Xenograft biologic mesh in parietal and general surgery: Technical assessment and review of clinical effectiveness and safety data - 05/12/16

Doi : 10.1016/j.jviscsurg.2016.08.002

A. Sainfort ^a,^⁎ , I. Denis Hallouard ^b, D. Hartmann ^c, G. Aulagner ^a,^c, Y. Francois ^d, O. Tiffet ^e, G. Barabino ^e, O. Nuiry ^b, X. Armoiry ^f
^a Pharmacie, hospices civils de Lyon, 69500 Bron, France
^b Pharmacie des dispositifs médicaux, centre hospitalo-universitaire de Saint-Étienne, 42055 Saint-Étienne, France
^c Équipe I2B – « Interactions biologiques et biomatériaux », UCBL1/ISPB, faculté de pharmacie, UMR CNRS 5510/MATEIS, 69373 Lyon, France
^d Service de chirurgie générale, hospices civils de Lyon, 69495 Pierre-Benite, France
^e Service de chirurgie, centre hospitalo-universitaire de Saint-Étienne, 42270 Saint-Priest-en-Jarez, France
^f Délégation à la recherche clinique et à l’innovation, cellule innovation/UMR-CNRS 5510/MATEIS, hospices civils de Lyon, 69500 Bron, France

^⁎Corresponding author at: Pharmacie, centre hospitalier d’Ardèche Nord, rue du Bon-Pasteur, BP 119, 07103 Annonay, France. Tel.: +33 475 678 901; fax: +33 475 673 718.

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Summary

Study aim

To describe the main technical characteristics of biologic prostheses used for parietal reinforcement and to present the state of the art on their risk/benefit ratio.

Methods

We conducted a technical analysis of manufacturer specifications of the biologic prostheses that are currently available in France accompanied by a literature review by selecting meta-analyses and systematic reviews, randomized controlled trials and publications of health technology rating agencies.

Results

Biological implants for parietal reinforcement are mainly intended for use in a contaminated environment where the use of synthetic prostheses is contra-indicated. We identified fourteen systematic reviews and meta-analyses and one randomized controlled trial. Six ongoing clinical trials were identified as well as two clinical trials that had been interrupted. In the current state of knowledge, there are no high-level evidence data on the therapeutic contribution of biologic prostheses that allow prioritization of the various biologic prostheses according to their characteristics or their different manufacturing processes.

Conclusion

Pending the results of current randomized controlled trials to validate the indications and an eventual specific reimbursement, indications for the use of biologic parietal reinforcement prostheses seems to be limited to rare clinical situations and only after collegial discussion.

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Keywords : Bioprosthesis, Abdominal wall, Digestive surgery, Literature review