Plastic polypropylene transvaginal mesh (TVM) devices used for the surgical management of stress urinary incontinence (SUI) in women are of two different designs – the transobturator sling (TOT or TVT-O) and the retropubic sling (TVT). The transobturator sling passes through the obturator space, while the retropubic sling hammocks the urethra and exits up and out behind the pubic bone.
Most mesh “slings” are made from polypropylene plastic, even though there is no evidence that a polypropylene sling offers any benefit in cure rates when compared to non-polypropylene mesh surgical repairs for SUI such as a fascia harvested from the patient’s own body or the Burch procedure that involves tightening up the soft tissues that are damaged in childbirth that leads to SUI.
Additionally, there is no evidence that cure rates are different when comparing the transobturator sling placement to the retropubic sling placement.
Transobturator slings, unfortunately, cause pudendal neuralgia and Complex Regional Pain Syndrome Type 2, and these diagnoses are much less likely to occur with a retropubic sling. These diagnoses are life-changing catastrophic pain syndromes that cause vaginal pain what makes sexual intercourse impossible, pelvic pain that reduces mobility to a sedentary level, and bowel and bladder dysfunction that include an inability to evacuate the bowels with severe anorectal pain and urinary retention.
The transobturator sling by its design places the pudendal nerve in peril while the retropubic sling does not. Even a properly placed transobturator sling has the potential to cause direct damage by way of compression from scar tissue from ongoing inflammation produced by the body attacking the plastic device in something called chronic foreign body reaction (FBR). Another possible cause of damage is the indirect irritation or damage to the pudendal nerve by way of traction to the nerve by muscle spasm or scar tissue pulling at the nerve.
Dr. Greg Vigna, a national pharmaceutical injury attorney, practicing physician, and pudendal neuralgia expert, in preparation of specific causation reports for his clients inside the Multidistrict Litigation in West Virginia with urogynecologist experts are noting intraoperative surgical findings of scar tissue compressing the pudendal nerve caused by the transobturator sling at the time of transgluteal decompression of the pudendal nerve.
A diagnosis of pudendal neuralgia requires an individual assessment using an MRI as a diagnostic tool to determine pudendal nerve entrapment. A properly performed CT guided pudendal nerve block may provide some temporary relief of pain resulting from an entrapped nerve. These patients may improve from decompression if symptoms warrant aggressive surgical management.
Dr. Greg Vigna, whose focus is on catastrophic pelvic injury, states, “What is clear is the transobturator sling by its design causes pudendal neuralgia, CRPS-2, and obturator neuralgia and the retropubic sling does not. This is one basis of the design defect in this litigation against manufacturers of the various transobturator slings along with the polypropylene plastic design that causes FBR. There is a warning defect in that patients are simply not warned of the unique risk of injuries to the pudendal nerve or obturator nerve that is associated with the transobturator sling when compared to the retropubic sling.” He goes on to say, “Not only are these diagnoses caused by the older transobturator slings but occur in the smaller single incision mini-slings that implant into the obturator membrane and obturator internus.”
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