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

FDA Questions Studies of Breast Implant Safety

Breast Implant Studies in Trouble continued...

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, MD, 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.

Charged with that task, the panel listened on Tuesday to testimony from the FDA, device manufacturers, women with breast implants, and doctors about how design better safety studies for breast implants.

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.

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