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FDA: Stay focused on science, not emotion, physicians urge

Article-FDA: Stay focused on science, not emotion, physicians urge

The U.S. Food and Drug Administration's (FDA) General and Plastic Surgery Devices Panel recently voted 7-2 in favor of silicone implants for breast augmentation, paving the way for American women considering breast augmentation surgery to have a choice for the first time in 13 years. We encourage the FDA to take the science-based advice of its panel and allow silicone breast implants back on the market.

The specialty of plastic surgery has always advocated that science should determine the availability of these devices, not emotion and special interests. The welfare of the public and our patients is our primary concern.

Plastic surgeons are not interested in supporting any device that is not safe. Like other implantable devices, silicone breast implants will not last a lifetime and will eventually need to be replaced. No medical device is without issues. An ethical decision does not require a perfect device but an informed choice after appropriate discussion between an informed patient and her plastic surgeon. With its vote, the FDA panel made it clear that members do not believe silicone breast implants cause systemic disease or other major health problems. In this, they are in agreement with the Institute of Medicine's landmark report of 1999 and more than 35 years of scientific evidence published in peer-reviewed medical journals.

Patient education imperative The conditions for approval set out by the FDA panel, mandating effective physician and patient education and continued data collection, are appropriate and, we agree, very important. Plastic surgery, as well as other medical specialties, has already answered many of the questions regarding the safety and effectiveness of silicone breast implants, and we are committed to work to resolve any lingering issues.

We believe that breast implants and informed choice offer health-related quality-of-life benefits for many women. Between 260,000 and 335,000 women chose breast implants for augmentation in 2004, according to the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons (ASPS). Another 62,000 women had breast reconstruction in 2004, according to the ASPS. Breast implant surgery can have significant psychological benefits. Woman choosing the procedure do so for a number of reasons and the choice is very personal.

As for silicone, people often ask, since saline-filled breast implants are available, why silicone? The answer is — silicone implants offer the most natural feel and look for women seeking breast augmentation or reconstruction, and the data from both manufacturers indicate improved outcomes for many patients. We believe that our patients have a right to make informed personal choices about their healthcare.

Financial bias? It is often implied that the opinions of plastic surgeons regarding breast implants are biased by financial considerations.

Actually, it is of little consequence to plastic surgeons whether they use saline or silicone implants since the procedure is very similar, and the cost is essentially the same to the patients, except for the differing cost of the implant. But it is important to our patients, and that is why, after reviewing the data, we support the availability of this medical device.

In 2003, the FDA took an unusual step in not following its advisory panel's recommendation to allow silicone implants back on the market for all U.S. women. Since then, plastic surgery has worked and will continue to work diligently to respond to the FDA's concerns. The FDA convened its panel last month to review the manufacturers' updated applications. We urge the agency to follow the panel's lead this time and base its decision on science and science alone.

Richard D'Amico, M.D., and Alan Gold, M.D., are co-chairmen of the American Society of Plastic Surgeons/American Society for Aesthetic Plastic Surgery Breast Implant Task Force.

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