As pelvic mesh complications lawsuit filings continue, more and more attention is being paid to the complications that can happen in connection with the implants used to correct pelvic organ prolapse in women.
Today’s pelvic mesh products used to treat pelvic organ prolapse were developed based on earlier mesh implants that had been used for decades to repair abdominal hernias.
These implants provided a non-surgical alternative to traditional surgical repair for pelvic organ prolapse.
Medical device companies developed the new products to be marketed as kits, providing doctors with materials necessary to implant the mesh.
To get FDA approval, the new products were put through an expedited approval process known as the 510(k) process. This process allows new devices that are similar to other devices already on the market to get FDA approval without extensive testing and clinical trials.
Some believe that a more rigorous approval process would have prevented many of the pelvic mesh complications being reported today.
For starters, some experts point out that even though polypropylene mesh had been used for decades to repair abdominal hernias, it had never been shown to be safe and effective as a treatment for pelvic organ prolapse.
Pelvic Mesh Complications
One reported problem with polypropylene mesh is its tendency to contract after implantation. This was a known problem since the days when the material had first begun to be used for hernia repair: hernia patients sometimes had to undergo a later round of surgery to relieve the complications caused by the contracting mesh.
As a foreign material inside the human body, pelvic mesh also tends to cause inflammation. Pelvic mesh complications related to inflammation include development of scar tissue that reduces elasticity and causes deformity inside the pelvis.
Sever pelvic mesh complications may require revision surgery for treatment. But these implants may become more firmly affixed within the body by the time complications appear, making surgery potentially tricky.
New tissue may have grown around the implant, tissue that must be surgically removed one step at a time, sometimes with multiple surgeries.
The implantation procedure itself puts some of the nearby tissue and organs at risk for damage. It’s not possible for the surgeon performing the implantation to see exactly what he or she is doing.
At the same time, the implantation requires working very close to nerves that are essential for walking, bowel function, and function of the muscles of the pelvic floor.
Compounding those risks can be the lack of skill of the doctor performing the implantation, who may not have undergone adequate training or certification to perform that particular procedure.
Manufacturers offered doctors a single day’s worth of instruction, with no particular evaluation of the doctor’s skills afterward.
Pelvic Mesh Lawsuits
Right now thousands of women are involved in pelvic mesh lawsuits seeking compensation for pelvic mesh complications they believe could have and should have been avoided.
They generally allege that these devices come with an excessive risk of pelvic mesh side effects, a risk that makes them defective by nature. They argue the manufacturers should have more adequately warned them and their doctors about the risk of pelvic mesh complications.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The vaginal mesh attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, vaginal mesh lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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