Press Announcements > FDA review indicates possible association between breast implants and a rare cancer

Possible Link between Breast Implants and a Rare Cancer

On January 26, FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. 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 recommending that health care professionals and women pay close attention to breast implants and do the following:

. Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program.
Report online or by calling 800-332-1088.

.. Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.

... There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.

.... Women should monitor their breast implants and contact their doctor if they notice any changes.

..... Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.


To Learn More:
FDA Press Release
Press Announcements > FDA review indicates possible association between breast implants and a rare cancer

FDA Consumer Article
Consumer Updates > FDA Advises Women with Breast Implants


Press Announcements > FDA review indicates possible association between breast implants and a rare cancer