Mesh manufacturers’ product warnings have not done enough to allow physicians and patients to truly appraise the risks versus benefits of using these devices.
“We are seeing some mesh loving implanters of transobturator slings who are oblivious to both the NICE recommendations and human anatomy stating the absurd, and at other times implanting doctors want to know the truth,” states Greg Vigna, MD, JD
California Department of Justice obtained a verdict against Johnson & Johnson for nearly $344 million dollars for endangering patients through deceptive marketing of pelvic mesh products. Despite this, Ethicon and the other vaginal mesh manufacturers have done little to undo the damage for their past misrepresentations.
“Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies,” said Attorney General Becerra.
Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “There has been little that the manufacturers have done to educate physicians of the specific pain syndromes that transobturator slings and retropubic slings cause. The surround sound of biased studies produced by manufacturers as money continues to flow to their ‘key opinion leaders’ to push the policies of AUGS and ACOG is deafening.”
In 2015, manufacturers added additional warnings to their products’ Instructions for Use (IFU) that include things such as “pain-which may be severe and chronic” and “neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur.” It is curious as to why this phrasing wasn’t there for the many years mesh was being pushed onto unknowing doctors.”
Dr. Vigna adds, “We believe manufacturers have not done enough with their warnings as they do not educate the specific neurological injuries caused by their devices that occur when properly placed, to allow for physicians and patients to truly appraise the risks versus benefits of using these devices.”
In 2019 the National Institute for Health and Care Excellence in England directed their physicians to do the following: “Do not offer a transobturator approach unless there are specific clinical circumstances (for example, previous pelvic procedures) in which a retropubic approach should be avoided.” (NICE 2019)
Dr. Vigna concludes, “The American Urogynecologic Society (AUGS) hasn’t meaningfully addressed the NICE recommendations nor has it studied the basis for the recommendations. AUGS is going down the same path as it did at the time of the April 16, 2019 ban by the FDA of transvaginal mesh products used for the treatment of pelvic organ prolapse. The position of AUGS was that these POP devices were safe when used by properly trained physicians. Clearly, AUGS and the American College of Obstetricians and Gynecologists (ACOG) haven’t caught on that transobturator devices are not a good idea as these devices are the most dangerous as they cause pudendal and obturator neuralgia sometimes years after implantation. It is time that their physician members who implant the devices as well as the manufacturers are educated in court.”
The Vigna Law Group targets the below transobturator (TOT) slings and mini-slings that cause pudendal and obturator neuralgia:
- Ethicon: TVT-O, Abbrevo
- Boston Scientific: Obtryx, Solyx
- Coloplast: Aris, Altis
The Vigna Law Group targets the below retropubic sling that cause ilioinguinal neuralgia, pudendal neuralgia, and Complex Regional Pain Syndrome:
- Ethicon: TVT, TVT-Exact
- Boston Scientific: Advantage Fit, Lynx
- Coloplast: Supris
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome. His cases are filed around the country with Martin Baughman, a Dallas, Texas firm. Ben Martin and Laura Baughman are national pharmaceutical injury trial attorneys in Dallas, Texas.
Learn more on the anatomical basis for TOT injury or irritation to the obturator and pudendal nerve and the treatments of obturator and pudendal neuralgia. Click here for a FREE BOOK on Vaginal Mesh Pain and for articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/. Visit, https://tvm.lifecare123.com/slingebook.html for information regarding sling related complications.
Greg Vigna, MD, JD
Vigna Law Group
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