Non-mesh repair of prolapse may damage the pudendal nerve.

SANTA BARBARA, CA, UNITED STATES OF AMERICA, April 3, 2019 / — Pudendal neuralgia (PN) is the most dreaded adverse event associated with transobturator sling (TOT) devices used for stress urinary incontinence. The arms of these polypropylene devices penetrate the obturator internis muscle which is adjacent to the trunk of the pudendal nerve as it runs through Alock’s canal behind the sacrospinous ligament. The TOT may cause the muscle to spasm and lead to scar tissue from chronic foreign body reaction that leads to traction on the pudendal nerve which may cause pudendal neuralgia which is a catastrophic pain syndrome.

Transvaginal mesh devices used previously for pelvic organ prolapse (POP) were designed to insert directly upon the sacrospinous ligament. Unfortunately for a generation of women the result was foreseeable… direct injury to the pudendal nerve resulting in pudendal neuralgia because the nerve runs behind the sacrospinous ligament. Devises such as the Johnson & Johnson Prolift and Boston Scientific Pinnacle Pelvic Floor Repair Kit caused serious injuries from blind placement of its arms to the sacrospinous ligament. New studies on the anatomic variations of the pudendal nerve reveal that 11% of women have pudendal nerve terminal branch, the inferior rectal nerve, runs separately from the main trunk and penetrates through the sacrospinous ligament making it especially susceptible to injury from the arms of the mesh. Isolated inferior rectal nerve injury will cause constipation and intractable anorectal pain.

Today, TVM POP devices are not routinely used and now surgical options for POP include transvaginal primary repair without mesh, abdominal sacrocolpopexy, laparoscopic assisted sacrocolpopexy, and robotic assisted sacrocolpopexy.

Greg Vigna, MD, JD, practicing physician, damages expert, and national pharmaceutical injury attorney is reviewing new pudendal neuralgia cases caused by transobturator slings. He states, “Analysis as to what caused the pudendal neuralgia is much more difficult today than what it was previously when women were commonly receiving a transobturator sling and a POP TVM product at the same time and it didn’t matter from a compensation standpoint which TVM device caused the injury.”

Dr. Vigna states, “SUI and POP are conditions that often occur together and today there is often a non-mesh repair of prolapse coupled with a TOT sling. It is necessary to determine if the POP procedure had the potential to cause injury to the pudendal nerve at its trunk or at its terminal branches as the manufacturers of the TOT slings will blame the doctor’s POP repair as the cause of the pain to avoid liability.”

Greg Vigna, MD, JD and the nationally prominent pharmaceutical injury attorneys he works with are reviewing newly injured TVM cases outside the MDL and women who have opted out of the matrix settlements inside the MDL. Dr. Vigna states, “We understand how to approach the specific causation issues required for individual litigation and how to sort out injuries caused by the device versus the remote possibility for injury from non-mesh repairs of prolapse.”

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