FDA Safety Communication – Risks of Certain Textured Breast Implants

PUBLISHED: Jul 24, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued a safety communication to inform health care providers and the public that the agency has requested that the manufacturer Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

Based on the currently available information, including newly submitted data, FDA analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s Biocell BIOCELL textured breast products implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.

BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.

Recommendations for Health Care Providers

  • You should immediately stop using (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 (CD30) and Anaplastic Lymphoma Kinase (ALK) 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.
  • Health care 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) Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.

See the safety communication for recommendation for patients and additional information.

Reference:

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