FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

) and encouraging patients and health care professionals to report adverse events to the agency. This voluntary recall is a direct result of the agency’s comprehensive efforts to improve the quality of data collected and analyzed, and the FDA’s ongoing work to evaluate all available safety information.

Textured breast implants overall are less common in the U.S. compared to other countries and specifically, macro-textured implants represent less than 5% of all breast implants sold in the U.S. Although this type of textured breast implant may represent a small proportion of the U.S. market, the continued availability of Allergan BIOCELL textured breast implants pose a public health risk to patients.

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