Document Dd4Don2KNBOMLX5j563N1eK2M

UNIKLINIK Klinik und Poliklinik fr Frauenheilkunde KLN und Geburtshilfe University Hospital of Cologne, Department of Gynaecology and Obstetrics, 50924 Cologne, Germany To whom it may concern Gynkologisches Krebszentrum (DKG) European Training Center in Obstetrics and Gynecology (EBCOG) Perinatalzentrum Level I Zertifiziertes Kontinenz- und Beckenbodenzentrum Priv.-Doz. Dr. med. Sebastian Ludwig Chief of Division Urogynecology and Plevic Floor Reconstructive Surgery Department of Obstetrics and Gynecology phone: telefax: Il@uk-koeln.de Cologne, 8th August 2023 PFAS Statement In our tertiary University department of Obstetrics and Gynecology, we perform around 120 surgeries annually to treat pelvic organ prolapse. For these procedures, we rely on the use of polyvinylidene fluoride (PVDF) meshes, which have proven to significantly reduce the risk of recurrence and reoperation. In addition to the classic apical fixations, we also perform an innovative technique to mimic the pelvic floor anatomy. In the so-called CESA/VASA operations, both uterosacral ligaments are mimicked in their anatomical course using specially developed PVDF meshes. In comparison, only a minimum of PVDF material is used. Compared to the classical unilateral mesh sacropexy (with PP or PET), less than one third of PVDF material is used (for example 16 cm2). Banning PVDF meshes bears the risk to leave no equivalent alternative available to treat our patients. As a university hospital, we have also tested the biomechanical properties of implanted PVDF meshes in animal models and together with the clinical application, an exceptional tolerance of these products is convincing. Over the years, our clinical experience has emphasized the importance of stable and non-degradable mesh materials for long-term implantation within the body. This is especially crucial as materials like polypropylene Tel. Nr.: 0221 / 478 -- Privatambulanz -4900 Operative Gynkologie -4959 Brustzentrum -86545 Minimal -- invasive Chirurgie -4959 Kreisaal -4965 Geburtsanmeldung Risikosprechstunde Prnatalmedizin und gynkologische Sonographie -6847 -4975 Reproduktionsmedizin und Gynkologische Endokrinologie -4959 Gynkologische Onkologie -4900 Ambulante Chemotherapie -4945 Beckenbodenzentrum -4900 Dysplasie- und Vulva- Sprechstunde -4959 Kerpener Strae 62 50937 Kln Telefon +49 221 478-0 Telefax +49 221 478-4095 www.uk-koeln.de Universittsklinikum Kln (AR) Vorstand: Prof. Dr. Edgar Schmig (Vorsitzender und rztlicher Direktor) Dipl.-Kfm. Gnter Zwilling (Kaufmnnischer Direktor) Prof. Dr. Dr. h. c. Thomas Krieg (Dekan) Vera Lux (Pflegedirektorin) Prof. Dr. Peer Eysel (stellv. rztlicher Direktor) Bank fr Sozialwirtschaft Kln BLZ: 370 205 00 Konto: 815 0000 IBAN: DE04 3702 0500 0008 1500 00 BIC: BFSWDE33XXX Steuernummer: 223/5911/1092 Ust-IdNr.: DE 215 420 431 IK: 260 530 283 PNV: Straenbahn Linie 9 Hst. Lindenburg, Linie 13 Hst. Gleueler Str./Grtel Bus Linie 146 Hst. Leiblplatz (PP) and polyethylene terephthalate (PET), widely used in surgical meshes, tend to degrade over time, leading to increased complications and inflammatory responses. In contrast, PVDF has emerged as a superior choice, remaining stable without signs of degradation, making it an innovative polymer endorsed by various surgical societies. In addition, we use a variety of PVDF products in our interdisciplinary Continence and Pelvic Floor Centre at the University of Cologne. Together with the Clinic for Urology and Visceral Surgery/Proctology, we perform a large number of interdisciplinary operations (more than 300 per year) in which we use PVDF products, as they are often the only option for long-term and effective, but also safe reconstruction of the patients' pelvic floor. We join other medical professionals in urging the expert committees and decision-makers to consider time-unlimited exceptions for surgical meshes made of PVDF and other PFAS materials. Such exceptions are vital for the well-being of our patients, as banning these materials would lead to increased complications and reduce treatment options. We must safeguard patients' health by prioritizing mesh materials with optimal biocompatibility and long-term stability in pelvic floor surgeries. Additionally, a nationally established urogynecoligcal registry, where every patient who has received such a PVDF product is registered with preliminary and, above all, follow-up data, contributes to this. This provides additional security, transparency and offers a certain degree of protection for the patients. Sincerely, Priv.-Doz. Dr. med. Sebastian Ludwig Chief of Division Urogynaecology and Pelvic Floor Reconstructive Surgery, University Hospital of Cologne, Dept. Obstetrics and Gynecology 2