Donald Ostergard says Many properties of polypropylene mesh, causing complications for patients, were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. These factors were not sufficiently taken into account prior to the sale of these products.
Study by Ackerman and Raz says that most reports due not follow up women after the one year mark. Mesh complications can take months or years to cut in. Study reckons complication of chronic pain could be as high as 31%.
Risk of a negative outcome after a mesh implant for incontinence is around 15%.
Mesh degrades and can turn brittle inside the body.
Doctors A. Lenore Ackerman and Shlomo Raz say synthetic slings are not safe.
This review says mesh erosion (including exposure, extrusion and perforation) varies widely from 0–33%. The average incidence of graft erosion is 10.3%. Other studies say it is 0–7.3%. Yet another study shows it is 0–21% for POP surgeries. If nothing else this review – which looks at a range of literature already out there proves nobody knows the true scale of this disaster
Mesh to be upgraded to a higher risk medical device in the EU by 2020. See pages 469/70.
American watchdog body, the FDA, upgrades the trocars (hooks) to implant vaginal mesh implants, to a higher risk device.
PROSPECT study says a vaginal repair for prolapse with mesh or graft material did not improve women’s outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication.
The implantation of any mesh for the treatment of prolapse via the vaginal route should be only considered in complex cases in particular after failed primary repair.
Don’t believe the hype
A report published in the Lancet says it follows for women for 18 years. It doesn’t. It only follows women for up to five years but takes statistics from an 18 year period.
The statistics used are called Hospital Episode Statistics HES. These figures are of women who go into hospital for a mesh complications so it doesn’t tell the story of women going to their GP for pain killers. Nor does it tell the story of women going for repeat antibiotics for urinary infections. HES data will be a vastly under reported set of figures for mesh complications.
A study in Denmark said it followed women for 17 years. The truth is it picked 90 women who had a mesh implant. Of those only 70 women agreed to a final interview and most were done over the telephone. It claims one woman had a mesh exposure and no other complications occurred. Two of the medics involved in this study had financial interests with the mesh manufacturers.
You cannot rely on a study of just 70 women in a biased trial to “prove” mesh is safe.