Women have revealed that pain and suffering can – and is – unbearable.
The situation has resulted in serious complications for the US Food and Drug Administration (FDA) in the US, which in recent years has been compelled to admit receiving thousands of adverse event reports over a three-year period ending in December, 2010. The FDA has since increased the risk classification for transvaginal mesh, and some time ago announced that it was requiring all manufacturers of TVM mesh to conduct post-market studies in an effort to determine the safety and efficacy – or lack thereof, as the case may be – of transvaginal and TVT mesh.
The situation has also left the FDA, having at one time approved TVM mesh as safe and effective within acceptable risk parameters, injecting increasing amounts of caution into the conversation without actually banning the devices. To that end, the FDA is of the view that use of transvaginal mesh may not necessarily be the most appropriate response to pelvic organ prolapse (POP) when compared with more traditional procedures involving more invasive surgery.
Various plaintiffs in transvaginal mesh lawsuits allege the mesh products bind to, and become entwined with organ tissue to a degree that it can’t be safely removed. There have also been allegations of sharp edges of mesh protruding through the vaginal wall having migrated from the initial insertion position and point of deployment.
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Further, noted the study, “The increase in MMP-9 in mesh explants that were removed for exposure indicates degradation; the positive association between interleukin-10 and M2 macrophages in mesh explants that are removed for pain is consistent with fibrosis.”
Not good news for vaginal sling patients and transvaginal mesh recipients from both sides of the border.