Sacramento , CA, 09/29/2015 /SubmitPressRelease123/
The Federal Drug Administration (FDA) on July 13, 2011 issued an advisory that serious complications associated with surgical mesh for transvaginal repair of Pelvic Organ Prolapse (POP) are ‘not rare’ and in April of 2014 proposed to reclassify the mesh devices used for POP from a moderate-risk device to a high-risk device. To date the FDA has not moved on issuing any advisory to the public regarding the safety of transvaginal mesh device referred to as a ‘sling’ used for Stress Urinary Incontinence but indicated that they would comment on this device in the future.
Manufacturers of the slings remain on the clock waiting for the FDA to comment on the safety of slings. Approximately 250,000 slings are placed annually in the United States each year by urologist and gynecologist in a simple 30-minute outpatient procedure. There are two broad categories of sling devices that include the retropubic and the transobturator slings. The manufacturers have attempted to decrease the amount of mesh required in these devices without giving up their efficacy for each of these categories by producing mini-slings thinking that by decreasing the amount of mesh should decrease their complications.
What is known medically today, but not recognized publicly by the FDA? Transobturator slings are six times more likely to cause pain than the suprapubic slings. Unlike the suprapubic sling, which attaches just behind the pubic bone, the transobturator slings penetrate the obturator membrane, which places both the obturator nerve and the pudendal nerve in peril of injury. These are key nerves that together account for functions including mobility, bladder, bowel, and sexual function. Pudendal neuralgia is a catastrophic pain syndrome with significant life-time cost as evidenced by Linda Gross vs Ethicon, a mesh case, where she was awarded 1 million dollars for future care alone for her diagnosis of pudendal neuralgia.
What is known medically today by the injured is significantly more than what it was in 2013? Today, women have multiple resources on the Internet through support groups or from freely available literature to obtain knowledge necessary to empower them to obtain the early diagnosis of obturator and pudendal neuralgia, which are the most catastrophic consequences of the transobturator sling device. These severely injured women are also being told by the support groups that legal representation is available outside of the West Virginia Multi-District Litigation, which is bogged down by 84,000 cases.
Dr. Greg Vigna, a national pharmaceutical attorney, physician, and Certified Life Care Planner believes that as long as FDA doesn’t move on these transobturator slings there will be potentially hundreds of pudendal neuralgia cases filed in the State Courts of the manufacturers into perpetuity.
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Dr. Greg Vigna, MD, JD
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