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Women speak of breast implant horror stories, others ask that ban be lifted
( 2003-10-15 15:24) (Agencies)

The women told regulators of breast implants that caused rock-like scars, of silicone leaching into their organs and oozing through their skin, of unending pain.

Dozens of women and critics who blamed silicone gel breast implants for damaging health effects urged the Food and Drug Administration on Tuesday not to lift its 11-year ban on the devices.

But after they sat down, a line of other women pleaded for access to the implants, calling them the most natural-feeling option to rebuild cancer-ravaged breasts or enlarge small ones.

The FDA opened the two-day hearing to seek advice on whether Inamed Corp. should be allowed to again sell silicone gel-filled breast implants here, like it does in Europe. The two key issues being debated are"_Inamed's own research found 46 percent of breast cancer patients getting silicone implants needed additional breast surgery within three years _ as did one in five otherwise healthy women who had breast enlargements.

_Whether Inamed has tracked women's health for a long enough period after implantation. Its key study covered just three years. FDA's own research suggests implants often break after seven years, and many women report side effects once they've had the implants for a decade.

Inamed argues that many studies worldwide over the last decade have exonerated silicone implants of causing serious disease, and that short-term complications like painful scarring and extra surgery are comparable to today's main option _ implants filled with salt water.

But women who say their silicone implants harmed them tell a different story.

``My bones still scream with pain,'' breast cancer survivor Pam Dowd, of Boise, Idaho, said at the hearing. She described having silicone scraped off her chest wall when leaking implants were removed in 1995.

Carolyn Wolf of Centerville, Virginia, described ``a long thin greasy glob'' of silicone oozing from her eye and X-rays showing it lodged elsewhere in her body even after the implants she had for 29 years were removed.

``We beg you, please protect the younger generation,'' she said.

Other women just as passionately defended the devices, noting that today's saline implants have problems, too, and that men received silicone testicular implants without concern.

Elizabeth Webber of Maryland told of her saline implants turning rock hard and causing disabling pain, until she had them replaced with silicone ones.

``I felt like myself, a whole natural and complete woman,'' Webber said. ``My breasts felt like mine.''

``I'm offended that a woman's option to choose a silicone gel implant was taken away,'' added Lisa Bancarz of California, who received gel implants for enlargements in 1987. She reported no side effects.

But it was the critics' wrenching stories that appeared to move FDA advisers. They grilled Inamed about why it couldn't provide long-term studies proving how long implants really last.

Joanne Kuhne, a company executive, said Inamed planned to follow the women for another seven years but wanted to resume sales while it did.

Ninety-three percent of women in the company's study remained satisfied with the implant two years later, she told the panel.

Today's implants may break less often than those used 20 or 30 years ago because doctors have made a key change, said Dr. Scott Spear, a Georgetown University plastic surgeon and Inamed consultant. They used to treat painful scar tissue by squeezing women's breasts to break it up, which also could break the implant.

``It's pretty clearly known ... this is not a good idea,'' Spear said.

The advisers plan to issue their recommendation Wednesday. The FDA is not bound by their opinion but typically follows it.

The FDA ended routine sales of the once highly popular silicone implants in 1992 amid fears that leaking devices could cause serious disease. Breast cancer patients and certain other women could still get the implants under strictly controlled research studies, but women wanting bigger breasts have had to use saline filled ones.

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

Inamed says in countries where both types are sold, women far prefer silicone implants.

The critics say painful scarring and re-operations aside, studies haven't tracked women for enough time to exonerate silicone implants. And they point to a National Cancer Institute that found a possible increase of lung and brain cancer among silicone implant recipients, and a rise in suicide compared to other recipients of plastic surgery.

 
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