Devices

New FDA Actions on Breast Implants

While declining to order textured breast implants off the market, FDA says it is taking several steps to improve communication on the risks of breast implants and focus on evidence generation. A statement attributed to principal deputy commissioner Amy Abernethy and CDRH director Jeffrey Shuren says the agency is taking steps “aimed at helping to ensure that women have access to the information they need about breast implants to make informed decisions and to further drive evidence generation that will help FDA make the most appropriate scientific regulatory decisions moving forward.”

Steps announced by Abernethy and Shuren include improving information available to women and healthcare professionals about breast implant risks, including the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants. They say they also are looking at ways to incorporate ingredient information into labeling in a way that is easy for patients to understand.

The notice also announces a change in the way breast implant manufacturers file medical device reports with FDA. The agency says it has ended all summary reporting of breast implant medical device reports and has notified manufacturers that they will be required to file individual medical device reports that will be publicly available in MAUDE (Manufacturer and User Facility Device Experience).

While FDA acknowledges that some international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL, the agency says it does not believe that, on the basis of all available data and information, the device meets the Federal Food, Drug, and Cosmetic Act banning standard. “We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including the risk that is higher with the use of textured implants, albeit still low,” the document says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome