FDA Allows Some Breast Implants, With Warnings

The government ruled Wednesday that saline-filled breast implants made by two California companies can stay on the market despite warnings that they break open at “alarmingly high” rates.

Giving its first formal approval of the long-sold implants, the Food and Drug Administration allowed the products to remain available as long as women are fully informed that many will have to undergo repeated surgeries.

“Women should understand that breast implants do not last a lifetime,” warned Dr. David Feigal, the FDA’s chief of medical devices.

“One of the things they should consider . . . is they’ve got about a 1 in 6 chance of facing another surgical operation” within three years of implantation, he added. Too many Americans have gotten breast implants without understanding that, he said.

About 130,000 American women received saline-filled breast implants last year even though the FDA had never declared the implants safe--they were available because of a government loophole.

But recently the FDA decided they could be sold only if manufacturers proved they are safe. On Wednesday, the agency ruled that brands sold by the two largest manufacturers, Mentor Corp. and McGhan Medical, both of Santa Barbara, can remain on the market. Implants made by three smaller competitors, all U.S. offices of foreign companies, must quit selling in the United States by Monday, the FDA ruled.

But the FDA issued lots of warnings--writing an entire booklet that plastic surgeons were ordered to give potential patients before the day of surgery, so women can decide if implants are worth trying.

Demand the booklet if your doctor forgets to offer it, Feigal advised.

Most additional surgeries were required because patients suffered painful scar tissue or an infection or because the implant broke and leaked, the FDA said.

Women’s health advocates sharply criticized the decision.

“The standard of safety is at a new low at FDA,” said Diana Zuckerman of the National Center for Policy Research for Women and Families. “Here you have the benefit which is cosmetic and the risks which are serious health problems.”

But FDA officials said they approved the implants because, complications aside, many women in the companies’ studies insisted they were happy with the implants.