A recall has been issued for a specific model of breast implant which has been linked to a rare form of cancer. The FDA said it called for the recall of the Biocell breast implants made by Allergan, Inc. as they were found to be associated with a disproportionate number of lymphoma cases, specifically anaplastic large cell lymphoma--a type of cancer that affects the immune system. The lymphoma occurs in the scar tissue (fibrous capsule) that surrounds the implant and in more advanced cases, may spread to lymph nodes near the breast. The cancer typically progresses slowly and can usually be treated by surgically removing the breast implant and/or the associated scar tissue. However, in rare cases when cancer spreads to the lymph nodes in other parts of the body, it may be fatal.
The Biocell breast implant was designed with a textured surface, intended to prevent the implant from slipping out of place and also to minimize scar tissue. The vast majority (95%) of breast implants sold in the United States do not have a textured surface. The FDA will be conducting additional investigations to determine whether the risk lymphoma is limited to specific models, or whether the risk applies to all textured breast implants.
Five hundred and seventy-three cases of this type of lymphoma have been identified by the FDA. Of these cases, 481 are attributed to Allergan implants. The FDA Principal Deputy Commissioner, Amy Abernethy, stated that while "overall incidence" of this type of cancer is low, Allergan's textured implants "appeared to be directly linked to significant patient harm, including death." Reports show 33 women have died of this lymphoma. Of the 13 deaths in which officials identified a breast implant manufacturer, 12 had Allergan implants when they were diagnosed.
Allergan is recalling Biocell saline-filled and silicone-filled textured breast implants and tissue expanders. These products will no longer be sold in the United States, and the surgeons should no longer implant the implants or tissue expanders. Similar action has already been taken in France, Australian, and Canada. Physicians have been instructed to return unused products to the company. But what about women living with these implants?
Dr. Elisabeth Potter, a plastic surgeon in Austin, Texas who has cared for women with cancer after receiving textured implants, spoke with USA Today and advised women with textured implants to talk with their doctors and monitor for symptoms such as pain, swelling, redness, or any additional abnormalities. The Cleveland Clinic notes that a common occurrence in this type of implant-related cancer is asymmetry: one breast may appear larger than the other, or look different in shape from the other. Usually, it takes at least two years after surgery for symptoms to emerge and the average length of time before symptoms appear is eight years.