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FDA Advisory Panel Calls for Breast Implant Registry

November 7th, 2011 Miguel A. Delgado Jr, MD

The Food and Drug Administration advisory panel has recommended setting up a nationwide registry to track safety problems for women with silicone breast implants for ten years.

It is not believed that the implants might not be safe; in fact in 2006 the FDA broke a 14 year moratorium on silicone implants by approving two new implants, one made by Allergan and one made by Mentor. But critics of the approval wanted more evidence for long term use.

The FDA required the two manufacturers to have follow-up studies of 40,000 patients each, ending in 2016. But the manufacturers have had a hard time complying. Allergan so far has about 60% follow-up and Mentor about one in four patients of their original 40,000. The manufacturers need to get the doctors to comply who in turn need to get the patients to comply. It is difficult to get women to continure to come in for yearly follow-up visits and filling out long questionnaires when they aren’t haven’t any issues. The idea of the breast registry is still in its beginning stages and the idea of having incentives for doctors and their patients is being considered.

The panel also discussed the current recommendation that women have an MRI (to look for a silent leak) three years after implantation and then every two years thereafter. They pointed out that most insurance companies don’t cover an MRI if there isn’t a problem, and most women are reluctant to pay out of pocket. Therefore the panel recommended not requiring future post-approval studies to mandate women who are not having issues undergo an MRI.

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