Dr. Ostergard on Degradation, infection and heat effects on polypropylene mesh

Nov 2nd, 2011 | By | Category: Medical News

Degraded single polypropylene fiber 1000x

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.

 

Dr. Donald Ostergard

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.

The article which is available here. in the International International Urogynecology Journal, Volume 22, Number 7,   Published April 2011, Open Access at Springerlink.com

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6 Comments to “Dr. Ostergard on Degradation, infection and heat effects on polypropylene mesh”

  1. Liz Reece says:

    Thank you for bringing this horrifying information into the public domain, Jane, and deepest thanks to Dr Ostergard for all his work. I have read other research of his, always gratefully.

    When, when is this sort of information going to be seen in the right circles such that doctors STOP using mesh? It is beyond belief that so much published research is so pro mesh… It doesn’t add up when we know of so many harmed people and hear of the misery they are trying to get help with. The research by Dr Ostergard suggests that there is a disaster waiting to happen as lots of women and men treated with mesh find that it has deteriorated or infections have surfaced over time.

    • Jane Akre says:

      He reminds me of so many others who were/are the lone voice. It reminds us all to listen to those lone voices… they may have something to say.

  2. [...] Dr. Ostegard’s research he shows how the mesh becomes encapsulated with bacteria when inserted vaginally. (see full [...]

  3. i appreciate someone telling the damn truth, i am about dead from this mess, from what my dr says i do not have much longer to be here ,i am in so much pain ,it doesn’t matter anymore.Ican’t take anymore , thanks for telling the truth.

  4. [...] Degradation, infection and heat effects on polypropylene mesh [...]

  5. [...] Degradation, infection and heat effects on polypropylene mesh [...]

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.