Women who underwent TO sling surgery had twice the requirement for a repeat surgical intervention compared to women who had the retropubic sling procedure.
Science has caught up to logic and reason, as a study to be published in the August edition of the journal Obstetrics and Gynecology showed, “that women who underwent transobturator (TOT) sling surgery had twice the requirement for a repeat surgical intervention compared to women who had the retropubic sling procedure.”
The study compared women with TOT versus those implanted with retropubic slings. Results indicate that within eight years after surgery, reoperation rates were 11.2% for patients undergoing TOT sling operation compared to 5.2% in those undergoing retropubic sling. Other observations provided by Emanuel Trabuco, lead author from the Mayo Clinic, that failure was more likely in those with combined surgeries for prolapse.
Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner has been critical of ongoing sales of this device stating, “Experts in the field of urogynecology have known for several years that catastrophic pain syndromes are 10 times more likely than retropubic slings and now this study supports the conclusion that TOTs are dangerous and much more dangerous than the retropubic sling.”
“Retropubic slings place the ilioinguinal nerve in peril as normal anatomic variation can bring the nerve more medial and can get acutely injured or can get pulled over time as the device shrinks. ” –Dr. Greg Vigna
Studies indicate that neuromuscular complications are far more common in women implanted with TOT slings than retropubic slings. Neurological symptoms of the pelvis include pain with sitting, painful bladder filling, can’t wear tight pants because of pain in the perineum, numbness of clitoris, pain with sex, groin pain, anorectal pain, and bowel and bladder dysfunction.
Dr. Vigna states, “My team of national pharmaceutical injury attorneys have dozens of women with pudendal neuralgia and obturator neuralgia caused by TOTs filed in the MDL proceeding through the Wave Discovery Process, ‘new injury’ cases filed in Courts across the country now that the MDL is closed to new cases, and cases in New Jersey waiting for their call to the courthouse.”
TOT devices include the Coloplast Aris and Altis, Ethicon Inc. TVT-O, Boston Scientific Obtryx and Solyx slings. Dr. Vigna adds, “Nearly 200,000 slings are placed in the United States per year and hopefully this study is enough to push the FDA to move this to a Class III Device, and physicians
to use other treatment options rather than the TOT for the surgical management of stress urinary incontinence (SUI).”
Dr. Vigna notes that retropubic slings are also dangerous because of the blind placement and adds, “Retropubic slings place the ilioinguinal nerve in peril as normal anatomic variation can bring the nerve more medial and can get acutely injured or can get pulled over time as the device shrinks. Ilioinguinal neuralgia presents as pain at the hairline to the labia majora to the groin”.
For more information on Neurological Complications of Slings read our Free eBook. For articles, videos, and other valuable resources, visit our Pudendal Educational Portal or https://tvm.lifecare123.com/. We can also be reached at 800-761-9206.