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Aus Liebe zum Leben / JOHANNITER Godeshohe SERVICEGESELLSCHAFT FOR RENATHERAPIEDIENSTE UND LEISTUNGEN Neuro-Urologie GSRT Godeshohe WaldstraRe 2-10 53177 Bonn Briefempfariger-Firmenname Committee for PFAS -- Euopean Chemicals Agency Neurologisches Rehabilitationszentrum Godeshohe Servicegesellschaft fur Reha-Therapiedienste and Leistungen mbH WaldstraBe 2-10 53177 Bonn Telefon +49 (0)228 381-0 Fax +49 (0)228 381-640 E-Mail ruth.kirschner- go.johanniter-kliniken.de www.godeshoehe.de Betreff: PFAS restriction proposal currently under discussion in the European Chemicals Agency Datum Tel.-/Fax-Durchwahl dd.mm06.07.2023 +49 (0)228 381-249/ 348 Dear Members of the ECHA, E-Mail @go.johanniter-kliniken.de Based on a long history of experience with PVDF meshes in pelvic floor surgery I am truly concerned about the potential ban of some irreplaceable mesh implants. I can follow the main goal of the proposal but for good patient care there must be time unlimited exceptions. Since 2006 I was head of the continence clinic at the Aachen University clinic and from 2012 up to 6/2023 I was the coordinator of the interdisciplinary continence centre at the University hospital in Bonn. I am following the discussion about sling material since 2010 1' 2' 3 PFAS restriction proposal currently under discussion in the European Chemicals Agency would limit the choices of material used for incontinence and prolapse procedures. Although there is some debate about superficial degradation of PP Mesh as one factor leading to complications, most authors, concluded that Polypropylene degradation may play a role in the continuous inflammatory response, mesh hardening and late deformations. 4,5,6,7 In a comparative study Gerullis et al. S looked at inflammatory infiltration, amount of macrophages and connective tissue reaction to investigate whether mesh material could be improved by highly aligned collagen threads crosslinked using either genipin or 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide and N-hydroxy succinimide (EDC/NHS). The authors concluded for all tested materials that Polyvinylidene fluoride (PVDF) performed better than Polypropylene (PP -- TVT) or reinforced PP (UltraPro) even not coated. Slings and other meshes used in pelvic floor made entirely of PVDF are in many ways beneficial for the patients. PVDF is a material with proven excellent biocompatibility, good mechanical and chemical properties, high hydrolysis resistance and compared with other materials such as for example Polypropylene demonstrate a slow aging process In polypropylene aging results in in post-crystallization leading to a reduction in strength of up to 47%, whereas with PVDF this is only up to 4,7 %. Mesh implants made of PVDF benefit from the good material properties. In conjunction with optimally adapted mesh parameters, this leads to unsurpassed properties in terms of tissue integration and sustainability. PVDF is associated with a considerable reduction of the risk of erosions, inflammations, fibrosis and hematomas.9 Geschaftsfuhrer: F Bank fur Sozialwirtschaft IBAN: DE88 3702 0500 0008 1384 00 BIC: BFSWDE33XXX Sitz der Gesellschaft: Bonn Amtsgericht Bonn, HRB 14210 St.-Nr. 206/5888/1311 Geschutzt durch die Bailey Brandenburg des Ritterlichen Ordens St. Johannis vom Spital zu Jerusalem The PVDF mesh implant is directly warp knitted and not cut from a surface area. This gives it edges, which allow easy, atraumatic insertion and adjustment without irritation of the surrounding tissue (no "saw teeth"). Even under load, the geometry is not changing significantly. The effective porosity remains maintained; permanent changes in mesh geometry do not occur, handling becomes easier and undesirable curling of the tapes is prevented. Mit freundlichen Gren GSRT Godeshhe Servicegesellschaft fr Reha-Therapiedienste und Leistungen mbH Name Prof. Dr. Ruth Kirschner-Hermanns Leitung der Neuro-Urologie Referenzen: 1. R. Kirschner-Hermanns, U.Klinge, B. Klosterhalfen, B. Brehmer, A. Heidenreich What can we learn from explanted slings and meshes in pelvic floor surgery? In: The Journal of Urology - April 2010; 183/4: 686 2. Najjari L, Hennemann J, Kirschner-Hermanns R, Maass N, Papathemelis T. Visualization of polypropylene and polyvinylidene fluoride slings in perineal ultrasound and correlation with clinical outcome. In: Biomed Res Int. 2014;2014:181035. doi: 10.1155/2014/181035. Epub 2014 Jul 13. 3. Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery: ICI-RS 2019? Rovner E, de Tayrac R, Kirschner-Hermanns R, Veit-Rubin N, Anding R. In: Neurourol Urodyn. 2020 Feb 7. doi: 10.1002/nau.24312. 4. Iakovlev VV, Carey ET, Steege J (2015) Pathology of Explanted Transvaginal Meshes 5. Iakovlev VV, Guelcher SA, Bendavid R (2015) Degradation of polypropylene in vivo: A microscopic analysis of meshes explanted from patients. J Biomed Mater Res Part B Appl Biomater. https://doi.org/10.1002/jbm.b.33502 6. Clav A, Yahi H, Hammou J-C, et al (2010) Polypropylene as a reinforcement in pelvic surgery is not inert: comparative analysis of 100 explants. International Urogynecology Journal 21:261-270. https://doi.org/10.1007/s00192-009-1021-8 7. Costello CR, Bachman SL, Ramshaw BJ, Grant SA (2007) Materials characterization of explanted polypropylene hernia meshes. J Biomed Mater Res Part B Appl Biomater 83:44-49. https://doi.org/10.1002/jbm.b.30764 8. Holger Gerullis, Bernd Klosterhalfen, Mihaly Boros, Bernhard Lamers, Christoph Eimer, Evagelos Georgas and Thomas Otto (2013) https://doi.org/10.1177/153350612472987 9. Uwe Klinge, Bernd Klosterhalfen, Alexander Oettinger, V Schumpelick PVDF as a new polymer for the construction of surgical meshes (2002), Biomaterials 23(16):3487-93 DOI: 10.1016/S01429612(02)00070-4 2