Donald R. Ostergard, MD, has had a long distinguished career in urogynecology and reconstructive pelvic surgery. Retired from the field, earlier this year he published an article:
Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known
Dr. Ostergard is the sort of doctor that others claim they trained with as part of the bragging rights. Here is his contact information at the University of Louisville School of Medicine. Dr. Ostergard is also the past president of the American Urogynecologic Society.
Surgical Mesh Properties Were Known When it Was Approved
Dr. Ostergard writes that many of the properties of surgical mesh were not taken into account before the marketing of mesh kits. This information was available to the Food and Drug Administration and the mesh kit manufacturers. He writes that the first polypropylene mesh kit cleared by the FDA was used in the transvaginal tape or TVT procedure to treat stress urinary incontinence.
The kit clearance was granted in 1998. Two years earlier in 1996, a woven polyester mesh kit obtained FDA approval.
Dr. Ostergard provides citations for what was known about kits implanted in women until 2003 at which time many new kits were cleared.
The information had been accumulating since the 1950s he says, and provides the documentation that was available for years and includes some of the following and more:
- An implanted device should not incite an inflammatory or foreign body response
- An implanted device should be chemically inert
- An implanted device should not encourage an allergic reaction
- An implanted device should stand up to mechanical stress
- An implanted device should not be modified by tissue fluids
- An implanted multifilament suture attracts bacteria 5-8 times greater rate than a monofilament suture
- Pore size is important for tissues to incorporate with the mesh
- As soon as mesh is implanted bacteria and host defense cells race to the mesh surface
- Bacteria migrate alongside the synthetic fibers
- Polypropylene mesh shrinks 30-50% after four weeks
- Bacterial colonization was found in 33% of mesh that had been removed
- The abdominal wall stiffens after mesh is implanted
- Mesh surface predicts bacterial adherence – multifilament mesh has a 205% increase in surface area which may explain infections up to years after it’s implanted
- Degradation occurs in all meshes.