Safety of mesh with fluoropolymer coating during intra-abdominal placement in large animals: results of the pilot study

Abstract

When performing laparoscopic intraperitoneal hernioplasty (IPOM), endoprostheses made of fluoropolymers are often used. However, there is no data in the literature on the intra-abdominal use of inexpensive polyester prostheses with a fluoropolymer coating compared to composite implants. Thus, the aim of the pilot study was a preliminary assessment of the safety profile of FTOREX mesh endoprostheses during intra-abdominal placement in large animals. 6 endoprostheses were installed laparoscopically intraperitoneally in each of the 3 pigs: 1) FTOREX; 2) FTOREX with a layer of carboxymethylcellulose; 3) REPEREN-16-2; 4) SYMBOTEX; 5) VENTRALIGHT ST; 6) decellularized pork peritoneum. Fixation was performed with a herniator, transfascial sutures were not used. Relaparoscopy was performed after 45 days, and withdrawal from the experiment was performed after 90 days. Performance characteristics, signs of deformation and retraction, parameters of spike formation were evaluated. All the animals survived, no complications were observed. There were no clinical manifestations or behavioral reactions indicating the presence of adhesions. The most convenient to use were the SYMBOTEX and FTOREX implants (5.0 points each). By the end of the experiment, deformation and retraction were noted in both variants of the FTOREX implants and the REPEREN prosthesis. These changes were completely absent only when using the SYMBOTEX endoprosthesis. According to the number of implants with adhesions, by the end of the observation, both variants of FTOREX prostheses occupied an intermediate position between the Reference (the worst indicator) and VENTRALIGHT ST (the best indicator). However, both FTOREX endoprostheses showed the best performance among all implants in the integral assessment of adhesions, as well as in terms of parameters such as the area and appearance of adhesions, and in terms of the strength of the joints, they were second only to the VENTRALIGHT ST endoprosthesis (0.67 vs. 0.5 points). During the study, there was no reliable dependence of deformation, retraction and adhesion formation indicators on the type of implant. The results of the pilot study showed that all the implants used did not cause any clinically significant adverse reactions or complications. FTOREX endoprostheses with their intraperitoneal installation have anti-adhesive properties that are not inferior to VENTRALIGHT ST or SYMBOTEX composite implants. However, having less rigidity, they are more often deformed and subjected to retraction.