Thinking Outside the Black Box

Current Perceptions on Breast Implant Safety and Utility

Pooja S. Yesantharao, M.S.; Erica Lee, M.S.; Nima Khavanin, M.D.; Sarah Persing, M.D., M.P.H.; Hillary Jenny, M.D., M.P.H.; Mya Abousy, B.S.; Kristen P. Broderick, M.D.; Justin M. Sacks, M.D., M.B.A.

Disclosures

Plast Reconstr Surg. 2021;147(3):593-603. 

In This Article

Abstract and Introduction

Abstract

Background: There is growing public concern surrounding breast implant safety. In fact, the U.S. Food and Drug Administration recently proposed changes to breast implant labeling, which include a boxed warning. Given such efforts to increase transparency on breast implant safety, this study assessed laywomen's perceptions of breast implant safety, and the impact of proposed changes to breast implant labeling on laywomen's decision-making regarding breast implants.

Methods: This was a cross-sectional investigation of women recruited through Amazon Mechanical Turk. Discrete choice modeling was used to query opinions on breast implants after viewing proposed labeling changes. Chi-square and analysis of variance were used for subgroup analyses, and McNemar analyses were used to assess changes in participants' responses.

Results: The authors received 500 survey responses. At baseline, 353 participants (70.6 percent) considered breast implants to be at least somewhat safe. After viewing the proposed boxed warning, 252 participants (50.4 percent) responded that they would be less likely to receive implants. In fact, a significantly greater proportion of participants considered breast implants to be either unsafe or very unsafe after viewing suggested changes to implant labeling than at baseline (58.4 percent versus 28.8 percent; p = 0.001). By the end of the survey, willingness to consider alternative options for breast augmentation/reconstruction increased significantly from baseline.

Conclusions: Improved labeling can enhance laywomen's understanding of breast implant safety and can impact decision-making. However, greater scrutiny of breast implants should not prevent women who need implants from receiving them. Transparency and objectivity in the surgeon-patient dialogue can ensure the appropriate use of medical devices such as breast implants.

Introduction

Growing evidence on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) combined with greater patient advocacy efforts has made breast implant safety a prominent issue.[1–3] Over 300 cases of BIA-ALCL have been documented in the United States alone, and countless other women have reported systemic symptoms in relation to implants, collectively referred to as breast implant illness.[4,5] Nonetheless, implant-based breast procedures are among the most commonly performed by plastic surgeons.[6] As such, the U.S. Food and Drug Administration has taken steps to better understand and address implant-associated risks, through the General and Plastic Surgery Devices Advisory Panel and subsequent recall of Allergan Biocell (Allergan, Inc., Dublin, Ireland) textured devices.[6,7] Increasing media attention on breast implants following U.S. Food and Drug Administration intervention, especially on topics that are still debated in the scientific community such as breast implant illness, has caused much consternation among providers on how to best facilitate dialogue on breast implant safety.[8]

To provide greater transparency regarding breast implant safety, the U.S. Food and Drug Administration released a draft guidance to improve breast implant labeling in October of 2019.[9] This guidance included one of the U.S. Food and Drug Administration's strongest device safety actions short of a recall: a boxed warning (i.e., "black box" warning).[10] In the context of such patient safety efforts, the objective of this study was to assess laywomen's baseline perceptions of breast implant safety/utility, and the impact of proposed changes to breast implant labeling on laywomen's breast implant-related decision-making. As a secondary objective, we assessed laywomen's opinions on the proposed changes to breast implant labeling.

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