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Thinking Outside The "Black Box" - Evaluating The Impact Of A Boxed Warning For Breast Implants
Pooja S. Yesantharao, MS, Erica Lee, MS, Mya Abousy, BS, Sarah Persing, MD, MPH, Pragna N. Shetty, MPH, Justin M. Sacks, MD, MBA.
Johns Hopkins Medicine, Baltimore, MD, USA.

PURPOSE: The growing evidence on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) has caused much consternation amongst providers on how to best facilitate dialogue with patients on breast implant safety. In October 2019, the US Food and Drug Administration (FDA) released a draft guidance to improve breast implant labeling. A boxed warning (or "black box warning") on the risks associated with breast implants is part of the FDA guidance. Historically, these warnings have been controversial. The purpose of this study assessed the impact of the FDA's draft guidance, including the boxed warning, on women's decision-making regarding breast reconstruction. Specifically, we aimed to comparatively elucidate the impact of standard counseling/education versus the recommendations put forth by the FDA draft guidance.
METHODS: This is an Institutional Review Board exempt cross-sectional study of 250 women recruited through Amazon Mechanical Turk. Respondents self-reported demographics and personal history/experience with breast implants. Discrete choice modeling was used to query opinions on breast implants after exposure to education on BIA-ALCL, and then again after exposure to the FDA draft guidance recommendations.
RESULTS: Of the 250 respondents, 15.2% (9.2% reconstructive and 5.8% cosmetic) had a personal history of breast implants, while 70.1% knew of someone with implants. Among respondents, 54.8% would consider receiving a breast implant. Change in participants' responses from the beginning to the end of the survey were assessed with each intervention: education/counseling on BIA-ALCL statistics led to a nonsignificant decline in participants who would consider receiving a breast implant (-1.3%, p=0.41), while listing the chemical composition of breast implants led to a significant decline (-17.3%, p<0.001) as did presentation of the boxed warning (-10.2%, p<0.01). After viewing breast implant composition and the boxed warning, the proportion of participants choosing autologous reconstruction or no reconstruction over implants increased significantly, with a greater increase in preference for autologous reconstruction (+10.7% for autologous, +4.3% for no reconstruction). Respondents who changed responses from "likely" to "unlikely" were significantly more likely to have never heard of BIA-ALCL prior to survey participation. Upon multivariate analysis, personal history of breast implants significantly increased odds of continuing to prefer implants at survey completion (OR: 1.5, p<0.01).
CONCLUSION: A boxed warning and more accurate ingredient labeling is important in promoting patient literacy with regards to breast implants, and has the potential to significantly-impact perceptions on breast reconstruction. However, breast implants play a substantial role in breast reconstruction and augmentation: over 300,000 women undergo implant-based breast procedures annually in the United States. Thus, information presented in the FDA draft guidance should be counterbalanced with appropriate education regarding the benefits of breast reconstruction and/or augmentation, including its psychosocial impact and alternative modalities (i.e. autologous flap-based procedures for those undergoing breast reconstruction). Our results demonstrate the substantial influence of patient education on perceptions: in the new era of breast implant safety, it is critical to appropriately frame the surgeon-patient conversation surrounding breast implants.


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