Patients Must Be Warned of Breast Implant Risks, FDA Says

By Roni Caryn Rabin

Getting breast implants comes with risks, and the Food and Drug Administration (FDA) is taking steps to ensure that women are aware of what they are. The regulator is now requiring "black box" warnings on packaging for implants, which can be sold only to medical providers who go over the potential complications with patients prior to surgery. While it is uncertain how effective the warning labels will be since patients are unlikely to ever see the packaged products, FDA's new checklist carries an expectation for patients to sign off after reviewing the document with their provider. The checklist points out the various medical problems that have been linked to implants, from joint pain and chronic fatigue to autoimmune disease and certain cancers. It also identifies subpopulations who are at an elevated risk for unfavorable outcomes, including women with diabetes and breast cancer patients who have undergone chemotherapy or radiation. In addition to the warning label and checklist, FDA is requiring for the first time that manufacturers disclose the ingredients use to make implants.

Read more on the New York Times.