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FDA requests recall of Allergan’s BIOCELL textured breast implants and tissue expanders

Jul 31, 2019

A rare anaplastic large cell lymphoma (BIA-ALCL), associated with textured surface breast implants, was first classified by the World Health Organization as a separate subtype of ALCL in 2016. 1The link between increased risk of this particular type of lymphoma and breast implants has been recently established and the Lymphoma Hub covered the management recommendations. 2,3The U. S. Food and Drug Administration (FDA) has now requested Allergan to recall BIOCELL textured breast implants and tissue expanders. 4This request follows recent Medical Device Reports describing 573 unique BIA-ALCL cases worldwide, and 33 BIA-ALCL-related deaths associated with these implants. 4

Although the FDA ordered the removal of the devices from the U.S, the company will voluntarily remove the devices from the global market. The particular textured surface shell involved in the majority of cases (481 out of 573 cases and 12 out of 13 deaths 4), is unique to the Allergan implant. Although the news is concerning for those with implants and their families, the FDA points out that the textured surface implants produced by Allergan contribute only less than 5% to the breast implant market in the U.S.

The complete list of the recalled products, alongside recommendations for affected patients and health care professionals, can be found on the FDA website. FDA will monitor the situation and act accordingly to the new developments. In the meantime, more information can be found on the dedicated FDA breast implants page.

  1. Swerdlow al., The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood.2016;127(20):2375-2390. DOI: 10.1182/blood-2016-01-643569
  2. Collett al., Current Risk Estimate of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants. Plast Reconstr Surg.March 2019;143 (3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):30S-40S. DOI: 10.1097/PRS.0000000000005567
  3. Dixon J.M.&   Clemens M.Breast implants and anaplastic large cell lymphoma. BMJ2018; 363. DOI: 10.1136/bmj.k5054
  4. The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. Available at: Published July 25 2019. [Accessed 30 July 2019]