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Addressing old post RE: New Material – Ovitex (initial post on 3/7/19)
I’m new to this site and joined specifically to weigh in on member “Good Intentions” post about the product Ovitex. I felt obligated to do this since a good friend of mine, a hernia patient came across this post doing some internet research after my recommendation that he choose surgeon that uses Ovitex for the hernia repair procedure.
A few things about me….
1. I am a hernia patient.
2. I have had two separate inguinal hernia repairs myself.
3. One with synthetic mesh and one with Ovitex.
4. I have spent most of my 30 year career working for medical device companies.I would like to address some ill-informed comments, which may not be to anyone’s fault, however I happen to have industry experience and know how to get detailed and specific data that the average consumer may not have access to.
The reason I’m taking this time to write this, is that this post has confused my friend and I was given him a recommendation.First off, it would be great if we could have long term patient studies with all medical devices, however, that is not possible due to how are system is set up and the cost of associated with such studies. If this were done for everything, the products would simply not be affordable for use in our already expensive healthcare system. That is just the reality.
Below is a portion from the original post….
“But it also shows how quickly the device makers will push their own products to market, with very very little data supporting their calms.”
That said, the company that makes Ovitex has done the biggest study in the most appropriate animal model ever done, even before the product was introduced and available for human use. What was done was far above and beyond what is required by the FDA for clearance, and what most companies in the hernia mesh space have ever done.
Below is another segment of the original post….
“It’s available for usage, apparently, based on primate studies, non-talking I assume”
I would just like to point that primate studies are extremely expensive to do. and most companies would only utilize rats or mice.Below is another segment of the original post….
“As far as “resorbability” I’m not sure that it gets there. Converting sheep rumen in to human tissue does not seem to be what they’re describing. It started as collagen and is still collagen when they looked at it again. But I don’t think that it’s new human collagen. It’s old dead sheep collagen. The cells and blood vessels are what the synthetic mesh people call “ingrowth”.
This comment goes against years and years of scientific research and evidence with collagen matrices (also often called extra cellular matrices or ECM). This is a field I’m very familiar with and have worked in within the field of would care. ECM’s have shown to aid in would healing and ultimately are replaced by the patients own collagen. There has been extensive research on ECM’s dating back before the 1970’s if anyone is interested in digging deeper.To come full circle about me, I have Ovitex in my right inguinal hernia and I have synthetic mesh in my left inguinal hernia and the difference is significant, as it relates to awareness, tightness and overall discomfort to me personally. Am I lucky, or did the company that makes Ovitex do there homework? I tend to think the latter since the same surgeon did both my hernia’s.
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5 Replies
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quote Informedpatient21:You might be surprised to hear that I’m over two years out since my Ovitex repair and seven years out from my mesh repair. They were both direct hernia’s. I’m currently 280 lbs and consider myself still an athlete however clearly in a lot poorer shape than I once was, which makes this an even more interesting “experiment”.Again, the main difference I notice, is that there is noticeably more restriction sensation and occasional pain on the synthetic side that I have learned to deal with over time.
Aside from our discussion about the mesh market in general, the details of your first hernia repair (type/brand of mesh, method of placement, etc.) would be very useful, along with your reasoning against using a synthetic mesh again, and for using a new product with no long-term human results. I can’t remember the details of the 31 patient paper, but I wouldn’t be surprised if none of them knew that Ovitex was used. Many patients have their hernias repaired and have no idea that any mesh device was used at all. You’re one of the few people who can supply a device to device comparison.
Those details could identify a “bad” mesh device, and show potential for a new device. Allowing people to at least avoid one device, and maybe choose Ovitex.
Ovitex’s difficulty in marketing the new device will be that they are competing against all of the bad products that have almost identical marketing data on their web pages. Internal results, IHMR results, labels like “gold standard”, etc. Looking at marketing literature alone, they all look amazing. Real world anecdotes like yours might be the best true information that a patient can find.
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quote Informedpatient21:I need to get some sleep.
That’s something I got very little of for a full year with the mesh inside. I had a low grade fever each night and slept at most 2 hours a night, usually just before dawn. There many other issues as well. Everything came to an end when that mesh was removed.
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I appreciate your reply and your thoughtfulness. You might be surprised to hear that I’m over two years out since my Ovitex repair and seven years out from my mesh repair. They were both direct hernia’s. I’m currently 280 lbs and consider myself still an athlete however clearly in a lot poorer shape than I once was, which makes this an even more interesting “experiment”.
I also have a six year old autistic son that requires a lot of restraining, holding, picking up and playing/wrestling as he is non-verbal as well and activity is a lot of how we communicate. I work out regularly although its been on an off over the years. When I do it’s typically weight training and boxing work with a speed bag and heavy bag as well as light sparring and skiing especially. So a good experiment….that is true.
Again, the main difference I notice, is that there is noticeably more restriction sensation and occasional pain on the synthetic side that I have learned to deal with over time. My understanding was that the product had been on the market just under a year when I had my surgery, but it was the animal data that my surgeon shared with me and some other things I learned about the company, as well as my industry understanding of biologic materials. You might be right about the FDA, but it’s a complex problem. If we waited for long term patient data for every medical device innovation, by the time the products made it to market, they would be unaffordable, as I stated previously……and to that point, yes, to some degree, we are all living experiments. That is the case with the food we eat, the package the food is stored in, the exhaust that we breathe from the facility that makes the package the product is stored in, but over time, we learn and move forward based on knowledge and understanding.
I respectfully disagree with you that being on the inside of the industry does not give me an advantage, as I know how the system works. That being said, I can recognize more easily when a company is doing work well above that “bar on the floor” you mentioned. 510(k)’s do not require extensive primate research, but the Ovitex company chose to do it.
As far as the regenerative nature of biologic materials, that is something as I said, I have personal industry experience with which also influenced my decision. As you can gather, it’s much to much to delve into on this post, but would be happy to answer specific questions at another time. I need to get some sleep.
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[USER=”2859″]Informedpatient21[/USER]
I really am interested in your results. You really are a good experiment, just like I was for having bilateral mesh implantation for a direct hernia on one side with fixation,and for a lipoma on the other side with no fixation. Both sides were bad, after mesh implantation, resulting in removal three years later.
I assume that you are still in the early period of healing from your Ovitex implantation. The most interesting time might be when all of the mesh should have been resorbed (based on the animal studies) and you are back to being fully active. At least as active as the synthetic mesh allows you to be. And the types of activities you engage in. Unfortunately, with the goal of one-size-fits-all, good results from sedentary people are used to justify using mesh in active people, I think. Activity matters.
I hope that you won’t see this as some sort of challenge. But there really is very little real data out there, from humans, who can describe how they feel. You are one of the few.
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I wish you the best of luck with your new hernia repair.
You did not address two of my points though.
The first is chronic pain. Animals do not tell how much pain they are experiencing. They don’t “work” either, especially in captivity. Generally, they just sit in one spot and wait to be fed. So, in my opinion, animal studies are worthless for chronic pain evaluation.
Second is the long-term results. As I said, captive animals don’t have to go to work. They sit, get fed, the mesh is excised and evaluated, or something similar. Or in this case, the site of the procedure is excised and evaluated. I don’t think that an animal study lasts more than few months does it?
Other things to note. The FDA has been asleep at the wheel for many years. The bar to go above and beyond their requirement is on the ground. The 510(k) process. So that has little value.
As far as resorbability, it might be that the tissue is indistinguishable from the patients tissue after a certain amount of time. But is the “new” tissue the good strong fascia type material or some weaker form of tissue? The basic problem of the hernia is weak tissue. So, time will tell. You will be a good experiment, especially since you are experienced in the field. I hope that you will consider yourself that way and report the results back to people that can use them.
Overall, your rationale is the same rationale that gave us the mesh that you have on the other side. In broader terms a better question would be “is Ovitex, the company, a more honorable and honest and capable company than J&J or Bard or Covidien (now Medtronic),or any of the others that supposedly used similar protocols to develop their products?”. Don’t forget companies like Atrium with their crosslinked fish oil coated synthetic mesh. No offense, but working in the medical device field is not really a good reference. That’s where all of these problems were developed.
My fundamental point was that this new material has followed the same basic path as what is out there now. There is no long term phuman data to show that it is better than what is out there. And, I assume, there are no plans to follow up and track results now that it is on the market.
I wish you the best of luck. And I hope that the results are good and that over time it will become apparent that the new product is better than what is out there. But, I’m going to guess, that there will be no way to be sure. Just stories from the internet.
Could you share more about the synthetic mesh that you have and the details of the surgery, and the original hernias (direct or indirect)? That would have some value. Your description is very broad and not very useful, at this point. Please come back, at least once a month and describe your activities and the results. Are you a runner, a weightlifter, a soccer player, etc.? Tell us how Ovitex is doing. If you can make it to two years, that would be a good selling point.
Again, no offense intended. We all want to be part of something good. I chose my screen name for a reason though.
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