Apr 20, 2011
Results from a Structured Expert Consultation Process
Published in: Plastic and Reconstructive Surgery, v. 128, no. 3, Sep. 2011, p. 629-639
Posted on RAND.org on September 01, 2011
BACKGROUND: There are increasing concerns about a possible association between anaplastic large cell lymphoma (ALCL) and breast implants. We conducted a structured expert consultation process to evaluate the evidence for the association, its clinical significance, and a potential biological model based on their interpretation of the published evidence. METHODS: A multidisciplinary panel of 10 experts was selected based on nominations from national specialty societies, academic department heads, and recognized researchers in the U.S. RESULTS: Panelists agreed that (1) there is a positive association between breast implants and ALCL development but likely under-recognition of the true number of cases; (2) a recurrent, clinically evident seroma occurring >= 6 months after breast implantation should be aspirated and sent for cytologic analysis; (3) anaplastic lymphoma kinase (ALK)-negative ALCL that develops around breast implants is a clinically indolent disease with a favorable prognosis that is distinct from systemic ALK-negative ALCL; (4) management should consist of removal of the involved implant and capsule, which is likely to prevent recurrence, and evaluation for other sites of disease; and (5) adjuvant radiation or chemotherapy should not be offered to women with capsule-confined disease. Little agreement, however, was found regarding etiologic risk factors for implant-associated ALCL. CONCLUSIONS: Our assessment yielded consistent results on a number of key issues regarding ALCL in women with breast implants, but substantial further research is needed to improve our understanding of the epidemiology, clinical aspects, and biology of this disease.