FDA letter to healthcare providers: Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)
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.
FDA wants all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. They are also asking healthcare providers to report to the FDA cases of BIA-ALCL in patients with breast implants.
BIA-ALCL is a type of lymphoma and is not a cancer of the breast tissue. Current literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000. While the majority of patients who develop BIA-ALCL have had textured implants, and most cases reported in the literature describe individuals who have had textured implants, there have been reports of BIA-ALCL in patients with smooth-surfaced implants.
The FDA continues to actively work alongside the American Society of Plastic Surgeons (ASPS), international regulatory agencies and other experts in the clinical and scientific communities to evaluate all available information to understand the nature and possible factors contributing to BIA-ALCL in patients with breast implants.
