Document d7GO4ZK6rLya3QwxrjQqLqEG

European Chemicals Agency PEAS consultation Villalobos Mori, Rafael Chief of the Abdominal Wall Unit Surgery, Amau de Vilanova University Hospital Spain Dear Members of the European Chemical Agency, I have become aware that the proposed PFAS ban may have unintended consequences on well established and irreplaceable mesh implants used for hemia treatment, which are made of Fluoropolymers. This concern has prompted me to compose this letter. Asa dedicated hernia surgeonforover 13 years, | can attestthatal relevant medical guidelines recommend the use of meshimplants as the gold standard for herniatreatment,These implants serve a permanentload-bearingfunction andtypically remain in the patient'sbodyforan average of25 years, and In some cases, upto 60years. Inthe eventof amesh implant failure, reoperation isrequiredin the majorty. of cases, which always carries higher risks of complications compared to the initial intervention. 1 have 8 years of experience using polyvinylidene fluoride (PVDF) meshes in different abdominal wall surgery techniques. | have used this material in different locations of the abdominal wall of my patients with averylongfollow up and I've never had problems related to this material. That results that 13nd myteam have obtained reflex the excellentutility and safety. Infact, the PVDF meshesare the most . important material to repair the abdominal wall defects in my Unit. The main focus of the discussion concerning a potential PFAS ban is the substances' extreme durabilty (*forever-chemicals). However, this very characteristic is the strongest argument against banning these substancesfor specific long-term medical implants, especialy for hernia meshes. Theres currently no equivalentatenative to fluoroptohlatymemeetsrthseessential requirementof long-term stabilty. Considering the relasmtalilqvuaentiltiyes of material used (on2fleyw gramsper mesh implant) andthesignificant patient and socio-economic benefits, ban on herniameshesmadeof Fluoropolyrmers would be disproportionate and lead to severe negative consequencesfor patients and the healthcare system. 1 acknowledge the environmental concerns related to different PFAS materials and support the initiative to critically assess their widespread use and seek alternatives. However, it is crucial to weigh these environmental concerns against the immediate negative impacat ban on certain medical devices could have on patients' health. With patient safety in mind and in the spirit of proportionalty, | urge the European Chemicals `Agenctoy grant an indefinite exemption formeshimplants madeoffluoropolymers, particularly PVO. If - You have any further inguiries, please feel free to contact me. Sincerelyyours, 7 _ _ or _ 7/) DER comeon t Swervme de CITUX ja 1. Villalobos Mori Rafael, Maestre Yolanda, Gonzslez-Barranquero Alberto, OlsinaKissler Jorge. HERNIA LUMBAR DERECHA: DOCKING POSTERIOR COMO NOVEDAD ENEL ABORDDEALeJTEEP. ROBOTICO CON MALLA PVDF Video ATLAS de la AEC 2. Gonzdlez Barranquero Alberto, Espert J, MaestrYe, Liompart M, Gas C, Olsina J, Vilalobos Mori Rafael ANALYSIS OF RECURRENCE AND RISK FACTORS IN LAPAROSCOPIC SANDWICH TECHNIQUE FOR PARASTOMAL HERNIA REPAIR. Surgical endoscopy. Accepted in Sep 2023 3. Villalobos Mori, Rafael, Madrazo Z, Maestre Y, Gonzalez BarranquerAo,Gas C, OlsinJa OMEGAtrial: A multicenterrandomized controlled non-inferiortiitayl ofOnly MEsh fixation with 2 Glue Applicator comparing traumatic vs atraumatic fixation of the mesh in ventral/incisional laparoscopic repair. Trial running