FDA Starts Silicone Implant Review
Dozens of women who blame silicone-gel breast implants for crippling health problems lined up Monday to plead with government scientists not 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 if it's time to allow their widespread sale.
The list of speakers at Monday'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.
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 and Mentor corporations, 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 on Monday to hear testimony from the public.
"No medical device lasts a lifetime," said Dr. Caroline Glicksman, a New Jersey plastic surgeon who said she 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 would not lift restrictions on the implants' sale until questions about breakage in particular are settled.
Inamed and Mentor filed studies with the FDA suggesting that over three to four years, anywhere from roughly 1 percent to 20 percent of implants rupture, requiring patients to undergo additional surgery to remove or replace them.
But those studies tracked small numbers of women for a short time, FDA scientists cautioned in preliminary analyses posted on the agency's Web site last week. One FDA estimate suggested that up to three-quarters of the devices might rupture within 10 years of implantation.
It's the second time in less than two years that the FDA is debating the silicone-gel implants. In October 2003, its advisers narrowly recommended allowing the implants to be sold again. The agency declined to follow that advice