FDA rethinking ban on silicone implants

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.

"I live in pain every day," said Sherry Henderson of Louisiana, who had her silicone implants removed after 11 years and cites a litany of diseases including lupus and chronic fatigue. "We are tired of all the suffering."

"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.

Some women pleaded for access to an implant they say feels more natural.

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, a whole, natural and complete woman," Weber said. "My breasts felt like mine. 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.

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