feel a little bit like I am sitting with a beautiful vessel inside the harbor but I forgot to give you the map to where our mines are,” Mr. Pyott says of the Botox patents that he said were filed in different countries. “There could be a big bang when you hit one of our patents.”

But Mr. Gal, the analyst, devoted his Christmas vacation to unearthing about 90 patent applications worldwide by Allergan. These included Botox for sinus headache, fibromyalgia pain, ulcers, inner ear disorders and uterine problems as well as appearance treatments like “buttock deformity.”

Nevertheless, there are still a few ailments that Botox does not claim to solve. Botox doesn’t work on stuttering, for example, because it involves too many parts of the anatomy — including the lips, the larynx and the tongue, says Dr. Brin of Allergan.

“Stuttering is too complicated,” Dr. Brin says a little wistfully. “It didn’t pan out.”

Surgeon studies benefits of scar-reducing tape

2009-04-13T11:41:00.001-04:00

Sunday, April 12, 2009

BY ABIGAIL LEICHMAN

NorthJersey.com

SPECIAL TO THE BERGEN RECORD

An Englewood Cliffs plastic surgeon is leading a study on an elasticized tape that may reduce or prevent raised scars.

Dr. Steve Fallek said he became intrigued by Kinesio Tex Tape — developed by a Chinese chiropractor in the 1970s — while watching the 2008 Olympic Games. Beach volleyball player Kerri Walsh had the tape fixed to her shoulder, reportedly to enhance circulation and to stabilize the muscles after surgery.

Fallek contacted the company and discovered that Tex Tape, widely used by physical therapists, also has been helpful in preventing and minimizing raised scars.

"There are anecdotal reports that people swear by it not only for muscle pain and recovery from surgery and injury, but also to prevent and minimize keloid scars," said Fallek, who also practices in Manhattan and writes about plastic surgery in magazines such as Us Weekly and Life and Style.

"So many products on the market claim to promote healing, but there are no scientific studies that any of these things work," he said. "I wanted to do a study to test this one out."

Fallek began the investigation early in March and is seeking additional participants ages 18 and over who have one of two types of thick, collagen-based scars: hypertrophic and keloid.

Hypertrophic scars are generally red and raised but do not grow beyond the boundaries of the original wound. Keloids, most common in African-Americans, keep growing indefinitely. "The body lays down scar tissue and doesn't turn off the healing process," explained Fallek.

Kinesio provided tutorials to Fallek on how to apply the tape, and it is supplying the product for the study at no cost. The applications are non-invasive, painless and free to study participants. "The only restriction is anyone who's sensitive to adhesives," he said.

A plastic surgeon's typical anti-scar arsenal consists of products ranging from sunscreen, Vitamin E, silicone gel sheeting and cocoa butter to steroid injections, laser surgery and massage. Fallek said he's often asked about advertised products such as Mederma, which is made of onion extract, but there is no scientific proof of its effectiveness.

"Everybody is interested in preventing and minimizing scars, and there's so much misinformation out there," he said. "I thought we could take this to a different level since nobody has scientifically studied this before."

To inquire about participating in the study, contact Fallek's North Jersey office at 201-541-4181 or info@fallekplasticsurgery.com.

An Englewood Cliffs plastic surgeon is leading a study on an elasticized tape that may reduce or prevent raised scars.

Fallek contacted the company and discovered that Tex Tape, widely used by physical therapists, also has been helpful in preventing and minimizing raised scars.

"So many products on the market claim to promote healing, but there are no scientific studies that any of these things work," he said. "I wanted to do a study to test this one out."

Fallek began the investigation early in March and is seeking additional participants ages 18 and over who have one of two types of thick, collagen-based scars: hypertrophic and keloid.

To inquire about participating in the study, contact Fallek's North Jersey office at 201-541-4181 or info@fallekplasticsurgery.com.

Heads Up, Botox

2009-04-02T14:12:00.002-04:00

Ron Heflin/Associated Press

By CATHERINE SAINT LOUIS

Published: April 1, 2009

IN the seven years since its approval for cosmetic use, Botox has succeeded in winning over the hearts and brows of many a desperate housewife — not to mention an age-defying politician or two. The wrinkle smoother has made billions for its maker, Allergan, and made it harder and harder to guess the age of news anchors. She could be 50; only her dermatologist really knows.

A NEW WRINKLE Will Reloxin, expected to be approved by the F.D.A. this year, be more effective or affordable?

But this blockbuster drug may soon face fierce competition if the Food and Drug Administration approves Reloxin, another injectable made from the botulinum toxin, which has had success temporarily smoothing wrinkles in other countries.

The buzz among doctors that has been spreading in the news media and on beauty-oriented Web sites like RealSelf.com is that Reloxin works more quickly and lasts longer than the roughly four months Botox does. Dr. Leslie Baumann, a University of Miami dermatologist who did some of the clinical trials for Botox and Reloxin, recently said on NBC’s “Today” show, “It’s time that we have something that lasts a little bit longer” than Botox.

But does the truth match the early expectations for Reloxin? Much is at stake for Medicis Pharmaceutical, the American drug company that has licensed the wrinkle smoother from its French maker, Ipsen, and has conducted the pivotal trials, which have been presented to the F.D.A. for approval. So far, studies have not proven definitively that either Botox or Dysport (as Reloxin is known in Europe and South America) has an edge in terms of how long it lasts or how quickly it takes effect.

“To be honest, if you just talk about aesthetics, there are no good comparative trials on Dysport and Botox,” said Dr. Berthold Rzany, an author of “Botulinum Toxin in Aesthetic Medicine” and the director of evidence-based medicine at Charité, the university hospital in Berlin, Germany.

Only small studies exist, Dr. Rzany said, adding that at least 300 participants would be needed to prove that one of the drugs lasts longer. Choosing a longer-lasting product would matter to consumers because both drugs are expensive. In England, a visit for Botox or Dysport costs roughly $250 to $430, said Dr. John Curran, the former president of the British Association of Cosmetic Doctors. (There is no information yet about how it might be priced in the United States.)

In the run-up to Reloxin’s possible approval by the F.D.A., several doctors in England, France, Germany and Brazil, who have injected both Botox and Dysport for cosmetic purposes, were interviewed to see what could be gleaned from their years of experience.

The resounding response is that one drug doesn’t necessarily keep the wrinkles at bay longer than the other. A skilled doctor can achieve similar results with either Botox or Dysport, the doctors agreed, but at least three doctors said that Dysport was less expensive for them to use.

Dosing is at the heart of much of the controversy about which wrinkle relaxer lasts longer, most of the foreign doctors said. A different amount of Dysport than Botox is needed to tame, say, frown lines or crow’s feet, but exactly how much is still a matter of debate. If approved, Reloxin will be deemed appropriate for the area between the eyebrows, but like Botox, doctors will likely inject it in other parts of the face as well.

“Educational efforts around appropriate utilization and dosing will be massive pending F.D.A. approval,” said Jonah Shacknai, the chief executive of Medicis.

But doctors in the United States will still face a learning curve, foreign doctors said. Going from Botox to Reloxin is akin to mastering a new language.

Dr. Doris Hexsel, a researcher and a dermatologist in private practice in Brazil, said that in 2004, three years after Dysport was approved there for cosmetic use, it took her a month to become familiar with the new drug after years of working with Botox. While she used a dosage that many other doctors found to be safe for the lower face, she was not entirely happy with the outcome.

“I gave to my patients stronger results than I would like,” said Dr. Hexsel, the author of medical books about botulinum toxins. She adjusted the dosage and, she said, “patients are happier with Dysport.” She added that she doesn’t wish to promote one drug over the other.

Some doctors say there is no grounds for asserting that one drug outlasts the other.

“If anyone out there is saying that Dysport is better than Botox, they are marketing,” Dr. Curran said. “They are both very good products. They do an excellent job medically and aesthetically. By altering the dilution you can get the same effect.”

Dr. Benjamin Ascher, a plastic surgeon in Paris who specializes in botulinum toxins, feels the same way. “Reloxin is a little bit stronger, which is not necessarily good or bad,” said Dr. Ascher, who has had research financed by Allergan and Ipsen. “When you have a product that works, it matters how much you put in the injection.”

Dr. Robin Stones, a medical director at Court House Clinics, which has seven outposts in England, uses both drugs. “There are certain situations when I may choose one or the other,” but not because of “patient preference,” Dr. Stones said. “Clients don’t tell me there’s any difference.”

By contrast, Dr. Nick Lowe, a dermatologist with patients in London and Santa Monica, Calif., thinks that Botox and Dysport work differently. He capitalizes on those differences and occasionally injects both drugs in a single visit to separate areas. If a patient has prominent crow’s feet around the eyes, “where you want a little more spread,” he said, he uses Dysport, which “definitely lasts a bit longer.”

Want to tame upper-lip lines? Botox, which he said doesn’t spread as much, is Dr. Lowe’s choice. (But for his own brow, Dr. Lowe, who used to consult for Allergan, prefers Dysport. “I get a slightly more natural look,” he explained, adding, “I don’t like that Dr. Spock look.”)

The F.D.A. will most likely update Medicis in mid-April, but most analysts expect a final decision on Reloxin later this year.

IF Reloxin is approved, an injector’s expertise will matter even more, doctors said. Dr. Seth Matarasso, a dermatologist in San Francisco who lectures about Botox, said he is still shocked that some doctors know little about facial anatomy, dilution procedures and complications. A new botulinum toxin, he said, is “a concern for the neophyte or someone who doesn’t inject a lot.”

Kate Lyra, an actress living in Rio de Janeiro and a patient of Dr. Hexsel’s, found an upside to Dysport. Five years ago, she said it tamed her slight frown lines and crow’s feet for about eight months, compared with five months with Botox.

“It definitely lasts much longer,” she said of Dysport. But, if the doctor lacks expertise, she said, you could be saddled with “a very odd expression” for longer.

At this point, it is unclear whether Reloxin will be less expensive than Botox for American doctors, and whether they will pass along savings to patients. Ultimately, the prospect of Reloxin injections lasting longer than Botox may make all the difference.

Consider a patient of Dr. Ascher’s who spoke on the condition that she not be named. Dr. Ascher had treated her frown lines and crow’s feet with Botox every four months, before switching to Dysport, which she said lasts five to six months.

“I am only going twice a year,” she said, “and only paying half.”

Dr. Fallek to study tape to prevent thickened scars

2009-03-06T15:04:00.000-05:00

A Quirky Athletic Tape Gets Its Olympic Moment

Beach volleyball champion Kerri Walsh wearing a new type of athletic tape. (Natacha Pisarenko/The Associated Press)

Watching Olympian Kerri Walsh compete in beach volleyball last week, many viewers were wondering the same thing: what is that black thing on her shoulder?

A tattoo? A bizarre fashion statement? No. Ms. Walsh was sporting a new type of athletic tape called Kinesio, touted by physical therapists as a better way to relieve pain and promote healing of injured muscles.

The appearance of Kinesio on the well-toned Ms. Walsh — she even wore it while meeting President Bush — has spurred international interest in the little-known brand. In black, pink, blue and beige, the tape has been spotted on a number of other Olympians, including the shoulder of U.S. water polo player Lauren Wenger and the elbows of Canadian Greco Roman wrestler Ari Taub. Members of Spain’s basketball team and Jamaica’s track team are wearing it.

Ms. Walsh and the other athletes don’t have endorsement deals with Kinesio USA; the company simply donated 50,000 rolls of the tape to 58 countries for use at the Olympic Games. But whether its appearance on the international athletic scene is a sign of its therapeutic benefit or just smart marketing remains to be seen.

Traditionally, white athletic tapes are wrapped around gauze to form a stiff bandage that immobilizes a joint or muscle. By comparison, the 100-percent cotton Kinesio tape is said to be modeled on the thickness and elasticity of real skin. The flexible tape is applied to the skin in specific patterns, depending on the injury, a technique designed to create support and guide injured muscles and joints without limiting the athlete’s range of motion.

“This tape moves with the body, so the biomechanics are still there,” said John Jarvis, director of Kinesio USA.

Both the tape and the new wrapping technique have spread mostly by word-of-mouth among athletes and trainers who swear by it. Cycling great Lance Armstrong reportedly dedicates a page to the tape in his latest book. Recently soccer superstar David Beckham traded jerseys after a game and was spotted with pink Kinesio tape on his back.

Some limited data suggest it may be effective. In July, the Journal of Orthopaedic & Sports Physical Therapy published a study of 42 people with shoulder injuries. Half of them were treated with Kinesio tape applied in a pattern designed to support the injured muscle. The other half were given a “sham” treatment in which two strips of tape were simply pressed across the arm. The study was conducted by physical therapists at Winn Army Community Hospital in Fort Stewart, Ga., who didn’t receive funding from the tape company. Notably, the study participants who received the real therapeutic tape treatment reported an immediate improvement in pain.

Last year, Research in Sports Medicine published a study from San Jose State University showing that in 30 healthy test subjects, use of the tape along the lower trunk area appeared to increase the range of motion.

Kinesio claims that in addition to supporting injured muscles and joints, the new taping method helps relieve pain by lifting the skin, allowing blood to flow more freely to the injured area. The tape is also widely used in pediatric physical therapy for muscle disorders like cerebral palsy.

Given Kinesio’s high profile at the Olympics, it seems likely that we will be seeing more and more of it. Mr. Jarvis said the tape already is used by many professional basketball, baseball and football teams. Before the Olympics, the company Web site received about 600 views a day. Since Ms. Walsh appeared with the spider-like Kinesio pattern on her shoulder, Web traffic has jumped to 345,000 views daily.

It’s Cold and Your Skin Is Suffering. So What Are You Doing to Moisturize?

2009-02-12T10:15:00.002-05:00

Gabriella Minotto

Arctic waters leave long distance swimmer Lynne Cox's skin feeling "freeze-dried." Cox has developed a daily and nightly regimen of moisturizers to keep her skin from suffering.

By CAMILLE SWEENEY

Published: February 4, 2009

IT’S been a challenging winter for people with dry skin. The country has been blasted with Arctic air, making this winter the coldest so far in a decade, according to Scott Stephens, a meteorologist with the National Oceanic and Atmospheric Administration National Climatic Data Center. With the cold comes low humidity — sometimes as low as 10 percent — along with moisture-stripping winds that can cause chapped, flaky skin.

“We’ve studied fish that live in Arctic waters, searching for a natural antifreeze in their skin,” said Dr. Tom Mammone, executive director of research and development at Clinique Worldwide. “A few years ago, we began to study the protein extensin, a natural antifreeze found in carrots, which prevents the carrots from developing ice crystals in the ground. We found, when we tested it, that it can work on human skin, too. So we added it to our product to help to prevent skin from changing temperature and from forming damaging crystals that can impair the barrier.”

Dr. Neil Sadick, a dermatologist in Manhattan, said, “Using a product that contains a plant glycoprotein mixture such as this can make a significant difference, helping to keep cells humidified and keep the skin protected against environmental assault, such as cold, dry air.”

Yet among the thousands of expensive moisturizers on the market, many skin care experts across the country recommend some half-dozen or so tried and true, inexpensive brands: Eucerin Dry Skin Therapy Plus Intensive Repair Body Crème ($8.99), Nivea Creme ($7.99) and Aveeno Skin Relief Moisturizing Lotion ($9.29).

“In this kind of weather, moisturizers that contain humectants and fats that help repair that outer layer of skin can be a good strong barrier against the elements,” Dr. Greenberg said. Petrolatum products — think Vaseline Petroleum Jelly or Aquaphor — can be ideal for specific spot treatments on the face, he said, including chapped lips or cheeks, and dry, cracked skin on hands and feet.

One of winter’s biggest conundrums is not the fluctuation of temperature, say dermatologists, but how to best mitigate it, which can seem counterintuitive. A hot shower or bath after a long, cold day may seem like the best way to hydrate the skin, but you’ll be doing your skin more harm than good.

“Hot water exposure is among the worst things for your skin this time of year,” said Dr. Barbara Reed, a dermatologist in Denver. “People splash their face with hot water, jump into a hot bath or stand under the steaming hot water of a shower, and their skin suffers and reacts.”

The cycle is vicious, she said: “The affected skin releases a chemical that makes it feel itchy. So people scrub harder. And, once they’re out of the water, that itchiness may cause them to rub their skin dry with a towel.”

This breaks down the skin barrier further and makes the skin even more susceptible to drying and chapping. Instead, dermatologists recommend using only lukewarm water in the wintertime and a gentle cleanser, followed by a daily moisturizer applied within three minutes of being out of the water to lock in the moisture.

“My rule is the drier the skin, the thicker the moisturizer,” Dr. Reed said. “And, even in the wintertime, especially a dry one like this, I recommend people moisturize daily with a sunscreen of an S.P.F. of 50 or above.”

But, she said, as with many skin issues, her advice is not always taken until it’s too late. People are so preoccupied with coping with the cold and the wind damaging their skin, she said, “a lot of them don’t realize how harmful the sun can be — even if it’s just beaming through your car window.”

FDA OKs 1st Eyelash Drug Latisse

2009-01-29T13:15:00.000-05:00

Latisse Promotes Longer, Darker, Thicker Lashes; Glaucoma Drug Inspired It

By Miranda Hitti
WebMD Health News

Dec. 26, 2008 -- The FDA has approved Latisse, the first drug to promote eyelash growth, according to Allergan, the company that makes Latisse.

Latisse, which will be available by prescription starting in the first quarter of 2009, contains the active ingredient of the glaucoma drug Lumigan, which is also made by Allergan.

Eyelash growth is a known side effect of Lumigan. But Lumigan and Latisse are used differently. Lumigan is an eyedrop, and Latisse gets dabbed along the lash line on the upper eyelids to promote longer, thicker, darker lashes.

Allergan states that "Latisse users can expect to experience longer, fuller, and darker eyelashes in as little as eight weeks, with full results in 16 weeks." If Latisse is stopped, eyelashes will gradually return to their previous appearance as new eyelashes grow in.

Allergan also notes that Latisse may cause darkening of the eyelid skin, which may be reversible, and it "may also cause increased brown pigmentation of the colored part of the eye, which is likely to be permanent."

Latisse may also promote hair growth in other skin areas that it frequently touches, so Allergan recommends blotting it off any skin other than the upper eyelid's lash line to prevent that side effect.

According to Allergan, Latisse was well-tolerated in its clinical trials, with the most common side effects being eye redness, itchy eyes, and skin hyperpigmentation.

Earlier this month, an FDA advisory panel recommended that the FDA approve Latisse and also recommended further studies in certain groups of patients, such as young patients and people who lost their eyelashes to chemotherapy.

2009-01-15T11:45:00.001-05:00

Skin Deep

Seeking Self-Esteem Through Surgery

By CAMILLE SWEENEY

Published: January 14, 2009

WHEN 18-year-old Kristen of River Edge, N.J., began to develop curves at 15, she was disappointed that breasts didn’t follow. “They never grew,” said Kristen. “I didn’t feel like a woman.”

Ryan Collerd for The New York Times

Kristen, 18, and Michael Laudisio, 22, below, said cosmetic surgery improved their lives

And, in fact, at 15, Kristen wasn’t yet a woman. But to someone raised in a culture of celebrity obsession and makeover TV shows — not to mention the fact that when Kristen was 16, her mother and older sister had received breast implants — she believed a shapely bust line was her due. So, last May, as a high school graduation gift from her parents, Kristen underwent breast augmentation surgery with saline implants, approved by the Food and Drug Administration for people 18 and older.

“I just wanted to look normal, and now I do,” said Kristen, whose family members asked that their last name not be used.

To the rigors of teenage grooming — waxing, plucking, body training and skin care regimens that were once the province of adults — add cosmetic surgery, which is fast becoming a mainstream option among teenagers. But with this popularity, some experts are concerned that the underlying motivation for many of the young people seeking surgery — namely, self-esteem — is being disregarded in the drive to look, as Kristen puts it, “normal.”

The latest figures from the American Society for Aesthetic Plastic Surgery show that the number of cosmetic surgical procedures performed on youths 18 or younger more than tripled over a 10-year period, to 205,119 in 2007 from 59,890 in 1997. This includes even more controversial procedures: liposuctions rose to 9,295 from 2,504, and breast augmentations increased nearly sixfold, to 7,882 from 1,326. (The latter two procedures have been associated with the deaths of two 18-year-olds: Amy Fledderman of Pennsylvania, who died in 2001 of fat embolism syndrome after undergoing liposuction, and Stephanie Kuleba of Florida, who died last spring from complications because of anesthesia used during a breast augmentation and inverted nipple surgery.)

At this point, the recession is apparently having little effect on teenage cosmetic surgery. While figures aren’t available for 2008, reports from doctors suggest that parents are keeping their commitments for procedures that are covered by insurance only if considered reconstructive, and that can be costly if they aren’t covered. The most frequent procedure, otoplasty, or ear reshaping, costs an average of $3,000, while rhinoplasty costs $4,500, according to the American Society for Aesthetic Plastic Surgery. These costs can be twice as much in the New York area.

“If parents have bought into the concept, if they’re supportive of a procedure for their child, they seem to be going through with it despite the economy,” said Dr. Alan Gold, a plastic surgeon in Great Neck, N.Y., and president of the society.

In fact, one of the most popular times for procedures for young patients is winter break, and several doctors said they noticed no drop in the number of adolescent patients last month.

Critics say that with plastic surgery becoming more common, parents are more likely to find themselves having to learn how to say no to a son or daughter with a tarnished self-image who is begging for the same quick surgical fix that the parents themselves may have had.

“Our children are barraged with images of ideal women and men that aren’t even real, but computer composites,” said Jean Kilbourne, co-author of “So Sexy, So Soon,” a book on teenagers and pre-teenagers. “These girls and boys can’t compete. The truth is, no one can. And it leaves teens feeling more inadequate than ever and a lot of parents unsure as to the right thing to do.”

Dr. Frederick Lukash, a plastic surgeon in New York City and Long Island who specializes in treating adolescents, said: “Unlike adults who may elect cosmetic surgery for that ‘wow’ factor to stand out in a crowd, to be rejuvenated and get noticed, kids have a different mantra. They do it to fit in.”

Still, some parents are at least as concerned about their children’s discomfort with their appearance as their children are. Jill Marks, whose 11-year-old daughter Julia is a rhinoplasty patient of Dr. Lukash’s, said that when Julia was 6 she started taking her to doctors, including ear, nose and throat specialists, to find out what could be done about her crooked nose. “I knew she was having a hard time with it physically, but also emotionally,” Ms. Marks said. “I’d see her in the bathroom pushing her nose to make it straighter. Some kids would ask her, ‘Why’s your nose so crooked?’ I didn’t want her to have to go through that anymore.”

A recent survey of more than 1,000 girls in the United States ages 8 to 17 sponsored by the Dove Self-Esteem Fund — which has a partnership with the Girl Scouts of the U.S.A. and is linked to Dove’s Campaign for Real Beauty, a program aimed at changing narrow cultural definitions of beauty — showed that 7 in 10 girls surveyed believed that when it came to issues including beauty and body image they did not “measure up.” Only 10 percent found themselves to be “pretty enough.”

“It’s clear there is an epidemic of low self-esteem among girls,” said Ann Kearney-Cooke, director of the Cincinnati Psychotherapy Institute, adviser to Dove’s study and author of the book “Change Your Mind, Change Your Body.”

“I work with a lot of teens on body image,” Dr. Kearney-Cooke said. “I have girls who say they want lipo when really what they need is to learn how to exercise and diet. If a girl thinks no waist, big breasts and chiseled features is the only definition of beautiful, I try and teach them to recognize the narrow view of what’s considered acceptable appearance in our culture, and how to challenge that view.”

Apart from the fact that what may be considered less than ideal at 15 or 16 may change over time — baby fat around a chin, say, or small breasts — experts say adolescents may not fully understand that the change they’re making is permanent.

“They may not be any happier with their new look, then what?" asks Diana Zuckerman, president of the National Research Center for Women and Families. “And even if all goes well at first with breast implant surgery, for example, it may require follow-up procedures. And we know how wrong breast implants can go with breast pain, ruptures, hardening, even a strange sloshing sound that sometimes occurs with saline implants.”

But plastic surgeons say that as body parts develop at different rates in different people, the opportunity to transform a teenager with low self-esteem and a crooked nose into someone with self-confidence is often justified because a well-timed operation could prevent destructive behaviors, including eating disorders, bullying and self-mutilation.

“There are general guidelines we follow with regard to physical development, but we take each candidate on an individual basis,” said Dr. Richard D’Amico, a plastic surgeon in Englewood, N.J. “Someone can develop at an accelerated or slowed-down rate. And, of course, levels of maturity vary.”

Michael Laudisio, now 22, of Massapequa, N.Y., admits he might not have been mature enough to understand the full implications when his ears were pinned at age 10, but he said his family’s decision to do it changed his life profoundly. “I had really big ears like no one else and was teased about it all the time,” he said. “That surgery made me free.”

But it can be a very fine line between corrective surgery and cosmetic, and even within a family there can be vastly differing opinions. “I’ve had mothers dragging their daughters in to have something done, and of course, if the teen is not on board, I’ll suggest another appropriate course of action,” said Dr. D’Amico, adding, “You don’t get self-esteem from a scalpel.”

Axis Three Launches Groundbreaking Surgical Simulation Software -- 'Portrait 3d', First Physics-Based Software for Breast Procedures

2008-10-31T11:13:00.004-04:00

LOS ANGELES, Oct 31, 2008 (BUSINESS WIRE) -- Axis Three, the leader and pioneer of surgical simulation tools for the cosmetic surgery industry, today announced the launch of the Portrait 3d software product, the first simulation software based on physics-driven tissue typing. It is the first product of its type ever to be launched for the cosmetic surgery marketplace.

"Portrait 3d is the culmination of five years of development and is based purely in science," said Jim Blumel, VP of US Operations. "It represents a major advancement in the 3D surgical simulation market and significantly propels Axis Three far ahead of any competing products by leaps and bounds." The product was recently profiled on the CBS show 'The Doctors'.

Like its XS-300 predecessor, Portrait 3d enables surgeons to visually communicate and collaborate on the outcomes of various breast procedures by using the patient's own image presented in photo-realistic 3d. For the first time ever, accurate volumetric and linear measurements can be taken from the patient's own 3d model, and the results of actual surgery can be simulated, measured, and viewed from all angles.

"Portrait 3d is the next generation of our simulation software," said Paul Moffett, Head of Technology. "It is the first product that incorporates tissue typing based on skin elasticity and parenchyma/glandular tissue firmness."

Portrait 3d also contains additional significant advancements including:

Implant Manufacturers Catalogues: A full range of accurate, digital versions of implants from the leading implant manufacturers are available for use within the simulations physics engine. This allows subtle differences between variants that are extremely hard to visualize with less advanced systems.

Lighting Engine: Accurate virtual shadowing can be calculated during the simulation, ensuring a 'true to life' rendering of the implant.

Multiple Comparative Views: Ultimate flexibility to display and compare all patient images and simulations.

Freehand Notation Tools: A series of virtual marker tools let notes and diagrams be drawn over the patient scan.

The response from women who have experienced the Portrait 3d during their surgical consultation has been overwhelmingly positive. A sample group of 350 patients surveyed illustrates the value of Portrait 3d to their surgical consultation:

-- 96% said it improved communication with their doctor

-- 94% said it reduced uncertainty about the surgery outcome

-- 89% said it helped select appropriate implant size

-- 94% said it enhanced their overall consultation experience

"After seeing the post-op simulation on their own body, patients feel much more comfortable and confident -- even more excited - about proceeding with the surgery," said Dr. Paul Zwiebel, a plastic surgeon in Denver, Colorado.

The Portrait 3d is now available throughout the United States, with service and support provided locally.

Axis Three will be exhibiting at the ASPS trade show in Chicago, Illinois on November 2-4, 2008. Anyone interested in seeing a demonstration of the system and learning more about its capabilities are invited to attend.

About Axis Three

Axis Three is the leader and pioneer of surgical simulation tools for the medical industry. Through an exclusive licensing agreement, Axis Three has integrated image capture technology developed by Siemens with its own proprietary software to create a powerful, flexible and intuitive platform that can be tailored to a variety of surgical needs. Axis Three has offices in Fairfield, Connecticut; New York, NY, Los Angeles, CA, Dallas Texas, and Belfast, Northern Ireland. For more information about Axis Three, please visit www.axisthree.com.

Pre-surgery imaging eases implant anxiety

2008-10-30T10:27:00.001-04:00

Tuesday, October 28, 2008
Last updated: Tuesday October 28, 2008, EDT 8:25 PM

BY ABIGAIL LEICHMAN

SPECIAL TO THE RECORD

New three-dimensional medical imaging systems are helping mastectomy patients in North Jersey get a better idea of how they will look after reconstructive surgery.

The new technology "helps alleviate the patient’s stress over what she might look like," said Dr. Allen Rosen of The Plastic Surgery Group in Montclair. "Now they don’t need to imagine. They go into surgery feeling more reassured."

Rosen provided a physician’s perspective to the engineering team at Canfield Scientific in Fairfield, which spent two years developing software for a 3-D system. In January, he received the first Breast Sculptor for his practice. There are now a handful in use nationwide.

"Just as all women come in different shapes and sizes, so do implants," he said. "The biggest unknown with breast surgery is determining the size of the implant and hoping that they aren’t going to be too big or not big enough. This technology gives the individual woman the chance to see what she will look like after a certain implant."

When Marianne Leone of Lincoln Park visited Rosen six weeks after her mastectomy in February, the doctor took photos of her using a special camera with multiple strobes and lenses. He was then able to use a cursor to manipulate the resulting 3-D digitized images from any angle. Finally, using the software’s 3-D library of styles and sizes of gel and saline implant models, he had Leone "try them on" before choosing the best option for her.

Leone said the 3-D system helped her decide to have her remaining breast augmented to match the shape of the reconstructed side.

"It gave me a great visual image, not just like sticking an implant in a bra," said Leone, 47. "The reconstructed breast is rounder and fuller and doesn’t sag like [a breast] does on a woman my age. I saw that there was going to be a big difference and that gave me more incentive to have them both done."

Dr. Steve Fallek, an Englewood Cliffs plastic surgeon, was in on the development of another 3-D imaging system. He was one of three physicians in the nation to start using the Axis Three Portrait 3-D system a year ago.

"This gives a better, more natural way to see how the patient will look from different angles and with different sizes of implants," he said. "I can plot different points on the breast and I can add or subtract tissue and change the nipple position."

The two-dimensional systems in use today just don’t give women a realistic idea of what they will look like, Rosen said.

"It was more like drawing a breast on a picture, making the process difficult for both physicians and patients," said Rosen, a former Teaneck resident who has been doing breast reconstruction for 20 years at hospitals, including St. Mary’s in Passaic.

Both physicians said the advanced imaging helps patients with their expectations.

"If the patient says, ‘I have small breasts and I want to go bigger,’ we can show her what that will look like," said Fallek, who works mainly at Englewood Hospital and Medical Center.

Three-dimensional imaging also helps the surgeon, said Rosen, an assistant clinical professor in the department of plastic surgery at the University of Medicine and Dentistry of New Jersey in Newark.

"The Breast Sculptor gives me an amazing ability to predict what I might have to do in surgery," he said. "We’re craftsmen and artists as well as physicians."

Rosen thinks more patients will begin to demand the service.

"It’s especially important to me that breast cancer patients learn about this," he said. "These women are thirsting for information on options in breast reconstruction."

Even better than the speedy recovery, Leone said, is the reassurance her new look gives to her husband and their two girls, ages 13 and 11, who had been devastated by their mother’s illness.

"This made me feel I was put back together again," she said.

New three-dimensional medical imaging systems are helping mastectomy patients in North Jersey get a better idea of how they will look after reconstructive surgery.

FILE PHOTO

"This made me feel I was put back together again," said Marianne Leone of Lincoln Park.