Document DvMX2k5Zo3xmNpa634VwQd8eM

Prof. Francesco Gossetti Medico Chirurgo Specialista in Chirurgia Generale e Oncologia Dear Members of the European Chemicals Agency, I am very concerned about the published PFAS restricon proposal, which include mesh materials that have been used successfully in hernia surgery for decades, namely fluoropolymers. Of parcular concern to me is the possible ban of polyvinylidene fluoride (PVDF), a fluoropolymer that is the material of choice for the treatment of ventral hernias in the Department of Cardiothoracic-Vascular and Transplant Surgery, Abdominal Wall Surgery Unit, Policlinico Umberto I - Sapienza University of Rome, Italy for over 10 years [1]. I have been focused on the topic of hernia surgery since 1990 and also specifically on meshes. Unl December 31 st, 2022 I was Director of the Abdominal Wall Surgery Unit at Policlinico Umberto I - Sapienza University of Rome. During this me, I explanted and analyzed over 75 meshes in paents with mesh-related complicaons. I never had to remove any PVDF mesh from retromuscolar posion implanted by myself or other colleagues (also in different posion). I have published over 80 publicaons that are listed on Pubmed, most of them on the topic of hernias or meshes. In the past 10 years, I have operated on over 160 paents with PVDF meshes and can confirm the excellent results and uniqueness of these meshes. PVDF is a synthec, non-absorbable, highly non-reacve fluoropolymer of high purity with excellent mechanical, chemical and biological properes [2-4]. Meshes made of PVDF have good biocompability; they elicit a minimal foreign body reacon with much smaller foreign body granulomas compared to meshes made of polypropylene (PP) and polyester (PES) [4-9]. This, in combinaon with mesh designs with high effecve porosity, reduces the risk of "bridging" scar reacons, i.e. complete filling of the mesh pores with fibrous ssue and associated mesh contracon/shrinkage, which can be monitored by the availability of MRI-visible variants in vivo [10- 13]. These excellent, partly unique properes in combinaon with the superior biostability/aging resistance compared to PP and PES [3, 14, 15] make PVDF meshes in our opinion currently the best soluon for the treatment of hernia paents with the aim of achieving lasng treatment success. A ban of currently the best material for hernia treatment, namely PVDF, would be a big setback for hernia surgery in general and would force physicians to use less suitable materials. Therefore, I call on the European Chemicals Agency to grant a me-unlimited exempon for PVDF. Please do not hesitate to contact me if you have any quesons. Rome, 23 August 2023 1. Gosse F, D'amore L, Grimaldi MR, et al (2023) Rives-Stoppa Repair of Incisional Hernias Using PVDF Mesh: A 10-Year Experience of a Dedicated Surgical Team. JSM Gastroenterology and Hepatology 2. Urban E, King MW, Guidoin R, et al (1994) Why make monofilament sutures out of polyvinylidene fluoride? ASAIO J 40:145-156 3. Laroche G, Marois Y, Schwarz E, et al (1995) Polyvinylidene Fluoride Monofilament Sutures: Can They Be Used Safely for Long-Term Anastomoses in the Thoracic Aorta? Arficial Organs 19:1190-1199. htps://doi.org/10.1111/j.1525-1594.1995.tb02282.x 4. Klinge U, Klosterhalfen B, nger AP, et al (2002) PVDF as a new polymer for the construcon of surgical meshes. Biomaterials 23:3487-3493. htps://doi.org/10.1016/S01429612(02)00070-4 5. Conze J, Junge K, Wei C, et al (2008) New polymer for intra-abdominal meshes-PVDF copolymer. Journal of Biomedical Materials Research Part B: Applied Biomaterials 87B:321-328. htps://doi.org/10.1002/jbm.b.31106 6. Klink CD, Junge K, Binnebsel M, et al (2011) Comparison of long-term biocompability of PVDF and PP meshes. J Invest Surg 24:292-299. htps://doi.org/10.3109/08941939.2011.589883 7. Gerullis H, Klosterhalfen B, Bors M, et al (2013) IDEAL in meshes for prolapse, urinary inconnence, and hernia repair. Surg Innov 20:502-508. htps://doi.org/10.1177/1553350612472987 8. Karabulut A, Simavli SA, Abban GM, et al (2016) Tissue reacon to urogynecologic meshes: effect of steroid soaking in two different mesh models. Int Urogynecol J 27:1583-1589. htps://doi.org/10.1007/s00192-016-3013-9 9. Junge K, Binnebsel M, Rosch R, et al (2009) Adhesion formaon of a polyvinylidenfluoride/polypropylene mesh for intra-abdominal placement in a rodent animal model. Surgical Endoscopy 23:327-333. htps://doi.org/10.1007/s00464-008-9923-y 10. Bitner R, Bingener-Casey J, Dietz U, et al (2014) Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (Internaonal Endohernia Society [IEHS])--Part 3. Surgical Endoscopy 28:380-404. htps://doi.org/10.1007/s00464-013-3172-4 11. Zinther NB, Wara P, Friis-Andersen H (2010) Shrinkage of intraperitoneal onlay mesh in sheep: coated polyester mesh versus covered polypropylene mesh. Hernia 14:611-615. htps://doi.org/10.1007/s10029-010-0682-z 12. Muysoms F, Beckers R, Kyle-Leinhase I (2018) Prospecve cohort study on mesh shrinkage measured with MRI aer laparoscopic ventral hernia repair with an intraperitoneal iron oxideloaded PVDF mesh. Surg Endosc 32:2822-2830. htps://doi.org/10.1007/s00464-017-5987-x 13. Vierstraete M, Beckers R, Vangeel L, et al (2023) Prospecve cohort study on mesh shrinkage measured with MRI aer robot-assisted minimal invasive retrorectus ventral hernia repair using an iron-oxide-loaded polyvinylidene fluoride mesh. Surg Endosc. htps://doi.org/10.1007/s00464-023-09938-3 14. The HerniaSurge Group (2018) Internaonal guidelines for groin hernia management. Hernia 22:1-165. htps://doi.org/10.1007/s10029-017-1668-x 15. Baker JJ, berg S, Rosenberg J (2023) Reoperaon for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Naonwide Cohort Study. Annals of Surgery 277:335-342. htps://doi.org/10.1097/SLA.0000000000005206