June 21, 2016 ~ Greg Vigna, MD, JD, is both a doctor and a lawyer who is directing his expertise as a traumatic injury specialist now to pelvic mesh injuries. This story is reposted from last October. At the time, Dr. Vigna was a sponsor of Mesh News Desk, which he is not today.
As a physician he specializes in Physical Medicine and Rehabilitation caring for patients with severe traumatic brain injuries and spinal cord injuries. He understands` the game changing effects of these injuries on the patient and her family.
He is also a Certified Life Care Planner who understands the economic cost of a catastrophic injury both now and in the future. Third, he is a personal injury attorney who only represents those with catastrophic injuries. Dr. Vigna focuses on the severe pain syndrome of pudendal neuralgia or nerve pain from injury to the pudendal nerve. One of the most read stories on Mesh News Desk is about pudendal nerve damage from mesh used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Q: What brought pelvic mesh pelvic mesh injury cases to your attention?
A: Pudendal neuralgia (PN) is a catastrophic injury as damaging to the life of an individual as paralysis from the waist down. As a physician I recognize there is a great cost to a catastrophically-injured person and their family, psychologically and economically. The purpose of going into TVM caused pudendal neuralgia is this is one of the most difficult, expensive disorders one has to live with. The lifetime cost in relation to treating pudendal neuralgia is easily $1.4 million to $2 million over a lifetime.
I see spinal cord and brain injuries all the time. A person is hit on the freeway by an uninsured motorists and suddenly they are no longer economically viable. Their families are now indigent. Here we have a similar situation. The purpose of product liability law is to cost-shift to those better able to handle the cost. In this litigation for the worst injured there has not been a successful cost-shift. These women are disproportionately left to become indigent. I’m pleased to say there are attorneys willing to step up to represent all, including the 2 percent who are severely injured.
A: I believe one to two percent of women involved in this litigation have a pain syndrome consistent with pudendal neuralgia. Simply, there are only a few medical conditions as destructive to an individual and the family unit as a pudendal neuralgia. It is a horrendous pain syndrome that interferes with any meaningful mobility and interferes with sexual, bladder, and bowel function. As a physician who sees over ten spinal cord injured patients a day, without hesitation I would rather be paralyzed from the waist down than have what these women have.
Q: To what extent does the POP and SUI mesh surgery and the trocars play in causing pudendal nerve injury?
A: To date there has not been a trial that highlights pudendal nerve injury other than Linda Gross trial. In pelvic organ prolapse surgery (POP) there is a blind component, which offends common sense. I’m more concerned with the word ‘blind’ than the use of trocars since ‘blind’ should not be in the same sentence as the word surgery. There are certainly anatomical variations in humans and even a properly placed device will come dangerously close to the pudendal nerve. There are pudendal neuralgias (pain) in appropriately positioned devices that may directly injure the nerve or over time will be pulled by traction as well as scar tissue from the foreign body response that causes entrapment and nerve damage.
Dr. Mario Castellanos, a urogynecologist specializing in mesh related pudendal neuralgia, published a study in 2012 that described the anatomic basis of pudendal neuralgia with the JNJ Prolift. This study shown that the arms of the device came within a centimeter of the rectal branch of the pudendal nerve. There are no treatments for that damage. They have intractable rectal pain and dyspareunia and there is no decompression surgery that deals with the rectal branch. In SUI, the literature is clear, there is a six times greater chance of damage with any sling device that offends the obturator membrane.
There is a busy pain pelvic pain clinic in Phoenix that has only seen one case of a severe pain syndrome from a retropubic sling (TVT). All of the rest are from the TVT-O. Over time, I believe transobturator slings will cause more damage than POP devices. The FDA still has not moved on transobturator slings. Over time the litigation process will end transobturator slings. If not, I will sue them into perpetuity.
Q: Are they defectively designed?
A: Yes. When the obturator membrane is involved the obturator nerve and the pudendal nerve are at risk of injury, both acutely and over-time. They’re trying to make it smaller with less mesh, to hook onto the membrane but still these devices such as the mini-arc single incision device are all defective.
If you are going to ask one question, of your doctor who suggests mesh, I’d ask why not use the retropubic sling (TVT) versus the ones that offend the obturator membrane? If they say with the retropubic sling there is a potential of puncturing the bladder, those issues are easily dealt with because the bladder heals but nerve damage is nerve damage. The catastrophic pain syndrome that turn women into train wrecks are from the transobturator slings.
Q: What are a woman’s chances of recovering from pudendal nerve damage?
A: If a pudendal nerve is entrapped, six months after decompression I can predict what kind of life care needs a patient will have. I’ve had clients who have improved; they can function and sit. My goal is to educate women to empower them to get the care they need to demand from their doctors the care they need and deserve. With education, they are empowered to ask their attorney if this is a situation that would require individual litigation. And if those attorneys want to proceed with individual litigation or meaningful settlement discussions, I can help with case management, ensuring the life care plan is adequate by reviewing the life care plan and critiquing it. I am offering that as a non-consulting expert through my company Litigation Support Consulting Service, LLC.
A: Simply he was the only physician at the time providing what I believed was a rational treatment for pudendal neuralgia. The general tenant is that one must attempt complete mesh removal of the device both vaginally and abdominally with the Da Vinci Robot. If pain persist that is consistent with pudendal neuralgia there must be a diagnostic block and then pudendal neurolysis (or decompression) if the nerve is found to be entrapped in surgery.
Q: In general, how do you see this litigation going?
A: First, as a physician I must say the medical community has failed in mobilizing to protect and treat these women. There has been an utter lack of leadership from the American College of Obstetricians and Gynecologist. Simply by making a mandatory Continued Medical Education requirement for clinicians to participate in that describes the symptoms of pudendal neuralgia could have saved significant distress for women turned away by uneducated ears. To date I am unaware that American Medical Systems, JNJ, Boston Scientific, and Caldera informed their implanting surgeons of the symptoms of pudendal neuralgia which is clearly the most severe medical complication from both a properly placed mesh device or a malpositioned device which is an expected outcome of the flawed design.
Second, it is an impossibility to provide equitable compensation to everyone involved in an aggregate settlement of this magnitude. That being said, for the most part the settlements to date have done fairly well for 97 to 98 percent of the injured women understanding the cost and delays of individual litigation. I must clarify, that as a catastrophic injury physician and attorney I care most about those permanently disabled, who represent the 1-2%. These women with pudendal neuralgia are at risk of being left behind to become indigent.
A: To date, disappointingly, there has not been a case go to trial with what I would determine to be an adequate life care plan for a mesh injured pudendal client. That being said, the Linda Gross vs. Ethicon case, medical care was awarded at $1 million over her life expectancy and she had pudendal neuralgia. The settlements to date are a fraction of that amount. I must state I am most concerned for the most injured in this litigation.
Life care plans are individualized and designed to help provide all necessary and appropriate medical care and non-medical services for the rest of her life. If she can’t manage around the house, if she can’t work in the yard, cook, clean, and play with the kids she is left with guilt because she cannot fulfill her role as a wife and a mother. We’re trying to take the burden off so she can assume the role with the help of monetary awards.
Q: Are you able to operate on nerves so she has a semblance of a normal life?
A: A lot of women who have ongoing pain with pudendal neuralgia go to a consultation with a pudendal neuralgia specialist such as Dr. Hibner and Dr. Castellanos and get a block that provides pain relief for a short time. Some have lasting improvement for 4-6 months and they simply have another block for ongoing symptoms. But for the women who are impaired with pain, they are candidates for a neurolysis. That procedure involves her lying flat on her stomach and cutting through a portion of the sacrotuberous ligament to expose the nerve. If it is entrapped, they decompress it. If they find retained mesh and scar tissue then they decompress. Its nerve surgery and there are only two doctors in North America, Dr. Hibner and Dr. Castellanos who can deal with this certain complication and mesh.
Q: Why aren’t there more doctors to address this condition?
A: PN was so rare there are only a few centers that would address it. Pudendal neuralgia would occur in people who would squat a lot. They took care of this at the Mayo Clinic with Dr. Stanley Antolak and at Baylor Medical Center there was a program. Also at Johns Hopkins. These physicians went to France where they studied pudendal nerve surgery at Nantes. When this mesh device hit the market with no regard for the nerves of the pelvis it created a whole generation of women with PN. Simply our medical system was completely unprepared to handle it. Sadly our medical community still does not understand it.
The American Academy of Ob-Gyn should have made everyone do a course on pudendal nerve injuries. The companies that sell pelvic mesh should have made sure every implanting surgeon was educated on the worst complications of the device, which is pudendal neuralgia. Basically these women are going to surgeons who don’t understand the symptoms.
I assist women on finding a doctor with the skills to diagnose, then assists them to find a physician who can treat. Another thing that’s important is that the ‘diagnosis of chronic pelvic pain’ will often be denied SSI disability without the specific diagnosis. I’ve never had a client with pudendal neuralgia denied earned disability benefits.
Q: How are you handing your pudendal damage cases?
A: It really depends about how they are progressing with their treatments. I am optimistic that many of my clients who have been unable to obtain the care they need because of financial constraints will have greater opportunities to afford necessary care because the lending community is now understanding the value of pudendal neuralgia. It is difficult to devise a valid life care plan when care has simply not been obtained. I have women that simply in good conscience I will not recommend any type of binding arbitration going forward unless similarly injured women receive favorable outcomes. Unfortunately, to date, there have been little precedent cases to determine the market value for this particular injury.
A: Yes. The leadership level attorneys understand that they must represent everyone on their docket. They are asking for my assistance as a medical expert to review their complex cases that have symptoms and disability that would suggest a pudendal neuralgia. They are asking me to develop life care plans for their clients and analyze cases.
The path to compensation for the worst injured is perilous but for those with pudendal neuralgia there is little else to lose. Signing the Settlement terms as it stands currently affords them a lifetime of being a medical indigent. I must say that any device used for Pelvic Organ Prolapse and any Sling that offends the obturator membrane is unreasonably dangerous. The medical evidence is clear. A docket of 400 to 700 pudendal neuralgia clients is obtainable if the leadership in this litigation works together and provides a path for a timely resolution for the worst injured. The Defendants do not want to see a pudendal case in court since there is simply too much for them to lose.
Regardless of the numbers, I plan on suing the manufacturers of the transobturator slings into perpetuity until the manufacturers understand that it is not in their financial interest to continue on with the device or the FDA rings the bell with a warning to allow the manufacturers of the device to hide behind an ‘informed’ consent.
I offer services for attorneys who have or may have pudendal clients and I represent women co-counseling with leading firms on pudendal clients. This implicates all manufacturers. I’m fortunate to have met capable attorneys willing to represent pudendal clients who might decide that they must go down the difficult and perilous path of individual litigation against a pharmaceutical company.
I’m there to help women in any capacity. I’ll help their attorneys. I want women to get the care. #
Drs.Vigna and Hibner e-book on pudendal nerve injury. TVM_Ebook_Dr.Vigna
The following articles assisted a woman get the diagnosis and for her disability hearing. I send the below articles to every woman who calls from the TVM123.com website.
Most doctors cannot treat pudendal neuralgia:
Pelvic mesh kits cause pudendal neuralgia:
Myofascial Pelvic Pain Syndrome:
Use of Botox in management of pelvic pain:
Tight Clothes and pelvic pain:
Mesh News Desk, March 2013, Pudendal and other Nerve Damage https://www.meshmedicaldevicenewsdesk.com/pudendal-and-other-nerve-damage-posterior-femoral-cutaneous-ileoinguinal-and-obturator-in-the-transvaginal-mesh-patient