Related Experiment Video
Updated: May 23, 2026
Endoscopic Bilateral Nipple-sparing Mastectomy via a Single Axillary Incision with Immediate Pre-pectoral Implant-based Breast Reconstruction
Published on: May 17, 2024
Acellular Dermal Matrix-assisted Implant-based Breast Reconstruction: Surgical and Patient-reported Outcomes From the
Christian X Lava1,2, Karen R Li2, Qian Mao3
1From the Georgetown University School of Medicine, Washington, DC.
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/m2. 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.