Safety Alerts for Human Medical Products > Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer

Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer




AUDIENCE: Plastic Surgery, Oncology, Hematology

ISSUE: 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.

BACKGROUND: In total, the agency 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. An estimated 5 million to 10 million women worldwide have breast implants. According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

RECOMMENDATION: In an effort to ensure that patients receiving breast implants are informed of the possible risk, 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 health care professionals report any confirmed cases of ALCL in women with breast implants.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* 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 links to the FDA Press Release, Medical Device Safety Communication, Preliminary FDA Findings & Analyses, and Questions and Answers about Anaplastic Large Cell Lymphoma, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241101.htm

Safety Alerts for Human Medical Products > Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer