Friday, September 17, 2010
Thursday, September 16, 2010
Monday, April 19, 2010
Spa Owner Charged With Nearly Killing Customer With Illegal Liposuction
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.
Friday, April 16, 2010
Awake for Breast Implants? If You Wish
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.
“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.”
Thursday, April 15, 2010
Study blasts lack of training in cosmetic surgery marketplace
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
Tuesday, February 2, 2010
Beware the Corporate MD Shill
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.”
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.”
Monday, January 25, 2010
A new way to use frequent flier miles!
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
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
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