AUGS Statement on the Management of Mesh-Related Complications describes unique risks caused by the arms of polypropylene retropubic and transobturator slings

“There is clearly a disconnect between what has been published in the literature over the past 10 years regarding the serious neurological pain syndromes caused by mid-urethral slings and what implanting physicians in the fields of urology, urogynecology, and gynecologist actually know.” states Greg Vigna, MD, JD.

Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “There is little evidence from the multiple depositions of implanting physicians and defense experts that there has been any attention to the 2020 American Urogynecological Society (AUGS) and the International Urogynecological Association Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist (AUGS 2020) by urologist, urogynecologist, or gynecologist. This paper describes the unique risks of ‘Extrapelvic Pain’ caused by the arms of polypropylene retropubic and transobturator slings. Unfortunately, this important paper has been essentially ignored by implanting physicians.”

The Joint Position is important as it is the first time AUGS has recognized the serious neurological injuries caused by transobturator polypropylene devices used in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) and neurological injuries caused by retropubic slings. AUGS 2020 cited the key authoritative articles from 2010 and 2012 that described the mechanism of injury to the pudendal and obturator nerves caused by transobturator and retropubic slings and those serious neurological injuries, in a significant majority, occur in properly positioned devices.

“There is clearly a disconnect between what has been published in the past decade regarding the serious neurological pain syndromes caused by mid-urethral slings and what implanting physicians know.” — Dr. Greg Vigna

Dr. Vigna adds, “I believe the FDA will change the risk classification of transobturator slings to a Class 3 Device from a Class 2 and keep retropubic slings a Class 2. Ultimately, I expect that transobturator slings will be banned by the FDA, like POP polypropylene devices, and retropubic slings will become more costly related to ongoing litigation related to these devices as serious injuries occur. This change in risk classification by the FDA is needed to reconcile the current classification of risks of mid-urethral slings to be more consistent with England’s National Institute for Health and Care Excellence (NICE) 2019 current recommendations”… which are as follows:

1.5.9 When planning a retropubic mid-urethral mesh sling procedure, surgeons should:

  • use a device manufactured from type 1 macroporous polypropylene mesh
  • consider using a retropubic mid-urethral mesh sling colored for high visibility, for ease of insertion and revision. [2013, amended 2019]

1.5.10 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. [2019]

1.5.11 Do not use the ‘top-down’ retropubic mid-urethral mesh sling approach or single-incision sub-urethral short mesh sling insertion except as part of a clinical trial. [2019]

Dr. Vigna concludes, “We are filing serious injury cases weekly against Ethicon, Boston Scientific, and Coloplast across the country and including a malpractice action against the implanting physician when it makes sense.”

Dr. Vigna is a California and Washington DC lawyer with Martin Baughman, PLLC, a national pharmaceutical injury law firm in Dallas, focusing on the neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome.

The transobturator (TOT) slings and mini-slings that cause pudendal and obturator neuralgia:

  • Ethicon: TVT-O, Abbrevo
  • Boston Scientific: Obtryx, Solyx
  • Coloplast: Aris, Altis

The retropubic slings that cause ilioinguinal neuralgia, pudendal neuralgia, and Complex Regional Pain Syndrome:

  • Ethicon: TVT, TVT-Exact
  • Boston Scientific: Advantage Fit, Lynx
  • Coloplast: Supris

The Vigna Law Group has serious injury cases filed across the country caused by transvaginal mesh used for POP and polypropylene slings used for the treatment of SUI. Injuries include pudendal neuralgia, obturator neuralgia, and ilioinguinal neuralgia. Cases are currently filed in California, Texas, Arkansas, Tennessee, North Carolina, Ohio, Idaho, Minnesota, Michigan, Oregon, Pennsylvania, New York, Massachusetts, Minnesota, and Florida. The Vigna Law Group has serious injury cases filed in the consolidated state court litigation in New Jersey against Ethicon and in Massachusetts against Boston Scientific. Trials for the serious neurological pain syndromes are anticipated in November 2020 and are expected to continue indefinitely.

Click here to learn more about TOT complications including obturator and pudendal neuralgia. Read a FREE BOOK about Vaginal Mesh Pain and 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 and listen to podcasts by Dr. Vigna and national pharmaceutical injury attorneys Laura Baughman and Ben Martin by clicking this link https://vignalawgroup.com/news/podcasts/

References:
https://www.nice.org.uk/guidance/ng123/resources/urinary-incontinence-and-pelvic-organ-prolapse-in-women-management-pdf-66141657205189
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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