Product News and Recalls

FDA Formalizes Warning Process for Breast Augmentation Surgery

fda formalizes breast implant warningsAfter decades of procedures and millions upon millions of implant recipients, the FDA has formalized procedures that, among other things, now require patient notification of the potential risks and complications that come with breast augmentation surgery.

The move comes after several cases of breast implant-associated large cell lymphoma were reported in primarily European markets. Initially thought to be tied to the textured implants used mostly by European doctors, focus in the U.S. quickly shifted to any possible link between the disease and the smooth implants used here.

Textured implants were developed with the idea that the roughed surface of the implant would work to hold it in place and keep its shape over time. However, the surface was also causing small abrasions in the surrounding tissue and, again, over time, was causing changes that would lead to cancer in some cases.

The condition comes with a good prognosis if caught early. Still, regulators in the United States have recently formalized and implemented a set of steps that must be taken prior to conducting any form of breast augmentation surgery; the most common type of cosmetic surgical procedure performed in the country.

Implants of any type will now come with a boxed warning; generally reserved for drugs or medical devices that carry a severe risk of death if used. In addition, doctors who perform the surgery must now provide their patients with information and literature that review the side effects and risks that come with the procedure. The documents must be signed after being reviewed.

Some 400,000 breast augmentation procedures are conducted in the U.S. every year with 100,000 of them involving cancer patients. Whether those numbers will be impacted by warnings and signed notification checklists remains to be seen.