Inguinal risk statement (PP1208DL, PP1208DR, PP1509G): Mesh complications may include but are not limited to acute and chronic pain, extrusion/erosion, hematoma, infection, inflammation, recurrence, and/or seroma. ProGrip™ self-gripping polypropylene mesh is not intended to be used for laparoscopic hernia repair. Do not place the mesh in direct contact with the viscera. Direct contact with the viscera may lead to risks of adhesions, fistula formation, and bowel obstruction. Do not implant the mesh in an intra-peritoneal position. When implanting in a pre-peritoneal site, the mesh shall be placed with the grips towards the muscle fascia with the mesh completely covered with peritoneum.
Ventral risk statement (PP1515G, PP2015G, PP3020G, PP3030G, PP4030G): Mesh complications may include but are not limited to acute and chronic pain, extrusion/erosion, hematoma, infection, inflammation, recurrence, and/or seroma. The compatibility of ProGrip™ self-gripping polypropylene mesh with trocars and laparoscopic instruments has not been established. Do not place the mesh in direct contact with the viscera. Direct contact with the viscera may lead to risks of adhesions, fistula formation, and bowel obstruction. Do not implant the mesh in an intra-peritoneal position. When implanting in a pre-peritoneal site, the mesh shall be placed with the grips towards the muscle fascia with the mesh completely covered with peritoneum.
†Based on preclinical data, not necessarily indicative of human clinical outcomes.
‡Based on feedback from 6 surgeons, conducted in lab setting with cadaver. Surgeons compensated.
§Applicable to PP1515G, PP2015G, PP3020G, PP3030G, PP4030G.
ΩBased on benchtop data, not necessarily indicative of human clinical outcomes.
††The technique used to fixate the mesh (suture and/or tacks) is left up to the surgeon.
‡‡The textile self-gripping feature makes it possible to position the mesh without fixation, depending on the size of the defect, the hernia position, and the quality of the anatomical structures.
§§Compared to flat sheet meshes. Based on feedback from 6 answers, 5 surgeons (83%), conducted in lab setting with cadaver. Surgeons compensated.
ΩΩBased on animal study, not necessarily indicative of human clinical outcomes.
1. Based on internal test report #43615CR071, Design verification report. July 2023.
2. Based on internal test report #43615CR073, Design validation report. July 2023.
3. Based on internal test report #43615CR103, GROOT marketing questionnaire. July 2023.
4. Based on internal test report #43615CR042, Design output file. July 2023.
5. Benito-Martínez S, Rodríguez M, García-Moreno F, et al. Self-adhesive hydrogel meshes reduce tissue incorporation and mechanical behavior versus microgrips self-fixation: a preclinical study. Hernia. 2022;26(2):543–555.
6. Anadol AZ, Akin M, Kurukahvecioglu O, Tezel E, Ersoy E. A prospective comparative study of the efficacy of conventional Lichtenstein versus self-adhesive mesh repair for inguinal hernia. Surg Today. 2011;41(11):1498–1503.
7. Based on internal test report #43615CR123, Fixation information for ProGrip™ self-gripping polypropylene mesh in ventral hernia repair. September 2023.
8. Bruna Esteban M, Cantos Pallarés M, Artigues Sánchez de Rojas E, Vila MJ. [Prospective randomized trial of long-term results of inguinal hernia repair using autoadhesive mesh compared to classic Lichtenstein technique with sutures and polypropylene mesh]. Cir Esp. 2014;92(3):195–200.
9. Bruna Esteban M, Cantos Pallarés M, Artigues Sánchez De Rojas E. Use of adhesive mesh in hernioplasty compared to the conventional technique. Results of a randomized prospective study. Cir Esp. 2010;88(4):253–258.
10. Köhler G, Lechner M, Mayer F, et al. Self-Gripping Meshes for Lichtenstein Repair. Do We Need Additional Suture Fixation? World J Surg. 2016;40(2):298–308.
11. Jorgensen LN, Sommer T, Assaadzadeh S, et al. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg. 2013;100(4):474–481.
12. Pierides G, Scheinin T, Remes V, Hermunen K, Vironen J. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg. 2012;99(5):630–636.
13. Based on internal report #RE00475736, Herniamed Registry data extraction report 5-year follow-up inguinal hernia repair — fixation/no fixation. August 2022.
14. Based on internal report List of products manufactured in Trévoux by Sofradim Production. Volumes from 2007 to 2023. December 2023.
15. Klobusicky, P, Hoskovec D. Reduction of chronic post-herniotomy pain and recurrence rate. Use of the anatomical self-gripping ProGrip™ laparoscopic mesh in TAPP hernia repair. Preliminary results of a prospective study. Wideochir Inne Tech Maloinwazyjne. 2015;10(3):373–381.
16. Muysoms FE, Vanlander A, Ceulemans R, et al. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip™ laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016;160(5):1344–1357.
17. Birk D, Pardo CG. Self-gripping Parietene and Parietex ProGrip™ mesh laparoscopic hernia repair: have we found the ideal implant?. Surg Technol Int. 2012;22:93–100.
18. Bueno-Lledó J, Torregrosa A, Arguelles B, et al. ProGrip™ self-gripping mesh in Rives-Stoppa repair: Are there any differences in outcomes versus a retromuscular polypropylene mesh fixed with sutures? A "case series" study. Int J Surg Case Rep. 2017;34:60–64.
©2024 Medtronic. Medtronic, Medtronic logo, and Engineering the extraordinary are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 02/2024 – US-HR-2400011 – [WF# 10911774]