Coloplast was hit with a lawsuit filed by an Idaho woman who sustained injuries caused by the Altis mini-sling device.
On November 23, 2021, Coloplast was hit with a lawsuit filed by an Idaho woman who sustained injuries caused by the Altis mini-sling device used for the treatment of stress urinary incontinence (SUI). The lawsuit was filed in the Minnesota Consolidated Litigation (Case 27-cv-21-14260).
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.
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner states, “There is no reliable evidence that these single incision mini-slings prevent or substantially reduces the risk of chronic leg and chronic groin pain when compared with full-length transobturator slings. The National Institute for Health and Care Excellence (NICE) in England (NICE) position is ‘do not use… single-incision sub-urethral short mesh sling insertion except as part of a clinical trial’. Coloplast’s Altis Investigational Device Exemption study was not reassuring as there was no reliable evidence that the Altis mini-sling reduces the risk of chronic groin pain when compared to its full-length Aris transobturator tape (TOT).”
“A majority of our clients have symptoms of neurological injury. Coloplast has failed to disclose that these life-altering pain syndromes occur in a properly positioned Altis or Aris TOT.” — Dr. Greg Vigna
Dr. Vigna adds, “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, Coloplast to this day has not provided warnings of pudendal and/or obturator neuralgia listed in its Instructions for Use for its Altis and Aris TOTs 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 , “An overwhelming majority of our clients have symptoms of neurological injury from mid-urethral slings including pudendal and obturator neuralgia. Coloplast has failed to disclose that these life-altering pain syndromes occur in a properly positioned Altis or Aris TOT.”
Symptoms of neurological injury to the pudendal and obturator nerve from the Coloplast Altis and Aris sling 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 here: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59
Click here for a FREE BOOK on Vaginal Mesh Pain : https://vignalawgroup.com/publications/
For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal (https://pudendalportal.lifecare123.com/) or https://tvm.lifecare123.com/.
Click here for information regarding sling related complications: https://tvm.lifecare123.com/slingebook.html
Greg Vigna, M.D., J.D., Certified Life Care Planner
Academic Physician Life Care Planning
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