Thousands of women have suffered ill effects from surgical pelvic mesh, and now the FDA wants to more closely regulate its use to treat pelvic organ prolapse to help reduce future complaints. We support increased FDA oversight of pelvic mesh manufacturers and stricter product testing to help protect consumers from unsafe and ineffective medical devices.
Mesh kits have long been used to treat hernias and urinary incontinence with relatively few problems but using mesh to treat pelvic organ prolapse has not yielded the same positive results.
In the late 1990’s, pelvic mesh started being used to repair pelvic organ prolapse which occurs when the bladder and reproductive organs “fall down” into the vagina, and is usually seen in older women and women who’ve had children,
Pelvic mesh is a medical device categorized as an implant that is used to support surrounding tissue and surgically “hold” everything in its proper place. Mesh manufacturers promoted its use to surgeons as a superior alternative to traditional surgery to repair pelvic organ prolapse.
The data, however, does not support the manufacturers’ claims but rather shows that more than half these women end up having at least one more surgery to remove or repair the mesh, and sometimes more.
Countless women who’ve had pelvic mesh implanted to repair pelvic organ prolapse have complained of long-term pain, bleeding and infection. In some women, the mesh has moved, shrunk, eroded or is growing into surrounding tissues.
After a 3-year investigation, the FDA concluded that women who had pelvic mesh implants had more complications, more long-term complaints, and were more likely to need additional surgeries to remove the mesh than those women who had traditional prolapse repair surgery.
The FDA is now proposing that pelvic mesh be reclassified as a “high risk” (Class III) device rather than a “medium risk” (Class II) device as it is now classified. This reclassification serves two purposes: one, mesh manufacturers will have to meet stricter safety standards and prove its safety and effectiveness for treating pelvic organ prolapse; and two, the FDA will have stricter scrutiny over what is allowed on the market.
One important note: these proposals do not pertain to mesh kits used to treat hernias or urinary incontinence.
We support the FDA’s proposal to reclassify pelvic mesh as a “high risk” device. Medical devices can improve and save lives if they are safe and effective, and used for the purpose for which they are intended and were FDA-approved. We don’t think this proposal is an example of “more government” but merely the FDA doing the job it was created to do.
If you’d like to offer your opinion on the FDA proposal, the public may offer comments through July 30, 2014. Go to https://www.federalregister.gov/articles/2014/05/01/2014-09907/reclassification-of-surgical-mesh-for-transvaginal-pelvic-organ-prolapse-repair-and-surgical#h-27 for instructions on how to submit your comments.
And if you are one of the many victims experiencing negative side effects, complications, pain, bleeding or infection after undergoing surgery where pelvic mesh was used, don’t suffer in silence. Contact an experienced medical device attorney who can answer your questions and help you get the results you deserve.