Allergan announced July 24, 2019 a voluntary worldwide recall of BIOCELL®textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the rare incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).
BIOCELL® saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently. Allergan will provide additional information to customers about how to return unused products. Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.
-Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.
This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
For more information, visit Allergan’s website at www.Allergan.com.
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