Per- and poly-fluoroalkyl substances (PFAS) in hernia meshes: Weighing the evidence and implications of upcoming EU legislation

Dear Editor, An impending EU legislation may prohibit medical implants made of per- and poly-fluoroalkyl substances (PFASs) including the PVDF (polyvinylidene fluoride) and PTFE (polytetrafluoroethylene) hernia meshes.[1] Anticipated to be enforced by 2026/2027, this could significantly affect patient care and pose financial challenges for the companies involved. PFAS are a group of thousands of mainly man-made substances with fluorine atoms bonded to carbon atoms, which have increasingly found their way into medical applications, including hernia meshes made from PVDF and PTFE. Since they are commonly spread, so is the controversy surrounding their potential health impacts. With the impending EU legislation[1] set to regulate their use, we're faced with the question: does PFAS in hernia meshes exist in the future? Should the legislation pass without mesh manufacturers securing exceptions, they might experience significant revenue losses. In the worst-case scenario, they could confront a series of lawsuits, reminiscent of the fallout when Physiomesh was withdrawn from the market.[2] PVDF and PTFE meshes are usually advertised as meshes with low levels of degradation, which is supported by at least one study, which was industry-funded.[3] Their chemical properties are proposed to enhance durability,[3] potentially leading to longer-lasting repairs. While most findings stem from animal studies and histological observations, one cohort study with human patients compared different meshes and the risk of reoperation.[4] This study compared eight different meshes of different material compositions and among these, it was a PVDF mesh that had the lowest reoperation rate. However, the differences did not reach a significance level compared with some of the other meshes made from polypropylene. Despite the potential benefits, concerns surrounding PFAS cannot be overlooked. Several animal studies have suggested a correlation between PFAS exposure and potential health risks, including liver damage, hormone disruption, and even potential carcinogenic effects.[5] Though translating these findings directly to human exposure levels remains challenging, the concerns are real. There's also the issue of environmental impact. PFAS are known as "forever chemicals" because they do not break down easily in the environment. With the production and disposal of PFAS-containing products, we could be unintentionally contributing to a more significant environmental hazard.[5] The Upcoming EU Legislation With legislation looking to limit or potentially ban PFAS in various applications, the hernia mesh market might be on the brink of a significant shift. Manufacturers may need to reconsider mesh compositions, potentially impacting cost, availability, and the overall landscape of hernia repair options. Surgeons and patients will need to weigh the potential benefits of PFAS-enhanced meshes against their potential risks. Thus, potential advantages should be substantial to argue for their continued use under a potential exception from the legislation if this is possible at all. Conclusion The debate surrounding PFAS in hernia meshes is not just academic; it has tangible impacts on patients, surgeons, companies, and the environment. As we await the EU's decision, it is crucial to stay informed, critically evaluate the evidence, and ensure that any decisions made prioritize patient safety and long-term health outcomes. Ethical policy and Institutional Review board statement Not applicable. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest. Acknowledgement Not applicable.