News Feed Discussions Why isn’t Dynamesh available in the United States?

  • Why isn’t Dynamesh available in the United States?

    Posted by amevans_esq on November 1, 2019 at 3:35 pm

    I have spoken with a lot of surgeons about the different products and biomaterials that are available, and quite a few have expressed interest in mesh products made from Polyvinylidine Fluoride (PVDF) due to some encouraging studies and favorable biocompatibility profile. Even though Dynamesh — a PVDF product made by FEG Textiltechnik mbH — is cleared for sale by the FDA, they don’t sell it here. Does anyone know why? Perhaps an agreement with one of the US-based mesh manufacturers?

    Good intentions replied 4 years, 6 months ago 2 Members · 1 Reply
  • 1 Reply
  • Good intentions

    Member
    November 2, 2019 at 2:48 am

    It’s probably too expensive. Cost is a big factor in mesh device choice. Purchasing departments often are the ones making the medical device choices for large practices..

    PVDF as a material is not much different than the other thermoplastic fibers. And, with no data collection of real-world, long-term results, there is no “proof” that it has advantages. There is no valid justification for its usage, as there is little valid justification for choosing any mesh device.

    Mesh for hernia repair is run as a business, not a medical procedure. Marketing and sales drive the new products in to new markets, not results.

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