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FDA Questions Studies of Breast Implant Safety

Ongoing Safety Studies Have Lost as Many as 79% of Enrolled Patients

Manufacturers Say Safety Is a Top Priority

“Mentor’s top priority has been and always will be patient safety,” said John Canady, MD, 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.”

Mentor said it had worked with the FDA to send letters to participating patient and doctors enrolled in the study to stress the importance of their participation and that the company had made some changes to its study web site to make it easier to use.

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. 

Patients, Advocates Say Important Questions Haven’t Been Answered

But patients and advocates took issue with many of those arguments.

Sidney M. Wolfe, MD, director of the Health Research Group at the nonprofit 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, PhD, 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.

The hearing will continue on Wednesday.

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