A total of 733 unique cases of breast implant-associated cancer and 36 deaths have been identified around the world, and the vast majority of cases have been linked to breast implants made by Allergan, the Food and Drug Administration (FDA) said in a press announcement.
The FDA analysis of global medical device reports for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) covers reports received through Jan. 5, 2020. Since the FDA’s last assessment in early July 2019, there have been an additional 160 new cases and three deaths reported. Of the 733 total unique cases of BIA-ALCL, 620 involved Allergan implants and 47 involved implants from an unknown manufacturer. Of the 733 total cases, 496 involved textured implants, and 209 did not specify the implant surface. Among the 36 deaths, 15 of the 16 patients for which the manufacturer of the implant was known are reported to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis. In terms of implant surface, of the 36 deaths, 16 cases involved textured implants, and 19 cases did not specify the implant surface.
BIA-ALCL is not breast cancer. Instead, it is a type of non-Hodgkin’s lymphoma, a type of cancer that affects the immune system. BIA-ALCL is usually found in the scar tissue and fluid near the implant. In some cases, the cancer can spread to other parts of the body.
At this time, the FDA believes the incidence of BIA-ALCL is low. But it is a serious disease that can be deadly if not diagnosed and treated early. Most patients are treated successfully with surgery, but some may require chemotherapy and/or radiation therapy.
For decades, the FDA has been monitoring adverse events related to breast implants including cases of BIA-ALCL as well as systemic signs and symptoms referred to by patients as breast implant illness (BII). There are limited references to “breast implant illness” in medical journals, but symptoms considered to be breast implant-related include fatigue, memory loss, rash, “brain fog,” and joint pain.
From November 2018 to October 2019, the FDA has received 2,497 medical device reports with symptoms consistent with BII, which adds to about 1,080 reports of similar symptoms from January 2008 to October 2018. The FDA believes the increase in medical device reports related to breast implants may be due to increased awareness from the press and social media, as well as the FDA’s General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.
The FDA has also released a video, Seven Things to Consider Before Getting Breast Implants, which includes information about risks, complications, and BIA-ALCL and systemic symptoms.