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Autologous Slings Making a Comeback in India as Polypropylene Sling Use Declines

Magnifying glass over the country India on a colorful map

Dr. Greg Vigna

Dr. Greg Vigna

Polypropylene slings have significantly decreased in many countries. This has led to a renaissance of the rise of natural autologous fascial slings.

We have several cases where a physician’s mere selection of a TOT that ultimately caused pudendal or obturator neuralgia is negligent conduct that serves as the basis of malpractice....”
— Dr. Greg Vigna

SANTA BARBARA, CA, UNITED STATES, April 7, 2022 /EINPresswire.com/ -- "Their use (polypropylene slings) has significantly decreased in many countries, and they are no longer available in some countries. This has led to renaissance of use of natural autologous fascial sling, especially rectus fascia for the surgical management of SUI," explains JB Sharma, et al. Federation of Obstetric & Gynecological Societies of India. 2021.

Greg Vigna, MD, JD, national neurological injury attorney, practicing physician, and Certified Life Care Planner states, “We are well past the time that implantation of a transobturator sling (TOT) is justified. We have several cases where a physician’s mere selection of a TOT that ultimately caused pudendal or obturator neuralgia is negligent conduct that serves as the basis of malpractice against a physician implanter." The basis of this position includes the following:

1) The 2019 National Institute for Health and Care Excellence (NICE) in England position on polypropylene mid-urethral sings is ‘do not use… single-incision sub-urethral short mesh sling insertion except as part of a clinical trial’ and ‘do not offer a transobturator approach unless there are specific clinical circumstances in which the retropubic approach should be avoided.’

2) The American Urogynecological Society (AUGS), International Urogynecological Association (IUGA), Society of Gynecological Surgeons (SGS), and American Association of Gynecological Laparoscopist (AAGL) has either developed, endorsed, or supports the 2020 Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist that recognizes obturator and pudendal neuralgia from the arms of a transobturator (TOT) sling.

3) The Consent Agreement signed by Ethicon with numerous State Attorney Generals where they are required to do the following:
a. Do not represent that any inflammatory or foreign body reaction is only transient or, in all instances, minimal.
b. Do not represent that a foreign body reaction “may occur” with implantation of the device, but instead indicate that a foreign body reaction to the device will occur, the extent of which may differ and may result in adverse reactions, which may be ongoing.
c. State the Risks include excessive contraction or shrinkage of the tissue surrounding the mesh.

4) The literature that serves as the basis for 2020 Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist.

Dr. Vigna adds, “We have several combination medical malpractice and product liability cases involving retropubic slings and transobturator slings. That number will be increasing substantially as we investigate early injury cases after implantation going forward.”

Symptoms of neurological injury to the pudendal and obturator nerve from a TOT occur acutely after implantation or years later with symptoms that 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

Learn more about 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. For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/. For information regarding sling related complications, visit: https://tvm.lifecare123.com/slingebook.html

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