Thirteen years after most use of silicone gel breast implants was banned, the government reopened an emotional debate yesterday on whether to rescind the restrictions -- despite lingering questions about how often the devices can break inside women's bodies and how bad those breaks are.
In an extraordinary day-long hearing, dozens of women, many in tears, told federal health advisers of pain and crippling health problems when silicone leaked from broken implants into their breasts and beyond. Others, angry at their difficulty in getting what they called the most natural-feeling implant to rebuild cancer-ravaged breasts or to enlarge small ones, urged the Food and Drug Administration to lift its near-ban.
"My plan to be more beautiful was ironic," said Rebecca Smith-Miles of Michigan, describing how rocklike scar tissue formed around her gel implants within two years. "I was uglier by the day."
"They poisoned my mother," said a tearful Brenna Dowd of Boise, Idaho, speaking after her mother, Pamela, told of surgeons having to scrape silicone off her chest wall from broken implants. Pamela Dowd said she still suffers disabling pain, and, like many implant recipients, she has been denied health insurance.
Women happy with the gel implants charged that U.S. hurdles to get an option widely available overseas are unfair -- and that silicone is used in other medical devices without concern.
"We all deserve to feel beautiful, and if not beautiful, at least normal," said Anna Daly of Nashville, who received silicone gel implants in a research study after breast cancer surgery last year. She said today's main option, implants filled with saltwater, sloshed in her chest and often wrinkled.
"We have a right to decide what is right for our own bodies," agreed Virginia Silverman of California's Orange County, who received gel implants in 2001 and called saline implants too uncomfortable.
Just 15 months after being rebuffed, two manufacturers have again asked the FDA to lift the restrictions. Inamed Corp. and Mentor Corp. argue that newer generations of silicone gel implants are safe and more durable than earlier versions.
Yesterday, the FDA opened a three-day meeting to ask its scientific advisers if there is enough proof. The agency is not bound by the advice; indeed, this same panel in 2003 narrowly recommended lifting the near-ban, but the FDA refused.
Agency reviewers remain skeptical that the Santa Barbara, Calif.-based companies have settled the issue. In preliminary analyses released last week, FDA scientists estimated that three-quarters of the gel-filled devices could break and leak within 10 years of implantation, requiring additional surgery to remove or replace them. Inamed and Mentor, those analyses noted, submitted studies tracking rupture rates for just three or four years.
