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Source: Cosmetic Surgery Times; Jun2005, Vol. 8 Issue 5, p1, 3p

Cosmetic surgeons protest FDA's proposal on breast implants Limiting access to silicone raises 'fairness' questions

BY BETH KAPES

STAFF CORRESPONDENT

National report-With science prevailing over emotion and anecdotes, federal health advisers ecendy recommended that silicone gel breast implants be returned to the U.S. market after a 13-year restriction.

But the U.S. Food and Drug Administration (FDA) advisory panel recommended that only board certified plastic surgeons be allowed to implant the devices - a prerequisite that has left cosmetic surgeons outraged.

Dr. Crockett

"We feel that this is an unfair decision, particularly because a major portion of those who participated in the clinical trials that led to this decision were cosmetic surgeons " says Claude H. Crockett Jr., M.D., F.A.C.S., president of the American Academy of Cosmetic Surgery (AACS). "We're working towards overturning this suggestion and implementing fairness in the inserting of these implants."

"This recommendation may not be sustainable for many reasons," says plastic surgeon V. Leroy Young, M.D., of the BodyAesthetic Plastic Surgery and Care Center, St. Louis. "The very fact that there may be an atititrust issue involved due to the recommendation's limitations, and the fact that some general surgeons are much more qualified to insert implants than a first-year plastic surgeon, are reasons that are powerful enough (to overturn this recommendation) prior to the final ruling."

In a 7-2 vote on April 13,the FDA committee recommended approval of Mentor Corp.'s newer silicone implants because the product was deemed reasonably safe and more durable than older versions. Mentor's rival manufacturer, Inamed Corp., failed to persuade the panel just one day previously that its implants were approval-worthy.

Prominent restrictions

But even with scientific data indicating that Mentor's implants show a rare breakage rate of about 1A percent over three years, and some evidence indicating that they may last as long as 10 years, FDA advisers were firm in stressing that sales of the implants should resume only if Mentor meets the following strict conditions:

o Prospective patients must sign consent forms acknowledging the risks of implants, including that they may ultimately break and require removal or replacement.

o Mentor may sell silicone implants only to board certified plastic surgeons who complete special hands-on training to insert implants in a way that minimizes risk of breakage.

o Mentor must open a registry to track how patients fare long term, and continue more formal studies to determine how often implants rupture within 10 years - information that, to date, is unknown.

Other recommendations

The panel also recommended that patients get an MRI scan five years after the insertion of the implants and every two years thereafter. Consideration of removing broken implants is also suggested to minimize the risk of silicone migrating into the breast or beyond.

A federal advisory anel recommends that Mentor be required to

open a registry to track how patients fare long-term and continue more formal

studies to nail down how often implants rupture within 10 years.

..

Although the suggested restrictions were designed to support patient safety, the recommendation to limit who inserts the devices has caused consternation among cosmetic surgeons.

Proper training is key

While the rationale for the limitation is that it theoretically will reduce the complication rate, the key is to make certain that proper training is part of the equation, according to 1. Olding,M.D.,chief of plastic surgery, Washington University Medical Center, and spokesman for the American Society of Plastic Surgeons.

"These should be implanted by those who have a full understanding of who best benefits from silicone -very thin women with small breasts and those with very little subcutaneous tissue, such as breast reconstruction patients.

"The panel wants to make certain that patients have every opportunity to have the best results," says Dr. Olding, who served on a 2003 FDA panel that reviewed a pre-market approval bid by Inamed for its silicone- gel implant. Although the panel recommended approval, the FDA turned the request down.

"Understandably, not every cosmetic surgeon performs breast implants," Dr. Crockett says. "But a majority (of implant procedures) are completed by non-plastic surgeons. The panel's recommendation is not only being looked at closely by the AACS, but also by the manufacturers."

Not FDA-enforceable?

During the recent panel hearings, Miriam Provost, Ph.D., the FDA's acting deputy director, division of general, restorative and neurological devices, mentioned that while limiting training to board certified plastic surgeons was a recommendation they could make, this condition was not FDA-enforceable, according to Josh Levine, president and CEO, Mentor Corp. "We will defer to the wisdom of the FDA on this matter," Mr. Levine said in a statement to Cosmetic Surgery Times. "Further, Mentor will comply with any and all conditions FDA attaches to approval of these products.

Presuming the FDA does not impose any mandates to the contrary. Mentor has no intention or interest in limiting the distribution of its silicone gel-filled breast implants to board certified plastic surgeons."

The FDA typically - though not always - follows the recommendations f its advisory panels.

Patient registry

Because there is insignificant data on how often silicone gel implants fail, the FDA panel is recommending a patient registry in hopes of tracking long-term data to guide future implementation not only of Mentor's product, but others as well. As if foreseeing the FDA's plan. Dr. Young began the North America National Breast Implant Registry in July 2000 to study the impact of both saline and siliconegel implants, with more than 23,000 voluntary participants currently participating. "Requiring that Mentor conduct an implant registry is a victory that will ensure long-term follow-up," says Dr. Young, who testified at the FDA's advisory panel in April. "So far, our registry shows a rupture rate of 1 percent for saline, and 2 to 3 percent for silicone."

"The real issue is safety. Do silicone implants, if they rupture, lead to granulomas and other health concerns?" says CB. Boswell, M.D., a colleague of Dr. Young's whose work supports the implant registry. "It's not clear if the FDA will use Dr. Young's registry as a template, or create one of their own, but regardless, (what is important) is that they find the truth behind silicone's safety." Mentor's willingness to comply not only with the registry but with other recommendations is what led to the committee's nod of approval, while Inamed's lack of compliance left it out ofthe silicone race, according to Dr. Boswell.

"If ultimately approved by the FDA, Mentor's Memory Gel breast implants will be a significant addition to the options for women seeking breast augmentation or reconstruction in the United States," Mr. Levine says. "The panel deserves a lot of credit for thoroughly examining the scientific data before reaching the same conclusion we have reached - that Mentor's silicone gel-filled implants are a safe and effective option," he adds. And what if the approval doesn't happen? If not this year, it will come in the next year or two. Dr. Boswell says.

"Approval of silicone is imminent, because the FDA will have the long term

data they asked for," he says. CST

[Guest guest]

Thank you for this. I was on the old computer and that stupid virus is still

there. I tried to kill it, but it disappeared. Your message about the media

came in on the old computer. Could you please send it to me on the new

computer. I have sent the letter to at the university, that we wrote

to Alan Rock who was the Health Minister at that time. will send it

to me tonight. We will be sending it to our new health minister and the FDA.

Dr. Blais has told us that he is a nice man. We will see how nice he is once

he gets this letter. I wrote the letter, but made it worth reading, I

wish that he had helped me with the letter that I wrote yesterday to the

FDA.

Love you....Lea

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I copied Cosmetic surgeons protest FDA's proposal

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