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Assessing the Impacts of the FDA Boxed Warning on Breast Implants: Analyzing Reconstructive and Aesthetic Procedural Trends
Goutam K. Gadiraju
3, Renee Gao
*1, Yizhuo Shen
5, Sara P. Myers
2, Justin Broyles
41UMass Chan Medical School, Worcester, MA; 2Ohio State University, Columbus, OH; 3Harvard Medical School, Boston, MA; 4Brigham and Women's Hospital, Boston, MA; 5Yale School of Medicine, New Haven, CT
Background: On October 27, 2021, the FDA implemented a boxed warning and standardized Patient Decision Checklists (PDC) for breast implants to improve risk communication regarding complications like BIA-ALCL. While survey data suggested these mandates might decrease surgical interest, their real-world impact on national procedural volumes remains unknown. This study quantifies the longitudinal impact of the FDA boxed warning on implant-based reconstruction (IBR) and breast augmentation (BA).
Methods: Monthly procedural rates were retrieved from Epic Cosmos, spanning 177 healthcare organizations from January 2017 through January 2025. An Interrupted Time Series (ITS) analysis was performed to identify immediate level-changes and gradual slope-changes following the October 2021 warning. A cross-sectional survey of 407 reconstructive patients further evaluated the impact of the warning on patient-reported decision-making.
Results: Among 211,849 IBR and 12,206 BA procedures, ITS demonstrated a significant immediate decline in monthly IBR of 251.9 procedures (10.4% volume, p<0.01) following the warning. However, this decline was transient; IBR growth subsequently recovered with a 66.2% increase in slope compared to the pre-intervention trend (p=0.0016). Conversely, BA experienced a sustained decline in growth rate, reduced to 27.8% of its pre-intervention trend (p<0.01). Survey results corroborated this relative inelasticity in reconstruction, as 60.2% of respondents disagreed that the warning affected their clinical decision.
Conclusion: FDA boxed warnings modulate national procedural volumes, but their impact diverges sharply between reconstructive and aesthetic populations. The sustained reduction in BA versus the transient decline in IBR suggests that regulatory signals are heavily mediated by the clinician's role in translating quantitative evidence within longitudinal care pathways. Future regulatory actions must look beyond labeling alone and account for the clinical context and health literacy required to support values-concordant decisions.
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