How to Avoid and Deal with Pelvic Mesh Litigation

Jane Akre
July 25, 2016
karlovsky two

Mesh Medical Device News Desk, July 25, 2016 ~

That is the title of an article in August issue of UroToday by Dr. Matthew Karlovsky. Dr. Karlovsky, a board certified urologist, is with Arizona State Urological Institute in Phoenix in the Division of Female Pelvic Health.

He is fellowship training is in women’s urology. He has served as an expert and consultant in mesh litigation.

Dr. Karlovsky believes communication with the patient including a full informed consent, patient selection and good communication skills can minimize a lawsuit filed by a patient over complications developed from a transvaginal mesh implant. Your editor, Jane Akre, asked him some questions in an interview conducted on the phone last week.

Plaintiffs' lawyers filing into Charleston court.

Plaintiffs' lawyers filing into Charleston court.

Q: As you know, in some mesh litigation, the doctor is also named, how do you avoid being named in a mesh-related litigation?

Pinnacle pelvic floor kit brochure recalled by the fda

A: Certain physicians know what they are doing. They have a knowledge of anatomy and a confidence of surgery. Certain physicians understand which patients are good surgical candidates and which ones are poor.

Yesterday I was talking to a plaintiffs’ attorney about a malpractice case related to surgery and mesh he wanted me to believe the plaintiffs’ side more than the defense evidence. You have to look at the evidence on both sides. He said If I can just get you to understand the side of my client. I do more plaintiffs work than defense. I said to him I understand what she says is true, but I cannot discount evidence on the other’s side, that’s what the jury is for. I’m not the judge. Do you want a flimsy report to be shot down by defense attorney to make him look bad, to make the client look bad. I told him I couldn’t take his case.

When I say how to avoid litigation, it is pointed at the physician who has to be honest with himself and say I don’t have the training for this. That’s the person who maybe does one a month. Instead, let these cases coalesce around a smaller body of doctors who are highly trained. It’s a process which is happening already.

A lot has to do with particulars of informed consent. Some doctors see as a waste of their time. You never have to do mesh in any case, zero, even though mesh slings are considered a standard of care, you don’t have to do any. It’s not cancer! It can be embarrassing and uncomfortable.

It has to be seen as elective process. A lot of people trust doctors for good reason and patient trust when it comes to mesh there is a patriarchal way we look at doctors, there is an implied knowledge docs have there is something the doctor knows. If the doc is not willing to take on the burden of discussing the mesh, then they should totally avoid it like the plague. It’s better for the patient.

I just had a case like this Wednesday woman had a sacrocolppexy with mesh, a mesh vault suspension. A “Y” mesh was put in. In not even 3 months this thing eroded. She had dyspareunia and discharge. The doctor went back and said I don’t know what to do. The doctor gets frustrated. If you are not willing to go the distance with the patient, and it’s difficult, just don’t do those surgeries.

erosion and secondary infection

Q: What about 10 years down the road, even experienced doctors can have complications?

A: You have to take the risk of the unknown if you do the surgery. You may have to redo it. Reconstructive surgery will fail at some point and it has to be redone. By virtue failure of intent, the incontinence comes back. The sling fails, the patient gets older, or thinner or has diabetes, and for a certain percentage of people the standard of care does not equal perfection. That’s not falling below the standard of care, that is the risk of operations. If you have a competent physician and proper patient selection and the case is properly selected you are minimizing the chance for failure. But you can’t make it zero.

I’m saying talk to physicians groups. If you don’t want to take on the burden of discussing the unknowns of mesh in the future, let them known you may not be able to get it all out in the future, you have to take the burden upon yourself if you are going to do these things.

The problem with modern medicine is that everything is compressed in a five minute visit. There is no way to relay anything in a cogent manner. The practice of mesh in surgery has to slow down. If the patient is willing to understand, they can say no. The problem is there are so many unknowns that nobody knew about because nobody did the trials.

Look at Ethicon, for example. They launched their Prolift in 20005 but their IFU (instructions for use) in 2004 states nothing about risks, outcomes, consequences, or future precautions. There is no data. The data didn’t trickle into until 2007, 08, yet they warrant it’s safe for marketing via the 510k. They followed the FDA rules and able to slip it in there.

Corporate American has its hand in the cookie jar, the FDA, everyone’s hands are dirty. No one is absolved. Then they say in IFU the product is safe according to animal studies. If you don’t know as a manufacturer its safe, how can you as a physician say it’s safe?

Everyone says its fine. It’s irresponsibility going up the chain.

Protest in Charleston WV fed court

Protest in Charleston WV fed court

Q: You still use mesh and believe it has a place??

A: It’s still a viable option. Let’s say you had a tissue sling and it didn’t work. You have to give that option to the patient. You have to say this is available and here is the success and failure rate. It may fail in the future, it may cause pain. You have to be willing to undertake those risks and plenty of people willing to take those risks. If a patient had three bladder surgeries and the patient says, I can’t live this way, I don’t want a pessary. Fix it! You have to put mesh in.

Mesh kits are not available anymore so you take a piece cut 3 by 5 put into the compartment defect but not go through multiple compartments at the time. It’s a lot of mesh to put in anchoring different compartments, creating anchor points creating banding and a point of contraction.

I never liked one size fits all kits and I never used them. I didn’t like the sense of doing too many things at once.

Let’s say you put mesh in anterior compartment, you’re not going through obturator membrane. So the likelihood of contracture and scarring is low. I’m not a crusader to get mesh off the market. It’s not perfect I’m in the middle saying physicians you better watch it. I’m saying to pt if you are having a problem, I will help you fix the problem.

Let’s say the data says it’s not safe, take it off the market. You can’t have it both way… whoops then withdraw it from the market and say it’s for business reasons. They’re lying.

Introducers, Caldera

Introducers, Caldera

Q: Are doctors even trained in non-mesh repairs anymore?

A: Doctors are trained in non-mesh repairs. The pendulum is swinging the other way. That was the only way they knew to do it before. I can certainly take an educated guess in training programs non-mesh repair being taught because it’s part of what you have to know.

A: What do we consider to be informed consent?

Part of it is the risk of the procedure and also the risk of not having a procedure done in the future. If there are other things going on like incomplete bladder emptying, there is a risk of not doing something. And the benefit and the drawback of doing those things. The element of the unknown in the literature has to be disclosed, that has to be disclosed. Your success and failure rate has to be disclosed. That helps alleviate the unknown and improves the honestly in the informed consent process. You have to be honest with your own outcomes, understanding there is an element of the unknown. Will it have to be removed, will there be erosion, pain? That is a big black box and we don’t know the answers. All of it makes up informed consent. The patient has to know there is an element you don’t know

Every person is responsible for themselves. That is the informed consent discussion.

Pen drawing, Wellcome Trust, WikiCommons

Pen drawing, Wellcome Trust, WikiCommons

Q: Sounds more like uninformed consent?

A: Again, there is no obligation to do mesh. There must be an understanding that going into battle, such as surgery, is taking on an unknown. If you don’t want to take on the surgery, fine. She is in charge of her own body. Physicians should steer clear if they do not want to take on this burden.

J&J Shareholders meeting protest 2014

J&J Shareholders meeting protest 2014

Q: What about what patients who are being told today by the medical community such as “The mesh has been recalled” and “There’s no more bad mesh on the market?

A: Basically my opinion there has been a confluence of bad things in the soup - manufacturers, marketing, a lack of training, cases where physicians say I don’t use that crap mesh - that’s the word the physicians use, there is a lot of misunderstanding and miscommunication going on.

If you are not willing to convey the complications, don’t go anywhere near that. You have to weed people out and there is an attrition happening right now. That’s a good thing. We want that. We want fewer people doing it and we want the really best ones around. It’s still a viable option. You cannot take it away from market. It has to be available.

There are bad actors out there. There is no absolutism. Anyone who thinks absolutism is a crusader. There is damage from people who are crusading. It has to be a thoughtful, slow process. That’s the best way to mitigate solutions with patients. Don’t take everything away because you are not advancing patient care. It has specific limited indication. It has to be available. The fact it will be less available and those better those are what we want. Don’t want to be an absolutist in anything.

Explanted mesh.

Explanted mesh.

Q: What are the trends inside the industry now? Are fewer doctors using it?

A: Fewer doctors are doing it. Fewer doctors are trained to do mesh, or want to be trained to do mesh and this is how it is. We want fewer doing it. I think that is a good thing for this whole chaotic mess that has occurred. It’s been unfortunate and we can’t fix people. They are permanently damaged. For the people thinking in the future, they benefit from the damage of other people, and it’s not just mesh. That’s an unfortunate human condition.

Q: As long as we learn from our mistakes?

A: You don’t know product that’s why you need trials. For a medical ethics class it’s a great subject. The companies were following the letter of the law as laid out by the FDA, so they were not doing anything illegal, but was it ethical?

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