What about the Informed Consent for Breast Implantation?

Abstract

Sir:FigureWe read with great interest the article about results obtained by Kim et al.1 from a structured expert consultation process concerning the presumed association between anaplastic large cell lymphoma (ALCL) and breast implants. We congratulate the authors for the exhaustive description through which this dramatically important argument is faced. Basing the investigation on the evidence of the reported cases in the literature,2–4 several aspects of this new clinical entity have been evaluated, including evidence for the association, its clinical significance, and a potential biological model.1 Although some issues regarding ALCL in women with breast implants remain unclear, panelists' conclusions were consistent with a positive association between breast implants and ALCL development but likely underestimated the true number of cases.1 However, anaplastic lymphoma kinase–negative ALCL arising around breast implants should be considered as a clinically indolent disease with a favorable prognosis distinct from the systemic counterpart.1 Furthermore, the panelists set recommendations addressing diagnosis (i.e., aspiration and cytologic analysis of recurrent, clinically evident seroma occurring ≥6 months after breast implantation) and management (i.e., removal of the involved implant and capsule to avoid recurrences and strict evaluation for other sites of disease) of implant-related ALCLs.1 Finally, given that ALCL developing around breast prostheses seems to behave as an indolent disease, Kim et al.1 concluded by suggesting that treatment should focus on local therapies, with aggressive systemic chemotherapy and radiation therapy likely being unnecessary, especially in early-stage cases when the mode of presentation are symptoms and signs linked to or within the fibrous capsule (e.g., seroma, effusion, capsular contracture). Within this context, how should physicians approach patients who require breast implantation? Does informed consent need to include information concerning the possibility of development of implant-related ALCL? Is the classic form, which follows, still ethical and legal? “Currently, medical investigations have not demonstrated any increased risk of breast disease or breast cancer in women who have breast implant surgery for either cosmetic or reconstructive purposes. If they occur, breast diseases develop independently of breast implants. It is recommended that all women perform periodic self examination of their breasts, have mammography according to American Cancer Society guidelines, and seek professional care should they notice a breast lump.” There already have been several criticisms of delay in identifying and downplaying the significance of recent evidence regarding the risks of breast implant–related cancer when speaking to female patients during a recent members-only webinar posted on the American Society of Plastic Surgeons and American Society for Aesthetic Plastic Surgery Web sites.4–6 How should surgeons face this situation? As articles presenting evidence of a possible association between ALCL and implants have now been published and a U.S. Food and Drug Administration alert raised, how could new cases of peri-implant ALCL be justified by physicians to patients who will receive prostheses starting in 2011 without any mention of this risk in the informed consent? Further reports by independent groups should benefit from the dedicated breast implant registry7 that has been recently created. Current U.S. Food and Drug Administration and plastic surgery society1,7–9 guidelines in the United States and those of the European Commission in Europe, further investigations by independent groups, and increased awareness by physicians should lead to earlier diagnoses and proper treatment of implant-related breast ALCLs. Until a connection between breast devices and ALCL is confirmed, breast implants remain safe and effective. In the meantime, although it is actually and realistically estimated that the potential risk of women with breast implants developing ALCL is extremely low (De Jong and colleagues calculated that an incidence of ALCL in the breast would vary between 0.1 and 0.3 per 100,000 women with prostheses per year, which is five cases in 1.7 to 5.1 million person-years10), patients should be aware of this rare complication that should appear in the informed consent for both cosmetic and reconstructive breast implantation. Davide Lazzeri, M.D. Plastic and Reconstructive Surgery Unit Tommaso Agostini, M.D. Burn Center Unit, Hospital of Pisa, Pisa, Italy DISCLOSURE There are no financial conflicts of interest to report in association with the contents of this communication.