- The Washington Times - Tuesday, October 14, 2003


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

The women told regulators of breast implants that hardened and created rocklike scars, of silicone leeching into their organs and oozing through their skin, and of unending pain.

But after they spoke, 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 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 receiving silicone implants needed additional breast surgery within three years — as did one in five otherwise healthy women who had breast enlargements.

• Some say Inamed has not tracked women’s health for a long-enough period after implantation. The company’s key study covered three years. The FDA’s research suggests implants often break after seven years, and many women report side effects after they’ve had the implants for a decade.

Inamed says that many studies worldwide over the last decade have exonerated silicone implants of causing serious disease. They say 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 Centreville described “a long, thin greasy glob” of silicone oozing from her eye and said X-rays showed 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.

But other women just as passionately defended the devices, noting that today’s saline implants have problems, too, and that men receive 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,” Miss Webber said. “My breasts felt like mine.”

But it was the critics’ wrenching stories that appeared to move FDA advisers. They asked Inamed why it couldn’t provide long-term studies proving how long implants 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.

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

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