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Dr. Vigna is also a national pharmaceutical injury lawyer with offices in Washington D.C. and California who has focused on the pain syndromes caused by polypropylene slings and TVM devices for prolapse.
When the pelvic mesh multidistrict litigation (MDL) closed in 2018, Dr. Vigna began filing his vaginal mesh cases against the mesh manufacturers on behalf of women suffering these devastating neurological pain syndromes. He was the first lawyer to file a pudendal neuralgia (nerve pain) defective product lawsuit after the MDL was closed.
Dr. Vigna now represents dozens of women in their cases of severe mesh injury, including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome across the country with leading pharmaceutical injury law firms who are individually litigate cases. There are no matrix settlements with his law firm and resolution of a claim is either at trial or at individual mediation ordered by the court or requested by the defense and is based on the strengths and weaknesses of the case, economic damages, the risk tolerance of the injured woman, and pain and suffering.
Dr. Vigna tells Mesh News Desk the courts are beginning to open up after COVID-19 closures, and his vaginal mesh trials for the catastrophic pain syndromes will start later this year and are lined up for months going forward with cases being filed weekly across the country.
“I think this litigation is going very well. I began my focus on vaginal mesh in 2013, and I thought these cases were very good back then. The literature supported causation for ilioinguinal, obturator, and pudendal neuralgia at that time and medical evidence has developed and has gotten stronger for mesh causing neurological complications and has supported various treatment options for women suffering from life-altering pain syndromes involving the muscles and nerves that are impacted by the mesh.
“Shortly after the MDL closed, we filed the first pudendal neuralgia case. Then the FDA decided to ban the sale of POP (pelvic organ prolapse) devices unless placed through the abdomen."
“In 2019, the NICE recommendation out of England said TOT (transobturator) devices should not be put in routinely as the retropubic sling is the preferred polypropylene option unless there was a specific pelvic procedure or anatomical problem where a retropubic sling is not possible. We believe that polypropylene retropubic slings, like TOTs, are unreasonably dangerous as the pain syndromes are equally as destructive for an individual woman, but simply less common than TOTs.
“Then, in 2021, more literature came out from Dr. Zimmern in Dallas and Dr. Fuentes, who published that 30-40 percent of women need a second surgery to remove mesh arms because their disabling pain symptoms persist after vaginal revision. He has described patients with pudendal neuralgia (PN) among those in the study. Then a recent study from China on 1,800 pelvic organ prolapse devices, primarily the Prolift device (Ethicon), has come in with evidence that we have known for years that latent injuries occur months to years after implantation; the average onset of injuries or symptoms was seven months, which is well outside when doctor’s follow-up postoperatively.
“By far, however, the most important development was the American Urogynecologic Association (AUGS) 2020 joint statement with the International Urogynecological Association (IUGA). Dr. Christian Twiss, a Dr. Raz protege, in the Joint Statement, wrote of ‘extrapelvic pain’ (EPP) from retropubic slings (TVT) and transobturator polypropylene devices (TOT) that relate to the specific neurological injuries that we represent. This AUGS position paper helps the litigation as it supports our position on causation, safer alternative design arguments, and failure to warn positions. Unfortunately for women, very few doctors have read the AUGS joint position and the authoritative citations that serve as its basis.
“In depositions, there have been implanting doctors who are big fans of TOT (transobturator) mesh that are oblivious that a properly placed has the potential to cause obturator and pudendal neuralgia acutely or years after implantation. In depositions, many have testified that had they known of the extrapelvic pain described by the Joint Statement, they would have warned their patients. That really helps our litigation as manufacturers have known of the literature and adverse events for well over a decade.”
A: “The vast majority of docs are unaware of the 2020 position statement.
“There should be a mandatory CME taught by the leaders in mesh-related complication to anyone who places Mid-Urethral slings (MUS). That would be easy to do. AUGS has not done that. Instead, they have been flooded by years of biased studies that are not sufficiently powered to identify the pain syndromes or simply bury the evidence as ‘other pain’ in the results with no further discussion.
“The manufacturers have been aware of these injuries, obturator neuralgias since the early 2000s. In 2003, 2004, obturator neuralgia was known. Pudendal neuralgia with TOT was described in 2010, and the literature is building and building. And the manufacturer is still not disclosing the risk of neuralgia, the magnitude of the risks, and the highly invasive treatments that are required for life. These cases are going to go on in perpetuity well after polypropylene slings are removed from the market as latent injuries arise. We have signed two latent Prolift injuries in the past month alone despite this device being removed from the market in 2012.”
“The AUGS position paper on the management of mesh-related complications covers erosion and other erosion type complications where the management is already widely known. AUGS really needs to publish a separate position paper on the management of ‘extrapelvic pain’ as opposed to having it buried in a ten-page paper.
“The mesh manufacturers are not presenting implanting doctors with the literature that serves as the basis for extrapelvic pain. In fact, an implanting doctor recently testified in a deposition that the sales reps still call on him but to this day has never presented the position paper to him and had he known of the neuralgias that may occur acutely or years after implantation of a properly positioned TOT he would have warned a patient that he implanted a TOT on the morning of the deposition.
“Taking a step back, physicians still don’t have a good concept on how these neurological injuries destroy women. They might have seen one or two patients in their practice. They might not have understood the symptoms to understand the nexus between the sling and the pain syndrome.
“There needs to be significant education. I see no evidence of that.”
“They mention chronic pain, chronic dyspareunia (painful sex), but these are general terms. We believe a specific diagnosis should be included as this would stimulate implanting physicians to fully understand ilioinguinal neuralgia, obturator neuralgia, and pudendal neuralgia improve timely identification of complications, and allow for a more informed consent process as to safer options.
“The neuralgias require multiple surgeries, travel to specialists, vaginal physical therapy, pudendal nerve blocks, vaginal trigger point injections, and other highly invasive procedures.
“I believe the specific diagnosis should be included in the IFU, and that would put a doctor on notice of potential complications. During depositions, implanters say, ‘Yeah, I’m aware of chronic pain and dyspareunia,’ but when doctors hear about pudendal neuralgia, they quickly say, ‘Well, had I known that I would have warned on pudendal neuralgia.’
“Many doctors understand the word “neuralgia” and that word needs to make it into the IFU with the specific nerves that are known to be impacted by retropubic or transobturator slings and that these complications may occur months or years after implantation.”
“We are closely looking at the care the women receive after implant. If it was a revision surgery, was there any mention of a mal-positioned device? From time to time, we are naming physician implanters for selecting a TOT device over a retropubic sling or for the failure to diagnose and treat a neurological pain syndrome in a timely manner. If she has severe pain after an obturator device, these devices come out much easier right away rather than six months to a year later.
“Our position is the manufacturers still have not warned of the neurological complications of their devices but that will not shield a physician from a malpractice claim especially if they are in a position to know these injuries. It is a case by case analysis that I provide with discussion with my team.
“I believe the FDA will eventually make transobturator slings (TOT) a class III device, essentially putting all implanting physicians in the market on notice of the unique dangers of TOTs compared with retropubic slings, and place the USA market more in line with the NICE recommendations from England.”
“Defense experts generally blame the doctor. They focus on any kind of evidence that might suggest a mal-positioned sling. Defense experts often testify that the device should never have been implanted. The literature is clear, that was cited by the Joint Position Statement, that in a vast majority of TOT cases with obturator and pudendal neuralgia, the device was in a proper position, distant from the nerve, and compression of the nerve is related to soft tissues including muscles impacted by the mesh.”
“They are highly technical and complicated. The litigation so far has been about erosion-type injuries. The multidistrict litigation (MDL) did very little working up of cases of neurological injuries, and when an attorney has 2,000 to 3,000 clients, it’s too many to litigate. We represent the most injured with disabling pain. We don’t have matrixes. These cases all require individual workups. Every case will be individually mediated. The law firm I’m working with is Martin Baughman, and our lawyers see the big picture and that these women who are disproportionately impacted by pain need to be compensated, unlike what happened in the MDL."
“You have the big 3: Ethicon with TVT, TVT-O, the TVT Abbrevo, and TVT Exact. Then you have Coloplast with their Aris mid-urethral sling and the Altis device. Finally, Boston Scientific has Advantage Fit (MUS), Lynx, Obtryx, and Solyx sling devices. Those are the big three we are seeing. Understanding that latent injuries continue from the POP devices that were banned by the FDA.”
“Women who come to us with symptoms of neurological injuries, more doctors are available who have the skill and knowledge to diagnose, and other specialties such as PM&R and Pain MDs are picking up the slack in terms of diagnosing pelvic pain-specific neurological injuries. We are seeing multiple specialties after complete mesh removal now providing pudendal neuralgia blocks, Botox, and referring patients to pelvic floor physical therapy. If people don’t respond, we are seeing more women referred to specialists for spinal cord or peripheral nerve stimulators and Ketamine Infusions.
“The standard of care is complete removal, and yes, you can remove pelvic mesh in most cases. Sometimes, the anchors cannot be located or break off for mini-slings. Failure to remove the anchors in mini-slings or locating the arms of the device is part of the defective design.
“Something nice happened with the Affordable Care Act. Women who have Medicaid in some states that do not offer a surgeon who can do a complete mesh removal have had luck with Medicaid paying a specialist from other states to do the surgery. That didn’t happen years ago.
“We have women going through the proper channels to see if they can get care with their public plan, and there has been some success. It takes a smart, diligent, and nimble woman to find the path to care they deserve.”
“We are filing new injury cases involving pudendal, obturator, and/or ilioinguinal neuralgia about once a week around the country. We’ve been very picky with the cases we pick. They are expensive and a ton of work, going through motions, depositions, and expert reports. We are focused on neurological pain syndromes where we see future care costs between $400,000 to $700,000 per decade of life, vocational disability, impairments in mobility, and sexual disabilities. Pain that suggests the neurological injury is our criteria for representation. We know it when we hear it.”
“Unfortunately we had two Obtryx cases in Tampa recently pushed off the calendar for yet another court-ordered mediation in December, but have other cases at the end of the year and are lined up going into 2020. Covid related issues are bogging down the courthouses across the country and have pushed our cases back 15 months.”
“Our criteria are again the pain syndromes caused by TVM devices involving the groin pain and pelvis. Women can’t wear tight pants, they have clitoral pain, and they are unable to sit. Other symptoms include dyspareunia that prevents any vaginal penetration, tailbone pain, and anorectal pain. Bladder pain is common with filling. We’re getting women calling with those symptoms, two to four a month. We are signing new implant injuries as elective procedures are now occurring as COVID is approaching an end. ”
“I feel good about these cases. Pudendal neuralgia, obturator neuralgia, and ilioinguinal pain are uncommon diagnoses without mesh and are very specific to polypropylene TVM devices and we believe we can prove causation and can get our ladies compensated.”
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LEARN MORE:
AUGS 2020 Joint Position Statement
MND, Pelvic Mesh MDL is Closing, June 2018
Vigna discusses Pelvic Mesh Pain Book on MND Podcast
April 2, 2019, Urinary Incontinence and Pelvic Organ Prolapse in Women: Management, NICE Guidelines ,
