Sling manufacturers have failed to add additional warnings to their instructions for use and to date have not provided a ‘Dear Doctor Letter’ to physicians.

“Women continue to be vulnerable to the risk of serious complications associated with Mid-urethral slings”…Una Lee, MD, Female Pelvic Medicine and Reconstructive Surgery

Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “Despite the American Urogynecological Society and the International Urogynecological Association 2020 Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist that describes the unique risks the arms of polypropylene retropubic and transobturator slings that cause pudendal, obturator, and ilioinguinal neuralgia the manufacturers have failed to add additional warnings to their instructions for use and to date have not provided a ‘Dear Doctor Letter’ to physicians.”

Dr. Vigna continues, “To date, we have taken dozens of depositions from the defense experts and implanting physicians who haven’t read the AUGS 2020 Joint Position Statement and to date have no understanding of what the Joint Position Statement reference to ‘Extrapelvic pain’ represents. To be clear the ‘Extrapelvic Pain’ from transvaginal mesh devices including mid-urethral slings are unique complications related to the arms of the mesh and these complications are not present in the non-mesh surgical treatment of stress urinary incontinence or pelvic organ prolapse.”

“It is time for the Ethicon, Coloplast, and Boston Scientific to send out Dear Doctor Letters regarding the added unique risk of Extrapelvic Pain from mid-urethral slings.” — Dr. Greg Vigna

Dr. Vigna adds, “The defense experts, many of them on faculties of teaching hospitals, have no understanding that ‘Extrapelvic Pain’ relates to specific neurological complications and myofascial pain syndromes unique to armed polypropylene devices and they are unaware of the citations in the literature that serves as the basis for 2020 Joint Position Statement. Not to mention, they have no idea of the recent flood of literature since 2019 that relates to latent injuries and catastrophic pain syndromes that require complete mesh removal.”

Dr. Vigna concludes, “It is time for the Ethicon, Coloplast, and Boston Scientific to send out Dear Doctor Letters regarding the added unique risk of Extrapelvic Pain from mid-urethral slings with the references listed below for physicians to study. AUGS has been ineffective in protecting women who are vulnerable to the risk of serious complications from retropubic and transobturator slings and are making the same mistakes they made with the pelvic organ prolapse (POP) devices that required the FDA to act to ban POP polypropylene devices from the market.”

Dr. Vigna is a California and Washington D.C. 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 who specialize in ‘one off’ catastrophic injuries caused by the IVF filter and vaginal mesh.

To 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, visit: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59

Visit our webpage for a FREE BOOK on Vaginal Mesh Pain.
Click here for Podcast from the Vigna Law Group.
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
1155 Coast Village Rd., Suite 3, Santa Barbara, CA
1-800-761-9206

References:
Dray, Crosby, et al. A Retrospective Analysis of Surgical Outcomes and Risk Factors for Persistent Postoperative Symptoms Following Synthetic Mid Urethral Sling Revision. The Journal of Urology. Vol. 202, 339-346, August 2019.

https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf

Reading List:

Baron, Rigaud, et al. Management of post-operative urinary incontinence after mid-urethral sling explantation for pelvic or perineal pain. March 3, 2020

Misrai, Roupret, et al. Surgical Resection for Suburethral Sling Complications After Treatment for Stress Urinary Incontinence. The J of Urology. Volume 181, 2198-2203, May 2009.

Rigaud, Labat, Riant, et al. Functional Results After Tape Removal for Chronic Pelvic Pain Following Tension-Free Vaginal Tape or Transobturator Tape. The Journal of Urology 2010.

King, H.B. Goldman, et al. Prospective Evaluation of the Effect of Thigh Dissection for Removal of Transobturator Mid Urethral Slings on Refractory Thigh Pain. The Journal of Urology. Vol. 196, 1207-1212, October 2016.

Greg Vigna, M.D., J.D., Certified Life Care Planner
Academic Physician Life Care Planning
+1 800-761-9206
email us here

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