Dr. Greg Vigna

Serious injuries continue at the hands of doctors who do not know of the risks of pudendal and obturator neuralgia from a properly placed transobturator sling.

SANTA BARBARA, CA, UNITED STATES, March 1, 2022 /EINPresswire.com/ -- “Ethicon’s current Instructions for Use for its mid-urethral slings describe the risk of ‘excessive contraction or shrinkage of the tissue surrounding the mesh’. Unfortunately, Ethicon continues to be elusive on the topic of nerve entrapment related to this admitted soft tissue adverse event. The result is clear, ongoing serious injuries at the hands of doctors who do not know of the risks of pudendal and obturator neuralgia from a properly placed transobturator sling." explains Greg Vigna, MD, JD.

Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and certified life care planner states, “The language from Ethicon’s TVT-O and Abbrevo Instructions for Use (IFU) does not include the words ‘nerve entrapment’, ‘pudendal neuralgia’, and ‘obturator neuralgia’ and does not warn women that these diagnoses are caused by the Prolene mesh of a properly positioned device.”

Dr. Vigna continues, “Ethicon’s position is that their current TVT-O and TVT Abbrevo IFU is sufficient to warn women of the risks of pudendal and obturator neuralgia at the same time many of Ethicon’s retained experts are testifying that nerve entrapment, pudendal neuralgia, and obturator neuralgia are not complications that result in a properly positioned transobturator slings.”

Dr. Vigna adds, “Defense experts have been quick to testify that there are only three unique injuries caused by the polypropylene mid-urethral slings and those include what they describe as the three ‘e’s which are erosion, extrusion, and exposure. Now they need to deal with a fourth ‘e’ which is ‘excessive contraction or shrinkage of tissue surrounding the mesh’ that has been included in Ethicon’s current IFU.”

Dr. Vigna concludes, “We are getting closer to the truth, and that ‘excessive contraction or shrinkage surrounding the mesh’ is likely a substantial factor in causing nerve entrapment that were not warned by the manufacturers of mid-urethral slings despite being known for over a decade and is now recognized by the American Urogynecological Society (AUGS), the International Urogynecological Association (IUGA), Society of Gynecological Surgeons (SGS), and American Association of Gynecological Laparoscopists (AAGL) when they endorsed the 2020 AUGS-IUGA Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist which included treatment algorithms for the described ‘extrapelvic pain’ caused by the arms of the transobturator sling related to pudendal and obturator neuralgia from nerve entrapment.”

Symptoms of neurological injury to the pudendal and obturator nerve from the transobturator slings include:
1) Groin pain
2) Hip pain
3) Inability to wear tight pants
4) Clitoral pain or numbness
5) Severe pain that makes vaginal penetration impossible
6) Tailbone pain
7) Anorectal pain
8) Painful bladder
9) Pain with sitting

Click here to learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia. Read our FREE BOOK on Vaginal Mesh Pain and, for articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/.

Click the link for information regarding sling related complications: https://tvm.lifecare123.com/slingebook.html

References:
Abbrevo IFU: https://hostedvl106.quosavl.com/qb/
Consent Order: https://www.clydeco.com/clyde/media/fileslibrary/Consent_Judgment_-_Ethicon.pdf
2020 AUGS-IUGA Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist (See extrapelvic pain): https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf
https://www.jnjmedicaldevices.com/en-US/product/gynecare-tvt-abbrevo-continence-system

Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
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