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Speakers square off on silicone-gel implants at hearing

Tuesday, April 12, 2005

WASHINGTON -- Thirteen years after most use of silicone-gel breast implants was banned, the government reopened emotional debate Monday on whether to lift the restrictions -- despite lingering questions about how often the devices can break inside women's bodies and how bad those breaks really are.

In an extraordinary daylong 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, but that, like many implant recipients, she has been denied health insurance.

On the other side, 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, Tenn., who received silicone-gel implants in a research study after breast cancer surgery last year. She said today's main option, salt water-filled implants, sloshed in her chest and often wrinkled.

"We have a right to decide what is right for our own bodies," agreed Virginia Silverman of Orange County, Calif., 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.

Monday, the FDA opened a three-day meeting to ask its scientific advisers if there's enough proof. The agency isn't 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.

Moreover, silicone can break and leak without immediate symptoms. FDA documents suggest that if the agency approved widespread sales, recipients would need regular MRI exams, perhaps every year or two, to check for breakage -- exams that cost hundreds of dollars.

Silicone-gel breast implants began selling in 1962, before the FDA required proof that all medical devices are safe and effective. Complaints that they broke and caused illnesses began in the late 1980s, and in 1992 the FDA banned gel implants except for patients with breast cancer or a few other conditions, who could get them by enrolling in strictly controlled research studies.

The implants largely have been exonerated of causing such serious or chronic illnesses as cancer or lupus. But breaks and resulting silicone leakage, as well as painful scar tissue and other local complications, remain in question -- and the FDA told manufacturers last year that durability questions in particular must be settled before it will lift the near-ban.

"No medical device lasts a lifetime," Dr. Caroline Glicksman, a New Jersey plastic surgeon, told the FDA's advisers Monday. She said the FDA's decision should be based "on facts, not politics and emotion."

But Carolyn Wolf of Centreville, Va., told of yellow strings of silicone oozing from her eyes two decades after she received silicone implants, and begged the FDA's advisers to heed the experience of older implant recipients in judging newer versions.

"What happened to me will eventually happen to thousands of women with silicone implants," she said. "If (newer) implants are so safe, make sure the manufacturers prove it."

About 264,000 breast enlargements and 63,000 breast reconstructions were performed last year, according to the American Society of Plastic Surgeons.


On the Net:

Food and Drug Administration: http://www.fda.gov/


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