Document KRYL5GOY3n6J4E2KpxvdZkOXo
To whom it may concern,
As a medical professional with more than 15 years of experience with PVDF-meshes for pelvic floor reconstructive surgery, I feel compelled to address the proposed restrictions on PFAS substances. My experience in treating patients with pelvic organ prolapse, urogynaecological conditions, have confirmed the critical role of stable and non-degradable mesh materials in achieving positive outcomes and ensuring the well-being of my patients. Long-term stability of the material is one of the most important characteristic of any type of implant. For that very reason, PVDF-meshes are demonstrably superior to any meshes made from other materials such as polypropylene (PP), or polyester (PET).
I do believe that while environmental concerns are important, any decision to restrict PFAS materials in surgical meshes must be made through a careful evaluation of their medical benefits and impact on patients' health. I recognize the necessity of protecting the environment and human health from harmful substances. However, such decision should be based on an informed approach that safeguards both the environment as well as the well-being of the patients.
In conclusion, I would like to appeal to the expert committees, regulatory bodies, and political decision-makers to prioritize patient health and access to effective medical treatment when considering the restriction of PFAS surgical meshes. Time-unlimited exceptions for PFAS materials, such as PVDF, are essential in ensuring that medical professionals can continue to provide optimal care and achieve positive outcomes for patients across various surgical specialties.
Dr. A. Kavallaris Gynaecologist Oncologist Head of the Department of Gynaecology Oncology St. Luke's hospital, Thessaloniki, Greece.