The breast implant manufacturer Allergan has announced a voluntary worldwide recall of its Biocell textured implants and tissue expanders. According to a recent press announcement by Allergan, the recall was in response to a request by the U.S. Food and Drug and Administration (FDA). The FDA found that patients who had textured implants had a higher risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
Recent FDA analysis found that of the “new worldwide reported total of 573 unique BIA-ALCL cases,” 481 are reported to have had Allergan breast implants at the time of diagnosis.
Textured breast implants account for less than 5% of the implants sold in the United States. While those who have the implants are considered at greater risk for developing BIA-ALCL, the cancer is still considered rare and the FDA is not recommending the removal of them in women who are not experiencing symptoms. Symptoms of BIA-ALCL, which may occur years after the initial implant surgery, include pain or persistent swelling in the breast implant area.
For more information on the recall and the specific breast implants included in it, visit FDA.gov.