Mesh Medical Device News Desk, August 6, 2019 ~ If one legal team is any indication, doctors who implant polypropylene mesh to treat incontinence, could be brought to court on medical malpractice charges. 

The team is targeting doctors who implant TOT mesh (transobturator), known to cause some of the most severe nerve damage to patients, but med mal complaints could be expanded to include TVT (tension-free tape) as well.   

This concern was the talk at the AUGS (American Urogynecologist Society) conference in 2016, which your editor attended.

In a legal precedent, a team of lawyers is now planning to file medical malpractice lawsuits against the doctors who implant pelvic mesh slings which cause catastrophic nerve damage, or who fail to treat women in pain after a mesh implant.

Image: from Dr. Veronikis,  shows the difference between a TVT and a TVT-O (also known as TOT implant) and the differing exit points.

Polypropylene pelvic mesh has been the subject of more than 100,000 product liability lawsuits filed in the U.S. against Johnson & Johnson, C.R. Bard, Boston Scientific, American Medical Systems (AMS), and others. Larger mesh implants to treat pelvic organ prolapse (POP) were banned by the FDA earlier this year.

Until now, those civil actions have named the mesh makers alleging defective manufacturing and breach of warranty, along with a failure to warn doctors, who then cannot warn their patients.

This seismic change of adding medical malpractice to the complaint could frighten doctors into curtailing use of synthetic pelvic mesh implants, and represents a particular a concern for urogynecologist members of the American Urogynecologic Society (AUGS),  which still considers all pelvic mesh to be the Gold Standard.

Here is the news release announcing a newly filed case where medical malpractice is included in a TVT-O (transobturator) lawsuit, filed by this newly formed legal team.

Dr. Greg Vigna, MD, who focuses on catastrophic injuries from mesh devices, is also a lawyer who has teamed up with Ben Martin and Laura Baughman of Dallas, talked to Mesh News Desk. 

 

Q: It’s hard to imagine with all of the mesh injuries reported, that doctors are still implanting pelvic mesh, at least through the vagina (transvaginally).  

Dr. Greg Vigna, MD, JD

“It is bad.  This is 2019 so things are different than they were in 2008 when there was not much literature available for doctors to know. We believe doctors have some liability.

“Certainly for now, for implants post August 2019 concerning injuries from a transobturator sling, we need to look at the placement of this device and if you have a neurologically-injured woman, there is enough literature showing these transobturator sling (TOT) devices shouldn’t be placed.

“Along with that, there are issues with a failure to timely diagnose an injured woman if she has groin pain suggesting obturator neuralgia, and the failure to treat, that more likely than not, worsened the outcome.

“If you have a patient with a transobturator sling and neuralgia, you can get it out in a week or two. The device can come out very easily. But over time, the body grows into the device and it becomes a difficult surgery. The longer it’s in, it damages the nerve and produces the worst outcomes.

“Our responsibility as lawyers is to provide the best assessment of the situation to allow for compensation for these injuries and if it’s a case where the doctor failed to act in a way that made the injury worse or caused the injury, we need to name that doctor in addition to the manufacturer.”

 

Initially, law firms decided that doctors should join them in claiming they didn’t know so the firms could also allege failure to warn by manufacturers.

Pudendal nerve from Painspa, UK

“I would disagree with that. In the literature, pudendal neuralgia has been linked for years with the TOT device. Certainly the manufacturer had good reason to understand this. When pain complaints are piling up, a reasonable investigation into why they are having pain would lead the manufacturer to understand there is a foreseeable injury from the mini-slings and TOT devices.

“From the POP (pelvic organ prolapse) devices, which are banned, to the transobturator slings, any devices that have a transobturator component can cause obturator and pudendal neuralgia.

“We believe the manufacturers knew this and didn’t disclose this to doctors. And to this day the manufacturers are not being forthcoming providing open education to doctors on the severity of injuries.  So why wouldn’t the manufacturers tell doctors? If you are going to do a sling, do the retropubic sling because the rate of surgical complications over 8 years is 2.5 times less than TOT.”

 

They are still not telling them that?

“They are downplaying the magnitude of the risk. The manufacturers are still not disclosing in the IFU (instructions for use), discussing how they need to come out if a person has leg pain or pudendal neuralgia following a device implant.”

 

What’s a doctor to do?  If AUGS says a TVT or TOT device is the Gold Standard?

“It’s within their standard of care to stay abreast of the literature describing a 2.5 times risk of surgery comparing a retropubic to transobturator placement over 8 years.

“Just that data point alone, they should choose a retropubic over transobturator sling. Regardless, the neuromuscular complications of the sling have been in the literature and that should be well known by the doctors and manufacturers. If these complications arise, they need to be dealt with rather than dismissed. If a woman is complaining after TOT placement of groin pain that pain needs to be treated quickly.”

*Editor Note* Mesh News Desk has covered using one’s own fascia to create a sling as an alternative to polypropylene. This involves two surgeries- harvesting, then implanting and has a longer recovery time, but complications may be reduced.

Harvested fascia lata


Is the focus on doctors who implant TOT for now? 

“Yes, but we have retropubic sling cases that are catastrophic as well.”

 

Will most TOT cases filed in the future then involve the doctor in the litigation?  

“Probably not because it will be decided on a case-by-case basis. It depends on the venue and the malpractice caps in that state. We will consider what we need to do to improve the chance for meaningful compensation for our clients.

“This is huge for the TVT as well. Acute unilateral pain appears to be more common than what is described in the literature in that women come out from a TVT surgery with left sided labial or groin pain, consistent with illioinguinal neuralgia.”

This is doctors’ worst nightmare.

Protesters at AUGS, 2018

“I think it’s what needs to be done. There should be a timely diagnosis for mesh-related complications. If a woman has pudendal neuralgia and obturator neuralgia from an obturator sling and she is only obtaining a partial mesh removal and continues with her symptoms and that patient is dismissed without a treatment plan, it might change the liability for the doctor.

“The standard of care is changing and, considering data from the neurologic complications standpoint, we believe doctors have a responsibility to do better.”

 

Is AUGS interested in this message? 

“AUGS needs to be interested in the best outcome for women.  The obturator sling is like POP devices in that many POPs have a transobturator component. It’s not the inner pelvic component sacrospinous ligament that can injured, the transobturator placement can injure the pudendal nerve.

“It’s time for TOT slings to come off the market. These are device-related complications and we believe TOT is unreasonably dangerous.  I’ve felt this for many years and now the data is catching up with logic and reason.    ###

 

LEARN MORE:

AUGS – https://www.augs.org/

AUGS Position Statement on mesh – Gold Standard

Press Release – Greg Vigna Portal – https://tvm.lifecare123.com/second-wave-of-transvaginal-mesh-litigation-includes-physician-liability.html

Dr. M. Trabuco, Mayo Clinic – Dr. Vigna refers to a July 2019 Mayo Clinic study by Dr. Enmanuel Trabuco, MD, (here) which shows transobturator surgery has a higher failure rate of 11.2 percent compared to 5.2 for retropubic sling.  200,000 procedures are performed each year to treat stress urinary incontinence. Dr. Trabuco says there is a 1.9 percent chance of mesh erosion into the vagina. The failure rate was even higher when the TOT was combined with vaginal prolapse repair.

 Mesh News Desk, Dr. Raz Tells Doctors Why He Will No Longer Use Synthetic Mesh Slings, April 2016 – fascia sling

Mesh News Desk, Pelvic Mesh Remains on the Market Despite FDA Action, April 2019