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Published on: August 19, 2025
SERI Surgical Scaffold in 2-Stage Breast Reconstruction: 2-Year Data from a Prospective, Multicenter Trial
Nolan Karp1, Mihye Choi1, David A Kulber1
1NYU School of Medicine, New York, N.Y.; USC Keck School of Medicine, Los Angeles, Calif.; Private Practice, Los Angeles, Calif.; Aesthetic Center for Plastic Surgery, McLean, Va.; Private Practice, San Francisco, Calif.; PC, Eugene, Ore.; Allergan plc, Irvine, Calif.; Teleos Plastic Surgery, Pasadena, Calif.; and Northwestern Specialists in Plastic Surgery, Chicago, Ill.
Background:
Soft-tissue support devices are used during breast reconstruction. This study investigated long-term clinical data following SERI Surgical Scaffold (SERI) implantation, a bioresorbable, silk-derived scaffold for soft-tissue support.
Methods:
This was a prospective, multicenter study in 103 subjects who received SERI during stage 1 of 2-stage breast reconstruction with subpectoral tissue expander placement (Natrelle Style 133V; Allergan plc, Dublin, Ireland) followed by subpectoral breast implant placement. Investigator satisfaction (11-point scale: 0, very dissatisfied and 10, very satisfied) at 6 months was the primary endpoint. Ease of use, satisfaction, scaffold palpability/visibility, breast anatomy measurements via 3D images, SERI integration, histology, and safety were also assessed through 2 years after stage 1 surgery.
Results:
Analyses were performed on the per-protocol population (103 subjects; 161 breasts) with no protocol deviations that could affect outcomes. Ease of use and subject and investigator satisfaction with SERI were high throughout 2 years. Breast anatomy measurements with 3D images demonstrated long-term soft-tissue stability of the lower breast mound. Key complication rates per breast were tissue/skin necrosis and wrinkling/rippling (8.1% each) and seroma, wound dehiscence, and breast redness (5.0% each). Over 2 years, 4 breasts in 4 subjects underwent reoperation with explantation of any device; 2 breasts required SERI explantation. SERI was retained in 98.8% of breasts (159/161) at 2 years.
Conclusions:
SERI was associated with high and consistent levels of investigator and subject satisfaction and demonstrated soft-tissue stability in the lower breast through 2 years. SERI provides a safe, long-term benefit for soft-tissue support in 2-stage breast reconstruction.
