Implantation of a mid-urethral sling & sacrocolpopexy mesh is an unnecessary risk especially when dyspareunia & disabling pain is produced by both devices.
“Implantation of a mid-urethral sling and sacrocolpopexy mesh is an unnecessary risk especially when dyspareunia and disabling pelvic pain may be produced by both devices. Differentiating which device is the primary pain generator is clearly beyond the skill of a majority of urogynecologists who are implanting these devices. The injuries and clinical course of these two product cases, like those experienced during the transvaginal mesh era, are heartbreaking” …Greg Vigna, MD, JD
Dr. Vigna, national pharmaceutical injury attorney, practicing physician, and Certified Life Care Planner states, “Despite the proven safety and efficacy of the Burch for treatment of stress urinary incontinence, urogynecologists continue to implant mid-urethral slings following the sacrocolpopexy mesh placement when they could simply extend the dissection and provide the Burch sutures and have similar efficacy without all the known complications of mid-urethral slings including the life-altering neurological pain syndromes caused by the arms of polypropylene mid-urethral slings that are described in the 2020 Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist.”
“Seemingly some urogynecologists don’t understand that the FDA banned polypropylene transvaginal mesh to protect women from the risks of the devices.” — Greg Vigna, MD, JD
Dr. Vigna adds, “Clearly the literature doesn’t support a benefit of utilizing mid-urethral slings over the Burch at the time of sacrocolpopexy mesh. In fact, a two-year study comparing Burch with midurethral sling with sacrocolpopexy showed no difference in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urge incontinence, and patient satisfaction.”
Dr. Vigna continues, “Seemingly some urogynecologists don’t understand that the FDA banned polypropylene transvaginal mesh to protect women from the risks of the devices. Now we have a situation where mid-urethral slings are being placed at the time of a sacrocolpopexy when simply a Burch can be provided by extending the dissection to allow for the Burch procedure to be completed.”
Dr. Vigna concludes, “We are investigating injuries caused by retropubic and transobturator slings placed at the time of placement of sacrocolpopexy mesh for combined product liability claims against Boston Scientific, Coloplast, and Ethicon and possible claims of medical malpractice against the implanting physician.
The Vigna Law Group targets the below transobturator (TOT) slings and mini-slings that cause pudendal and obturator neuralgia:
- Ethicon: TVT-O, Abbrevo
- Boston Scientific: Obtryx, Solyx
- Coloplast: Aris, Altis
The Vigna Law Group targets the below retropubic slings that cause ilioinguinal neuralgia, pudendal neuralgia, and Complex Regional Pain Syndrome:
- Ethicon: TVT, TVT-Exact
- Boston Scientific: Advantage Fit, Lynx
- Coloplast: Supris
Dr. Vigna is a California and Washington DC, lawyer, and with Martin Baughman, PLLC, a national pharmaceutical injury law firm in Dallas, focuses on the neurological injuries caused by transvaginal mesh devices including pudendal neuralgia,
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 click here: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59
Read our FREE BOOK on Vaginal Mesh Pain.
Listen to our Podcast from the Vigna Law Group.
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://tvm.lifecare123.com/slingebook.html
Greg Vigna, MD, JD
Vigna Law Group
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