Xenograft biologic mesh in parietal and general surgery: Technical assessment and review of clinical effectiveness and safety data.
OBJECTIVE
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.


CONCLUSIONS
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.
Pharmacie, hospices civils de Lyon, 69500 Bron, France. Electronic address: asainfort@ch-annonay.fr.
A
A
Sainfort
Pharmacie des dispositifs médicaux, centre hospitalo-universitaire de Saint-Étienne, 42055 Saint-Étienne, France.
I
I
Denis Hallouard
Équipe I2B - « Interactions biologiques et biomatériaux », UCBL1/ISPB, faculté de pharmacie, UMR CNRS 5510/MATEIS, 69373 Lyon, France.
D
D
Hartmann
Pharmacie, hospices civils de Lyon, 69500 Bron, France; Équipe I2B - « Interactions biologiques et biomatériaux », UCBL1/ISPB, faculté de pharmacie, UMR CNRS 5510/MATEIS, 69373 Lyon, France.
G
G
Aulagner
Service de chirurgie générale, hospices civils de Lyon, 69495 Pierre-Benite, France.
Y
Y
Francois
Service de chirurgie, centre hospitalo-universitaire de Saint-Étienne, 42270 Saint-Priest-en-Jarez, France.
O
O
Tiffet
Service de chirurgie, centre hospitalo-universitaire de Saint-Étienne, 42270 Saint-Priest-en-Jarez, France.
G
G
Barabino
Pharmacie des dispositifs médicaux, centre hospitalo-universitaire de Saint-Étienne, 42055 Saint-Étienne, France.
O
O
Nuiry
Délégation à la recherche clinique et à l'innovation, cellule innovation/UMR-CNRS 5510/MATEIS, hospices civils de Lyon, 69500 Bron, France.
X
X
Armoiry
D034861:Abdominal Wall / Q000601:surgery*; D001705:Bioprosthesis; D003094:Collagen; D013505:Digestive System Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D013526:Surgical Mesh
C422414:Permacol; C568444:strattice; C588278:surgisis; D003094:Collagen
Abdominal wall; Bioprosthesis; Digestive surgery; Literature review