FDA to rethink near-ban on silicone-gel breast implants

Wednesday, October 15, 2003

WASHINGTON -- Women pleaded with the government on Tuesday to continue a ban on most silicone gel breast implants, telling of years of pain and suffering they blame on leaking devices.

As many as 46 percent of women who get silicone-gel breast implants need additional surgery within three years, research indicates.

Manufacturer Inamed Corp. argues that implants filled with silicone gel are comparable to today's only option, those filled with salt water -- which just as frequently require more surgery, too.

That doesn't justify letting routine sales of silicone implants resume, a line of women told advisers to the Food and Drug Administration.

"My bones still scream with pain," said breast cancer survivor Pam Dowd of Boise, Idaho, who had silicone scraped off her chest wall when her leaking implants were removed in 1995. "We are being asked one more time to trust the manufacturers. ... We have no reason to believe they're telling the truth."

They spoke as the FDA's advisers began a two-day meeting to decide if Inamed has proved its case. Dozens of women are lined up for a chance to sway the decision, most of them critics.

However, some women pleaded for access to an implant they say feels more natural.

"Unfortunately for me, I'm just a woman seeking to undergo a cosmetic procedure," said Michele Colombo, 34, charging the FDA with keeping implants away from women seeking bigger breasts as a moral judgment when cancer patients can get them in studies -- and men can get silicone testicular implants.

Elizabeth Weber of Maryland tried saline implants after cancer surgery, but they turned rock-hard, causing disabling pain. She had them replaced with silicone implants and "I felt like myself," Weber said. "I hope you give other women the same choice."

The FDA ended routine sales of silicone gel implants in 1992 amid fears they could break apart and cause serious disease as the silicone leaked into women's tissues. While some women seeking breast reconstruction because of cancer or other problems still could get silicone implants in strictly controlled research studies, women wanting bigger breasts have had to use saline-filled implants.

Despite thousands of lawsuits that sent one of the largest implant makers, Dow Corning, into bankruptcy, major scientific studies have never proved that silicone-gel implants cause serious diseases like lupus or cancer.

Silicone gel has remained legal in Europe, and Inamed says in countries where women have the option, they far prefer it to saline.

But critics say studies haven't tracked women for long enough to truly exonerate silicone-gel implants.

FDA found one in five women who received silicone implants for breast enlargement in Inamed's study needed additional surgery within three years. That risk was even larger -- 46 percent -- for breast cancer survivors who received the implants.

Both rates are similar to reoperations seen with saline-filled implants, which the FDA allows to sell as long as women are forewarned.

Proponents had hoped the silicone implants would not cause as many return trips to the operating room. Sometimes the additional surgeries were done to treat painful scarring. In 7.5 percent of enlargement cases and a quarter of cancer survivors, implants were removed or replaced, because of pain, improper position, breakage or, sometimes, patient desire for a different size.

What about long-term effects? FDA's research suggests implants are more likely to break later, after about seven years.

While FDA agrees there's little proof that implants cause serious disorders such as lupus, agency scientists say rare diseases aren't completely ruled out. Additionally, they plan to tell the meeting, a possible increase in lung cancer and brain tumors found in a handful of studies requires more research.

FDA's advisers will issue recommendations Wednesday. The FDA isn't bound by the advice but usually follows it; it hasn't set a deadline for deciding the fate of Inamed's appeal.

It's a potentially huge market: last year, 236,000 Americans had breast enlargements, over six times more than a decade earlier.

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