TVM devices have caused 1000s of women neurological injuries including ilioinguinal, pudendal, & obturator neuralgia, as well as complex regional pain syndrome.
Polypropylene transvaginal mesh (TVM) devices have been in the US market for over two decades causing neurological injuries to thousands of women. Unfortunately, the symptoms of the neurological injuries that include ilioinguinal neuralgia, pudendal neuralgia, complex regional pain syndrome, and obturator neuralgia remain ignored and poorly understood by urologists, gynecologists, and urogynecologists because of a lack of warning by the manufacturers of the specific nerves the devices injure, the magnitude of harm, and frequency of injuries, along with the embarrassing lack of affirmative action by American Urogynecological Society (AUGS) to ensure the safety of women they are entrusted to protect.
The focus of Dr. Geoffrey Cundiff, President of AUGS, is misguided to the detriment of women as evidenced by ‘President’s Perspective’ on the front page of AUGS’ website as it focuses on the ethics of Expert Witnesses who offer testimony based on their individual skill, knowledge, experience, and training. AUGS is attempting to limit the testimony of the growing ‘substantial minority’ of its members that have concluded that certain devices are unreasonably dangerous by making Plaintiff Experts subject to disciplinary action by AUGS that it views as ‘deliberately erroneous, deceptive, misleading or without scientific basis.’
“Without AUGS requiring mandatory CME women are left to the internet to figure out their diagnosis.” – Dr. Greg Vigna
AUGS is entrusted to protect women and to date has not required its members to perform mandatory Continued Medical Education (CME) on the symptoms of neurological injuries associated with the devices and the treatment options available understanding that timely diagnosis and treatment of neurological injury can limit the harm caused by these devices.
Dr. Greg Vigna, a practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “Without AUGS requiring mandatory CME women are left to the internet to figure out their diagnosis. The symptoms of neurological injuries include burning, shooting, numbness, and stabbing pain. Women can’t wear tight pants because of allodynia and have vivid description of feeling a foreign body such as a golf ball in their anus or vagina. Pain may be referred to the medial aspect of the thigh, painful bladder filling, numbness of the clitoris or hyperarousal, and tail bone pain.”
The FDA has acted to remove the Boston Scientific Uphold device and the Coloplast DirectFix Anterior device used in the treatment of pelvic organ prolapse on April 16, 2019.
Dr. Vigna adds, “Dr. Cundiff and Board Members of the AUGS need to take a hard look at its past failures instead of focusing on activities of testifying experts because the transobturator slings are marching down the same path that led to the FDA banning the transvaginal mesh devices used for pelvic organ prolapse as AUGS did nothing to protect women from unreasonably dangerous devices. Clearly, the FDA will soon determine that the transobturator and minislings on the market are Class III devices (higher-risk) that will lead to the removal of the Boston Scientific Obtryx and Solyx slings, Ethicon TVT-O sling, and the Coloplast Altis and Aris slings to extinction as they offer no benefit when compared to the retropubic sling with severe risk of permanent neurological injury.”
For articles, video resources, and information on the neurological complications of TVM visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/. We also have a new eBook discussing the consequences of sling implantation.