Document gb9aY0vv1pqZaazZ2rbZjZZ5J

UNIVERSITY HOSPITAL RHEINISCH-WESTFALISCHE TECHNISCHE HOCHSCHULE AACHEN CLINIC FOR GENERAL, VISCERAL AND TRANSPLANT SURGERY Director: University Professor Dr. med. U. Neumann Clinic for General, Visceral and Transplant Surgery of the RWTH Aachen, PauwelsstraBe 30, 52074 Aachen, Germany Prof. Dr. med. U. Klinge E-mail Address: =@ukaachen.de Public Transport: Bus, Lines: SB 1,3,5,33,45,70 Phone: (0241) 80 89 352 Fax: (0241)8082417 Signature and Date of Your Letter My Character Date: 11.05.2023 Subject: The draft restriction on the use of PFAS is causing concern. It is feared that surgical meshes made of PVDF could be banned after a short transition period. For 30 years, the investigation of textile implants for the treatment of tissue defects has been a central focus of clinical and experimental research in the Department of Surgery at RWTH Aachen University. Within this framework, I have worked intensively with my colleagues on improving implant safety and have acquired numerous third-party funded research projects. With this research activity, which has now lasted 30 years, with > 140 publications (see Appendix 2) on the subject of mesh implants, more than 250 invited lectures on implants and numerous book contributions, it was possible to significantly improve the previously predominant oversized materials by introducing the concept of large-pored lightweight meshes. I was able to contribute this expertise as an expert witness for courts in the USA and Australia in numerous proceedings. Medical implants must basically have a high stability and resistance to degradation if they have to function for years or decades in the tissue and the aggressive cellular environment of the biological foreign body reaction. This is all the more true if they have a large contact surface area, as is the case with "Surgical Meshes". These textile implants made of different materials are recommended for tissue reinforcement by all professional societies [Appendix 1: 1-4] as the therapy of choice and are routinely used as standard worldwide. Among the currently used polymers, PVDF fulfils the requirements for textile medical implants in an outstanding way as it shows no signs of degradation after implantation and induces a low inflammatory and fibrous reaction due to its hydrophobic surface. In contrast, the alternative polymers available show dramatic disadvantages in some cases, which have led to over a hundred thousand documented court cases worldwide [Appendix 1: 6]. Among other things, the hydrophilic polymers made of polyester are subject to rapid hydrolytic degradation, while those made of polypropylene are subject to oxidative surface decay with the release of micro-particles and increased cellular activation of the inflammation and scarring processes [Appendix 2: 1,29]. 5436727v1