Surgimend matrix - unspecified

Description of Event or Problem

ANTICANCER RESEARCH (2019) published "A Retrospective Head-to-head Comparison Between TiLoop Bra/TiMesh and Seragyn in 320 Cases of Reconstructive Breast Surgery"Background/Aim: "Clinical data concerning synthetic meshes in comparison to acellular dermal matrices (ADMs) in breast reconstruction are limited. Also, direct comparisons between titanium-coated polypropylene mesh and partially absorbable polypropylene mesh have not yet been reported. "Materials and Methods: "This analysis represents a retrospective, single-surgeon, multi-center study of 320 cases using either TiLoop Bra/TiMesh (n=192) or Seragyn (n=128) in breast reconstruction. Results were compared with ADM-based reconstructions (Epiflex and SurgiMend)."Results: "Major complication rates (i.e. revision surgery) occurred in 3.9% (Seragyn) and 8.3% (TiLoop Bra/TiMesh) of all cases. Minor complications occurred in 18% (Seragyn) and 8.9% (TiLoop Bra/TiMesh). Subgroup analysis showed red breast syndrome to occur more often in the Seragyn group (3.9% Seragyn vs. 0.5% TiLoop Bra/TiMesh, p<0.05).Conclusion: TiLoop Bra/TiMesh and Seragyn do not differ significantly in complication rates. There was no difference in performance when compared to ADMs.This report is for adverse events/complications:Complication rates in patients using SurgiMend:- Patients: 63 - Oncological intervention: 57 (90.5%) - Aesthetic Surgery: 6 (9.5%)- Complications: - Total: 7/63 (11.1%) - Revision surgery: 3/63 (4.8%) - Seroma requiring aspiration: 1/63 (1.6%) - Red Breast Syndrome/Rash: 3/63 (4.8%)doi:10.21873/anticanres.13383 Note from manufacturer: Even though the literature doesn't provide information directly relating SurgiMned to the adverse events. The adverse events/complications happened in patients using Surgimend.

Additional Manufacturer Narrative

An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.