The Food and Drug Administration (FDA) wants to add its most serious warning to breast implants to alert health care providers and consumers of the risk of developing a rare type of cancer associated with the devices.
The agency proposed the following boxed warning: “breast implants are not considered lifetime devices” and “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma” also known as BIA-ALCL. In the draft guidance, the FDA also proposed that patients who are considering breast augmentation review a “decision checklist” that spells out the risks associated with the implants. The FDA is currently seeking public comments.
The FDA’s recommendations come just months after the agency warned consumers that it was aware of 573 reports of BIA-ALCL in people worldwide who had received breast implants. Among them were 33 deaths. In July, the FDA took a bold move and ordered medical device company Allergan to recall of its Biocell textured breast implants and tissue expanders because among the 573 reports of BIA-ALCL, 481 of them were Allergan implants. Among the 33 deaths, only 13 reported the type of implant, and in 12 cases, those implants were made by Allergan.
Most women do not experience problems with their breast implants. However, about 20 percent end up having their implants removed within eight to 10 years due to complications, the FDA said.
BIA-ALCL is not a form of breast cancer, but a type of non-Hodgkin’s lymphoma, a cancer of the immune system. In most cases, the cancer is found in the scar tissue and fluid near the implant. However, sometimes, the cancer can spread throughout the body, making the disease more difficult to treat.