Breast Implants and their Black Box Warning

In 2021, the U.S. Food and Drug Administration (FDA) issued guidelines for adding a “black box” warning on all breast implant packaging. In addition, the agency now requires cosmetic surgeons to provide specific information about the potential health risks that breast implants may pose. At the same time, the FDA updated their screening recommendations–now proposing an MRI or ultrasound 5-6 years after augmentation as well every 2 -3-year interval going forward.

The black box warnings address two key issues: the link between textured implants and an immune system cancer that can develop in the scar tissue capsule that forms around breast implants and the possibility that breast implants can cause systemic symptoms in patients. The immune system cancer is known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (bia-ALCL). The other issue with implants causing symptoms is known as breast implant illness.

The concerns surrounding textured implants and bia-ALCL are relatively new. While the first case was found about 20 years ago, a possible link between bia-ALCL and textured implants was not established until 2011. This is primarily due to the relatively low number of women who have textured implants and later developed bia-ALCL. According to the FDA, only 733 cases worldwide have been identified.

However, breast implant illness is much more common, and it is not a new issue. The first indications that breast implants may cause a constellation of symptoms date back to the early 1990s. Women with silicone breast implants reported symptoms like brain fog, memory loss, fatigue, rashes, joint pain, and fevers.

The FDA took silicone breast implants off the market as a result. The concern was that they may increase the risks of some women developing autoimmune diseases. While silicone breast implants were banned, various scientists conducted studies to identify a link between breast implants and autoimmune disease. In 2007, after reviewing 15 years of research, the FDA decided there was no evidence of a link and allowed silicone implants back out on the American market.