FDA panel on post-approval studies of silicone breast implants

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A panel of expert advisors to the FDA has been asked to look into the matter of the thousands of women who enrolled in studies designed to evaluate rare complications that might arise years after they received silicone gel breast implants.

In June, after a preliminary review of study data, the FDA concluded that breast implants were largely safe and effective but were not “lifetime devices,” citing high reoperation rates for complications like hardening of the breast and rupture of the implant. Although the review at the time had found no evidence that silicone implants were linked to rare problems like breast cancer or connective tissue diseases, concerns that have plagued the devices for decades. The agency noted then that studies were still in progress to better answer some of those questions about rare events.

Some of the potential rare events that the FDA and patient advocacy groups wanted continued monitoring for included connective tissue diseases like lupus, rheumatoid arthritis, and scleroderma; nerve problems; cancer; suicide; interference with mammograms; problems in babies born to women with breast implants; and women with implants who might have had trouble getting pregnant or breastfeeding.

Now, however, it seems those studies have lost so many of the women they were supposed to follow that they are unlikely to offer any insight into the long-term safety of the devices. The said studies were designed that enrolled more than 82,000 women with silicone breast implants and 16,000 women with saline implants for comparison. The studies were supposed to follow the women for 10 years.

But three years into the studies, Mentor, the maker of Memory Gel implants, has lost 79% of the patients they enrolled, while Allergan, the maker of Natrelle implants, has lost nearly 40% of their study participants two years after enrollment. As a result, experts said the studies had already lost the power to detect the rare events they were designed to look for.

“Based on these study designs, it's not going to be more powerful to just double the length of time the studies are running,” said Phil Haeck, president of the American Society of Plastic Surgeons, who attended the hearing. It is the panel's task in the two-day meeting to help the FDA find a way to “fix the current dilemma,” Haeck said.

“Mentor's top priority has been and always will be patient safety,” said John Canady, medical director of Mentor Worldwide in testimony to the General and Plastic Surgery Devices Advisory Panel to the FDA. “The current large, post-approval study, unfortunately, though, has not given us the additional data that we hoped for, but I can assure you that plastic surgeons have tried hard in this effort,” he said.

Canady said the major reason many women were lost was that most women who get their implants feel fine after their surgeries and that “patients who feel well just don't go to the doctor.”

Other company representatives testified that the requirements of the studies, which include regular return trips to their plastic surgeon, filling out an annual, 27-page questionnaire, and recommended MRI scans to check for silent rupture - which patients have to pay for at up to $2,000 a scan - were simply too burdensome for doctors and patients. The company asked the panel to consider letting them use other sources of data, including case reports and patient registries, to meet the requirements.

Sidney M. Wolfe, director of the Health Research Group at the non-profit Public Citizen in Washington, D.C., says women are also less likely to return to a doctor or study when they've experienced a bad outcome, which means the studies may be missing important safety problems. “The flip side is that people who are enraged at their plastic surgeon who didn't bother telling them that these would have to be replaced in four, five, or six years go to someone else, so it works both ways,” Wolfe says.

By the end of the day, panel experts seemed unconvinced that the companies were doing enough to follow up with patients. Jason T. Connor, a statistical scientist with Berry Consulting in Orlando, Fla., who was a temporary voting member of the advisory panel, noted that it was in the company's best interest not to look too hard for safety problems with their products. “We're running really large 40,000-patient studies that tell us nothing because the companies aren't incentivized to get the results we really care about,” said Connor.

Jean Silver-Isenstadt, executive director of the National Physicians Alliance, said the FDA needed to show its commitment to enforcing post-approval studies. “We believe that this agency has to walk the walk,” she said. “Its mission is to protect patients, and when it sets criteria for approval, that should be real. When the agency begins to look more like window-dressing (for companies), that will shake the faith of physicians and patients.”

The hearing will continue on Wednesday when the panel will make its final recommendations on post-approval studies.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.

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