FDA Requests Global Recall of Textured Breast Implants Associated With Cancer

The U.S. Food and Drug Administration (FDA) requested that Allergan voluntarily recall its BIOCELL textured breast implants and tissue expanders following reports of an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan agreed and is removing these products from the global market. Thirty-eight other countries have already recalled the implants.

The FDA’s request was based on a recent worldwide report that indicated 573 unique BIA-ALCL cases, including 33 patient deaths. Of the total BIA-ALCL cases, 481 reportedly occurred in women with Allergan breast implants at the time of diagnosis. In addition, 12 deaths occurred in patients with these implants; the manufacturer or texture was unknown for 20 of the other deaths.

“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the United States, and continued distribution of Allergan’s Biocell BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL,” the agency noted in a press release.

The FDA does not recommend that asymptomatic women with textured breast implants have them removed. Symptoms of BIA-ALCL include swelling, pain, and skin irritation. The FDA said it will continue to evaluate any new information and may take action against other breast implants, if needed.

Do you have #breastimplants or know someone who has #breast #implants?

A very rare #cancer has been reported associated with breast implants, called breast implant-associated anaplastic large cell #lymphoma, or #BIA-ALCL. Read the FDA warning here: https://t.co/rUDGFfwvTE pic.twitter.com/IfxOr1bRq6

— Gary Goldman, MD (@GaryGoldmanMD) June 27, 2019

FDA recommendations

The FDA recommended the following information for healthcare providers:

• You should immediately stop implanting Allergan BIOCELL breast implants and work with your facility to return existing inventory.
• At this time, the FDA does not recommend removal of these or other types of breast implants in patients who have no symptoms due to the low risk of developing BIA-ALCL.
• You should inform your patients about the risk of developing BIA-ALCL and what to look for.
• Prior to implantation of any breast implant, provide your patients with the manufacturer’s patient labeling, as well as any other educational materials, and discuss the benefits and risks of the different types of implants.
• Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant changes. In some cases, patients presented with a seroma, mass, hardening adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, ensure an evaluation is conducted by experts familiar with the diagnosis and treatment of BIA-ALCL.
• Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation and anaplastic lymphoma kinase markers.
• Develop an individualized treatment plan considering current clinical practice guidelines, such as those from the Plastic Surgery Foundation of the National Comprehensive Cancer Network (NCCN)External Link Disclaimer when choosing your treatment approach.
• Report all cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Healthcare personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of personnel reporting the event and the patient confidential.
• Submit case reports of BIA-ALCL to the Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology (PROFILE) RegistryExternal Link Disclaimer to contribute to a better understanding of the causes and treatments of BIA-ALCL.