Coloplast Corporation has been hit with a lawsuit filed by a woman who sustained injuries from the Altis Single Incision Sling System transvaginal mesh device.
SANTA BARBARA, CALIFORNIA, UNITED STATES, October 3, 2019 /EINPresswire.com/ — On October 2, 2019 Coloplast Corporation has been hit with a lawsuit filed by a woman who sustained injuries caused by the Altis Single Incision Sling System transvaginal mesh (TVM) device used for the treatment of stress urinary incontinence (SUI) in the lawsuit filed in United States District Court for the Middle District of North Carolina (Case No.: 1:19-cv-01017)
On April 16, 2019 the FDA ordered Boston Scientific Corporation and Coloplast ‘to stop selling and distributing their products (TVM devices for prolapse) immediately’ as there was no ‘demonstrated reasonable assurance of safety’ and their proposed prospective controlled 522 post-market surveillance study was deemed to be futile by FDA experts to show the necessary evidence that the benefit of the device out-weights the potential risks of the device. Between January 1 to December 31, 2008, there were 1,371 reported adverse events reported to the FDA for synthetic slings used for SUI. The FDA is still currently looking into the literature regarding the use of synthetic sling-related complications and has provided recommendations on how to mitigate mesh-related risks and counsel patients.
The American College of Obstetricians and Gynecologist (ACOG) on January 2019 in ‘Frequently Asked Questions Special Procedures’ stated that traditional sling surgery (autologous slings made from the patient’s own tissue), have ‘none of the risks associated with synthetic mesh’ which include ‘erosion, infection, long-term pain.’
Dr. Greg Vigna, practicing physician, national pharmaceutical injury attorney, and certified life care planner states that mini-slings were designed by manufacturers including Ethicon (Secur), American Medical Systems (mini-Arc), Coloplast (Altis), and Boston Scientific (Solyx) to reduce the amount of mesh by eliminating the mesh that goes through the groin and leg to reduce the leg pain complications observed in their own post-marketing surveillance efforts. Eight studies when combined ‘showed that compared to the patients who received the TVT-O, the patients who received adjustable SIMS (mini-slings) had a similar incidence of groin pain.’ Dr. Vigna adds, “Blind placement of the mini-sling devices places the pudendal nerve and obturator nerve in peril to acute injuries and chronic injuries as the device contracts causing catastrophic, life altering pain. These devices are no better than the traditional transobturator slings and simply need to come off the market.”
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. Vigna states, “We are filing severely injured women suffering with disabling injuries nationwide, associating with local attorneys who are proven trial attorneys. Thomas Henson, Jr. and his firm Henson Fuerst, P.A., is assisting us on our North Carolina cases and he is former Past Chair and Board of Directors for the Brain Injury Association of North Carolina.”
Dr. Vigna’s litigation team represents women coast to coast with women that were implanted over a decade ago with TVM products that have recently become symptomatic as the device degrades and contracts pulling vital structures required for sexual function, bowel and bladder function, and sexual function. They also have women with severe neurological injuries causing catastrophic life change pain from 2019 implants and women proceeding in the Wave Discovery procedure in the West Virginia MDL awaiting remand.
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
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Source: EIN Presswire