Acellular Dermal Matrix–assisted Implant-based Breast Reconstruction: Surgical and Patient-reported Outcomes From the Mastectomy Reconstruction Outcomes Consortium Study

Background: Acellular dermal matrices (ADMs) are used in most of the United States but are not FDA-approved for this indication. We evaluated SurgiMend (Integra) in immediate 2-stage subpectoral reconstruction versus no ADM. Methods: An FDA-aligned statistical analysis plan was applied to the prospective Mastectomy Reconstruction Outcomes Consortium cohort. Patients underwent 2-stage subpectoral implant-based breast reconstruction with SurgiMend or without ADM. BREAST-Q Physical Well-Being (Chest) scores were collected preoperatively and at 1 week, 3 months, 1 year, and 2 years. The primary outcome was composite clinical success, defined as a decline in BREAST-Q score of 4 point or less at 1 year and no major complication within 2 years. Results: Among 987 patients, 119 (12.1%) received SurgiMend and 868 (87.9%) underwent reconstruction without ADM. Mean age was 48.1±10.4 years. Mean body mass index was 25.8±5.3 kg/m 2 . Most patients underwent mastectomy for cancer (SurgiMend 85.7%; control 92.9%); nearly half underwent prophylactic procedures (SurgiMend 47.9%; control 52.9%). At 1 year, BREAST-Q scores were higher in the SurgiMend group (44.5% versus 39.1%; difference 5.4%, 95% CI −5.2 to 16.0). In propensity-adjusted analyses, major complications were lower with SurgiMend (33.7% versus 46.7%; difference −13.1%, 95% CI −22.5 to −3.7). Composite clinical success was significantly higher with SurgiMend (32.4% versus 21.1%; difference 11.2%, 95% CI 1.7 to 20.8; P = 0.02). Conclusions: SurgiMend was associated with fewer complications and higher patient-reported outcomes, supporting its safety and effectiveness in postmastectomy reconstruction.