Plastic Surgeons' Perspective on the FDA Breast Implant Regulatory Mandates.

[BACKGROUND] In 2021, the US FDA issued a new checklist, labeling, and rupture-screening recommendations for breast implants to improve the decision-making process.

[OBJECTIVES] The aim of this study was to understand plastic surgeons' perspective on these changes and their perceived impact on clinical practice.

[METHODS] In September 2023, a 27-question multiple-choice cross-sectional survey was distributed to 4352 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 and 64 years (58%) and had been in practice for more than 20 years (52%). Surgeons felt that 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 remained divided as to whether the black-box warning and patient decision checklist had an overall positive impact on clinical practice patterns.