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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?

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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.

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Authors and Affiliations

  1. Nottingham Breast Institute, City Hospital, Nottingham University Hospitals NHS Trust, Hucknall Road, Nottingham, NG5 1PB, UK

    Fayyaz A. K. Mazari, Kristjan S. Asgeirsson, Lisa Whisker, Eleanor Gutteridge, Tuabin Rasheed & R. Douglas Macmillan

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  1. Fayyaz A. K. Mazari
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  2. Kristjan S. Asgeirsson
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  3. Lisa Whisker
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  4. Eleanor Gutteridge
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  6. R. Douglas Macmillan
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Corresponding author

Correspondence to Fayyaz A. K. Mazari.

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Conflict of interest

Fayyaz A. K. Mazari, Kristjan S. Asgeirsson, Lisa Whisker, Eleanor Gutteridge, Tuabin Rasheed, and R. Douglas Macmillan declare no conflict of interest.

Ethical approval

The study was approved by the hospital medical devices review board. Ethical approval was not required as Veritas® was already approved for use in the UK and was being used in other oncoplastic units around the country.

Informed consent

Informed consent for use of Veritas® was obtained from all patients included in the study.

Funding

This project was internally funded by Nottingham Breast Institute. No external funding was received for this project. Veritas® used in this study was provided to the unit at a reduced cost by the manufacturers and the first four units were provided free of charge. The manufacturers did not have any other input in the conduct of the study or writing of this paper.

Patient consent

Patients provided written consent for the use of their images.

Additional information

Presentation

Presented as poster presentation at Oncoplastic Reconstructive Breast Surgery (ORBS) International Meeting September 2017 at Nottingham, UK.

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Mazari, F.A.K., Asgeirsson, K.S., Whisker, L. et al. 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?. Eur J Plast Surg 41, 421–428 (2018). https://doi.org/10.1007/s00238-017-1389-5

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  • DOI: https://doi.org/10.1007/s00238-017-1389-5

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