On October 24, 2019, the United States Food and Drug Administration (“FDA”) issued a draft guidance addressing textured breast implants that have been linked to breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”).”
Part of that guidance recommends a Black Box Warning, the most serious level of warning, in the device’s labeling to help ensure women receive and understand information regarding the serious risks of textured breast implants. Part of that warning should include:
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breast implants are not lifetime devices;
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the chances of developing complications increase the longer a patient has the implant, and additional surgery may be required to address the complications; and
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breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms (like fatigue or joint pain).
Additionally, the draft guidance recommends that textured breast implant manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure. A patient decision checklist gives patients the opportunity to acknowledge individual risks of textured breast implants and can be used to help guide discussion during a patient’s consultation with a surgeon. The proposed checklist specifically addresses the risk of BIA-ALCL.
Finally, the FDA confirmed that it is coordinating with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation, to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology, which collects data from patients with a confirmed diagnosis of BIA-ALCL. The FDA contends that this will contribute to a better understanding of textured breast implants and BIA-ALCL, as well as improve FDA communication updates to the public regarding textured breast implants and BIA-ALCL.
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