Purpose: Case reports [Li,2009] and a case-control study [deJong,2008] have suggested a potential association between breast implants and ALK-negative anaplastic large cell lymphoma (ALCL), an extremely rare non-Hodgkin's lymphoma (NHL) of the breast. We aimed to review the available evidence on ALCL and breast implants including case reports and epidemiologic studies and provide a critical evaluation.

Methods: Search methods: i) Database=PubMed; ii) Search terms=”breast implant” and “lymphoma”, or “primary breast lymphoma”; iii) Inclusion criteria: language=English; human studies; iv) Expand search based on review of references.

Results: This review revealed that: 1) Breast-ALCL has been reported in women with and without breast implants [deJong,2008] and, 2) with and without a prior cancer history [Li,2009]. The only case-control study examining an association between ALCL and breast implants to date [deJong,2008] included 6/11 ALK-negative ALCL cases with no history of breast implantation. Nine of 22 (41%) ALCL cases reported among patients with breast implants had a personal history of breast cancer (N=8) or lymphoma (N=1) [Li,2009]. 3) Authors concluded ALCL in the anecdotal case reports does not behave aggressively as is expected based on the epidemiology of ALK-negative ALCL, and spontaneous resolutions have been reported [Li,2009]. Although most patients with ALCL received chemotherapy and/or radiotherapy, some were followed with only observation and no known cause-specific deaths have been reported in patients with breast implants [Li,2009]. 4) Device type in case reports is often unknown [Li,2009]; reports have included saline- and silicone-filled devices [Li,2009]. 5) Interval between implantation and ALCL diagnosis varies widely in the reports, between 1-23 years [deJong,2008]. 6) Primary breast lymphomas may be difficult to definitively diagnose and distinguish from secondary involvement of disease originating elsewhere [Domchek,2002]. Five of eleven ALCL cases in the case-control study had disseminated disease with involvement of other sites providing uncertainty about the breast as the primary site [deJong,2008]. 7) Breast implant patients have been reported to have demographic and lifestyle characteristics which may influence their risk of certain cancers [Brinton,2000]; the relevance of these characteristics to ALCL risk is unknown. 8) While no prospective epidemiologic studies have examined ALCL risk among breast implant patients to date, several have reported no significantly increased NHL risk [Lipworth,2009].

Conclusions: Taken together, the evidence regarding a breast implant-breast ALCL association is inconclusive.