Document xzng9mQB76okJmkmnJJg6rkVQ

Dieter Berger, M.D., Professor Resident Physician Spital Mannedorf Asylstrasse 10 CH-8708 Mannedorf Switzerland e-mail: @hin.ch Private: Muhlebergweg 12 D-88410 Bad Wurzach To whom it may concern, Very recently I heard that the European Union plans to forbid fluorinated polymeres. After 41 years of general and gastro-intestinal surgery with a broad experience in the field of oncological surgery with multivisceral resections including replacement of visceral arteries and veins and in the field of hernia surgery I could not believe it. ePTFE-based vascular prosthesis is absolutely crucial when replacement of eg. the hepatic artery, the protal vein or the celiac trunc are necessary to provide curative approaches for oncological patients. As the former president of the German Hernia Society, former president of the Working Group "Hernia" of the DGAV, the German Society for General and Castro-Intestinal Surgery, and guest surgeon in almost all European countries and Asia performing hernia and parastomal hernia surgery I would like to point out that hernia patients will suffer from a variety of complications, dramatically reduced quality of live until complication-induced death by that decision of the European Union. Dynamesh IPST is crucial for a variety of patients! Some patients need a stoma, like an ileostomy, a colostomy or urostomy due to a variety of benign and malignant diseases. According to data of the ILCO (the German support group for stoma carriers) there are about 100,000 - 150,000 patients with a stoma in Germany. Since a long time it is known that around the ostomy a hernia can develop'. Risk factors have been defined but can mainly not influenced preoperatively2. The frequency of a socalled parastomal hernia is described to reach at least 30 - 50%3-5. More than 80% of these patients suffer from symptoms, predominantly problems with stoma care leading to unexpected leakages which means for some patients a complete isolation from other people6. So it is absolutely clear that patients with a parastomal hernia suffer heavily, and prevention is better than cure. Previous surgical dogmas concerning the surgical ostomy formation did not prove to be effective7,8. Therefore starting in 2004 there are a lot of studies and meta-analyses dealing with the question of mesh-based prevention of parastomal hernias during the creation of the stoma9. These techniques based on the so-called keyholetechnique which means the use of a flat mesh with a central hole through which the stoma loop is brought. After promising initial results more recent studies and meta-analyses showed that the frequency of parastomal hernias could not be diminished significantly10. The keyholetechnique only delays the development of the parastomal hernia, but does not prevent it permanently11. Since 2006 Dynamesh IPST is available12. Some cohort studies also demonstrate very promising results13-15. A very recently finished and well designed randomized trial ("chimney-trial") was in fact stopped by the ethical committee in Finland because the effectivity of that 3-dimensional "funnel-like" mesh lead to the conclusion that it would be unethical to deprive patients of the prophylactic use of that mesh16. The final publication of this study is in preparation at the moment. The difference to previous studies using the keyhole-technique is clearly given by the 3dimensional structure with a funnel, the so-called "chimney-technique", which inhibits widening of the central hole induced by shrinkage of the surrounding mesh. For this reason the keyhole-technique for repair of parastomal hernias demonstrated an unacceptable recurrence rate, and is therefore abandonned today17. Dynamesh IPST is also used for the repair of parastomal hernias and proved to be effective15,18. An alternative procedure the so-called sandwich-technique is equally effective but a little bit more difficult to perform19. So a nation-wide analysis revealed the importance of the chimney-technique also for repair of parastomal hernias as well as the sandwichtechnique20. Table 1 demonstrates the results of the different techniques used in this study. So it is absolutely clear that there is no alternative for Dynamesh IPST or Dynamesh IPOM for treatment of parastomal hernias. The sandwich-technique can only be performed with flat meshes made by polyvinylidenefluoride. The meshes are placed intraperitoneally and must be elastic for the sandwich-technique. Sandwich means that 2 meshes are covering each other which excludes all other products of the market designed for intraperitoneal use because these products are coated/covered to prevent intraabdominal adhesions. It is absolutely unknown what happens with the coating/cover, if it gets in contact with a second mesh. Furthermore the elasticity of uncoated PVDF meshes is crucial for the technqiue and is not provided by any of the coated/covered alternatives. In summary parastomal hernia implie severe reduction of quality of life of stoma patients and should therefore be prevented or adequately treated21. Scientific data clearly demonstrate that Dynamesh IPST is crucial for a lot of patients in terms of prevention and therapy of parastomal hernia. Dynamesh IPST cannot be replaced by any other available mesh on the market. In terms of treatment aspect, the flat meshes made of polyvinylidenefluoride are the only meshes which can be used for the so-called sandwich-technique. That technique provides the most effective treatment of parastomal hernias so far. I therefore urgently call for time-unlimited exemption for Dynamesh IPST and all PVDFbased meshes to ensure adequate treatment options for hernia patients! Table 1: Frequency of use Keyhole 16.3% Recurrence rate 35.9% Sugarbaker 38.8% Sandwich 15.4% Chimney 8.3% 21.5% 13.5% 15% Literature 1. Londono-Schimmer EE, Leong AP, Phillips RK. Life table analysis of stomal complications following colostomy. Dis Colon Rectum 1994; 37(9): 916-20. 2. Niu N, Du S, Yang D, et al. Risk factors for the development of a parastomal hernia in patients with enterostomy: a systematic review and meta-analysis. Int J Colorectal Dis 2022; 37(3): 507-19. 3. Makarainen E, Rautio T, Rintala J, Muysoms F, Kauppila JH. Incidence of parastomal and incisional hernia following emergency surgery for Hinchey III-IV diverticulitis: A systematic review. Scand J Surg 2022; 111(2): 14574969221107276. 4. Liu L, Zheng L, Zhang M, Hu J, Lu Y, Wang D. Incidence and risk factors for parastomal hernia with a permanent colostomy. J Surg Oncol 2022; 126(3): 535-43. 5. Feng D, Wang Z, Yang Y, Li D, Wei W, Li L. Incidence and risk factors of parastomal hernia after radical cystectomy and ileal conduit diversion: a systematic review and metaanalysis. Transl Cancer Res 2021; 10(3): 1389-98. 6. Moreno-Matias J, Serra-Aracil X, Darnell-Martin A, et al. The prevalence of parastomal hernia after formation of an end colostomy. A new clinico-radiological classification. Colorectal Dis 2009; 11(2): 173-7. 7. Luo J, Singh D, Zhang F, et al. Comparison of the extraperitoneal and transperitoneal routes for permanent colostomy: a meta-analysis with RCTs and systematic review. World J Surg Oncol 2022; 20(1): 82. 8. Hardt J, Meerpohl JJ, Metzendorf MI, Kienle P, Post S, Herrle F. Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation. Cochrane Database Syst Rev 2019; 4(4): CD009487. 9. Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg 2004; 139(12): 1356-8. 10. Prudhomme M, Fabbro-Peray P, Rullier E, Occean BV, Bertrand MM. Meta-analysis and Systematic Review of the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia. Ann Surg 2021; 274(1): 20-8. 11. Brandsma HT, Hansson BM, Aufenacker TJ, et al. Prophylactic Mesh Placement During Formation of an End-colostomy Long Term Rct on Effectiveness And Safety. Ann Surg 2023. 12. Berger D. Prevention of parastomal hernias by prophylactic use of a specially designed intraperitoneal onlay mesh (Dynamesh IPST). Hernia 2008; 12(3): 243-6. 13. Kohler G, Hofmann A, Lechner M, et al. Prevention of parastomal hernias with 3D funnel meshes in intraperitoneal onlay position by placement during initial stoma formation. Hernia 2016; 20: 151-9. 14. Conde-Muino R, Diez JL, Martinez A, Huertas F, Segura I, Palma P. Preventing parastomal hernias with systematic intraperitoneal specifically designed mesh. BMC Surg 2017; 17(1): 41. 15. Kohler G. [Principles and parallels of prevention and repair of parastomal hernia with meshes]. Chirurg 2020; 91(3): 245-51. 16. Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials 2019; 20(1): 652. 17. Hansson BM, Slater NJ, van der Velden AS, et al. Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg 2012; 255(4): 685-95. 18. Fischer I, Wundsam H, Mitteregger M, Kohler G. Parastomal Hernia Repair with a 3D Funnel Intraperitoneal Mesh Device and Same-Sided Stoma Relocation: Results of 56 Cases. World J Surg 2017; 41(12): 3212-7. 19. Berger D, Bientzle M. Laparoscopic repair of parastomal hernias: A single surgeon's experience in 66 patients. Dis Colon Rectum 2007; 50(10): 1668-1. 20. Makarainen-Uhlback E, Vironen J, Falenius V, et al. Parastomal Hernia: A Retrospective Nationwide Cohort Study Comparing Different Techniques with Long-Term Follow-Up. World J Surg 2021; 45(6): 1742-9. 21. Nasvall P, Dahlstrand U, Lowenmark T, Rutegard J, Gunnarsson U, Strigard K. Quality of life in patients with a permanent stoma after rectal cancer surgery. Qual Life Res 2017; 26(1): 55-64.