FDA Emphasizes Lymphoma Risk in Women with Breast Implants.

[Argirios Argiriou]

February 8, 2019

FDA Emphasizes Lymphoma Risk in Women with Breast Implants
By Amy Orciari Herman

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

Breast implants — regardless of the surface or fill type — put women at increased risk for anaplastic large cell lymphoma (ALCL), the FDA warned on Wednesday as part of its ongoing investigation into the association.

ALCL most often develops in the fibrous scar tissue that forms around the implant. As of September 2018, the agency had received nearly 460 unique reports of ALCL tied to breast implants, including nine related deaths. While two-thirds involved implants with textured surfaces, 5% involved smooth surfaces; surface type was not reported for the rest. Nearly 60% of cases presented with seroma, and 30% with breast swelling or pain.

The estimated incidence of implant-associated ALCL ranges from 1 in 30,000 to 1 in 3,800.

The FDA urges clinicians to consider ALCL in patients with late-onset, peri-implant seroma, and to refer such patients to a multidisciplinary team for assessment. All cases of implant-associated ALCL should be reported to the agency at the third link below.

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