FDA Provides Update on Breast Implant-Associated Anaplastic Large Cell Lymphoma
The US FDA provided updated information to women with breast implants and their health care providers on the risk of developing a specific type of lymphoma.
According to a United States Food and Drug Administration (FDA) press announcement released on February 6, 2019, results from an updated analysis of reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) suggest that, as of September 2018, 457 women have been affected by this disease, with 9 related deaths. FDA has received a total of 660 medical device reports of BIA-ALCL since 2010.1
“In 2011, the FDA was the first public health agency in the world to communicate about the risks of BIA-ALCL, warning women that the available information at the time indicated that there is a risk for women with breast implants for developing this disease, stated Binita Ashar, MD, general surgeon and the director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, in an FDA press announcement.2
Dr Ashar further stated that “BIA-ALCL will be one important topic of discussion at the agency's upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA's headquarters in Silver Spring, Maryland, March 25-26, 2019.”1
BIA-ALCL is a rare subtype of non-Hodgkin lymphoma that has been classified by the FDA as “a known risk of breast implants.”1 According to guidelines from the National Comprehensive Cancer Center (NCCN) covering the diagnosis and treatment of this disease — guidelines that have been endorsed by FDA — most women with BIA-ALCL present with “a large spontaneous perioprosthetic fluid collection occurring at least 1 year and on average 7 to 10 years following cosmetic or reconstructive implantation following cosmetic or reconstructive implantation with a textured surface implant.”3 Based on data from retrospective case reviews of patients with BIA-ALCL, smooth implant devices have not been definitely associated with this disease.3-5
Furthermore, BIA-ALCL guidelines from the NCCN emphasize that early diagnosis and treatment of this disease is typically associated with an excellent prognosis, although metastasis has been reported.3 These guidelines stress the importance of initial ultrasound evaluation of women presenting with signs and symptoms of BIA-ALCL, with fine-needle aspiration recommended as the method of fluid sampling.3
“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr Ashar wrote.1
- United States Food and Drug Administration. Statement from Binita Ashar, MD, of the FDA's Center for Devices and Radiological Health on agency's continuing efforts to educate patients on known risk of lymphoma from breast implants. Published February 6, 2019. Accessed February 7, 2019.
- United States Food and Drug Administration. FDA update on the safety of silicone gel-filled breast implants. Published June, 2011. Accessed February 8, 2019.
- Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J. 2019;39(S1):S1-S3.
- Brody GS, Deapen D, Taylor CR, et al. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg. 2015;135(3):695-705.
- Doren EL, Miranda RN, Selber JC, et al. U.S. epidemiology of breast implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg. 2017;139(5):1042-1050.