BACKGROUND: In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. FDA continues to collect and evaluate information about ALCL in women with breast implants.
RECOMMENDATIONS: Healthcare providers: If you have patients with breast implants, you should continue to provide them routine care and support. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended. Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturers’ labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
Patients: Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants. If you already have breast implants, there is no need to change your routine medical care and follow-up.
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch safety alert, including a link to the FDA update, at:
REFERENCE: FDA MedWatch update