Boston Scientific was hit with a lawsuit filed by a woman who sustained injuries caused by the Obtryx transobturator sling device.
On December 16, 2021, Boston Scientific was hit with a lawsuit filed by a Washington State woman who sustained injuries caused by the Obtryx transobturator sling device used for the treatment of stress urinary incontinence (SUI). The lawsuit was filed in the United States District Court for the District of Massachusetts, Central Division (Case 4:21-cv-40129).
The Plaintiff is represented by Ben C. Martin and Laura Baughman of Martin Baughman, PLLC and Greg Vigna, MD, JD. Ben Martin and Laura Baughman are national pharmaceutical injury attorneys in Dallas, Texas. Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome.
“Our strategy is to work up our cases for trial as each case is unique with its own strengths and weaknesses.” — Dr. Greg Vigna
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner states, “The American Urogynecological Society (AUGS) has recognized the catastrophic pain syndromes, pudendal and obturator neuralgia, caused by the arms of TOTs in the 2020 Joint Position Statement on the Management of Mesh-Related Complications for the FPMRS Specialist. Despite this, Boston Scientific to this day has not provided warnings of pudendal and/or obturator neuralgia listed in its Instructions for Use for its Obtryx and Solyx slings understanding that women become symptomatic acutely following implantation or months to years after implantation. This despite the 2019 NICE recommendations for physicians, ‘Do not offer a transobturator approach unless there are specific clinical circumstances in which a retropubic sling approach should be avoided.’”
Dr. Vigna adds, “The modus operandi for defense firms representing pharmaceutical manufacturers facing the potential for sizable verdicts is to delay. That tactic is fundamentally flawed as access to care has improved and there are now dozens of physicians from multiple specialties across the country that provide care for pudendal and obturator neuralgia which includes ultrasound guided nerve blocks, radiofrequency nerve ablations, Botox to the spastic pelvic floor muscles, spinal cord stimulation, peripheral nerve stimulation, and Ketamine. Each of these procedures are aimed at management of the neuropathic pain caused by the specific design of the device.”
Dr. Vigna concludes, “Our strategy is to work up our cases for trial as each case is unique with its own strengths and weaknesses. By virtue of our expertise in dealing with the neurological injuries caused by the polypropylene slings and transvaginal mesh we understand which cases we can represent and more importantly which cases to decline. Delay by the defense will fail as our cases get better overtime and Martin Baughman has proven capabilities to manage multiple pharmaceutical trials at the same time.”
Symptoms of neurological injury to the pudendal and obturator nerve from transobturator slings include:
- Groin pain
- Hip pain
- Inability to wear tight pants
- Clitoral pain or numbness
- Severe pain that makes vaginal penetration impossible
- Tailbone pain
- Anorectal pain
- Painful bladder
- Pain with sitting
To learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia click this link: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59
Read our FREE BOOK on Vaginal Mesh Pain and for articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/ We also have information regarding sling related complications.
References:
https://www.augs.org/assets/1/6/Joint_Position_Statement_on_the_Management_of.99428.pdf
https://www.nice.org.uk/guidance/ng123/resources/urinary-incontinence-and-pelvic-organ-prolapse-in-women-management-pdf-66141657205189
Greg Vigna, MD, JD
Vigna Law Group
+1 800-761-9206
email us here
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