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Silicone Breast Implants Redux

A California company hopes to bring back the banned devices

THURSDAY, Oct. 9, 2003 (HealthDayNews) -- Silicone gel breast implants, left for dead and buried in 1992, are ready for a comeback.

On Oct. 14 and 15, the U.S. Food and Drug Administration (FDA) will review safety data from a silicone gel implant manufacturer that is seeking to bring the devices back for cosmetic use. The implants are now only approved for use in reconstructive surgery for breast cancer patients.

The FDA is the same agency that banned the implants 11 years ago following complaints from hundreds of women who claimed leaking silicone had damaged their health.

The company, INAMED Corp., will present data from a core clinical study of about 1,000 women, another study of an additional 25,000 women, and other scientific information, says Joann Kuhne, who will be one of the company's presenters at the hearing.

"These implants have probably been tested more than any other medical device, and we believe that all our data supports the safety and effectiveness of our breast implants," says Kuhne, senior director for regulatory and clinical affairs for Santa Barbara, Calif.-based INAMED.

The company's presentation will include details on a number of key safety issues, based on a two-year follow-up. They include the rate of ruptures, development of scar tissue around the implant site, and post-surgical complications. The company will also offer reports on patients' satisfaction rates with their implants, Kuhne says.

Dr. Jane Petro is a Valhalla, N.Y., plastic surgeon who feels the time is right for the FDA to look at bringing back the implants for cosmetic reasons.

"Silicone gel plays a very important role in breast reconstruction, and may be able to play a role in pure cosmetic surgery," Petro says.

"Patients need to be well-informed about risk," she adds. "There is a certain degree of medical uncertainty about the silicone gel. I don't think anything is absolute."

If the FDA approves the implants for cosmetic purposes, it would be a major about-face for the agency following furious controversy about the safety of the devices. Silicone gel implants were at one time the preferred method of breast augmentation because of their soft, pliable texture.

But in 1992, responding to hundreds of women's claims that ruptured implants had leaked silicone into their bodies and caused long-term chronic immune system disorders, the FDA banned the sale of the implants.

The ban and subsequent lawsuits against the four companies that manufactured the implants resulted in billions of dollars in settlements to women. One company, Dow Corning, filed for bankruptcy to settle $3.2 billion in claims against it.

But since then, science has weighed in with research that cleared the implants of causing health problems.

Studies by the Mayo Clinic, Harvard Medical School and, in 1999, a National Academy of Sciences' Institute of Medicine panel found no evidence that leaked silicone from gel implants caused systemic disease. However, the studies did report localized problems of pain and the potential for scarring at the site of the implant.

The FDA says it won't be influenced by the controversy surrounding the implants. "We are interested in simply just the safety and efficacy of the device and will strive to make a decision as quickly as we can," says spokeswoman Sharon Snider.

The renewed debate comes as increasing numbers of American women are opting for cosmetic breast augmentation, according to the American Society of Plastic Surgeons (ASPS). There has been a nearly 600 percent increase in the number of women having implants in the last decade, from 32,000 in 1992 to 225,000 in 2002, the ASPS says. The large majority of these women have had saline implants, which are FDA-approved.

There are still critics of the gel implants, however. They say FDA approval should not come until the implants have been proven safe for at least 10 years.

"We know that silicone gel implants break because they're soft and have a relatively thin outer shell that can wear out over time," says Diane Zuckerman, president of the National Center for Policy Research for Women and Families. "When they leak they break down to a liquid silicone than can travel to the organs."

Zuckerman says she will speak at the FDA hearing and oppose any approval that is based on data less than 10 years.

But Petro, who has been involved in silicone gel clinical trials for another company, Mentor Corp., thinks the agency should vote to bring the implants back.

"Silicone is a ubiquitous substance. It coats heart valves, IV catheters, is the case for pacemakers. I don't hear anyone complaining about the silicone in these products," she says.

More information

Visit the Food and Drug Administration for information on risk associated with breast implants. For information on how breast implants affect mammography, visit the Mayo Clinic.

SOURCES: Joann Kuhne, senior director, regulatory and clinical affairs, INAMED Corp., Santa Barbara, Calif.; Diane Zuckerman, Ph.D., president, National Center for Policy Research for Women & Families, Washington, D.C.; Jane Petro, M.D., professor, surgery, New York Medical College, Valhalla, N.Y., Institute of Aesthetic Surgery and Medicine, Mount Kisco, N.Y.; Sharon Snider, spokeswoman, U.S. Food and Drug Administration, Rockville, Md.
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