Plastic Surgeons' Perspective on the FDA Breast Implant Regulatory Mandates

Abstract

Background: In 2021, the US Food and Drug Administration (FDA) issued a new checklist, labeling and rupture screening recommendations for breast implants to improve the decision-making process.

Objectives: This study aims to understand the plastic surgeon's perspective on these changes and their perceived impact on clinical practice.

Methods: In September 2023, a 27 multiple-choice cross-sectional survey was distributed to 4,352 active members of the American Society of Plastic Surgeons to evaluate attitudes on the FDA's black box warning, informed decision checklist, and updated rupture screening recommendations.

Results: A total of 591 responses were collected (13.6%). The majority of respondents were between the ages of 45 to 64 (58%) and had been in practice for more than 20 years (52%). Surgeons felt like some additions were appropriate, however the majority (57%) stated that the informed decision checklist did not have a positive impact on workflow; 66% were also neutral or disagreed with the reported incidence rates related to complications and cancer. Nearly half of respondents (47%) did not feel the black box warning improved their patients' understanding of the risks and benefits. Additionally, 47% of respondents also believed these requirements, in combination, did not improve the overall patient experience with implants.

Conclusions: Respondents had an overall positive response towards the addition of risk information provided by the FDA issued guidance and updates to rupture screening recommendations. However, they remain divided as to whether the black box warning and patient decision checklist had an overall positive impact on clinical practice patterns.