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FDA Affirms Safety of Breast Implants

 
Date: Monday, October 10, 2011

Author: Daniel Kuy, MD, FACS

On Sept 8th, 2011 the Food and Drug Administration and the Medical Device Advisory Committee conducted a panel hearing over two days on silicone gel filled breast implants. Dr. William Maisel, chief scientist for the Food and Drug Administration Center for Devices said, “we believe the benefits and risks of the silicone implants are sufficiently well understood.” After two days of discussion testimony, the agency officials said silicone breast implants were safe and studies would continue.

Dr. Maisel said, “We felt before the meeting that silicone breast implants were safe and we continue to feel that way after the presentations and discussion over the past two days.” There are risks to the implants, however, Dr. Maisel said, including ruptures, a hardening of the area around the implant, the need to remove the implants, scarring, pain, infection, and asymmetry. “Women should feel assured that the FDA continues to believe that currently marketed silicone breast implants are safe and the current post approval studies will continue to better understand these potential risks.”

The committee also agreed that the patient should no longer be told that their breast need to be screened with an MRI three years after getting the implants or every two years following. Most patients have ignored the requirement because MRIs are expensive and it is still not clear what should be done when unforeseen ruptures are discovered. The risk associated with leaking implants may not be greater than the risk of the operation needed to take them out. The FDA continues to believe, as does the pane members that the MRI is the goal standard for evaluating breast implants for silent rupture.

US surgeons performed nearly 400,000 breast implant procedures last year, more than half the operations used silicone gel filled breast implants. Unfortunately, many study participants have been lost to follow up. One frequently mentioned reason for the low followup rates in the post market studies was that augmentation patients see no reason to return for checkups if they have no problems. Dr. Maisel said that the decision to keep the implants on the market is not just based on the companies’ market studies. The FDA has looked already that the studies conducted prior, which have longer and better followup than the ones launched after the approval of the silicone filled breast implants.

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