Telabio study of reinforced biological meshes

[newagehernia]

is that rTapp or reTep?

[newagehernia]

I am interested in using this ovitex mesh for bilateral hernias I have. right one direct (perhaps the permanent bio hybrid version and the left one indirect (perhaps the resorbable version). The two problems I always have is finding a doctor who you can find out if they will even entertain using this mesh before shelling out a consultation fee to find out ´no´. the other issue is does this mesh able to be implanted using some version of laparoscopic TEP or a very thin instrument or its a little thicker and could cause challenges? Also can it be glued in place or does not need to be?

[UhOh!]

I think it’s easy to see “doctors consulting for industry” and have a negative view. As I see it, much of the origin of such skepticism comes from two places, neither malicious (as hocking products because there is a profit motive would be):

1. Confirmation bias. When people work really hard to develop something they see it as superior and want the world to adopt it. So they look for evidence that it is working. It doesn’t have to be for profit motive, but can come from believing they’ve truly discovered a better way (because who would work really hard to develop the second best way to do something…). In the hernia repair field, probably no better example than the Millikan plug and patch (which seems retrospectively to be one helluva lot more ego-driven than anything @pszotek has said above!).

2. Incentives. People respond to incentives, and behavior change only comes from changes to the incentives. Surgeons are no different; they are judged by certain metrics and tailor their practices accordingly. Now, I’m not talking about monetary or economic incentives necessarily. For a hundred years, the metric by which hernia surgeons have been judged is recurrence. So, hernia repairs were designed to minimize recurrence (or formation of a new hernia of a different type in the same location). Surgeons did exactly what they were incentivized to do. Now, that’s starting to change, and methods and materials must change, too.

All that said, I’d be most interested in talking to doctors using procedures and/or materials that they developed. Because that’s where innovation comes from, and innovation is how we move away from inferior approaches to everything.

[pszotek]

Alephy,

Working on getting the contacts. Reached out to them to make sure they are ok with me giving out their email. As soon as I hear back will get their email addresses to you.

Dr. S

[Alephy]

Thanks a lot Dr. Szotek!

Do you think you could send me their e-mail addresses (also via private message in case this is more appropriate), so I can ask them some questions (mostly logistic/cost/insurances etc)?

Thanks again!

[pszotek]

Alephy,

Maria Bergmeister – Universitat Innsbruck

Or

Al Windsor – UK

They have the most experience with the product there and are open to using alternative products such as this. If you want me to email them and introduce you just shoot me an email and I will put you in contact.

pszotek@indianahernia.com

Let me know if you need anything
Dr. S

[pszotek]

Alephy,

Ofcourse. Happy to reach out and find out your best option for discussion. Everyone has the right and should do their own research and make their own decisions. Part of that process is gathering information so that you can make the decision that is right for you. This is why I related our experiences with Ovitex as there is not a lot of data out there on it so I was just trying to help give you more information. I believe in a model of patient choice so much that I recently discussed this very same issue with a participant from this very website who had researched Synecore and was interested in that repair with the robot. I did not hesitate to let them know I know surgeons using it and would be happy to use it for their repair if they desired. This is exactly how we started using Ovitex in robotic Inguinals. A patient did their research and asked me to do the repair with it so we agreed as he felt that was best for him and he understood the long term risks of recurrence with a product that had not been around for very long. Needless to say he did great and so I began offering patients a choice who desire alternative products and our data has been at least equivalent to any synthetic data at this point. Since we use text messaging directly to my patients I am always available to them and alway in contact with them. As a result if we were having problems I would know about it better than at anytime in my career or any surgeon that does not directly communicate with his patients 24/7. Let me see best location for you and get back to you. If you want to do a telehealth visit with me just let me know as another option for information.

Dr. S

[Alephy]

Thanks Dr. SzoteK,

I am currently based in Switzerland, I would be thankful if you could let me know of any surgeons here or in the neighboring countries that use these particular meshes. I am still considering options so this at the moment would be just for information purposes should I decide to go forward with surgery…hope it makes sense…

[pszotek]

Alephy,

1) persistent pain can be a result of any surgery but in hernia surgery it is believe that at least some percentage of it is due to the amount of FBR to the mesh/inflammation

2) less foreign body reaction is better for any surgical implant

3) most biologic materials tend to have less FBR (they are collagen and protein based) and less severe complications as they are tissue but historically they have suffered from a higher recurrence rate – reherniation

4) it stands to reason if we can lower the FBR using more natural materials and not increase the recurrence rate this is heading in the right direction and that’s what I’m trying to do

5) I have a number of patients who have had hernias at different times and now have synthetic in one side and OviTex in the other and they say they notice a difference in the implants from a soreness/tightness perspective

Lastly, every patient is free to live with their hernia but when they choose not to (or it is dangerous for them to do so) that’s when they have to weigh the risks and benefits. Risks and benefits should be weighed anytime someone has surgery. And it should be noted that by far the large majority of patients heal well and have an improved quality of life after hernia surgery regardless of the material choice. We’re all striving to improve the procedure and outcomes for our patients.

Hope that helps!
Dr. S

[pszotek]

Thanks again for your reply good intentions. No offense taken. The point was merely that I was providing a reply to this topic and made the mistake of not completely explaining everything. I was trying to help out while picking my son up from swim practice and should have more fully elaborated. This is an open forum and you have the right to post and question as you did which gives the integrity of the feed. At the end of the day though this was merely a Paul Harvey scenario where you needed to know the rest of the story…

I am sorry that you had your experience with Soft mesh. Traditionally it has performed well and I used to use it prior to switching to ProGrip and then ultimately giving folks the choice more recently. I think the mere fact that anyone is willing to sit down and discuss it with a patient and give them a choice is far above the norm of what someone will experience in this country when referred for hernia surgery. I actually wish everyone did as you and others are doing by getting the information fully before proceeding. I think one thing that needs to come to light is surgeons being forced to use products such as Bard Soft Mesh without giving the patient or surgeon a choice by hospital administrators who choose it for us based on big contracts and kick backs that are not reported to any database. It is most likely that you received Soft Mesh because that was what the surgeon was told they were going to use by someone with zero medical background because it is the cheapest mesh by cost out there.

I participate here and I use these alternative products because of my belief that we can provide more value to patients through a shared decision than a paternalistic model of telling them this is the best product and this is how I am going to do it. At the end of the day most of the data out there is tainted somehow. The only way to really know is forums like this where patients are being open and honest. I actually love your reply but wish you would make them less of an attack on the surgeons as we are here to help and not getting a dime for merely trying to help folks make an informed decision on here.

I wish you the best and appreciate you pointing out my consultant work. We will all continue to work together to inform patients of the dangers of hernia surgery. At the end of the day we are all in this together and I am just trying to help folks with our experiences and my patient’s experiences. I am the only surgeon I know right now that has a direct HIPAA secure text messaging system that allows patients direct Texting access to me 24/7 so I would say my finger is on the pulse of patient experience better than it has ever been in my career. If there is a problem I actually know about it as my patients text me directly at 1pm or 1am. This is a free service that they can use forever. There is no better way to actually know what truly is or is not working than give someone your direct cellphone texting capability.

For example when I say there is less chronic pain with Ovitex it’s because I literally text my patients nearly everyday post-op for two weeks asking them and getting their responses. Then we follow them through the system every 3 months for 2 years and then yearly after that. In addition they can text me anytime in between. I tailor the repairs to the hernia. For giant indirects I feel the Velcro of ProGip is more secure as the mesh will not slide. I had this discussion with a patient and fixed him last week. We did ProGrip on the left and a small direct on the right with a combo robotic tissue repair/Ovitex reinforcement. Several days later he texted me saying he was having more discomfort on the left where the synthetic mesh was placed. This is a very common scenario and folks tend to report more soreness for the first two weeks with the synthetic yet at 6-12 months its seems to be similar. This is insight that no surgeon who does not provide direct to his cell phone texting capability 24/7 could ever provide you because they do not know what they do not know. There has been no better learning experience or influence on my practice then texting directly with my patients 24/7.

Have a great weekend and keep making sure we all provide the rest of the story for those depending on this site.

Dr. S

[Alephy]

OH btw less inflammation also means less likelihood for urticaria attacks probably I guess🤔

[Alephy]

Is it correct to say that less inflammation response means less likelihood of pain and body reaction? Btw the article caught my eye as it also mentions absorbable meshes (in positive terms), for which there is not as much evidence. I think it is possible to infer from animal trials if they are in pain or not…albeit always done for short perios of time…from my side though I don’t like at all the idea of being cured at the expense of animals suffering 😔

[Good intentions]

Thank you Dr. Szotek. While I can see that you have been offended and started to slide into typical internet “shading” in your response, that post is actually the type of information that everyone that comes to this site is expecting. Real-world professional information.

In my own profession I have found that it s best to assume that the audience is well-informed and to speak to that level, rather than over-simplifying things, and leaving the audience unsatisfied.

There are still many unanswered questions, such as “do you ask your patients specifically about their comfort level or do you just assume that a “non-report” means non-existent?”.

Normally there would be an apology for offending someone who is offering their time freely to the forum, but I can’t do that here. It would be dishonest. The hernia repair field is full of misinformation and promotion, like much of today’s commercial world. It is what it is.

The HerniaTalk forum is described so “The management of this forum would like to encourage a free and open discussion of all topics relating to hernias on this hernia discussion forum.” and invites surgeons to contribute their knowledge. So thank you for that, your post really is very informative. But I’m not sorry for pointing out the flaws in your presentation. As someone who was fooled by the promotion of Bard Soft Mesh and the pitch that “it’s the surgeon’s experience that matters”, I think that I have every right to be cynical.

I hope that you’ll get over your sense of offense and continue to post, just with more complete transparency. There’s nothing wrong with getting paid for consulting. The conflict of interest just needs to be shown. It’s common across all professions.

My intent was not offend you, but to let the other readers of the thread know the full story, and give you the opportunity to share, as you did. The things that should have been shown at the beginning, so that they can make that “informed decision” that you describe in your post.

• This reply was modified 4 years, 3 months ago by  Good intentions.

[pszotek]

Thanks for pointing this out “Good Intentions” as you are correct that I am a consultant with TelaBio and it is cute how you went and pulled the Sunshine Act numbers however I can only wish that my 1099 matched your numbers. I know you also meant to add that I am a consultant for Medtronic, Bard, and have been for other companies over the years. I also know that you meant to add all the surgeons partaking in these discussions are also consultants for various companies at some level. This is how we improve things for patients. If we did not work with companies to improve the products you would be left with the same plastic synthetic products that we are all concerned with. How do you suggest we make things better for our patients if we cannot or do not work with companies to improve the techniques/materials available for repair?

Since you seem to know everything about my practice and recommendations for patients, I also know that you forgot to add that 30 out of my last 35 patients received ProGrip synthetic mesh for their inguinal hernia repairs because I felt it was a better repair in those patients and I tailor all my repairs to each patient and each patient’s desires. Each and every patient gets a choice of their repair using a shared decision making model. I also know that you meant to mention that this past Tuesday I did an abdominal wall reconstruction explanting a Biologic and implanting ProGrip mesh. I use a model of care delivery that is tailored to each patient and they are allowed to decide what is best for them. I offer all types of products and have done repairs with them all. If patients want 100% absorbable we use Bard Phasix. If patients want no product at all we discuss risks and benefits and perform the repair with a tissue repair. I would be happy to hear your proposed better model of patient care as we are all striving to do what is right for our patients?

As far as your reference of a chronic pain patient with Ovitex from one of the surgeons on that list clearly we cannot discuss when hiding behind generalizations and each individual case which would be impossible on a forum like this secondary to HIPAA laws. You are welcome to reach out and discuss this anytime you like personally with me so that you know that I do have good intentions for my patients and the folks on this forum. I follow all my patients indefinitely and we have not had one that has reported chronic pain related to the Ovitex implant so I guess your input in how to define that or better report it would be appreciated?

Have a nice weekend and it was my mistake not to add the disclosure of being a consultant for TelaBio as that was not the good intention of my reply above. It was merely to report my experience and I should have clarified that I actually use ProGrip also in cases that have indications and patients are ok with it. In fact, I use it more often currently.

[Good intentions]

“We have not observed any chronic groin pain and we suspect that these implants will continue to perform at the highest level. ”

How do you evaluate chronic pain and discomfort? Not observing is the same thing that the synthetic mesh surgeons say. They haven’t heard anything. Not knowing does not mean it doesn’t exist.

And I know of at least one patient from a surgeon on your list who had pain from the reinforced Ovitex mesh and had the mesh removed because of it.

Dr. Szotek, your comments sound exactly like those of the surgeons using the fully synthetic meshes. Low recurrence rates and no “observations” of pain. And “suspecting” that the product will have good long-term results is hard to comprehend.

I hope the product works as well as you all are hoping it will. But any good research scientist can see that there is much more hope than evidence for the wholesale use of this product.

And, as I’ve noted in other posts, you really should be telling people that you are a paid consultant for Tela Bio. You made $148,000 in fees from Tela Bio last year. It’s just not right to promote a product that you’re getting paid to develop, without letting people know. It’s not ethical. Even though this forum seems like just a few people gabbing about hernia repair, people are going to use your promotion of this product to make decisions that will affect the rest of their lives. Full, detailed disclosure is the right thing to do.

These are real people with real lives and families. Not just names on the internet.

• This reply was modified 4 years, 4 months ago by  Good intentions.

[pszotek]

Alephy,

The majority of the use has been in the US but they are available in Europe also. There is a surgeon in Germany that I trained last year in use of them and several throughout Europe. Alistair Windsor in/near London has been using it for over a year since I visited and introduced him to it the spring of 2019. Shoot me an email and I can put you in touch with the closest to you depending on where you are located.

Dr. S

[Alephy]

Thanks for the info Dr. Szotek! I wonder, are the Ovitex meshes only sold/available in the US?

[pszotek]

Thanks for inquiring about this early work. As part of our practice we are offering reinforced Biologic repairs using TelaBio Ovitex. I placed the first implant ever in a human in 2015 and have done extensive work along with Dr. Towfigh, Dr. DeNoto, Dr. Sawyer, and Dr. Ferzoco to name a few on the use of this product. We currently have about 400 cases overall and have done approximately 175 robotic inguinal hernia repairs using Ovitex over the past 2-3 years. Our experience shows a 1.8% recurrence rate at >2 yrs for robotic inguinals (not significantly different than our synthetic recurrence rate) and less than 1% overall for all hernia repairs in this series of about 400 cases. The one thing we have noted is the improved comfort and no question reduced inflammatory response with the use of Ovitex. We have not observed any chronic groin pain and we suspect that these implants will continue to perform at the highest level. I give patients the choice to decide and we tailor the repair to their desires using a product of your choice or even open tissue repairs. One thing that we always recommend is not to sell yourself short and avoid the benefits of robotic repair because of a fear of classic synthetic mesh as the retained foreign body/permanent suture is likely equivalent in weight or even less than what we would used for tissue repair using Ovitex. Since we are seeing exactly the same outcomes with the reinforced Biologic Ovitex with minimal retained foreign body I feel you can have the best of both worlds and be safe from chronic groin pain while having a low recurrence rate.

Thanks for inquiring on the Ovitex product and if you have any interest in learning more about it or about our repairs feel free to reach out and I would be happy to help you as I currently have the largest series of repairs using this product in the country and offer it regularly. In fact we used it two times yesterday.

Thanks!
Dr. Paul Szotek
Indiana Hernia Center
pszotek@indianahernia.com
http://www.indianhernia.com

[pszotek]

Newagehernia,

Having performed over 260 Ovitex robotic inguinals I would say that option is technically easier but I have done 4 TEP procedures. That was my pre-robot era operation with ProGrip. Although doable I think it’s technically more difficult in my hands. Dr. S