FDA reviews possible risk of anaplastic large cell lymphoma (ALCL) with breast implants

The FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL). Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. The FDA is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, the FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals. The FDA is requesting that healthcare professionals report any confirmed cases of ALCL in women with breast implants.

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm.