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What's New In Plastic Surgery

Friday, October 27, 2006

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DANGEROUS CURVESThe trial of a Beverly Hills doctor suspected of using illegal implants reveals a plastic-surgery secret: Women want silicone, FDA be damned.

By Ginny Graves for Allure Magazine (November 2006) Photos of well endowed women embellish the website of Frederic Corbin, a board-certified plastic surgeon with offices in Beverly Hills and Brea, California. What's more surprising, however, is a shot of Corbin meeting with the Dalai Lama and a personal essay titled, " A Virtuous Act: Dr. Corbin's Charitable Journey to India, " that chronicles his visit to the country to repair cleft palates. It remains to be seen if federal prosecutors will be swayed by Corbin's virtue during his current trial. His alleged crime is smuggling illegal silicone breast implants from Mexico into the United States and falsifying patients' medical records so they could receive American-made silicone implants that are typically available only through tightly regulated clinical studies. The reason for his backdoor methods: Silicone implants have been accessible only to select women who are part of a clinical trial since 1992, when the Food and Drug Administration pulled the devices from the market over concerns that leaking gel was causing a number of illnesses, including cancer and auto-immune diseases. Demand at the time slowed. But it never died, and over the years, silicone has rebounded--and become increasingly coveted. " silicone looks and feels more natural than saline, especially in women who are thin, " says Laurie Casas, associate professor of plastic surgery at Feinberg School of Medicine in Chicago.

Corbin allegedly began his blackmarket surgeries in 1996. According to court documents, he imported French-made gel implants from Tijuana after a patient bought a pair there and asked him to perform her surgery. Over the next few years, court records allege, he placed contraband implants in at least five women. Meanwhile, as a clinical-trial investigator for Mentor Corporation, one of the two American companies who manufacture silicone implants (the other is Inamed) and are vying for FDA approval, Corbin also had access to legal silicone. More than 2,000 doctors in the country are eligible to give patients silicone through Mentor's study. Once a physician is an approved investigator in the study, they may perform surgery with silicone-gel implants if the patient meets all the criteria. Once the surgery is complete, the physician is required to send paperwork to Menton. The physician also has to see the patient at scheduled intervals and provide follow-up documents to Mentor for each visit. Women having reconstruction after a mastectomy quality for the implants, as do those with chest-wall deformities and asymmetrical breasts.

When patients didn't fall into one of those categories, Corbin allegedly created fake medical profiles for them. For instance, in the records of one 21-year old patient, he allegedly changed her chief complaint from " small breasts " to " small, drooping breasts " (she wore a 34B), because women who require a surgical breast life that will include the removal of some tissue are also allowed, by the rules of the clinical study, to receive gel implants.

The FDA began investigating Corbin's practices in 2001, when staffers began to share damning stories. His operating-room technician's statement to law enforcement officers, for instance, was particularly graphic. She told investigators that in early 2001, prior to a routine audit by Mentor, in which the company examines doctors' records to make sure they're adhering to the rules of the clinical trial, she warned Corbin that the office logbook contained notations about the imported French implants. He allegedly responded, " I can't believe you kept such good records...You could f*ck me with these...You're gonna have to rewrite all this. " Neither Corbin nor his attorney responded to requests for comment.

To potential patients, Corbin undoubtedly appeared upstanding. He maintains officers in two tony locations, and his website touts his 20 years of experience as well as his membership in the American Society of Plastic Surgeons (ASPS). But if anyone chooses to search the Medical Board of California website, they would find that he has run afoul of the law before. In 1992, he was arrested and accused of fabricating as office visit to help a patient commit insurance fraud. He pleaded no contest to a misdemeanor (a reduced charge), paid a $4,000 fine, and performed 25 hours of community service, Still, the Medical Board of California placed him on two years' probation. Then, several years later, St. Jude Medical Center in Fullerton, California, revoked his staff privileges, because he failed to mention the charges against him during a routine application process at the hospital. In 1999 the state medical board issued a Public Letter of Reprimand, which defined the infraction and is available to the public on the board's website.

The question of why a successful plastic surgeon would jeopardize his practice over a few surgeries is open to speculation, but financial gain is the leading theory among some plastic surgeons. Doctors pay more for silicone than saline, but in Los Angeles, where women are savvy about implants, establishing a reputation as the surgeon to go to for silicone could be lucrative. Can a doctor gain a competitive edge by offering silicone when other doctors wouldn't? " I'd say the answer is yes, " says Teitelbaum, a plastic surgeon in Santa . Another doctor explains that patients can be quite persuasive in their requests: " I've had patients says, 'I don't know why you won't put silicone in me, because there are other doctors who will,' " says McGuire, associate clinical professor of plastic surgery at the University of California in Los Angeles. " I'm sure I've lost patients because I wasn't willing to go out on a limb to give them silicone. "

If the allegations are true, Corbin isn't the first doctor to bolster his practice (or fatten his wallet) by providing patients with illegal implants. In 1995, a federal grand-jury returned a 15-count indictment against J. Dan Metcalf, a family practitioner in Oklahoma City, who bought hundreds of silicone implants from Brazil, using them not only in his own patients but also selling them to other doctors. " Importing an unauthorized medical device is potentially dangerous, " says Bruce Cunningham, president of the American Society of Plastic Surgeons. " There's no way to know the provenance of the device. It could be a blackmarket imitation that doesn't meet U.S. standards with respect to design or production. " Blatant lawbreaking is rate, experts believe. But many plastic surgeons admitted that a number of doctors bend the rules regarding silicone by exploiting unintended loopholes in the clinical-study guidelines. " There is some wiggle room, and some doctors are willing to wiggle more than others, " McGuire says. For instance, doctors are allowed to use silicone implants in patients with severe asymmetry, but the guidelines don't specify how asymmetrical the breasts have to be. " The truth is, all women's breasts are asymmetrical, and the road from normal to abnormal is subjective, " says one doctor who asked not to be identified. " A lot of surgeons liberally interpret those requirements to give patients silicone. "

Doctors also are allowed to replace saline implants with silicone for a number of reasons--if the breasts look rippled, say, or the implants leak--a gray area that even some patients know to use to their advantage. " A woman can say, 'My left breast is smaller than it used to be, and I'm sure the implant is leaking,' " McGuire says. " The doctor may suspect she's doing it to get silicone, because usually a saline leak is obvious. But saline can also leak slowly over time, and if a woman believes her breast size has changed, it's hard for a doctor to disagree. After all, a woman lives with her breasts every day. "

The clinical-study guidelines for reconstruction after a mastectomy are more clear-cut, but some doctors feel they indicate an inconsistency by the FDA. After all, they ask, if silicone is dangerous, why would women who have had cancer be allowed to use it? " The FDA knew they couldn't deny silicone to the breast-cancer population, because saline is generally not as effective in reconstruction patients, " says Spear, professor and chairman of surgery at town University Hospital and, as a consultant for implant manufacturer Inamed, one of the few plastic surgeons who attended the first FDA panel meetings about silicone. " The ethicist on the FDA's scientific panel in the early 90's pointed out that if they're safe for some women, they should be safe for all, but the FDA didn't see it that way, " Spear says. Over the past decade, dozens of scientific studies have not been able to demonstrate silicone as a cause of illness, according to Casas. In 1999, the National Academy of Science's Institute of Medicine reviewed the scientific studies on the safety of silicone and concluded that women with gel implants are no more likely than anyone else to develop cancer, connective-tissue diseases, or neurological problems, findings that were echoed by a study on connective-tissue diseases published in the New England Journal of Medicine the following year.

Based on the evidence, a scientific panel convened by the FDA in April 2005 voted to reapprove Mentor's gel implants. In the summer of 2005, the FDA declared both Mentor and Inamed breast-implant devices approvable, provided that plastic surgeons receive training to use them, and the companies establish an independent committee to review the results of its ongoing clinical trials. Most experts believe that the FDA, which typically follows the advice of its scientific panels, is poised to greenlight gel-filled implants for the widespread use again once the public-comment period expires in October.

Still, detractors exists. Most recently a study found platinum in the blood, hair, urine, and breast milk of 16 women with implants, some of whom had the implants removed because of health problems. (Platinum is used to transform silicone into a harder, gel-like form.)In a letter dated June 30 to Acting FDA Commissioner von Eschenbach, DeLauro, a Democratic congresswoman from Connecticut, cited the study and said it demonstrates the need for more research. Although the FDA review on the subject, on June 16, 2006, said that the research so far suggests that platinum in implants poses very little risk, DeLauro's letter may carry some weight because she sits on the committee that decides the FDA's funding. " When she sends a letter of this type, it's important, " says Zuckerman, an epidemiologist and expert on women's health who is president of the National Research Center for Women & Families, a nonprofit organization. " We'd like the FDA to do its own research, rather than relying on research funded by implant manufacturers. "

Plastic surgeons point out that the Institute of Medicine research was funded by the government. The biggest problem with silicone implants, from their point of view, is how to tell when an implant ruptures. " Silicone is a thick gel and doesn't pour out when the sack breaks, so most ruptures aren't obvious, " Casas sys. " The best thing we can do is see patients regularly, preferably every year. If the implant remains soft, and you can displace it evenly in all four directions, it's probably intact. "

Even if an implant leaks, most doctors don't believe it would cause severe health problems, because the gel is so thick it usually doesn't migrate far. When the ASPS surveyed nearly 1,000 plastic surgeons in 2005, 93 percent says there were rarely a significant problem with rupture. " Silicone is legal in every other country except Canada and has been for years, " McGuire says. Silicone implants account for over 90 percent of the augmentation market outside this country, and assuming they receive approval, most experts say their use is likely to soar in the United States and Canada, as well. " Our surveys indicate that the vast majority of plastic surgeons plan to use them in their practice, " Cunningham says.

It's quite possible that Corbin won't be among the, however. If the jury finds him guilty, he could face up to ten years in jail and lose his license to practice medicine. Many of his colleagues view this kind of infraction with mixed feelings. " We've all been frustrated by the ban on silicone, " Casas says. " Having only one type of implant limits our ability to give each patient the best possible results--it's like living in a country with only one type of car. " Teitelbaum adds, " The ban put doctors in a compromised position. We're obligated to abide by the law, but ethically, we should follow the science, and the science of silicone shows not only that it's safe, but also that it's a better implant. If the Hippocratic oath is about doing what's right for the patient, in one sense Corbin did the right thing. "

posted by Dr. McGuire