The Food and Drug Administration (FDA) has announced that data reviewed on the risks associated with textured breast implants and anaplastic large cell lymphoma (BIA-ALCL) does not require a ban of this medical device under Food Drug and Cosmetic Act standards. The agency conducted an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant specific registries, on the heels of a public advisory committee meeting held in March 2019 to evaluate the safety of breast implants.
Noting that regulatory action must be based on scientific data, FDA intends to focus on improving awareness of risk-benefit information of textured implants, both from the manufacturer to the physician, and from the physician to the patient. FDA plans to implement improvements to manufacturer labeling, which may include a black box warning and a patient decision checklist. FDA also plans to educate pathologists about testing for lymphoma specific to breast implant use.
Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in the MAUDE database, a move which provides greater transparency than summary reporting. FDA cautions that information in medical device reports is important but is not verified as accurate or dispositive on causation. Device reports cannot be used to determine incidence rates, causation or associations, as many reports can be duplicative or incomplete.
While the association between certain implants and the development of BIA-ALCL has been an issue of concern to FDA since 2011, FDA is still investigating the cause of the association and plans to continue to monitor, assess and report findings while strengthening the available evidence so that women and healthcare providers can be better informed about BIA-ALCL as they consider breast implants. Read the FDA statement on efforts to protect women’s health.
This alert does not purport to be a substitute for advice of counsel on specific matters.
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