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FDA updates safety alert on breast implant–associated anaplastic large cell lymphoma, reports 9 deaths
The FDA issued a safety alert update on breast implant-associated anaplastic large cell lymphoma, recommending clinicians provide routine care and support for their patients who have breast implants.
As of Feb. 1, the FDA received a total of 359 medical device reports of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), which included nine deaths.
The FDA identified ALCL as a rare T-cell lymphoma that is associated with breast implantation in 2011; however, at that time, there were too few cases to determine risk factors. The agency has collected and evaluated information about ALCL in women with breast implants through medical device reports, literature and speaking with other experts in the field to update the 2011 safety alert.
Risk for ALCL appears very low among women with breast implants, but still greater than that of women who do not have implants. It is most common in women undergoing breast implant revision operations for late-onset, persistent seroma and can be identified through symptoms such as pain, lumps, swelling or asymmetry.
Data suggests BIA-ALCL occurs more frequently with implants that have textured surfaces rather than smooth surfaces. Of the 231 medical device reports that included information on the implant surface, 203 were reported to be textured implants and 28 were smooth implants.
To provide the best care to patients, the FDA recommends clinicians:
- Provide the manufacturer labeling of the implant and any other educational materials to patients before surgery and discuss the benefits and risks of the different types of implants;
- Consider that a patient might have BIA-ALCL if they have late-onset, persistent peri-implant seroma. Some patients may present with capsular contracture or masses adjacent to the breast implant. Patients should be referred to an appropriate specialist for evaluation;
- Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests for BIA-ALCL testing. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation and anaplastic lymphoma kinase markers;
- Create a personal treatment plan in coordination with the patient’s multidisciplinary care team after considering guidelines from the Plastic Surgery Foundation or the National Comprehensive Cancer Network; and
- Report all confirmed cases of ALCL in women with breast implants to the FDA through a medical device report and submit case reports of BIA-ALCL to the PROFILE Registry to assist other clinicians and providers when trying to understand the causes and treatments of BIA-ALCL.
Further, because BIA-ALCL has only been identified in patients with late-onset symptoms, the FDA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.
Most patients with BIA-ALCL undergo removal of the implant and the capsule surrounding the implant, and sometimes chemotherapy and radiation.
Healthcare professionals and patients are encouraged to report all confirmed cases of ALCL in women with breast implants to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm.