The most severe complications of the transvaginal mesh debacle have always been and will continue to be the neurological complications caused by sling devices.
The American Urogynecologic Society (AUGS) in a joint writing with the International Urogynecological Association in April of 2020, publishing its “Expectations of Female Pelvic Medicine and Reconstructive Surgery Subspecialist in Diagnosis and Initial Management of Mesh Complications,” again has failed to mitigate the harm caused by the various transvaginal mesh devices used in the surgical management of stress urinary incontinence including transobturator slings, mini-slings that insert into the obturator internus muscle, and retropubic slings.
“The leadership of AUGS must move accordingly to protect women from injury and mitigate the harm that already has occurred to those who have been implanted.” — Dr. Greg Vigna
Greg Vigna, MD, JD, national pharmaceutical injury attorney and practicing physician states, “Dr. Geoffrey Cundiff, President of AUGS, has again failed to see the elephant in the room that the most severe complications of the transvaginal mesh debacle have always been and will continue to be the neurological complications caused by these devices. I urge Dr. Cundiff to stop being influenced by the paid physician consultants of the vaginal mesh manufacturers and do the following, some of which were recommended by respected journals and authorities:
- Do not offer a transobturator slings unless in exceptional circumstances, if at all (NICE Guidance Document, 2019)
- Do not use the mini-sling except as part of a clinical trial (NICE Guidance Document, 2019)
- Mandatory Continued Medical Education on the assessment of neuropathic pelvic pain, recommended by Dr. M. Possover.
a. Neuropelveological assessment of neuropathic pelvic pain. Gynecological Surgery 11, 139-144 (link below).
b. Risks, symptoms, and management of pelvic nerve damage secondary to surgery for pelvic organ prolapse: a report of 95 cases. International Urogynecology Journal. December 2011.”
Dr. Vigna continues, “Manufacturers of transobturator slings and mini-slings that are inserted into the obturator internus muscle are not taking ownership that their devices cause scarring and spasm of the obturator internus muscle which in turn causes traction or direct compression irritation and injury to the pudendal nerve that is adjacent to the muscle as it passes from the spine to the pelvis. The leadership of AUGS must move accordingly to protect women from injury and mitigate the harm that already has occurred to those who have been implanted.”
Dr. Vigna concludes, “Dr. Cundiff needs to do more than just recommend groin excision only by those with ‘appropriate multidisciplinary expertise’ as there are no recommended multidisciplinary centers, and women have to find their way through a maze of under-educated physicians who have been deceived by biased studies sponsored by the manufacturers and their paid consultants. Finding ‘appropriate multidisciplinary expertise’ is an impossibility for women with limited insurance or resources who live outside of places like Arizona, California, New York, or New Hampshire where there are clinicians who can diagnose the neurological complications of mesh devices, offer complete mesh removal, and treat the long-term neuralgias with state of the art modalities including nerve blocks, Botox, and neuromodulation from radiofrequency ablation or peripheral or spinal cord stimulators.”
The Vigna Law Group targets devices that cause pudendal and obturator neuralgia including the transobturator slings and mini-slings that are inserted into the obturator internus muscle including the following:
Ethicon: TVT-O, Abbrevo
Boston Scientific: Obtryx, Solyx
Coloplast: Aris, Altis
The Vigna Law Group targets retropubic sling devices that cause ilioinguinal neuralgia and Complex Regional Pain Syndrome include the following:
Ethicon: TVT
Boston Scientific: Advantage Fit
Coloplast: Supris
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome. He has clients with these diagnoses filed around the country with Martin Baughman, a Dallas Texas firm. Ben Martin and Laura Baughman are national pharmaceutical injury trial attorneys in Dallas, Texas.
Click here for a FREE BOOK on Vaginal Mesh Pain. For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/. Click here for information regarding sling related complications.
https://link.springer.com/article/10.1007/s10397-014-0838-4
https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf
Greg Vigna, M.D., J.D.
Vigna Law Group
+1 800-761-9206
email us here
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