3 mai, 2005 23:36
U.S. FDA to reconsider breast implant ban
Associated Press
WASHINGTON — Thirteen years after most use of silicone-gel breast implants was banned amid fears they were dangerous, the Food and Drug Administration is considering if it's time to lift the restrictions.
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.
On Monday, the FDA opens 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. The list includes dozens of women who say their implants left crippling scars, and others who call the silicone version a more natural-looking option that consumers should be free to choose.
"I'm 23 years old and I'm in bed most days almost all day," says Shannon Scott of Lakeside, Calif., who developed severely painful scar tissue and other health problems a year after receiving her breast implants in 2002.
Uninsured and on disability, she said she cannot afford to have them removed. She planned to tell the FDA committee that her surgeon never reported her complaints so that researchers could properly count side effects in studies that the government is using to determine the implants' fate.
Telling the other side is Kerri Branson of North Aurora, Ill., who first received silicone-gel implants in 1990 and was so pleased with them that she got a second set last summer to firm up breasts sagging from breast-feeding the four children she had in the interim.
"I've never ever regretted my choice," said Branson, 35. "I wish that other women could feel as great as I do."
Since 1992, silicone gel implants 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.
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.
