FDA raises bar for silicone breast implant approval: new guidance issued: recommendation of advisory panel rejected, additional safety data requested

FDA raises bar for silicone breast implant approval: new guidance issued: recommendation of advisory panel rejected, additional safety data requested

Kate Johnson

The Food and Drug Administration has revised its guidelines for manufacturers seeking approval to market silicone gel breast implants, curbing the hopes of the California company that seemed closest to this goal.

The new FDA guidance requires more rigorous investigation of lingering questions about the safety of silicone implants, says Dr. David W. Feigal Jr., director of FDA’s Center for Devices and Radiological Health.

“We want to make very clear to sponsors of breast implant products what we feel needs to be established in marketing applications … so that they can establish that those products are safe and effective,” he said in a press briefing. “Our goals in putting out this new guidance are to make the roadmap to approval as clear as possible.”

Silicone implants have been banned in the United States since 1992 because of concerns that they may possibly be linked to serious health problems, although they have been available to post-mastectomy patients taking part in approved clinical trials.

Besides reports of implants rupturing and silicone gel migrating elsewhere in the body, there have been concerns that implants may be linked to autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia.

But the criticisms have sparked much debate from manufacturers and other supporters who claim that the problems reported with silicone implants are no greater than those reported with the approved saline-filled implants that are currently on the market. And, a 1999 Institute of Medicine review found no evidence that silicone gel implants were causing serious disease.

Nevertheless, Dr. Feigal said that the FDA would like to see more data on the rupture rate of silicone implants, the consequences of rupture, and how physicians should manage patients with ruptures.

“We also need enough data to understand the silent rupture rate, and how silent ruptures progress to symptomatic ones,” noted Dr. Daniel Schultz, director of the FDA’s Office of Device Evaluation, who was also at the press briefing.

The FDA announced the revised guidance just hours after sending Inamed Corp. of Santa Barbara, Calif., a “not approvable” letter regarding the company’s application to bring the first silicone gel implant back on the market.

This was a somewhat unexpected move by the FDA, and an unusual rejection of its own advisory panel’s recommendation in October to accept the company’s application.

But Inamed Corp. will continue to seek approval, according to Dan Cohen, the company’s vice president for global government affairs.

“The new guidance is more rigorous than the previous one, but at the end of the day we both want the same thing–to put a product on the market that is both safe and effective,” he told this newspaper.

“We feel very comfortable with the FDA’s goal to give all manufacturers a way to get the product to the market. That’s all we require, knowing what the hurdles are, and based on what we understand right now, we’re hopeful we’ll be able to bring this in line,” he said.

During the FDA advisory panel hearing in October, Inamed presented safety and efficacy data from an ongoing trial of more than 940 women who received silicone implants. The women will be evaluated annually for 10 years.

Over the first 3 years of the study, the cumulative rupture rate of implants was 1.2% in women who had received breast augmentation, 6.3% in those who had undergone breast reconstruction, and 3.6% in those who had had revision.

In a subgroup of women being screened with annual MRIs, there were 15 “silent,” or asymptomatic ruptures among 597 implants–a rate of less than 3%.

But many women testified at the hearing that their implants did not rupture until about 6-7 years after surgery, and studies in the medical literature (not specific to Inamed’s product) indicate that the rupture rate increases to as high as 55% for implants with a median age of 16 years.

BY KATE JOHNSON Contributing Writer

COPYRIGHT 2004 International Medical News Group

COPYRIGHT 2004 Gale Group