Doctors and manufacturers of the transvaginal mesh (TVM) have known the risk of vaginal erosion and wrongly accepted this risk as ‘justifiable.’
Doctors and manufacturers of the transvaginal mesh (TVM) devices used for stress urinary incontinence and pelvic organ prolapse have known the risk of vaginal erosion for decades and wrongly accepted this risk as ‘justifiable’ considering the ease of implantation of vaginal mesh devices compared to historically safe, effective and more invasive surgical procedures used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Unfortunately for a generation of women across the world, the transvaginal mesh manufacturers Johnson & Johnson, Boston Scientific, Coloplast, and American Medical System, have orchestrated a great lie, “that the risk of erosion is ‘justifiable’ given the benefit of the device.”
The FDA on April 16, 2019 finally banned the remaining TVM devices used for POP from the market because the efficacy of the devices was no better than traditional non-mesh repair but these devices exposed women to all the complications of polypropylene mesh. Is this move by the FDA, the next step as they move onto a closer examination of the injuries caused by mid-urethral slings used for (SUI)? Will transobturator slings be next to be banned by the FDA like the Boston Scientific Uphold and Coloplast Restorelle Directfix devices used for pelvic organ prolapse, or will many of these devices be ‘voluntarily’ withdrawn from the market-place like the Johnson & Johnson Prolift and Prosima?
“We represent newly injured women after the MDL closed its doors to new cases and have cases filed against Johnson & Johnson, Coloplast, Boston Scientific, and AMS across the country.” – Dr. Greg Vigna
The truth is that an erosion is a serious injury that represents the incompatibility between the pelvic soft tissues and the plastic device laced with bacteria during implantation. The transobturator (TOT) slings and retropubic slings used for SUI have caused many of the same injuries by the same mechanisms as the POP devices. The TVM devices used in the surgical treatment of SUI pass through the vagina during implantation, are laced with the same vaginal bacteria during implantation, are made of the same polypropylene, and the arms are placed blindly increasing the potential for neurological and vascular injury.
Greg Vigna, MD, JD, practicing physician, practicing attorney, and Certified Life Care Planner and his team of national pharmaceutical injury attorneys are investigating injuries caused from TVM devices including fistulas, bowel erosions, vaginal erosion, bladder erosion, urethral erosion, dyspareunia, post-operative complications following removals including hematomas, and pelvic pain.
Dr. Vigna says, “We represent newly injured women after the MDL closed its doors to new cases
and have cases filed against Johnson & Johnson, Coloplast, Boston Scientific, and AMS across the country. We represent women within the MDL who are awaiting remand with diagnoses of pudendal neuralgia, Complex Regional Pain Syndrome, and obturator neuralgia. We will take all of these women to the finish line.”