BIA-ALCL Allergan Textured Breast Implant Recall
The Allergan corporation’s recent recall of BioCell® textured breast implants has prompted concern among many individuals about the safety of certain kinds of implants. Dr. Richard Zeff and our plastic surgery team would like to address some of the issues that are currently being discussed in the news regarding the recall so that you have a fuller picture of what’s going on.
The U.S. Food and Drug Administration requested that Allergan recall specific types of textured breast implants and tissue expanders from suppliers and doctor’s offices. Allergan ultimately recalled BioCell® textured implants and expanders worldwide, which include many types of implants in the Natrelle® line of products. This was due to an updated study that revealed additional cases of a very rare type of immune system cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL. The FDA believes that patients with certain types of textured breast implants may be at greater risk for the condition, so Allergan initiated a recall of BioCell® textured implants and expanders. BIA-ALCL has affected an extremely small number of patients, and the FDA is not recommending that patients with textured implants who are not showing symptoms have their implants removed. With that in mind, patients should remain vigilant about conducting regular self-breast exams to determine whether swelling, lumps, pain, asymmetry or other irregularities are present. If so, patients should consult their doctor immediately. Individuals should also maintain the recommended professional check-up and mammogram routines. Any patient who is concerned about BIA-ALCL should contact their plastic surgeon, where an exam and additional testing (if necessary) can be conducted.
While BIA-ALCL is very rare, it should also be noted that researchers believe it is highly curable when found early. Below, you will find links with more information about BIA-ALCL and Allergan’s recall of BioCell® textured breast implants and tissue expanders, as well as details about new recommendations regarding MRI screenings for patients with silicone breast implants. If you have any questions, please don’t hesitate to contact our practice.
FDA News Release Discussing BIA-ALCL and the Allergan Recall
FDA Discussion in March On Recommendations for MRI Screening
