Document jXJXe22ZwJVrybb5zvJeN7mk

PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Section III/IV: General comments / Non-confidential attachment Contents a) Scope or restriction option analysis ................................................................................................ 2 b) Hazard or exposure.......................................................................................................................... 5 c) Environmental emissions................................................................................................................. 9 d) Baseline............................................................................................................................................ 9 e) Description of analytical methods................................................................................................... 9 f) Information on alternatives........................................................................................................... 10 g) Information on benefits................................................................................................................. 13 h) Other socioeconomic analysis (SEA) issues ................................................................................... 18 i) Transitional period......................................................................................................................... 19 j) Request for exemption .................................................................................................................. 19 1 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik a) Scope or restriction option analysis General concerns regarding the scope of the restriction proposal The restriction proposal is subject to fundamental legal concerns. The general ban on the entire PFAS group contained in the proposed restriction contradicts the systematics of Articles 68 ff. of the REACH Regulation, which is geared towards the restriction of individual substances for which there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market. In any case, the comprehensive group-based regulation contradicts the principle of proportionality from Article 5 para 4 EU Treaty and the requirements developed for this by the European courts. Moreover, this approach is not in line with the Commission's requirements for the application of the precautionary principle (Article 191 para. 2 TFEU) as laid down in the Communication from the Commission on the precautionary principle (COM(2000) 1 final). This applies in particular with regard to uses of PFAS in medical devices and especially to the surgical meshes manufactured and distributed by the submitting company - FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH. We ask to exempt medical devices from the scope of the restriction, following an "essential use" concept, including upstream product Firstly, we hold that as to medical devices the restriction proposal is in conflict with the relevant basic act, i.e. Article 68 ff. REACH-Regulation, which only allows restrictions of substances for which unacceptable risks to human health or the environment, arising from the manufacture, use or placing on the market of the said substances, are present - thus, proven - and cannot be adequately controlled. The authors of the document do not prove anywhere in the restriction proposal which concrete and ,,unacceptable" risks to human health or the environment (see the prerequisite of Article 68 para. 1 REACH Regulation) result from the exposition of humans to medical devices containing PFAS. Secondly, the restriction proposal is inadequate and disproportionate with regard to medical devices. While the alleged risks are merely potential or described as "inevitable" without further proof given the exposition to PFAS from medical devices, there are direct health risks by a deteriorated health care that results from eliminating well-proven therapy options. These adverse effects of the restriction to human health as well as to public health and the resulting societal and economic consequences are not sufficiently taken into account in the restriction. This applies in particular to the surgical meshes made of PVDF produced by the submitting company, for which it can be demonstrated that, on the one hand, there are at most very minor and manageable effects on the environment, while on the other hand, extensive health and socio-economic disadvantages would result from the proposed ban. Regardless of the aforesaid, the different treatment of PFAS used in medical devices and PFAS used in pharmaceuticals seems to be inconsistent and arbitrary. While PFAS used as active substances of pharmaceuticals are generally exempted from the scope of the restriction proposal, the use of PFAS in medical devices shall in general be fully subject to the ban. In favour of the intended general exemptions, the authors of the proposal argue that the exempted product groups like pharmaceuticals are addressed in their specific regulations under EU law. We underline that also medical devices are strictly and coherently regulated by the EU medical device regulation (Regulation (EU) 2017/745). The proposal does not reflect this in an appropriate manner. Furthermore, the restriction proposal faces legal inconsistencies with regard to medical devices and in particular with regard to implantable devices and surgical meshes. The classification of different 2 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik groups of medical devices in the restriction proposal deviates from the classification in the medical device regulation without giving any evidence-based or other reasons for the distinctions the authors make - although this distinction has severe legal consequences. On the one hand, surprisingly, "meshes" in general are excluded from the group of implantable devices (which are granted a derogation). On the other hand, "hernia meshes" are singled out and privileged by a (potential) derogation against other "meshes" - even if those are implanted in the direct vicinity in the human body (e.g. gynaecological meshes). This shows an insufficient analysis of medical devices in the restriction proposal and contradicts Annex VIII chapter III no. 5.4 of the medical device regulation. In the seventh bullet point of this clause, the regulation explicitly and comprehensively names "surgical meshes" as a subgroup of implantable devices. Accordingly, mesh products have to be classified as "surgical meshes" as part of implantable devices and shall not be treated worse than implantable devices in general. Even if medical devices are included in the scope and if relevant risks from PFAS in these products could be proven, the risk-benefit-ratio of a restriction will still have to be properly assessed. Restricting PFAS-containing medical devices like surgical meshes entails risks, which include the lost medical options and socio-economic disadvantages due to unsuitable substitute materials. These very real risks must be weighed against the yet unproven health benefits of further reducing an already limited PFAS exposition from medical devices, and further reducing an already low amount of PFAS material used compared to other types of applications. We are convinced that the assessment will conclude that it is not possible to substitute the PVDF material in surgical implants, particularly in surgical meshes, without negative impact on patient benefit and safety. In this case, it is neither logical nor justifiable to grant a time-limited derogation. Even more, the usual derogation for only for 12 years would be unfounded. The idea behind the proposed time-limited derogations is that some more research will find suitable alternatives. With respect to surgical meshes, however, this idea is wishful thinking and not underlined with any facts. For more than 30 years, in the case of meshes, intensive research has been performed to find the medically optimal material - which is PVDF. Irrespective of this, any change to medical devices provided there are any technical alternatives at all - requires renewed conformity assessments under the MDR, which take several years depending on their scope. In the case of existing products, this can take up to 12 years, which must be added on top of the necessary time for research and development of a new product. In the light of this, medical devices that cannot be substituted without a deteriorated patient benefit and safety - like surgical meshes - need a time-unlimited derogation, including upstream products. This might be combined with clear rules to reduce environmental consequences to the possible minimum. Specific concerns regarding surgical mesh implants Implantable surgical meshes are standard treatment options of soft tissue weaknesses such as hernias, female organ prolapse and incontinence. Every year, more than 20 million hernia surgeries are performed worldwide. In about 80 % of the cases, a surgical mesh is used for reinforcement [a-1]. In Europe, around 1.3 million people undergo hernia surgery (Eurostat data, see Annex 2), of which about 1 million receive a hernia mesh. Furthermore, more than half of the women worldwide suffer from some degree of pelvic organ prolapse or urinary incontinence [a-2], which equals almost 2 billion women in the world and 192 million women in Europe. Urinary incontinence also affects men, 3 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik especially after undergoing radical prostatectomy as a treatment for prostate cancer. It has been estimated that there is an 11-20 % lifetime risk of a woman undergoing a surgery for prolapse or urinary incontinence by the age of 80 [a-3]. Surgical mesh is estimated to be used in a third of prolapse surgeries and 80 % of female incontinence surgeries [a-4]. Only a part of these cases is treated with meshes made of polyvinylidene fluoride (PVDF). The PFAS restriction proposal in its current form constitutes an effective ban for surgical mesh implants made of polyvinylidene fluoride (PVDF). A clear proof of the health risks resulting from exposition to PVDF meshes and socioeconomic analysis of PVDF meshes is completely missing from the proposal. The scientific literature [a-5, a-6, a-7, a-8] as well as our own socioeconomic analysis (section 8) show clear health and other socioeconomic benefits of urogynaecological and hernia meshes made of PVDF: Specifically, patients treated with PVDF surgical implants show lower complication and recurrence rates than patients treated with implants made of other materials. At the same time, the PVDF emissions from surgical meshes is negligible - small overall quantities (< 3 tons/year) of which 80-90 % are disposed of under controlled conditions via incineration. Based on this evidence, we deem a time-unlimited derogation for surgical meshes made of PVDF the restriction proposal strictly necessary. The proposed time-unlimited derogation is in line with the following considerations regarding the scope and the restriction options: 1) Surgical meshes made of PVDF fall under the Medical Device Regulation (EU) 2017/745 and are therefore already covered by an EU regulation that also requires a comprehensive biocompatibility assessment as well as long-term post-market surveillance on safety and performance in patients. Other products (plant protection, biocidal, medicinal) are exempted from the scope as "these are addressed under their respective regulations" (Annex XV, Summary). The same reasoning applies to PVDF surgical meshes - they should therefore not be under the scope of the restriction proposal or should be granted a time-unlimited derogation. 2) PVDF is a fluoropolymer and therefore falls in the category of low hazard and low risk use as established by other regulatory agencies. This is exemplified by the Regulatory Management Option Analysis (RMOA) for PFAS under the framework of the UK REACH carried out by the UK's Health and Safety Executive1. The assessment is further corroborated by scientific publications showing that PVDF fully meets the OECD criteria for a substance of low concern [a-9, a-10]. Moreover, PVDF is not bioaccumulative and non-toxic and therefore does not meet the criteria for substances of very high concern according to REACH (1907/2006, Art. 57, Annex XIII) and according to criteria established by the German Bundesumweltamt and the Stockholm Convention2. PVDF should therefore be outside the scope of the restriction proposal. 3) Apart from banning PVDF meshes under the current restriction proposal, other measures such as labelling or waste management would be more suitable and avoid the adverse effects of a full ban. The already small amount of PVDF emissions could thus be further reduced without compromising the health and socioeconomic benefits associated with the use of PVDF implants. 4) Leaving PVDF meshes in the scope of the restriction proposal, and thus ultimately banning them, would violate two important principles of EU law: First, the principle of proportionality 1 https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf 2 German Umweltbundesamt (https://www.umweltbundesamt.de/sites/default/files/medien/1410/publikationen/171027_uba_pos_pmt_su bstances_engl_2aufl_bf.pdf) and the Stockholm Convention on persistent organic pollutants (http://www.pops.int/Portals/0/download.aspx?d=UNEP-POPS-COP-CONVTEXT-2021.English.pdf) 4 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik is infringed because the lost socioeconomic benefits of banning PVDF surgical meshes are not proportional to the saved emissions. Second, the precautionary principle is infringed because the political ban of PVDF meshes would harm patients' health. PVDF for the use in surgical meshes should therefore be excluded from the restriction proposal by receiving a timeunlimited derogation. References [a-1] Bayln K, Rodrguez-Camarillo P, Elas-Ziga A, Daz-Elizondo JA, Gilkerson R, Lozano K. Past, Present and Future of Surgical Meshes: A Review. Membranes (Basel). 2017 Aug 22;7(3):47. doi: 10.3390/membranes7030047. [a-2] Olsen, A.L., et al., Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol, 1997. 89(4): p. 501-6. [a-3] https://ec.europa.eu/health/sites/health/files/scientific_committees/emerging/docs/scenihr_o_049.pdf [a-4] https://my.clevelandclinic.org/health/articles/16298-surgical-mesh-use-and-complications-in-women [a-5] Baker JJ, berg S, Rosenberg J. Reoperation for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Nationwide Cohort Study. Ann Surg. 2023 Feb 1;277(2):335-342. doi: 10.1097/SLA.0000000000005206. [a-6] Karalis T, Tsiapakidou S, Grimbizis GF, Mikos T. Surgical results in POP/UI surgery after using PVDF compared to other materials. A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2023 Mar 21;284:110-119. doi: 10.1016/j.ejogrb.2023.03.018. [a-7] Sabadell J, Pereda-Nez A, Ojeda-de-Los-Santos F, Urbaneja M, Gonzlez-Garca C, Camps-Lloveras N, Prez-Plantado , Canet-Rodrguez J, Prez-Espejo MP, Rodrguez-Mias N, Sarasa-Castell N, Palau M, Montero-Armengol A, Salicr S, GilMoreno A, Poza JL. Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial. Neurourol Urodyn. 2021 Jan;40(1):475-482. doi: 10.1002/nau.24586. [a-8] Garcia-Pastor P, Porrero-Carro J, et al. (2018) Prospective Multicenter Blinded Randomized Study Comparing PP and PVDF Mesh Implants in Lichtenstein Procedure with Respect to Pain and Recurrence. JSM Surgical Procedures 1(1): 1002. [a-9] Korzeniowski SH, Buck RC, Newkold RM, Kassmi AE, Laganis E, Matsuoka Y, Dinelli B, Beauchet S, Adamsky F, Weilandt K, Soni VK, Kapoor D, Gunasekar P, Malvasi M, Brinati G, Musio S. A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers. Integr Environ Assess Manag. 2023 Mar;19(2):326-354. doi: 10.1002/ieam.4646. Epub 2022 Aug 9. PMID: 35678199. [a-10] Henry BJ, Carlin JP, Hammerschmidt JA, Buck RC, Buxton LW, Fiedler H, Seed J, Hernandez O. A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers. Integr Environ Assess Manag. 2018 May;14(3):316-334. doi: 10.1002/ieam.4035. b) Hazard or exposure We see a very clear need to distinguish between fluoropolymers such as PVDF and low molecular weight PFAS. The hazards outlined in section 1.1.4 of ECHA's Annex XV Restriction Report are applicable to fluoropolymers only to a very limited extent. This is further corroborated by the fact that fluoropolymers are classified as "polymers of low concern (PLC)" according to the OECD criteria ([b-7], Table b-1) and according to other regulatory authorities [b-8]. The ECHA report lists the following hazards: persistence, long range transport, mobility, bioaccumulation, endocrine activity, and ecotoxicity. While all of these potentially apply to the production phase of the polymer (medical grade PVDF is even synthesised without use of lowmolecular weight PFAS surfactants), the main hazard associated with the final polymer is its persistence. This hazard can be addressed adequately by rigorous waste management. 5 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik There are a number of approaches to waste management of fluorinated polymers, one of which is incineration at municipal incineration plants. As outlined in B.9.18.2.4. Incineration of Annex B, there is an uncertainty about whether typical temperatures in municipal waste plants (850 C) are sufficient to fully convert any PFAS into HF and CO2. Krug et al. demonstrate [b-1] that 1200 C is a sufficiently high incineration temperature for all but the smallest PFAS (CF4, and to a smaller extent CF3-CF3). One approach to address the stability of CF4 is to prevent formation of the CF4 in the first place. This can be achieved by addition of fluorine scavenging additives such as Ca-salts (Ca(OH)2, CaCO3, CaO) [b-2]. Alternatively, there are a range of catalysts known to facilitate the degradation of CF4 [b-3] at temperatures relevant to incineration conditions. Furthermore, among the thermal degradation approaches it was demonstrated that the particularly stable PFAS CF4 can be thermally decomposed by inductively coupled plasma decomposition [b-4]. However, there are also innovative approaches to fluoropolymer decomposition. Hori et al. have demonstrated [b-5] that PVDF can be decomposed at quite moderate temperatures of 380 C in supercritical water. They have shown conversion rates of 97 % for fluorine into fluoride, and 98 % of carbon into CO2. Rigorous waste management of fluoropolymers under appropriate conditions guarantees decomposition of the polymer into its constituents in the form of CO2, and HF and therefore ensures no PFAS are released into the environment, neither as mobile bioavailable low molecular weight PFAS, nor in the form of microplastics. Fluoropolymers themselves are inconceivable to be bioavailable (because they are not water-soluble and are too big to permeate the cellular membrane) and therefore have no risk of bioaccumulation. In support of the low risks associated with fluoropolymers such as PVDF, the UK's Health and Safety Executive (HSE) has classified fluoropolymers as a "low hazard group". In its Regulatory Management Option Analysis (RMOA) for PFAS under the framework of the UK REACH, the HSE released the following statement on April 4th, 2023 [b-6]: "The restriction(s) set out above need not apply to low hazard groups or low risk uses, for example; fluoroplastics or fluoroelastomers (low hazard groups), intermediates, uses in sealed/contained systems (including use as heat exchange fluids in heat pumps and refrigeration systems), (low risk uses). These could be highlighted as derogations to any restriction proposal." Not only does PVDF meet all criteria of a polymer of low concern (Table b-1), it also does not meet any criteria of a substance of very high concern under REACH (Art. 57 of Regulation (EC) Nr 1907/2006): First, PVDF is not carcinogenic, mutagenic or toxic to reproduction (for evidence, see Annex 6 of this statement). Second, it does not meet the criteria of being "persistent, bioaccumulative and toxic" (PBT; REACH Annex XIII) - only the persistence criterion applies. Furthermore, PVDF does not meet the criteria of a substance of high concern according to any other current regulatory requirement or guideline: The German Umweltbundesamt3 suggests persistence, mobility and toxicity as criteria, but again only persistence is met by PVDF. Under the Stockholm Convention on persistent organic pollutants4 (Annex D), the criteria for these substances are their persistence, bioaccumulation, mobility and toxicity. Again, PVDF only meets the persistence criterion and is therefore not classified as a persistent organic pollutant. 3 https://www.umweltbundesamt.de/sites/default/files/medien/1410/publikationen/171027_uba_pos_pmt_su bstances_engl_2aufl_bf.pdf 4 http://www.pops.int/Portals/0/download.aspx?d=UNEP-POPS-COP-CONVTEXT-2021.English.pdf 6 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik In conclusion, fluoropolymers such as PVDF are substances of low risk and low concern. For both fluoropolymer synthesis as well as fluoropolymer disposal, there are technologies available to prevent environmental pollution with low molecular weight PFAS. The risk of environmental pollution from the fluoropolymer itself during its lifetime is minimal and evidence for adverse effects of fluoropolymer pollution on human health is missing. In our view, these arguments warrant an unlimited derogation for fluoropolymers such as PVDF in the restriction proposal. Table b-1: PVDF as a polymer of low concern according to OECD criteria Extract from [b-7: Korzeniowski et al. 2022]: Polymer of low concern (PLC) criteria descriptions and fluoroplastics and PLC criteria Polymer of low concern (PLC) assessment criterion CAS nb. Structure Polymer composition (must have C, H, Si, S, F, Cl, Br, or I covalently bound to carbon) Molecular weight (Mn) (Mn >1000Da and oligomer content <1%) Molecular weight distribution Mw number average Mn Wt% oligomer (<5% for <1000Da oligomers, <2% for <500Da oligomers) Assessment of PVDF (polyvinylidene fluoride) CAS 24937-79-9 -(CF2-CH2)n- Yes 70000-300000 2-3 Negligible Ionic character Reactive functional groups (RFGs) and functional group equivalent weight (FGEW) Neutral None and N/A Criterion description The polymer composition criterion requires structure and elemental composition of the polymer be described and identified (e.g., by Chemical Abstracts Service [CAS] number). The number average molecular weight (Mn) and oligomer content are the most commonly used criteria for PLC assessment. The EU assessment report (BIO by Deloitte, 2015) states that the "most potential health concern polymers have a number average molecular weight, Mn, <1000Da and oligomer content >1%." The higher the oligomeric content, the more likely a polymer is to be a health or ecotoxicological (OECD, 2009, p. 9). Molecular weight (MW) is an important predictor of biological effect because large molecules (>1000-10000Da) are too large to penetrate cell membranes (Supporting Information: in Beyer, 1993, p. 14). Because large molecular weight polymers cannot enter the cell, they cannot react with "target organs," such as the reproductive system, and are not bioavailable. "Therefore, as the Mn of a polymer increases, a reduced incidence of potential health concern effects might be expected" (OECD, 2009, p. 20). An additional PLC consideration is the weight percentage of oligomers that are <1000Da. Oligomers may be composed of, for example, dimers, trimers, and tetramers, meaning they have 2- monomer, 3- monomer, and 4-monomer units, respectively. The EU report (BIO by Deloitte, 2015) concluded that most potential health concern polymers have Mn of <1000Da and oligomer content of >1%: "...the distribution of potential health concern polymers exhibited an increased incidence of higher oligomer content that began at 5% for <1000Da and 2% for <500Da oligomeric content" (OECD, 2009, p. 24). Molecular weight distribution (MWD), also known as "polydispersity index," measures the heterogeneity of size of polymer molecules in a polymer. The MWD is an important parameter for predicting potential biological effects of polymers because, although Mn may be a large value, low MW oligomers <1000Da may be present, which could penetrate the cell. Electrical charge or ionic character can be anionic, cationic, amphoteric, or nonionic. Specifically, cationic polymers have been associated with aquatic toxicity (Auer et al., 1990; USEPA, 1997a). A "reactive functional group" (RFG) is defined as an atom or associated group of atoms in a chemical substance that is intended or can be reasonably expected to undergo facile chemical reaction (USFR, 2012). Some highly reactive functional groups (or a high ratio of RFGs per mole) have been associated with adverse human health and ecotoxicology (e.g., acrylates, methacrylates, isocyanates, anhydrides, aziridines; USEPA, 2010). The functional group equivalent weight (FGEW) is used to determine if the RFGs in a polymer are substantially diluted by polymeric material to allow the polymer to be a PLC (USEPA, 1997). The FGEW of a polymer is defined as the ratio of the Mn to the number of functional groups in the polymer. The FGEW is used as an indication of the degree of reactivity of the polymer; the lower the FGEW, the more reactive the polymer and the greater the potential for health and environmental impact (OECD, 2009, p. 10). 7 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Polymer of low concern (PLC) assessment criterion Low molecular weight leachables Residual monomers Ratio of residual monomers to molecular weight (typical value) Structural similarities to RFG of concern Reference standard Water solubility and octanol/water partition coefficient, Kow Particle size (median mass aerodynamic diameter, MMAD, should be >5m) Hydrolysis, light (h), Oxidation, biodegradation (aerobic and anaerobic) Thermal stability at normal foreseeable use maximum continuous temp. (C) Meets PLC criteria (Yes or No) Assessment of PVDF (polyvinylidene fluoride) No active leachables by USP class VI (121C) <50ppb ~10-12-~10-13 None Criterion description Low MW leachables are chemical molecules, either inorganic or organic, that migrate (i.e., leach) out of the polymer. These could be residual monomers or oligomers resulting from incomplete polymerization processes, surface residues, or other chemicals used in the manufacturing processes (e.g., initiators, catalysts, chain transfer agents, surfactants). Low MW leachables are critically important to the potential for a polymer to affect health and the environment, given that they may be able to migrate out of the polymer and cross cell membranes to potentially react with biomolecules. A report to the EU (BIO by Deloitte, 2015) concluded that "Polymers with <1% MW<1000Da and low water extractability are not able to cause systemic effects which are toxicologically or ecotoxicologically relevant." Monomers, by nature, are reactive. Unreacted monomers left in a polymer may migrate out of the polymer to react with biomolecules to cause potential adverse effects. Regulatory authorities (BIO by Deloitte, 2015) and the OECD Expert Group on Polymers (OECD, 2009) agree that the residual monomer content of a polymer is critical to determining if it qualifies as a PLC. - ASTM D3222-18a Insoluble/practica lly insoluble and N/A Powders: 5- 300m pellets: 2- 4mm - Water solubility is the extent to which a compound will dissolve in water. According to the OECD (2009) meeting of the Expert Group on Polymers, polymers with "negligible" water solubility, or those described as "hydrophobic" have been represented with a water solubility of 0.000001mg/L (110-6 mg/L; assigned arbitrarily; OECD, 2009). That is equivalent to 1ppt, a very conservative definition. Polymers with water solubility <10mg/L showed generally low health concerns. The octanol-water partition coefficient (Kow) is another criterion to assess chemicals and their environmental and health impact. The Kow is a physical-chemical property at equilibrium to represent the lipophilic or hydrophilic nature of a chemical, the distribution of a compound in octanol, representing the lipophilic nature, to its solubility in water, representing the aqueous nature. The higher the Kow, the more lipophilic the compound. Typically, a Kow >5000 or a log Kow >5 means high lipophilicity and, thus, a high potential to bioaccumulate or bioconcentrate. According to the Stockholm Convention, a bioconcentration factor of >5000 and a log Kow >5 is used as a criterion for bioaccumulation. Particle size is also a PLC criterion. Particles that are small enough to reach the deep lung upon inhalation are often associated with adverse health effects. Therefore, to qualify as a PLC, median mass aerodynamic diameter (MMAD) of the polymer particle size should be >5m. Stable 150C Yes Stability is resistance to physical, chemical, or biological transformation. Loss of stability in the polymer breaks it down into smaller pieces, producing low MW species. As was previously described in the Polymer of Low Concern section under the molecular weight, number average molecular weight, MW distribution, and % oligomer <1000Da heading, molecules with Mn <1000Da are capable of crossing cell membranes, making unstable polymers potentially hazardous to health and the environment. Polymers are stable; monomers are not. Abiotic degradation may involve sunlight, water, or oxygen. Photochemical transformation is a reaction involving the radiation energy of sunlight (ultraviolet radiation) that may break a bond in a molecule to change it to another chemical entity. Hydrolytic degradation of polymers is another potential way to break the polymer bonds, creating smaller oligomers that may be bioavailable. Chemical oxidation is a reaction involving the loss of electrons from one atom to another. Biotic stability is assessed by whether the polymer is degraded by microorganisms under oxygenated (aerobic) or anoxic (anaerobic) conditions; in vitro and in vivo stability studies demonstrate this. In vivo biodegradation involves the breaking of the polymer bonds by the action of bacteria, enzymes, and oxidants within the organism. Thermal stability of a polymer can be assessed when used as intended under normal, foreseeable use conditions or in extreme temperatures during disposal, such as by incineration. Thermal stability testing may involve Thermogravimetric Analysis (TGA), which determines mass loss over time and temperature of a test substance. - 8 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Polymer of low concern (PLC) assessment criterion Assessment of PVDF (polyvinylidene fluoride) Fluorinated polymerization aid (PA) used? (Yes or No) Recommended processing/application (use) temperature (TC) No - Processing: - 200C-250C Use max temp: 150C Criterion description References [b-1] Jonathan D. Krug, Paul M. Lemieux, Chun-Wai Lee, Jeffrey V. Ryan, Peter H. Kariher, Erin P. Shields, Lindsay C. Wickersham, Martin K. Denison, Kevin A. Davis, David A. Swensen, R. Preston Burnette, Jost O.L. Wendt & William P. Linak (2022) Combustion of C1 and C2 PFAS: Kinetic modeling and experiments, Journal of the Air & Waste Management Association, 72:3, 256-270, DOI: 10.1080/10962247.2021.2021317 [b-2] Wang F, Lu X, Li XY, Shih K. Effectiveness and Mechanisms of Defluorination of Perfluorinated Alkyl Substances by Calcium Compounds during Waste Thermal Treatment. Environ Sci Technol. 2015 May 5;49(9):5672-80. doi: 10.1021/es506234b. Epub 2015 Apr 16. PMID: 25850557. [b-3] Anus, A., Sheraz, M., Jeong, S., Kim, E., & Kim, S. (2021). Catalytic thermal decomposition of tetrafluoromethane (CF4): A review. Journal of Analytical and Applied Pyrolysis, 105126. [b-4] Sun, JW., Park, DW. CF4 decomposition by thermal plasma processing. Korean J. Chem. Eng. 20, 476-481 (2003). https://doi.org/10.1007/BF02705551 [b-5] Hisao Hori, Takehiko Sakamoto, Kenta Ohmura, Haruka Yoshikawa, Tomohisa Seita, Tomoyuki Fujita, and Yoshitomi Morizawa, Industrial & Engineering Chemistry Research 2014 53 (17), 6934-6940, DOI: 10.1021/ie500446s [b-6] https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf [b-7] Korzeniowski SH, Buck RC, Newkold RM, Kassmi AE, Laganis E, Matsuoka Y, Dinelli B, Beauchet S, Adamsky F, Weilandt K, Soni VK, Kapoor D, Gunasekar P, Malvasi M, Brinati G, Musio S. A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers. Integr Environ Assess Manag. 2023 Mar;19(2):326-354. doi: 10.1002/ieam.4646. Epub 2022 Aug 9. PMID: 35678199. [b-8] Regulatory Management Option Analysis (RMOA) for PFAS under the framework of the UK REACH carried out by the UK's Health and Safety Executive: https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf c) Environmental emissions - d) Baseline - e) Description of analytical methods - 9 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik f) Information on alternatives For surgical meshes, the polymers polypropylene (PP) and polyethylene terephthalate (PET) represent non-equivalent (i.e. inferior) alternatives to the polymer PVDF. Surgical meshes made of these polymers are available on the market. However, the alternative PP and PET mesh implants have a considerably higher recurrence rate due to material degradation over the long term ([f-1], Figure f-1) as well as higher complication rates ([f-2], Table g-2). Thus, there are no alternatives to PVDF for the use in surgical meshes that have equivalent performance and characteristics. We, as well as others [f-3], have identified PVDF as the ideal material for medical mesh implants, and it took us 30 years to develop and market the surgical meshes made of PVDF. Based on our research and development activities as well as collaborations with scientists and research institutions around the world, we are certain that there are currently no alternatives to PVDF with comparable or enhanced performance characteristics. Even if there was a substitute developed in the distant future, it would take another 30 to 35 years to bring the full range of products to the market (6-11 years for a single product group, but 30-35 years for the full product range) given the regulatory procedures and R&D capacities of a SME like FEG (see section 7d,e - Potential derogations marked for reconsideration, and 8d,e - Other identified uses). In this context, it is important to understand what a change of material means from a regulatory point of view in the field of medical devices: The regulatory effort for the approval of the modified product after a material change is almost the same as the effort for the approval of a completely new product (Table f-1; see also section 7d,e and 8d,e and Annex 10). Given the lack of alternative materials that match PVDF in its characteristics (especially long-term stability) as well as the economic burden of changing materials for existing devices, the complete product range of PVDF meshes will completely disappear from the market following a ban of PVDF. The disappearance of the PVDF meshes goes hand in hand with the complete loss of treatment variants. This happens because many PVDF meshes are unique in their shape and properties: For example, some PVDF meshes have a 3D shape that closely matches the anatomical structures they support (instead of flat meshes otherwise available on the market). Moreover, some PVDF meshes are visible in magnetic resonance imaging, thus allowing non-invasive diagnostics and an earlier detection of potential complications. These types of meshes are not available on the market otherwise, not even from alternative materials (Table f-2). In summary, the above-mentioned benefits of PVDF surgical meshes constitute clear evidence for a time-unlimited derogation under the PFAS restriction proposal (see also section g - Information on benefits). 10 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Figure f-1: Patients treated with PVDF meshes have a lower risk of being reoperated due to disease recurrence compared to patients treated with alternative mesh materials. Registry study from the Danish Hernia Database; study population comprised 2,726 with incisional hernias and 2,874 with primary hernias. Patients treated with PVDF mesh implants have by far the lowest reoperation rates for recurrence at maximum follow-up of roughly 10 years both for incisional and primary ventral hernias [f-1]. 11 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Table f-1: Resources required for developing meshes from new (unknown) alternative materials Phase Design development - verification and validation of product specifications 5 Clinical investigation (ISO 14155) - product validation Design transfer in the production - verification and validation of process specifications 6 CE-certification - approval by the responsible notified body TOTAL (per product group) TOTAL for all mesh implants currently placed on the market made of PVDF (13 product groups), considering that not all products can be developed at the same time 2-3 years 2-4 years 1-2 years 1-2 years 6-11 years 30-35 years Time Budget [] 1-1.5 million 1-3 million 1-1.5 million 0.5 Million 4-6.5 million 52- 84.5 million Table f-2: Available alternatives and loss of treatment variants/ diagnostic options if PVDF meshes are banned. PVDF device, proposed to be restricted indication alternatives, equivalent to PVDF DynaMesh-IPOM DynaMesh-IPOM visible DynaMesh-IPOM2 visible DynaMesh-IPOM open DynaMesh-IPST DynaMesh-IPST visible DynaMesh-IPST-D visible DynaMesh-IPST-R DynaMesh-IPST-R visible Dyna-Mesh-CICAT Dyna-Mesh-CICAT visible Dyna-Mesh-ENDOLAP Dyna-Mesh-ENDOLAP visible Dyna-Mesh-ENDOLAP 3D Dyna-Mesh-ENDOLAP 3D visible Dyna-MeshLICHTENSTEIN Dyna-MeshLICHTENSTEIN visible Dyna-Mesh-HIATUS Dyna-Mesh-DELTA Ventral7 and parastomal hernia repair (intraperitoneal) Parastomal hernia repair and prevention (intraperitoneal) Ventral hernia repair (extraperitoneal) Inguinal hernia repair (endoscopic / laparoscopic access route) Inguinal hernia repair (open access route) Hiatal hernia repair Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Not available Dyna-Mesh-SIS Not available available alternatives, inferior to PVDF Available Not available Not available Available Not available Not available Not available Not available Not available Available Not available Available Not available Available Not available Available Not available Not available Not available Available total loss of treatment variant and/or total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of treatment variant total loss of treatment variant total loss of treatment variant total loss of treatment variant total loss of treatment variant total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) - total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of treatment variant AND total loss of additional diagnostic option (MRI) - 5 i.a.material specifications (biocompatibility), yarn specifications, braid specifications, fabric specifications, anti-adhesive barrier specifications 6 Spinning specifications, warping specifications, warp knitting specifications, braiding specifications, fixing specifications, washing specifications, coating (anti-adhesive barrier) specifications, sterilization specifications, shelf life specifications 7 Ventral hernia: primary ventral hernia (umbilical hernia, epigastric hernia), incisional hernia 12 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik PVDF device, proposed to be restricted indication alternatives, equivalent to PVDF Dyna-Mesh-SIS visible Dyna-Mesh-SIS soft Dyna-Mesh-SIS direct Dyna-Mesh-SIS direct soft Dyna-Mesh-SIS direct visible Dyna-Mesh-PRM Dyna-Mesh-PRM visible Dyna-Mesh-PR soft Dyna-Mesh-PR visible Dyna-Mesh-PRR soft Dyna-Mesh-PRR visible Dyna-Mesh-PRS soft Dyna-Mesh-PRS visible Dyna-Mesh-PRP soft Dyna-Mesh-PRP visible Female incontinence treatment Not available Not available Not available Not available Not available Male incontinence treatment Not available Not available Not available Not available Not available Not available Not available Not available Pelvic organ prolapse treatment Not available Not available Dyna-Mesh-CESA Not available Dyna-Mesh-VASA Not available available alternatives, inferior to PVDF Not available Available Available Available Not available Available Not available Available Not available Available Not available Available Not available Not available Not available Not available Not available total loss of treatment variant and/or total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) - total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of additional diagnostic option (MRI) total loss of treatment variant AND total loss of additional diagnostic option (MRI) total loss of treatment variant AND total loss of additional diagnostic option (MRI) total loss of treatment variant AND total loss of additional diagnostic option (MRI) total loss of treatment variant AND total loss of additional diagnostic option (MRI) References [f-1] Baker JJ, berg S, Rosenberg J (2021) Reoperation for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Nationwide Cohort Study. Annals of Surgery Publish Ahead of Print: https://doi.org/10.1097/SLA.0000000000005206 [f-2] Sabadell J, Pereda-Nez A, Ojeda-de-Los-Santos F, Urbaneja M, Gonzlez-Garca C, Camps-Lloveras N, Prez-Plantado , Canet-Rodrguez J, Prez-Espejo MP, Rodrguez-Mias N, Sarasa-Castell N, Palau M, Montero-Armengol A, Salicr S, GilMoreno A, Poza JL. Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial. Neurourol Urodyn. 2021 Jan;40(1):475-482. doi: 10.1002/nau.24586. [f-3] Conze J, Junge K, Weiss C, Anurov M, Oettinger A, Klinge U, Schumpelick V. New polymer for intra-abdominal meshes-PVDF copolymer. J Biomed Mater Res B Appl Biomater. 2008 Nov;87(2):321-8. doi: 10.1002/jbm.b.31106. PMID: 18435400. g) Information on benefits Banning PVDF for the use in surgical meshes has numerous negative implications for patients, physicians, industry and society. PVDF features unique properties that make it a superior mesh material in terms of long-term stability (Annex 1, Annex 8, biocompatibility (Annex 6), lack of toxicity (Annex 6), purity (Annex 6), as well as minimal inflammation and fibrous connective tissue formation around the implant (Annex 7; see Section 7 for further details). This line of argumentation is further underlined by Annex E.2.9.3 of the restriction proposal stating that: 13 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Material properties like biocompatibility, heat resistance, low friction, chemical inertness of fluoropolymers like PTFE, PFA, FEP and PVDF are unique. Alternative materials available for this type of applications do not cover the whole range of properties. The properties of fluoropolymers provide increased lifetime of implants reducing risk of failure and risk of replacement. As a result of these unique advantages of PVDF surgical meshes, their use is associated with lower rates of reoperations due to disease recurrence and lower rates of complications: According to a nationwide registry study from Denmark [g-1], mesh implants made of the alternative materials polypropylene (PP) and polyethylene terephthalate (PET) have twice the hernia recurrence rate after 10 years compared to meshes made of PVDF (Figure f-1, Table g1, Annex 8). This registry study provides high quality real-world data because data entry is mandatory and all patients have a unique patient ID in Denmark. As a result, all reoperations for recurrence are captured in this data set, no matter which physician performs the reoperation. Furthermore, a randomized controlled trial on female incontinence meshes [g-2] showed that the number of complications is 1.6 times higher after treatment with PP meshes compared to PVDF meshes (Table g-2). Randomized controlled trials have the highest evidence level because they reduce bias and provide a rigorous tool to examine cause-effect relationships between an intervention and outcome [g-3]. Table g-1: Cumulated risk of reoperation due to hernia recurrence 10 years after primary ventral hernia repair Predicted values based on Baker et al. 2023 [g-1]. PET: polyethylene terephthalate, PP: polypropylene, PVDF: polyvinylidene fluoride. Mesh type DynaMesh-IPOM (PVDF) Ventralex (PP) Parietex (PET) Ventralight (PP) Proceed (PP) Symbotex (PET) Physiomesh (PP) Average other meshes Number of patients 416 257 895 190 133 312 599 398 Cumulative risk (% ) of reoperation due to hernia recurrence 5.5 6.5 10.5 12 14.8 20 19 12.6 14 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Table g-2: Occurrence of side effects of PVDF and PP meshes for incontinence treatment The number of complications are extracted from: Sabadell et al., 2021 [g-2]: PP: polypropylene, PVDF: polyvinylidene fluoride. Intraoperative Bleeding Vaginal perforation Other Early postoperative Temporary elevated PVR Cystitis Suburethral hematoma Obturator/hypogastric pain Vaginal exposition Other Late postoperative Repeated cystitis Voiding dysfunction Tape extrusion Obturator/hypogastric pain Dyspareunia Sling division De novo urgency Sum of complications (total number) Total number of patients % Complications Number of complications (PP mesh) 1 4 2 8 2 2 6 1 8 2 1 3 7 4 3 22 76 134 56.7 Number of complications (PVDF mesh) 1 2 1 10 3 1 4 1 4 5 1 2 2 1 0 10 48 137 35.0 These clear health benefits have critical downstream effects, including the number of hospitalizations, the patients' quality of life and productivity as well as health care system. The benefits become most evident when analyzing different socioeconomic aspects and how they are affected by the proposed restriction of PVDF meshes. The analysis estimates the costs of banning PVDF by calculating the lost benefits due to using inferior mesh materials in patients undergoing mesh implantation (of note, the analysis is based on various assumptions about monetary values of different parameters, which are detailed in section 8). In the first scenario based on current sales numbers, we estimate the socioeconomic costs of banning PVDF meshes at 1 billion per year. Over a 10-year period, the costs increase to 12 billion - 13 billion (net present value, adjusted for market growth and inflation). In the second scenario where all patients treated with a mesh in Europe receive an ideal PVDF mesh, the socioeconomic costs are estimated at 11 billion a year ( 137 billion - 144 billion net present value over 10 years; see Table g-3). Since not all benefits of PVDF can be monetized, the estimate should be interpreted as a lower bound. The first scenario can be regarded as a baseline reflecting the current market share of PVDF meshes with associated benefits and the current level of emissions (< 3 tons/year). In comparison, the second scenario illuminates possible consequences of a wider PVDF usage, e.g. if other companies expand their portfolios (various patents on PVDF meshes are held 15 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik worldwide8), and represents a worst case in terms of maximum possible emissions (< 10 tons/year; for detailed emissions, see section j - Request for exemption). Table g-3: Socioeconomic costs associated with a ban of surgical meshes made of PVDF in Europe (no-use scenario). Since FEG Textiltechnik a) has a product portfolio consisting of surgical meshes made of PVDF only and b) has a dominant market share in producing PVDF meshes in Europe and worldwide, the no-use scenario implies that the company would shut down and PVDF surgical meshes would essentially disappear from the market in Europe and worldwide. Due to this very specific situation, the absolute values of the no-use scenario are identical to the values of the baseline scenario. Thus, the no-use scenario implies that everything existing at baseline will completely disappear. The analysis focuses on the impact in Europe. Methods: Sales numbers, company profits (EBITDA) and growth rates were derived from internal documents (FEG Textiltechnik). Past monetary values were adjusted for inflation based on the historical inflation rates. Future monetary values were adjusted for inflation by assuming a 3 % p.a. rate and by a growth rate that is calculated from the sales numbers of the last 11 years (hernia: 6.5 %; urogynaecology: 7.3 %). Future values were discounted by 4 % p.a. to calculate the net present value (NPV). The socioeconomic analysis was performed in close collaboration with an expert consultancy in the field (Ramboll Deutschland GmbH, Hamburg, Germany). Scenario 1: Assuming current patient numbers for treatment with PVDF mesh (Europe) Scenario 2: Assuming all patients could be treated with PVDF mesh (Europe) level of socioeconomic impact of banning PVDF meshes type of socioeconomic impact of banning PVDF meshes estimated costs per year / # patients affected estimated costs over 10 years (NPV) / # patients affected estimated costs per year / # patients affected estimated costs over 10 years (NPV) / # patients affected PVDF mesh manufacturer and supply chain physicians patients patients loss of employment loss of profit 34.4 million (oneoff) 15.4 million 34.4 million (oneoff) 189 million 34.4 million (oneoff) 15.4 million 34.4 million (oneoff) 189 million complete loss of treatment variants complete loss of meshes that are MRI visible complete loss of treatment variants for urogynaecology complete loss of treatment variants for hernias preventable hernia reoperations for recurrence due to the use of less suitable alternatives (meshes) preventable urogynaecological complications due to the use of less suitable alternatives (meshes) n/a n/a 2,232 patients affected in urogynaecology 2,267 hernia patients affected 6,603 additional hernia reoperations for recurrence 2,462 additional urogynaecological complications n/a n/a 31,279 patients affected in urogynaecology 30,819 hernia patients affected 89,000 additional hernia reoperations for recurrence 37,500 additional urogynaecological complications n/a n/a 2,232 patients affected in urogynaecology 2,267 hernia patients affected 71,000 theoretically preventable hernia reoperations for recurrence 32,770 theoretically preventable urogynaecological complications n/a n/a 31,279 patients affected in urogynaecology 30,819 hernia patients affected 710,000 theoretically preventable hernia reoperations for recurrence 327,700 theoretically preventable urogynaecological complications 8 WO002016087896A1, CN000111821521A, RU000002670913C1 16 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik Scenario 1: Assuming current patient numbers for treatment with PVDF mesh (Europe) Scenario 2: Assuming all patients could be treated with PVDF mesh (Europe) level of socioeconomic impact of banning PVDF meshes type of socioeconomic impact of banning PVDF meshes estimated costs per year / # patients affected estimated costs over 10 years (NPV) / # patients affected estimated costs per year / # patients affected estimated costs over 10 years (NPV) / # patients affected patients society society society total costs total # patients adversely affected lost quality of life due to preventable hernia reoperations for recurrence lost quality of life due to preventable urogynaecological complications (willingness to pay) financial burden on health care system arising from hospitalizations due to preventable reoperations for hernia recurrence financial burden on health care system arising from hospitalizations due to preventable urogynaecological complications increased resource burden on hospitals due to preventable reoperations for hernia recurrence increased resource burden on hospitals due to preventable urogynaecological complications reduced productivity of patients due to preventable reoperations for hernia recurrence reduced productivity of patients due to preventable urogynaecological complications 544 million 203 million 159 million 24 million 20,000 excess bed days 5,000 excess bed days 2.5 million - 35 million 0.9 million - 13 million 1 billion 13,564 6.7 billion 5.9 billion 71.8 billion 2.9 billion 2.7 billion 38.8 billion 1.9 billion 1.7 billion 20.9 billion 350 million 324 million 4.7 billion 267,000 excess bed 213,000 excess bed 2.9 million excess days days bed days 69,000 excess bed days 66,000 excess bed days 918,500 excess bed days 31 million - 430 million 27 million - 377 million 328 million - 4.6 billion 13 million - 188 million 12 million - 174 million 178 million - 2.5 billion 12 billion - 13 billion 188,598 11 billion 108,269 137 billion - 144 billion 1,099,789 17 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik References [g-1] Baker JJ, berg S, Rosenberg J (2021) Reoperation for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Nationwide Cohort Study. Annals of Surgery Publish Ahead of Print: https://doi.org/10.1097/SLA.0000000000005206 [g-2] Sabadell J, Pereda-Nez A, Ojeda-de-Los-Santos F, Urbaneja M, Gonzlez-Garca C, Camps-Lloveras N, Prez-Plantado , Canet-Rodrguez J, Prez-Espejo MP, Rodrguez-Mias N, Sarasa-Castell N, Palau M, Montero-Armengol A, Salicr S, GilMoreno A, Poza JL. Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial. Neurourol Urodyn. 2021 Jan;40(1):475-482. doi: 10.1002/nau.24586. [g-3] Hariton E, Locascio JJ. Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG. 2018 Dec;125(13):1716. doi: 10.1111/1471-0528.15199. h) Other socioeconomic analysis (SEA) issues In its current form, the PFAS restriction proposal does not take into consideration the full socioeconomic costs of banning PVDF for use in mesh implants. Numerous publications have shown that PVDF meshes are superior to meshes made of other materials because patients suffer from less recurrences and adverse events (e.g. [h-1, h-2, h-3]). Therefore, banning PVDF would have far-reaching implications for patient safety. We have carried out a socioeconomic analysis to estimate the socioeconomic costs of banning PVDF meshes. In the first scenario based on current sales numbers, we estimate the socioeconomic costs of banning PVDF meshes at 1 billion per year. Over a 10-year period, the costs increase to 12 billion - 13 billion (net present value, adjusted for market growth and inflation). In the second scenario where all patients treated with a mesh in Europe receive an ideal PVDF mesh, the socioeconomic costs are estimated at 11 billion a year ( 137 billion - 144 billion net present value over 10 years; see Table g-3). Since not all benefits of PVDF can be monetized, the estimate should be interpreted as a lower bound. Please note that the analysis is based on various assumptions about monetary values of different parameters, which are detailed in section 8. In close alignment with the OECD report on "The economics of patient safety" [h-4, h-5], it is the governments' responsibility to protect patients from unnecessary harm. The evidence constitutes a clear call for a time-unlimited derogation for PVDF used for medical mesh implants. References [h-1] Baker JJ, berg S, Rosenberg J. Reoperation for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Nationwide Cohort Study. Ann Surg. 2023 Feb 1;277(2):335-342. doi: 10.1097/SLA.0000000000005206. [h-2] Sabadell J, Pereda-Nez A, Ojeda-de-Los-Santos F, Urbaneja M, Gonzlez-Garca C, Camps-Lloveras N, Prez-Plantado , Canet-Rodrguez J, Prez-Espejo MP, Rodrguez-Mias N, Sarasa-Castell N, Palau M, Montero-Armengol A, Salicr S, GilMoreno A, Poza JL. Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial. Neurourol Urodyn. 2021 Jan;40(1):475-482. doi: 10.1002/nau.24586. [h-3] Garcia-Pastor P, Porrero-Carro J, et al. (2018) Prospective Multicenter Blinded Randomized Study Comparing PP and PVDF Mesh Implants in Lichtenstein Procedure with Respect to Pain and Recurrence. JSM Surgical Procedures 1 (1): 1002. [h-4] Slawomirski L, Klazinga AA. (2017). The economics of patient safety: Strengthening a value-based approach to reducing patient harm at national level. https://dx.doi.org/10.1787/5a9858cd-en [h-5] Slawomirski L, Klazinga AA. (2022). The economics of patient safety: From analysis to action. https://doi.org/10.1787/18152015 18 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik i) Transitional period The current restriction proposal does not foresee any transitional period for hernia and urogynaecological meshes made of PVDF. The only exception is the hernia mesh, for which a derogation of 13.5 years has been proposed if further evidence is provided. From this scenario, it is clear that the restriction proposal ultimately leads to the disappearance of PVDF surgical meshes from the market, with grave socioeconomic consequences (see Section g and Section 8). Even a transitional period of 13.5 years is far from sufficient: As explained earlier, it took our company 30 years to identify, develop and market the ideal material for medical mesh implants: PVDF (see Table f-1 for further details). Even if there was a suitable substitute developed in the distant future, it would take another 30 to 35 years to make all product variants available on the market again (6-11 years for a single product group, but 30-35 years for the full product range). Moreover, the regulatory and financial effort for the approval of the modified product after a material change is almost the same as the effort for the approval of a completely new product. Hence, only a time-unlimited derogation for PVDF meshes in general can ascertain the continued supply of high-quality surgical meshes to patients. j) Request for exemption The request for exempting surgical meshes of PVDF from the PFAS restriction proposal is based on the following arguments: 1) Patients treated with surgical meshes made of PVDF have less disease recurrence and lower complication rates than patients treated with meshes made of alternative materials The introduction of the material polyvinylidene fluoride (PVDF) in 2003 was one of the few major innovations in the field of mesh implants, and one of the few for which the EU is envied internationally. Over 1 million patients have been successfully treated with PVDF mesh implants up until now (2023). Sound clinical data from different registries and countries (e.g. Denmark, Sweden, Germany, Austria, Switzerland) provide convincing evidence that the advantages of PVDF in terms of long-term stability are reflected in solid clinical results (Annex 1, Annex 8, [j-1, j-2]): Specifically, the Danish Hernia Registry shows that all investigated mesh implants made of the alternative materials polypropylene (PP) and polyethylene terephthalate (PET) have twice the recurrence rate after 10 years (Figure f-1, Annex 8, [j-1]). These results are in line with available clinical data from other registries as presented in Annex 8. Moreover, the use of PVDF surgical meshes has been associated with lower complication rates (Table g-2, [j-30]). This makes the introduction of PVDF mesh implants one of the most relevant innovations in the field of visceral surgery, with a direct impact on millions of patients. Innovations in the field of medical technology have become even more protracted and cost-intensive with the EU Medical Device Regulation (EU) 2017/745; MDR) becoming effective in 2017. With the now proposed PFAS restriction, the EU would not only remove one of the most relevant and promising innovations in the field of mesh implants from the market but also exclude it from healthcare: Mesh implants made of the polymer PVDF. With this, the EU would set back the development of mesh implants by decades and leave patients with unnecessarily high reoperation rates due to recurrence. 2) PVDF is a fluoropolymer with low hazard and low risk PFAS substances, to which the polymer PVDF also belongs according to the restriction proposal, are criticized due to their longevity (persistence) and uncontrolled spread (mobility) and the resulting risk of accumulation in the environment and in humans. However, the excellent longevity is the main 19 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik reason for the clinical superiority of mesh implants made of PVDF in terms of their lower recurrence rates compared to other meshes. Alternative materials with equivalent longevity are not available. Criticism of the uncontrolled spread of PFAS is only warranted with respect to the volatile, gaseous PFAS. In contrast, the polymer PVDF is not volatile and can be disposed of in a suitable manner by incineration at high temperatures. Through proper handling and disposal, the hazard of uncontrolled dispersal and accumulation of PFAS in the environment can be averted along the life cycle (production, application and disposal) while still reaping the benefits of PVDF's long-term stability (see also sections 2 - Emissions during the life cycle and 3 - Emission in the end-of-life phase). In support of this argument, other European regulatory agencies have categorized fluoropolymers such as PVDF as "low hazard" and "low risk"9. 3) PFAS emissions from PVDF surgical meshes are negligible In Europe, an estimated 277,000 tons of polymeric PFAS are produced annually (2020) [j-3] for applications such as lubricants and clothing. The current overall PVDF material demand for the provision of PVDF mesh implants is < 3 tons10 per year across Europe. Assuming a market development of 5 % growth rate, this amount is < 6 tons in 15 years or 0.0022 % of the current annual total amount of polymeric PFAS in the EU. Most of the PVDF used for mesh implants (65 %) is disposed of as production waste in suitable hazardous waste incinerators and can therefore be considered negligible in terms of PFAS emissions (see Sections 2 and 3). Another, not insignificant share of 23 % is incinerated in crematoria after patients` decease (Table j-2; see sections 2 and 3, Annex 9). Only the remaining part of 12 % is "disposed of" via burial (Annex 9; Table j-1). Table j-1: Waste and Emissions during the life cycle Phase Manufacturing phase Use phase End-of-life phase Waste 65 % 0 % 35 % thereof 65 % (23 % in total) thereof 35 % (12 % in total) Disposed of via hazardous waste incinerators Cremation (incineration) Burial (landfilling) Emission 0 % 0 % 0 % 12 % Table j-2: Cremation rates in European countries since 2017 or later [References see Annex 9] Average cremation rate in Europe is approximately 65 %. Country UK Norway Finland Germany Year 2017 2021 2021 2021 Cremation rate [%] 77 36 61 77 9 https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf 10 In Europe FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH is the clear market leader for mesh implants made of PVDF. In consequence, we are able to provide reliable and precise information on the Europe-wide emissions and waste from PVDF mesh implants. 20 | 25 PFAS Consultation June 2023 Netherlands Belgium General Comments (non-confidential) 2014 63 2020 74 Submitted by FEG Textiltechnik 4) PVDF can be used without additives The production of mesh implants from PVDF is technically more demanding than the production of mesh implants from alternative materials (PP, PET). In addition, PVDF as a material is considerably more expensive. Polypropylene, which is inexpensive and the most widely used polymer, requires a significant amount of additives (antioxidants, free radical scavengers, UV stabilizers and antiozonants) [j-4]. In contrast, PVDF can be used without any additives and thus represents a polymer of maximum purity, with all the associated advantages in terms of the toxicological and allergic potential of implants made of PVDF [j-5]11 . 5) Surgical meshes made of PVDF provide unique diagnostic features and new treatment variants As a SME with a start-up history, FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH is still a family owned company and market leader for PVDF meshes in the world today, with a fully integrated production line in Germany. In addition to the unique selling point of PVDF, the company has also innovated and developed its mesh implants in other ways. The most relevant developments include visible technology and meshes for special treatment variants. Our PVDF mesh implants with visible technology are the only mesh implants in the world that are visible in magnetic resonance imaging (MRI). This feature constitutes an additional, valuable diagnostic function for medical professionals. The MRI visibility of the mesh implants helps doctors to assess the position and orientation of the mesh implants without having to perform an additional surgical procedure. This is a great relief for the individual patient. The discontinuation of PVDF mesh implants also means the discontinuation of this additional function with the consequences of higher reoperation rates for diagnostic purposes. Some of the PVDF mesh implants have been developed for special treatment variants for which no implant alternatives exist, not even alternatives made of inferior materials (PP, PET). In these cases, the discontinuation of PVDF mesh implants also means the discontinuation of these proven and successfully applied treatment methods, e.g.: the treatment and prevention of parastomal hernia with the special 3D mesh implant DynaMesh-IPST, [j-6 to j-16] the treatment of hiatal hernia with the special 3D mesh implant DynaMesh-DELTA, [j17] the treatment of pelvic prolapse by means of pectopexy with the special DynaMesh-PRP, [j18 to j-23] the treatment of pelvic prolapse by means of bilateral sacropexy with the special mesh implant DynaMesh-CESA or DynaMesh-VASA. [j-24 to j-29] The ones who suffer are once again the affected patients, which would then have to be treated with inferior treatment methods/variants. 11 "Notably, only a few polymers (e.g. PVDF) can be used without additives"... 21 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik 6) Surgical meshes made of PVDF serve niche indications The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft follows the "tailored approach" by adapting the mesh design to specific indications. As a result, a very broad product portfolio has been developed to meet the individual medical requirements. In many cases, these products serve niche indications (< 10,000 cases/year) for which no other manufacturer has alternative products in its portfolio. The cost of a material change is - under the current regulatory framework [Annex 10] almost identical to the cost of a new product development. Under the current, very strict regulatory framework of the MDR, the development of these products for the relevant niche indications is no longer economically feasible (see sections 7 and 8). With the PFAS restriction, the products would disappear from the market without replacement. Conclusions In summary, the following facts highlight the advantages of PVDF surgical meshes: high clinical benefit though lower recurrence and complication rates high clinical benefit through the provision of mesh implants with unique diagnostic features, tailored design and focus on niche indications high socio-economic benefit (fewer recurrences and side effects, thus better quality of life and economic productivity of patients, saved hospital costs, less burden on the health care system; see sections 7 and 8) comparatively negligible amounts of material controllable disposal to minimize dispersal and accumulation in the environment Despite numerous benefits, the PFAS restriction proposal so far does not foresee a permanent exemption for the use of PVDF in mesh implants. Patients in Europe would thus be left with medical alternatives that have proven to be inferior (PP, PET). This would cause considerable additional treatment costs - not to mention the human suffering that can hardly be expressed in monetary value. To prevent the care of patients in Europe from falling back by two decades, the PFAS restriction proposal should urgently be adapted for medical devices and especially for surgical mesh implants. Therefore, we call for a permanent exemption for the group of PVDF mesh implants from the PFAS restriction. Should that not be possible, they should be granted a temporary derogation of maximal length, ideally well above the 13.5 years initially proposed. 22 | 25 PFAS Consultation June 2023 General Comments (non-confidential) Submitted by FEG Textiltechnik References [j-1] Baker JJ, berg S, Rosenberg J. Reoperation for Recurrence is Affected by Type of Mesh in Laparoscopic Ventral Hernia Repair: A Nationwide Cohort Study. Ann Surg. 2023 Feb 1;277(2):335-342. doi: 10.1097/SLA.0000000000005206. 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