About 70,000 textured breast implants are used in the U.S. each year. That's about 12.7% of all breast implants used here.
In 2011, the FDA identified a possible association between breast implants (whether they were used for augmentation or breast reconstruction) and anaplastic large cell lymphoma (ALCL); lymphoma is cancer of the lymphatic system. At that time, the FDA knew of so few cases of ALCL that it was not possible to determine what factors increased a patient’s risk. The agency emphasized the need to gather additional information to better characterize ALCL in individuals with breast implants.
In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significantly limited worldwide reporting and lack of data for global breast implant sales.
Based on the most recent available data, the FDA reports that BIA-ALCL occurs more frequently with textured breast implants than smooth-surfaced implants. On March 21, 2018, the FDA released an annual safety communication updating the current understanding of BIA-ALCL, including the following information:
As of September 30, 2017, the FDA received 414 medical device reports of BIA-ALCL, including:
It is unknown whether these patients had their original breast implants or replacements at the time they were diagnosed with ALCL. (The medical device reports (MDRs) that provided this information do not give information about a patient’s history of breast implants.)
The FDA website states, "In addition, it is difficult to determine the total number of cases or estimate risk from the MDR reporting system due to potential under-reporting of events, possible duplicate reporting, and lack of data about the exact number of breast implants."
Estimated risk of ALCL
BIA-ALCL is not common, and because the available data is limited regarding cases of ALCL related to breast implants, projecting exact risk estimates is difficult. Since 2016, however, several wide-ranging estimates of the lifetime risk for BIA-ALCL in women with textured breast implants have been published. Currently, 1 of 3,817 to 30,000 women with textured breast implants is estimated to develop ALCL.
ALCL can develop adjacent to or in the capsule of scar tissue surrounding the implant. Successful treatment most often involves removing the implant and the scar tissue; radiation therapy, chemotherapy or additional treatment is not usually required. The FDA recommends seeing a physician if the area around an implant looks or feels unusual.
de Boer M, van Leeuwen FE, Hauptmann M, et al. "Breast implants and the risk of anaplastic large-cell lymphoma in the breast." JAMA Oncology. 2018;4(3):335-341.
Loch-Wilkinson A, Beath KJ, Knight RJW, et al. "Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: High-surface-area textured implants are associated with increased risk." Plastic and Reconstructive Surgery. 2017; 140(4):645-654.
American Society of Plastic Surgeons. "BIA-ALCL Resources." https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers.