Unfortunately, the misrepresentation by Ethicon continues to be recirculated in the literature.
“Dr. Amy Gee, your article ‘Where Are We Now? Urogynecologic Mesh’ takes us back to 2004 and does not represent the current knowledge that is known by some members of your field. There was deceptive advertising and misrepresentation as part of their national marketing practices by Ethicon that relate to the basic questions of the biology of its Prolene mesh. If the underlying data came from Ethicon it must be examined by authors in your field to ensure the lies don’t live on in your literature,” states Greg Vigna, MD, JD, national pharmaceutical injury attorney.
Dr. Greg Vigna continues, “The urogynecology field is challenged, as the risk of mesh revision is 7.9 % at 15-years with a majority of revisions occurring after two years. More disturbing, looking behind the numbers is the fact that a majority of the revisions were for the more serious injuries, including pain, and represents injuries other than erosion into the vagina or for urinary retention. The 7.9% risk came from a captive study of 334,601 women who underwent sling placement and was designed to capture revision surgeries in women who travel for the care they require from physicians who have the skills to manage their complications that would have been lost to follow up in other study designs and capture outcomes well beyond the duration of most studies.”
“..no women would ever consent to this design had they been provided the legally required informed consent that would include the significant risks of serious pain and erosion of transobturator slings.” — Greg Vigna, M.D., J.D.
Ethicon’s misrepresentations to doctors are serious and far reaching how it tainted the field of urogynecology and were the basis of CA $302,000,000 verdict against Johnson & Johnson’s violations of California’s Unfair Competition and False Advertising Law for its pelvic mesh products. Ethicon avoided litigation with other states by agreeing to pay a $116.9 million dollar settlement to 43 States, including Ohio where Dr. Gee practices. (Reference case number: 37-2016-00017229-CU-MC-CTL)
Dr. Vigna adds, “Unfortunately, the misrepresentation by Ethicon continues to be recirculated in the literature. It is time for physicians in Dr. Gee’s position to purge the taint from Ethicon’s deceptive marketing and get to the truth on the basics of mesh biology and publish the truth.”
Dr. Gee wrote, “To date, urogynecologic meshes are Type 1 polypropylene, lightweight (<45 g/m2), and microporous (>75 mcm)”
Fact: Amid Classification Type 1 definition was published in the 1997 article and requires mesh to be ‘totally macroporous’ to be classified as Type 1. Ethicon has reasons to known that the composition of Prolene includes a small pore and never has been ‘totally’ macroporous. Amid Classification Type 3 definition includes mesh with both microporous and microporous elements.
See: Amid Classification: https://link.springer.com/article/10.1007/BF02426382 and read the internal documents used publicly in trials against Ethicon.
Fact: The weight of Prolene mesh is at least double the weight of what is considered lightweight mesh (<45 g/m2) and is considered heavy-weight mesh by Ethicon’s own scientist, supported by Ethicon’s internal documents and testimony from Ethicon’s own scientist.
See: Ethicon’s own scientist testimony by Dr. Brigitte Hellhammer and Dr. Holste who testify that Prolene is heavy-weight/small pore.
For more information, visit Vigna Law Group’s Ethicon overview.
Ethicon’s own consultants, Dr. Klosterhalfen and Dr. Klingeare considered authoritative in the field of biomaterials, including polypropylene and PVDF: https://www.tandfonline.com/doi/abs/10.1080/17434440.2018.1529565
Dr. Kosterhalfen/Klinge classify Prolene as heavyweight/small pore as early as 2005 and in 2012 published that Prolene behaves as heavy-weight/small pore in the human body as to its soft tissue and histological effects. Read more and click here: https://link.springer.com/article/10.1007/s10029-012-0913-6
Prolene mesh is now considered heavyweight, small pore in the authoritative literature (Urogynecology 28(7):p 452-460, July 2022).
Dr. Vigna concludes, “We are suing doctors and the manufacturers for complications caused by transobturator slings, as no women would ever consent to this design had they been provided the legally required informed consent that would include the significant risks of serious pain and erosion of transobturator slings when compared to other alternatives.”
Vigna Law Group is investigating the Red Flag Warning symptoms of serious pain syndromes caused by mid-urethral slings include:
- Groin pain
- Hip pain
- Inability to wear tight pants
- Clitoral pain or numbness
- Severe pain that makes vaginal penetration impossible
- Tailbone pain
- Anorectal pain
- Painful bladder
- Pain with sitting
Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic injuries and the neurological injuries caused by mid-urethral slings including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and complex regional pain syndrome. Ben Martin is a national pharmaceutical injury attorney in Dallas, Texas, with a license to practice in Pennsylvania. Cases are filed across the country.
To learn more on the anatomical basis for TOT complications including obturator and pudendal neuralgia and the treatments of obturator and pudendal neuralgia click here: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59
Click the following link for a FREE BOOK on Vaginal Mesh Pain, https://vignalawgroup.com/publications/, and for articles, video resources, and information visit the Pudendal Neuralgia Educational Portal by clicking here: https://pudendalportal.lifecare123.com/) or https://tvm.lifecare123.com/.
Follow this link for information regarding sling related complications: https://tvm.lifecare123.com/slingebook.html
Greg Vigna, MD, JD
Vigna Law Group
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