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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.
The SERI Surgical Scaffold (SERI) demonstrated high subject and investigator satisfaction and maintained soft-tissue stability in breast reconstruction over two years. This bioresorbable scaffold offers a safe, long-term solution for soft-tissue support.
Area of Science:
- Plastic Surgery
- Biomaterials Science
- Regenerative Medicine
Background:
- Soft-tissue support devices are crucial in breast reconstruction procedures.
- The SERI Surgical Scaffold (SERI), a novel bioresorbable, silk-derived scaffold, is designed for soft-tissue support.
- Long-term clinical data on SERI implantation was investigated.
Purpose of the Study:
- To evaluate the long-term clinical outcomes of SERI Surgical Scaffold (SERI) implantation.
- To assess investigator and subject satisfaction with SERI through two years post-implantation.
- To determine the safety and efficacy of SERI in two-stage breast reconstruction.
Main Methods:
- A prospective, multicenter study involving 103 subjects undergoing two-stage breast reconstruction.
- SERI was implanted during stage 1 with subpectoral tissue expander placement.
- Primary endpoint was investigator satisfaction at 6 months; secondary endpoints included ease of use, satisfaction, palpability, 3D breast anatomy measurements, integration, histology, and safety up to 2 years.
Main Results:
- High levels of ease of use, subject, and investigator satisfaction with SERI were observed throughout the 2-year study period.
- 3D imaging confirmed long-term soft-tissue stability in the lower breast mound.
- Key complication rates included tissue/skin necrosis and wrinkling/rippling (8.1% each). SERI was retained in 98.8% of breasts at 2 years.
Conclusions:
- SERI demonstrated high and consistent investigator and subject satisfaction.
- The scaffold provided reliable soft-tissue stability in the lower breast mound for up to two years.
- SERI offers a safe and effective long-term solution for soft-tissue support in two-stage breast reconstruction.
