Web Log – September 2011 – FDA Changes MRI Surveillance Guidelines for Silicone Breast Implants

Below is a portion of a letter sent to members of the Aesthetic Society of Plastic Surgeons to provide an update on the FDA’s silicone gel breast implant hearings.  This shift in surveillance advisory should be a welcome change for women considering silicone gel implant use.  We, the plastic surgery community in the United States, still await approval for use in this country of more very useful silicone gel implants that have been on the market internationally for up to a decade.

The Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee conducted a panel hearing on silicone gel-filled breast implants last week. The purpose of the hearing was to evaluate the progress of long-term post-approval market studies mandated when silicone gel-filled breast implants were approved by the Agency to return to market in 2006.   A key focus of the hearings, which included testimony from breast implant manufacturers, plastic surgeons and the public, was discussing innovative approaches to gathering data for future post-approval studies.

After two days of discussion and testimony about how to improve silicone breast implant study compliance, agency officials said silicone breast implants were safe and the studies would continue. “Women should feel assured that the F.D.A. continues to believe that currently marketed silicone breast implants are safe,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health, in remarks after the meeting.  “The current post-approval studies will continue.  The FDA is committed to seeing them completed and making sure the follow-up rates improve.”

Many experts at the hearings sighted the current labeling for MRI screening as unrealistic for healthy, asymptomatic patients. The panel agreed that patients should no longer be told that they should get an MRI three years after getting implants and every two years following. “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,” Dr. Maisel said. “But there was consensus among the panel that the requirements for ongoing M.R.I.’s should be removed.”

Towards the end of the final day of the hearings, the FDA panel commented that they were impressed by the organization of the two plastic surgery societies, our message and our efforts to generate data and address important issues such as international registries, labeling compliance, patient confidentiality, and informed consent.

 

Mark D. Wigod, MD, FACS

Plastic Surgery for Boise, Meridian, and the greater Southeastern Idaho Region

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