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FDA Confident in Safety Profile of Silicone Breast Implants

By in Breast Enhancement  » 

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

During the media briefing, 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.”

Are MRIs Required?

According to the New York Times, 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.

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.

ASPS Stance on MRI and Silicone Implants

Dr. Phil Haeck, president of the ASPS, and several members of the society testified before the FDA panel. They provided several recommendations in their testimony that would improve the post-approval studies and potentially change the labeling for silicone breast implants.

Regarding MRI screening, they said:

“The literature does not support the use of MRI as a screening tool for asymptomatic patients, particularly given the cost/benefit equation and the potential detrimental effects of false positives. In addition, the MRI requirement appears to be a detriment to maintaining enrollment of patients in the study.”

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