Complete resorption of Veritas® in acellular dermal matrix (ADM)-assisted implant-based breast reconstructions—is there a need for tighter regulation of new products developed for use in breast reconstruction?

Abstract

Background

Veritas® collagen matrix is derived from bovine pericardium and is currently used in soft tissue and breast reconstruction. This study reports the experience of implant-based breast reconstruction using Veritas® collagen matrix in a specialist breast unit.

Methods

This case series included all consecutive patients undergoing mastectomy and implant-based reconstruction using Veritas® over an 18-month period. Demographics, risk factors, operative parameters and postoperative outcomes were recorded prospectively.

Results

Nineteen patients underwent a total of 30 breast reconstruction procedures over the study period. Of these, 57.9% (N = 11) had bilateral procedures. Breast cancer was the commonest indication. Forty percent (N = 12) had concomitant axillary surgery. Forty percent (N = 12) had two-stage reconstruction. Prophylactic antibiotics and drains were used in all cases. Median mastectomy weight was 308 g (interquartile range (IQR) 205–363 g). Median implant volume was 350 ml (IQR 275–400 ml). Twenty percent (N = 6) had minor complications within 3 months. Forty-two percent (N = 8) of patients had complete resorption of Veritas® (50%, N = 15 reconstructions) with "bottoming out" of implants requiring revision surgery. Ten percent (N = 3) developed capsular contracture following radiotherapy and 3.3% (N = 1) had implant loss due to pain following postoperative infection. Product outcomes were reported to the manufacturers.

Conclusions

Veritas® collagen matrix has a comparable immediate postoperative complication rate when compared to other acellular dermal matrix. However, the long-term resorption rate in this series is high resulting in frequent correctional surgery.

Level of Evidence: Level III, risk/prognostic study.