Dr. Greg Vigna discusses the hope that Dr. Holly Ritcher will protect women by moving to ban transobturator slings from the marketplace.

“Dr. Holly Richter is in position to improve the reputation of American Urogynecologic Society (AUGS) which has failed to protect women from the dangers of transvaginal mesh. I believe she will do what is right and move to ban transobturator slings from the US marketplace”…Greg Vigna, MD, JD

Background:

In 2010, Dr. Richter published a study in the New England Journal of Medicine comparing transobturator slings used in the treatment of stress urinary incontinence to retropubic slings and noted the “patients in the transobturator-sling group were more likely to report neurologic symptoms, such as leg weakness and groin numbness” when compared to patients receiving retropubic slings.

In April of 2019 the National Institute for Health and Care Excellence (NICE) from England published recommendations for the management of incontinence for physicians which clearly stated, “Do not offer a transobturator approach unless there are specific clinical circumstances (for example, previous pelvic procedures) in which the retropubic approach should be avoided.”

“Dr. Holly Richter is in position to improve the reputation of American Urogynecologic Society (AUGS), which has failed to protect women from the dangers of transvaginal mesh.” – Dr. Greg Vigna

In March of 2020, A Joint Writing Group of AUGS and the International Urogynecological Association published the Joint Position Statement on the Management of Mesh-Related Complications and noted the following:

Patients with Extrapelvic Pain From TVM
Some patients report pain that may be attributable to nerve impingement from mesh arms that are outside the pelvis (in the groin or in the ischiorectal fossa). In these cases, complaints should map to dermatomal distributions, and appropriate neurologic and radiologic evaluations should be carried out. Anecdotal evidence has described extensive extravaginal mesh excision, with or without nerve release procedures; there are some data suggesting that this may be more successful in cases of obturator neuralgia than of pudendal neuralgia. With regard to TVM-related conditions, outcomes of these procedures have been variable, and there is insufficient evidence to support this approach. Accordingly, extended extravaginal excision of TVM extrapelvic arms should be considered rarely.

Midurethral slings—notably the full-length obturator-type slings—have been associated with pain in the groin.

Citing:
Scottish Independent Review of the use, safety and efficacy of transvaginal
mesh implants in the treatment of stress urinary incontinence and pelvic
organ prolapse in women.

Greg Vigna, MD, JD, national pharmaceutical injury attorney, practicing physician, and Certified Life Care Planner states, “The elephant in the room continues as AUGS is finally publicly acknowledging what manufacturers have known for over a decade that there are serious neurological injuries caused by TOTs. AUGS unfortunately continues to fail to protect women as it does not differentiate the frequency of dangers and difficulty of management of the neurological injuries caused by TOTs and retropubic slings. I hope that Dr. Richter moves to protect women and regain some credibility of AUGS.”

Dr. Vigna adds, “If AUGS doesn’t move toward the position of NICE, I see a blood bath occurring as defense manufacturers have biased high priced experts who are blaming the implanting physicians for pudendal neuralgia and obturator neuralgia caused by properly placed TOTs despite these physicians being largely oblivious as to the magnitude of the risk of TOTs because manufacturers still do not warn on the specific dangers of the devices and in their warning do not distinguish between TOTs and retropubic slings.”

Dr. Vigna predicts the future, “As severe neurological injuries occur at the hands of physicians for both retropubic slings and transobturator slings questions will arise about the decision to place those products. Obviously, physicians who are in bed with manufacturers understand the difference between TOTs and retropubic slings.”

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. His cases are 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.

Learn more on the anatomical basis for TOT injury or irritation to the obturator and pudendal nerve and the treatments of obturator and pudendal neuralgia here: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59

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.

References:
https://www.nejm.org/doi/full/10.1056/NEJMoa0912658
https://www.gov.scot/publications/scottish-independent-review-use-safety-efficacy-transvaginal-mesh-implants-treatment-9781786528711/pages/2/
https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf

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