Breast-Implant Photos on FDA Site
Monday, September 11th 2000, 12:00 am
By: News On 6
WASHINGTON (AP) â€” Federal health officials are posting on the Internet stark photographs of what a woman's breast looks like when a breast implant leaks or causes other problems, an effort to ensure women are fully informed of the risks before surgery.
Last May, the Food and Drug Administration ruled that saline-filled breast implants could continue selling even though they break open at high rates â€” as long as women are informed that one in six will require additional surgery within three years to fix problems.
The FDA demands that surgeons provide special brochures detailing those risks before surgery. But critics contend that by the time women visit a surgeon, most already have decided to get the implants and won't heed warnings â€” even if the surgeon doesn't downplay them.
And in an emotional meeting last spring, women told the FDA that written warnings don't convey what their chests look like after an implant failure. The FDA's scientific advisers urged the agency to provide photographs for potential implant recipients.
FDA officials searched the Internet and found one plastic surgery group that did show such photographs but paired them with other pictures showing that corrective surgery could help.
``We didn't feel that was very balanced,'' FDA medical device chief Dr. David Feigal said Friday.
So the FDA has posted on its Web page â€” http://www.fda.gov/cdrh/breastimplants â€” photographs showing three complaints. They are: capsular contracture, when scar tissue around the implant tightens enough to cause painful breast disfigurement; a deflated implant; and how the breasts wrinkle and sag if problem-causing implants are removed but not replaced.
Also available is a consumer handbook detailing the controversial history of breast implants and other options, such as rebuilding breasts using fat from other parts of the body. The free handbook also is available by calling 1-888-INFO-FDA, and the agency hopes to add the photos to an accompanying brochure within a few months.
Saline-filled implants are the only implant option for most women. Some 130,000 women received them last year. The FDA has banned silicone-gel filled breast implants except for a few women who get them in strictly controlled clinical trials.