An IFU must contain all warnings necessary to place doctors on notice of all material information when deciding the risk vs benefits of the medical device. Ethicon in 2015 largely re-wrote its Instructions for Use (IFU) for its polypropylene transvaginal mesh (TVM) mid-urethral slings used in the surgical management of stress urinary incontinence (SUI). [...]

TVM manufacturers' transobturator slings and mini-slings continue to cause acute and latent injuries to the pudendal nerve. Transvaginal mesh (TVM) manufacturers continued down the reckless path of destroying the lives of unknowing women as their transobturator slings and mini-slings continue to cause acute and latent injuries to the pudendal nerve. Most of the time [...]

The most severe complications of the transvaginal mesh debacle have always been and will continue to be the neurological complications caused by sling devices. The American Urogynecologic Society (AUGS) in a joint writing with the International Urogynecological Association in April of 2020, publishing its “Expectations of Female Pelvic Medicine and Reconstructive Surgery Subspecialist in [...]

Transobturator sling manufacturers put profit over safety despite health authority statements confirming TVT-O "should not be offered routinely…" Ben Martin, Esq., national pharmaceutical injury trial attorney and partner at Martin Baughman PLLC in Dallas Texas states: “Obturator neuralgia and pudendal neuralgia are caused by transobturator slings (TOT) and mini-slings that are inserted into the obturator internus [...]

English Health Authorities after a lengthy appraisal of the transobturator slings used in the surgical management of SUI wrote damning assessment English Health Authorities after a lengthy appraisal of the transobturator slings used in the surgical management of stress urinary incontinence wrote their damning assessment: “serious adverse events such as nerve damage, leg pain [...]

Synthetic polypropylene mid-urethral slings used in the surgical management of SUI became standard of care ... claims as to the safety of devices were false. Synthetic polypropylene mid-urethral slings used in the surgical management of stress urinary incontinence (SUI) became the de facto standard of care by aggressive marketing by mesh manufacturers. Unfortunately for [...]

Polypropylene mesh causes acute, chronic inflammation that cause pelvic floor myalgia, hip adductor myalgia (groin pain), pudendal and obturator neuralgia. The polypropylene mesh of transobturator (TOT) slings, commonly used in the surgical management of stress urinary incontinence (SUI), are designed to pass into the groin and through the thigh to provide a hammock-like support [...]

There is a large percentage of urologists, gynecologists, and urogynecologists who don’t place TOT slings because of catastrophic, life-altering pain syndromes. Cleveland Clinic’s Chair of its Obstetrics and Gynecology & Women’s Health Institute, Dr. Beri Ridgeway, in a 2019 presentation stated mid-urethral synthetic polypropylene slings are the “definite standard of care” after being cautioned [...]

Does the Altis sling, like other mini-slings, reduce the risk of obturator and pudendal neuralgia when compared to TVT-O or TOTs? Coloplast sponsored an Investigational Device Exemption (IDE) for the Altis sling used in the surgical management of stress urinary incontinence (SUI) to obtain data of safety and efficacy with 113 women and the [...]

Will transobturator polypropylene slings be next to be banned by the FDA? On April 16, 2019 the FDA banned the transvaginal mesh devices used in the treatment of pelvic organ prolapse because there was no evidence that the devices worked better than non-mesh repair and there was no data to support that they were [...]