Document KGE1vmM7XvbMErY7GENxddMjX

Barbora East, MD, PhD, FEBS AWS, general surgeon III. Department of Surgery of 1st Medical Faculty of Charles University, Motol University Hospital in Prague, Czech Republic Dear Members of the European Chemical Agency, I am medical doctor and dedicated hernia surgeon at Motol University Hospital in Prague, Czech Republic. I am member of the board of the European hernia society, where I serve as the Secretary for Quality and president elect for the upcoming 2024 annual congress of the European Hernia Society hosted in Prague. I have received information about a potential ban of numerous mesh implants made of fluoropolymers including PVDF. This ban would affect many well established and, in many ways, unique implants for which there are no equivalent alternatives available on the market: 1. Hernia meshes must provide permanent reinforcement of the abdominal wall or groin area over the patient's lifetime. Extensive scientific research [1-5] and clinical studies [6-8] have demonstrated the safety and efficacy of PVDF hernia meshes, with positive long-term outcomes and low complication rates compared to available alternative materials. 2. Mesh implants made of PVDF are in many cases associated with specific operation techniques (chimney technique to treat parastomal hernia (DynaMesh-IPST)) for which no alternative mesh implants are available. In the case of a ban, these important surgical procedures can no longer be performed. 3. Pre-shaped PVDF mesh (DynaMesh-ENDOLAP 3D) has unique handling properties and leads to less foreign body formation in the groin area, making the most common operation safer and without causing chronic pain. 4. PVDF hernia implants are available as MRI-visible variants. There are no other mesh implants on the market with this specific feature, which represents a clinically relevant improvement in terms of patient safety. [9-13] For these reasons and in the interest of patient safety, I call on the European Chemicals Agency to grant a time unlimited exemption for mesh implants made of fluoropolymers, in particular PVDF. I will be happy to answer any questions you may have. Sincerely yours, ________________________________ Barbora East, MD, PhD, FEBS AWS REFERENCES [1] 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? Artif Organs 19:1190-1199 [2] Mary C, Marois Y, King MW, et al (1998) Comparison of the in vivo behavior of polyvinylidene fluoride and polypropylene sutures used in vascular surgery. ASAIO J 44:199-206 [3] Silva RA, Silva PA, Carvalho ME (2007) Degradation studies of some polymeric biomaterials: Polypropylene (PP) and polyvinylidene difluoride (PVDF). Materials Science Forum 539-543:573-576. https://doi.org/10.4028/www.scientific.net/MSF.539-543.573 [4] Iakovlev, V.V., Guelcher, S.A., Bendavid, R., 2017. Degradation of polypropylene in vivo: A microscopic analysis of meshes explanted from patients: DEGRADATION OF POLYPROPYLENE IN VIVO. Journal of Biomedical Materials Research Part B: Applied Biomaterials 105, 237-248. https://doi.org/10.1002/jbm.b.33502 [5] Sternschuss G, Ostergard DR, Patel H (2012) Post-implantation alterations of polypropylene in the human. J Urol 188:27-32. https://doi.org/10.1016/j.juro.2012.02.2559 [6] Warren JA, McGrath SP, Hale AL, et al (2017) Patterns of Recurrence and Mechanisms of Failure after Open Ventral Hernia Repair with Mesh. Am Surg 83:1275-1282 [7] Zuvela M, Galun D, Djuri-Stefanovi A, et al (2014) Central rupture and bulging of low-weight polypropylene mesh following recurrent incisional sublay hernioplasty. Hernia 18:135-140. https://doi.org/10.1007/s10029-013-1197-1 [8] Baker JJ, berg S, Rosenberg J (2021) Reoperation for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Nationwide Cohort Study. Annals of Surgery Publish Ahead of Print: https://doi.org/10.1097/SLA.0000000000005206 [9] Khler G, Pallwein-Prettner L, Lechner M, et al (2015) First human magnetic resonance visualisation of prosthetics for laparoscopic large hiatal hernia repair. Hernia 19:975-982. https://doi.org/10.1007/s10029-015-1398-x [10] Weyhe D, Klinge U, Uslar VN, et al (2019) Follow Up Data of MRI-Visible Synthetic Meshes for Reinforcement in Large Hiatal Hernia in Comparison to None-Mesh Repair-A Prospective Cohort Study. Front Surg 6:17. https://doi.org/10.3389/fsurg.2019.00017 [11] Khler G, Wundsam H, Pallwein-Prettner L, et al (2015) Magnetic resonance visible 3-D funnel meshes for laparoscopic parastomal hernia prevention and treatment. European Surgery 47:127-132. https://doi.org/10.1007/s10353-015-0319-7 [12] Muysoms F, Beckers R, Kyle-Leinhase I (2018) Prospective cohort study on mesh shrinkage measured with MRI after laparoscopic ventral hernia repair with an intraperitoneal iron oxide-loaded PVDF mesh. Surgical Endoscopy 32:2822-2830. https://doi.org/10.1007/s00464-017-5987-x [13] Vierstraete M, Beckers R, Vangeel L, et al (2023) Prospective cohort study on mesh shrinkage measured with MRI after robot-assisted minimal invasive retrorectus ventral hernia repair using an ironoxide-loaded polyvinylidene fluoride mesh. Surg Endosc. https://doi.org/10.1007/s00464-023-09938-3