In a bold move, the Food and Drug Administration (FDA) ordered medical device manufacturer Allergan to recall its textured breast implants in the United States, in a “significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”
The FDA had previously warned that there had been 573 reports of cancer in people who had received the implants worldwide, including 33 deaths, 481 of which were Allergan implants. Among the 33 deaths, only 13 reported the type of implant, and in 12 cases the implants were made by Allergan.
Women who have implants affected by the recall do not need to have them removed, but should have regular follow-ups with their doctor and report any symptoms of BIA-ALCL, such as excessive fluid buildup around the breast implant causing pain, swelling or lumps in the breast or armpit. Symptoms usually occur between three and 14 years after implant placement.
The recalled implants include:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
BIA-ALCL is not a type of breast cancer. It is a rare type of lymphoma, which is a cancer of the immune system. It develops in tissue or capsule around the implant. Removing the implant and the scar tissue around it can cure the patient. However, if the disease is not caught early, the cancer can spread and be fatal.
BIA-ALCL has occurred in women who have received implants for cosmetic breast enlargement as well as women who received them for reconstruction after mastectomy for breast cancer, the FDA said.
The content of the implants – silicone or saline – is not a factor in the development of BIA-ALCL, but the covering of the implants is. Textured implants carry greater risks than smooth implants. And while several companies make textured implants, the vast majority of BIA-ALCL cases have occurred in women with Allergan implants.