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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.
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INTRODUCTION: As reconstructive surgeons have increasingly transitioned to the prepectoral plane for prosthetic breast reconstruction, the implications of mastectomy skin flap necrosis have become more concerning. Our goal was to evaluate the effect of skin flap necrosis on reconstructive outcomes in patients undergoing immediate prepectoral breast reconstruction. METHODS: A retrospective review was conducted of patients undergoing immediate two-stage prepectoral reconstruction at a single center with at least 3 months follow-up. Postoperative complications, reconstructive outcome, and time to final implant were compared between patients with and without mastectomy skin necrosis. RESULTS: A total of 301 patients underwent 509 prepectoral breast reconstructions. Forty-four patients (14.6%) experienced postoperative mastectomy skin flap necrosis. Demographic and reconstructive characteristics were similar between the necrosis and no necrosis cohorts. Patients with skin necrosis were more likely to undergo reoperation after tissue expander (64% vs 19%, p < 0.01) and undergo expander replacement (13.6% vs 3.5%, p = 0.02). However, rates of reconstructive failure (6.8% vs 6.2%), major infection (9.1% vs 9.0%), and minor infection (13.6% vs 17.5%) after expander placement were statistically similar. Patients with skin necrosis trended toward longer time before final implant placement, although the difference was not statistically significant (6.5 vs 5.0 months, p = 0.08). There was no difference in complication rates between the necrosis and no necrosis cohort after final implant placement. There was a higher rate of revision surgery after implant placement in the necrosis cohort (12.5% vs 4.1%, p = 0.047). CONCLUSIONS: Mastectomy skin flap necrosis is a concerning postoperative event, particularly in patients with prepectoral prostheses. We observed that patients with skin necrosis experience higher reoperation rates in the expander period, yet have similar infection rates and achieve similar final reconstructive outcomes compared to patients without necrosis.
