FDA Warns of Breast Implant Associated-Anaplastic Large Cell Lymphoma

PUBLISHED: Feb 7, 2019
Relevant to: All Healthcare Organizations

The Food and Drug Administration (FDA) wants to increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant.

Healthcare providers and patients, particularly those with new swelling, lumps, or pain around breast implants, should be to be aware of BIA-ALCL to expedite diagnosis of this malignancy.

In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (seroma), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the BIA-ALCL diagnosis.

The FDA is recommending that health care providers:

  • Prior to implantation, provide all patients with the breast implant manufacturer's labeling, including the patient-specific labeling, as well as other educational material prior, and make sure they are aware of the benefits and risks of the different types of implants. Most confirmed cases of BIA-ALCL have occurred in patients with textured surface implants, although there are known cases in patients with only smooth-surface breast implants.
  • Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant seroma. In some cases, patients presented with a mass or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the individual's case to a multidisciplinary team for evaluation.
  • 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 in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
  • Report all confirmed cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
  • 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 letter to health care providers, link below, for additional information, including in-depth background on BIA-ALCL.

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