- The Washington Times - Monday, April 11, 2005

ASSOCIATED PRESS

Women who blame silicone-gel breast implants for crippling health problems faced women who called them the best option in an emotional debate yesterday as government scientists consider whether it’s time to lift a decade-plus ban on most of the devices.

“They poisoned my mother,” said a tearful Brenna Dowd of Boise, Idaho. “I have never known a healthy mother.”

“I don’t want anybody else to suffer this way,” said Susan Helman of Florida, who described autoimmune diseases that she attributes to platinum left in her body when her implants broke apart.

Thirteen years after the Food and Drug Administration ordered silicone-gel implants restricted to use in strictly controlled research studies, the agency is considering whether it’s time to allow their widespread sale.

The list of speakers at yesterday’s hearing included dozens of women who say their implants left crippling scars, and others who call the silicone version a more natural-looking option than saline implants and who contend that consumers should be free to choose.

“We have a right to decide what is right for our own bodies,” said Virginia Silverman of Orange County, Calif. She initially chose salt water-filled implants for reconstruction after breast cancer surgery but found them so hard that she replaced them in 2001 with silicone-gel implants that she finds more comfortable.

“We are neither ignorant nor shallow,” said Arlene Nicole Cummings, who runs a pro-gel implant Web site. “Women along with their surgeons should be allowed to choose silicone or saline.”

Still in question is how long the devices will last inside a woman’s body — and just what happens if they break and the silicone gel oozes into the breast or beyond.

The FDA is conducting a three-day meeting with its scientific advisers to debate whether two manufacturers, Inamed Corp. and Mentor Corp., have proved that their implants are durable and safe enough to re-enter the U.S. market.

In preliminary analyses released last week, FDA scientists suggested the companies have not, saying their data is of “limited value” in settling the concerns.

It’s an emotionally charged issue, as evidenced by the FDA’s unusual decision to schedule at least 15 hours yesterday to hear testimony from the public.

“No medical device lasts a lifetime,” said Dr. Caroline Glicksman, a New Jersey plastic surgeon who has implanted thousands of the silicone-gel version. She said the FDA’s decision should be based “on facts, not politics and emotion.”

Silicone-gel implants were sold for decades until the FDA implemented the 1992 restrictions. Since then, they have been available only to women enrolled in strictly controlled research studies because of fears the implants could cause major health problems.

The implants have been largely exonerated of causing such serious illnesses as cancer or lupus. But painful scar tissue that can form around them, breaks that require surgery to remove or replace implants and other complications remain contentious. Just 15 months ago, the FDA told manufacturers that it wouldn’t lift restrictions on the implants’ sale until questions about breakage in particular are settled.

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