Facebook Twitter

FDA URGED TO REQUIRE PROOF SALINE-FILLED IMPLANTS ARE SAFE

SHARE FDA URGED TO REQUIRE PROOF SALINE-FILLED IMPLANTS ARE SAFE

Saline-filled breast implants should be banned for most women until manufacturers prove they're safe, an advocacy group said Thursday.

"No one knows the risks of these devices," said Joanne Mott, attorney for Public Citizen's Health Research Group.The Food and Drug Administration already is wrestling with the question.

Neither silicone-gel nor saline-filled breast implants ever went through FDA's approval process because they came onto the market before the agency began regulating medical devices in 1976.

FDA can make manufacturers prove their pre-1976 devices are safe and effective or take them off the market.

Two years ago, FDA restricted silicone-gel implants to breast cancer survivors in clinical trials, after thousands of women claimed leaking gel made them ill.

In Houston on Wednesday, Dow Corning Corp. agreed to pay millions of dollars in settlements to 18 women who claim silicone breast implants made them ill.

The plaintiffs' lawyers and Dow Corning refused to discuss the settlements, which halted two lawsuits from going to trial this week. However, courthouse sources who spoke on condition of anonymity said they totaled in the millions of dollars.

FDA plans at some point to make saline implants undergo formal safety review. It will announce a timetable this fall but hasn't publicly discussed whether sales could continue during that review.

In a petition filed Thursday, Public Citizen accused FDA of dragging its feet and urged it to treat saline implants just like the gel ones.

It asked that manufacturers Mentor Corp. and McGhan Medical be told to immediately start submitting safety data and that, during the review, sales be restricted to women undergoing mastectomies, those who need leaking implants replaced or women in strictly controlled clinical trials.

On FDA's present course, the earliest it would receive any safety data would be 1997, wrote Public Citizen's Dr. Sidney Wolfe.

"In the meantime . . . an increasingly larger pool of women is being created who may, in the prime of their lives, ultimately develop chronic illness, disfigurement and disability" because of the implants, he said.

He cited FDA documents showing 8,660 reports of serious injuries suffered by women with saline implants between 1991 and March of this year - and said the actual number probably is much larger because FDA only learns of a fraction of medical device injuries.

The devices, silicone shells filled with saltwater, are the only product still widely available for reconstructive breast surgery and enlargement.