Why is the FDA calling for the removal of certain breast implant models from the market?

The National Women’s Health Network (The NWHN) believes that more needs to be done to protect people against unnecessary harm caused by silicone gel-filled breast implants. Implants have been on the market for more than 30 years, and during that time they’ve been used by millions of people. 

Implants were marketed for many years before the United States Food and Drug Administration (FDA) had the legal authority to approve medical devices. It took an investigation by Congress and complaints by the NWHN and other women’s health groups to force the FDA to finally require manufacturers to study the devices. The NWHN took this action because we heard from many women that they believed their implants were making them sick. The FDA took implants off the market for several years and required studies.  The FDA officially approved silicone breast implants in 2005, but even then, the NWHN believed that approval was premature because adequate long-term studies of the devices had not been done. Many women who later report health problems feel fine during the first few years after getting breast implants, making long-term studies essential.

The FDA recognized the potential link between cancer and breast implants in 2011. Silicone gel-filled breast implants have been associated with Breast Implant Associated Lymphoma (BIA-ALCL). It is important to note that  BIA-ALCL is not breast cancer, it is a cancer of the immune system. According to the FDA, the most common symptoms of BIA-ALCL are persistent swelling and pain around the breast implant. Fluid collection around the site of the breast implant (known as a seroma) is also often found in cases of BIA-ALCL.

 In July 2019, the FDA called on Allergan, a manufacturer of textured breast implants, to recall their BIOCELL model of silicone gel breast implants from the market. While this did not guarantee that the implants would be removed from the market, Allergan did comply with the FDA recommendation, and notified the FDA that the implants would be recalled. The FDA announced that Allergan’s BIOCELL implants could cause “adverse health consequences and potentially death from BIA-ALCL”. 

In addition to the FDA calling on the company to recall breast implants, the agency issued a safety communication for individuals who are currently using the implants. Patients with breast implants who do not have symptoms are not advised to have the implants removed, as there is concern that doing so may put patients at increased risk for developing BIA-ALCL. It is recommended that patients who are exhibiting symptoms of BIA-ALCL have the implants removed immediately. The FDA has also called on healthcare providers to immediately stop inserting breast implants in their patients’ bodies. Despite the risks of breast implants, we recognize that many patients may still seek this surgery, and view the procedure as beneficial for their self-esteem, or their recovery from breast cancer. When this is the case, we recommend that patients follow the FDA’s, “Things to Consider Before Getting Breast Implants”, where the agency states that individuals with implants should seek consistent monitoring from their healthcare provider and understand that the implants are not lifetime devices and will need some maintenance for the duration that they are inside the body.