FDA Meeting Reviews Silicone Implant Safety and MRI Screening

New data was recently released by the USFDA regarding the safety of silicone breast implants. After two days of discussion with doctors and manufacturers, officials briefed the media about their position.

You can read a transcript of the media briefing, during which NPR reporter Nancy Shute asked: how often should women be getting a follow-up MRI?

“They get the first [MRI] 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, added Dr. Bill Maisel, who explained that at this time, 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 concluded that regular breast implant MRI screening should not be required.

The The New York Times article says:

“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.”

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 may have increased the potential for false diagnosis. Also, because an MRI is expensive, patients are likely to ignore the advice.

MRI screening is still the method of choice to detect implant rupture. However, the FDA is expected to study whether patients should only undergo an MRI when they have symptoms of (or suspect) problems with their breast implants.

The best advice for patients may be to simply pay attention to changes, and report any possible complications to a doctor.

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