FDA Panel Discusses Silicone Breast Implant Safety and Routine MRI Screening

The U.S. Food and Drug administration recently reviewed the safety of silicone breast implants, during two days of discussion with doctors and manufacturers.

During the media briefing that followed, Nancy Shute, a reporter from National Public Radio asked: how often should women be getting a follow-up MRI?

“They should be getting an MRI – they get the first one at three years post-implantation. And then they’re to get it about every two years thereafter,” said Dr. Jeff Shuren.

The MRI recommendation is based on feedback from the advisory panel that was held at the time these devices were approved, said Dr. Bill Maisel, adding that it “continues to be FDA’s position on screening for a silent rupture.”

However, the New York Times reports that a consensus was reached during the meetings which indicated that routine breast implant MRIs should no longer be standard practice.

Since silicone implants were introduced, patients were advised to regularly undergo an MRI screening to check for silent rupture of their silicone breast implants. This increased the potential for false diagnoses, and because an MRI is expensive, patients frequently ignored the advice anyway.

The FDA stance on MRI screening hasn’t changed. It’s still the method of choice to detect implant rupture. However, they are expected to study whether patients should only undergo an MRI when they have symptoms of (or suspect) breast implant rupture. They should pay attention to changes, and report any possible complications to a doctor.

“F.D.A. continues to believe, as does the panel, that M.R.I. is the gold standard for evaluating breast implants for silent rupture, said Dr. Maisel, “but there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.” That change is an option they will evaluate in further studies about silicone implant safety.

Despite the risks involved with breast surgery, the FDA continues to believe in the safety of silicone breast implants. Dr. Maisel comments: “We felt that way before the meeting, and we continue to feel that way after the presentations and discussions over the past two days,” he tells The New York Times.

You can read FDA’s media briefing (a PDF document) regarding silicone gel-filled breast implant safety on FDA.gov

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