Current risk of breast implant-associated anaplastic large cell lymphoma: a systematic review of epidemiological studies
Evan B. Lynch, Ryan DeCoster, Krishna S. Vyas, Brian Rinker, Mei Yang, Henry C. Vásconez, Mark W. Clemens
Abstract
Recent epidemiological studies have attempted to accurately determine the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). However, comparisons of previously published works are difficult due to widespread variations in reporting. We systematically review the epidemiology in order to better define the current risk of BIA-ALCL. Herein, we report the global epidemiology with an emphasis on the U.S. breast implant population while simultaneously assessing the oncologic safety of smooth-surface devices. In the current manuscript, a systematic review of PubMed and other scientific databases, as well as the grey literature, was conducted for epidemiologic studies on BIA-ALCL. Using analytical and descriptive epidemiology, we estimated the cumulative incidence and incidence rate of BIA-ALCL using a standardized approach. Cumulative incidence was reported at implant and patient-specific levels. The patient-specific cumulative risk within the U.S. market ranges from 1.79 per 1,000 (1:559) to 2.82 per 1,000 (1:355) patients with a textured implant. The implant-specific risk of Allergan textured devices ranges from 1:602-871 to 1:8,500, while the risk of commercially available Mentor Siltex implants is 1:50,000. No epidemiological study or regulatory agency reported a case of BIA-ALCL occurring exclusively with a smooth device. As such, with the removal of Allergan textured breast devices, this study demonstrates substantial gaps in the epidemiological knowledge of BIA-ALCL, including the current risk of commercially available textured breast implants in the U.S. market. Although the risk of BIA-ALCL is low, surgeons should exercise extreme caution when considering the use of a textured breast device for cosmetic or reconstructive purposes.