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Fascinating battle in the mesh device market
MinnBobber has been asking about a new hernia repair material recently, Ovitex. The data that TelaBio is using to market the newly introduced device is very interesting in that it supports the view that chronic pain affects 10 – 30% of people who have a synthetic mesh repair. But it also shows how quickly the device makers will push their own products to market, with very very little data supporting their calms. They also spell out in words how money is a major driver, even though the repair has to last 20 – 30 years before we die.
I apologize to Dr. Towfigh who praised Ovitex recently, and mean no offense. But I could not believe what I was reading on the TelaBio web page. I was shocked. It confirms, essentially, all of the bad things we’ve been talking about on the forum. It seems to start with a good concept but somehow has been introduced to market in the same way that the synthetic meshes have, with not long-term data. We’re all lab animals.
Here is the link, and excerpts.
http://www.telabio.com/ovitex.html
This is the paper that comes up if you click the “Experience in inguinal hernia repair” link. It’s their main reference for inguinal hernias. Amazing. 31 patients, 3 – 18 month follow-up. Also uses some of the same apparently erroneous ideas about lightweight mesh to support the concept.
https://www.sciencedirect.com/science/article/pii/S2405857218300196
“Reinforced BioScaffolds (RBSs; OviTex, TELA Bio) are a new category of hernia repair devices [10], which were introduced to the market in July of 2016.”
” RBS implants are designed to meet or exceed physiological biomechanical requirements, be isotropic, exhibit improved cellular and fluid kinetics, compliance strain within the physiological range, and provide load sharing during tissue healing and remodeling. Early results in a non-human primate model demonstrated good tissue integration and strength [20].”
” Surgeries were performed by a single community surgeon on an outpatient basis. All hernias were repaired using an open Lichtenstein technique with the RBS sutured in place using prolene suture. Minimal sutures were used to fixate the RBS material. For all repairs, a 4 × 8 cm four-layer RBS (polypropylene version) was used.”
“Average follow-up was 12.6 months (3 months-18 months).”
“Chronic Postoperative Inguinal Pain has been a well-documented yet unfortunate complication for patients undergoing elective inguinal hernia repair. The incidence of CPIP has been reported to vary between 10 and 34% and remains a major issue for both patients and surgeons today.”
“Based on studies showing that lighter weight meshes reduce reported pain, as well the evidence that biologic materials in inguinal hernia repairs do not increase recurrence rates, and the fact that RBS’s are offered at a similar price to inguinal synthetic devices, we found it logical to adopt this approach.”
“Our study has demonstrated that RBS are a viable alternative to classic synthetic materials in inguinal hernia repair. None of the grafts failed or required explantation. There were no major postoperative complications. In addition, there were no reported incidence of Chronic Postoperative Inguinal Pain. Limitations of the study are a single surgeon experience with relative short follow-up. ”
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5 Replies
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quote Good intentions:I got Unapproved, Green-screened again, above. I wrote quite a bit of stuff. [USER=”935″]drtowfigh[/USER]……
• Recurrence rates and long-term performance of biologics do not justify their high cost. However, if the cost were more manageable, recurrences arising from use of biologics would be significantly easier to re-operate on in the long run than reoperations of complications arising from failed synthetic meshes
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a hospital I contacted mentioned the cost of Ovitex being a reason/one reason they don’t use it.What does Ovitex cost? What does the traditional mesh cost?
Curious minds want to know…. -
I got Unapproved, Green-screened again, above. I wrote quite a bit of stuff. [USER=”935″]drtowfigh[/USER]
Well, in the meantime, notice that Tela Bio (I called them TelaLab above, my subconscious…), is doing exactly what a panel of surgeons said was one of the major problems in the hernia repair field. Placing short-term priorities over long-term patient benefits. I’ve excerpted a few items from a white paper they published, from a panel of surgeons they pulled together.
Also notice that they call out ease of reoperation for recurrence as a benefit. So, we’re back to suture repairs as a comparisons. The whole point of synthetic mesh has been sold as a reduction in recurrence rate.
Finally, how could lifelong safety NOT be the priority? What premise have they been working from?
It’s an interesting paper but, of course, they published it to show potential for Ovitec. It is fairly objective though.
http://www.telabio.com/assets/download/White-Paper-Mesh-Performance.pdf
SUMMARY: SURGEONS’ CONSENSUS STATEMENTS
• There is a growing concern among surgeons that short-term product priorities outweigh lifelong patient benefits
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• Recurrence rates and long-term performance of biologics do not justify their high cost. However, if the cost were more manageable, recurrences arising from use of biologics would be significantly easier to re-operate on in the long run than reoperations of complications arising from failed synthetic meshes
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• There is growing evidence that lifelong safety of implanted mesh is becoming the priority
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quote MinnBobber:To play “Angel’s Advocate” (not Devil’s) and support Ovitex use: I’ll list what appear to be strong positives for it.
1. The 5% permanent polypropolene polymer that is left after the bio liner goes away sure looks like it’s much better than
the big perm mesh.2. It’s certainly more flexible, would feel more natural in there.
3. From Ovitex:
The biologic material, derived from ovine rumen, is optimized to reduce foreign body response, minimize inflammation, and enable functional tissue remodeling. The interwoven polymer helps provide long-term strength, along with improved handling and load-sharing capability.I look at Ovitex vs regular mesh and wonder, why isn’t Ovitex the majority product, why would anyone use the big mesh?
Ovitex looks like it would be a big improvement in making mesh surgery much better.
What are the downsides of it? Is it just that there is a very short track record with it??
Interested in hearing discussion, thanksYes,it is an interesting discussion.
The ovine rumen does not actually “go away”. It is just “incorporated” in to the human body. It’s still there.
Just like the synthetic mesh the properties outside the body are not the same as the properties inside the body, after the body’s foreign body response. So you can’t really compare what it feels in like in your hand to how it will feel in your groin. And the “scarring” that happens, the first step in “incorporation” in general makes things stiffer.
TelaLab is “selling” their product with their marketing copy They only get a return on their research investment if surgeons use the product. That’s why they are recommending it for an alternate use in inguinal hernia repair, with just 31 experimental patients as support. It’s been said that the inguinal region is more complex and sensitive than other areas of the abdomen due to the nerves and other structures that are there and the flexing and movement during activity.
The downsides are unknown. But TelaLab will be happy to sell it to any surgeon that wants to “try” it. It’s another unproven product ready for experimentation on unsuspecting patients.
The bar for getting a device “approved” for use in the human body is very low. This is just one clear example of how easy it is and how the marketing guys will take over and start selling it as soon as possible. If you find someone to implant Ovitex in to your groin to fix your hernia you will be an experiment in progress. There is no person out there who will have had it used for an inguinal hernia repair more than two years.
And, you are talking about laparoscopic implantation. This is very different than the Lichtenstein repair. Apparently, by TelaLab’s ad copy, you would be the first patient to have Ovitex implanted between the abdominal wall and the peritoneum, for an inguinal hernia.
Notice also in the results that the 31 patient surgeon reported that there is no detail on how “pain” was evaluated. Zero. And there’s no indication that the surgeon actually reached out to the patients. Just that they did not “report” it. And the fact that they did not refill their prescriptions, which any self aware person might do with the opioid epidemic happening right now.
What he’s really saying is that they went away and did not come back.
It’s not “real” research. It’s just one guy reporting that nothing terrible happened so maybe this new material has potential. TelaLab took that as “all clear for sales”.
“All patients were prescribed standard postoperative narcotics (oxycodone 5 mg, 20 pills) for pain control. There were no requests for refills for pain medications in the group. There was no reported incidence of Chronic Postoperative Inguinal Pain(CPIP). ”
Got green-screened, changing a word so I can try again.
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quote MinnBobber:To play “Angel’s Advocate” (not Devil’s) and support Ovitex use: I’ll list what appear to be strong positives for it.
1. The 5% permanent polypropolene polymer that is left after the bio liner goes away sure looks like it’s much better than
the big perm mesh.2. It’s certainly more flexible, would feel more natural in there.
3. From Ovitex:
The biologic material, derived from ovine rumen, is optimized to reduce foreign body response, minimize inflammation, and enable functional tissue remodeling. The interwoven polymer helps provide long-term strength, along with improved handling and load-sharing capability.I look at Ovitex vs regular mesh and wonder, why isn’t Ovitex the majority product, why would anyone use the big mesh?
Ovitex looks like it would be a big improvement in making mesh surgery much better.
What are the downsides of it? Is it just that there is a very short track record with it??
Interested in hearing discussion, thanksYes,it is an interesting discussion.
The ovine rumen does not actually “go away”. It is just “incorporated” in to the human body. It’s still there.
Just like the synthetic mesh the properties outside the body are not the same as the properties inside the body, after the body’s foreign body response. So you can’t really compare what it feels in like in your hand to how it will feel in your groin. And the “scarring” that happens, the first step in “incorporation” in general makes things stiffer.
TelaLab is “selling” their product with their marketing copy They only get a return on their research investment if surgeons use the product. That’s why they are recommending it for an alternate use in inguinal hernia repair, with just 31 experimental patients as support. It’s been said that the inguinal region is more complex and sensitive than other areas of the abdomen due to the nerves and other structures that are there and the flexing and movement during activity.
The downsides are unknown. But TelaLab will be happy to sell it to any surgeon that wants to “try” it. It’s another unproven product ready for experimentation on unsuspecting patients.
The bar for getting a device “approved” for use in the human body is very low. This is just one clear example of how easy it is and how the marketing guys will take over and start selling it as soon as possible. If you find someone to implant Ovitex in to your groin to fix your hernia you will be an experiment in progress. There is no person out there who will have had it used for an inguinal hernia repair more than two years.
And, you are talking about laparoscopic implantation. This is very different than the Lichtenstein repair. Apparently, by TelaLab’s ad copy, you would be the first patient to have Ovitex implanted between the abdominal wall and the peritoneum, for an inguinal hernia.
Notice also in the results that the 31 patient surgeon reported that there is no detail on how “pain” was evaluated. Zero. And there’s no indication that the surgeon actually reached out to the patients. Just that they did not “report” it. And the fact that they did not refill their prescriptions, which any self aware person might do with the opioid epidemic happening right now.
What he’s really saying is that they went away and did not come back.
It’s not “real” research. It’s just one guy reporting that nothing terrible happened so maybe this new material has potential. TelaLab took that as “all clear for sales”.
“All patients were prescribed standard postoperative narcotics (oxycodone 5 mg, 20 pills) for pain control. There were no requests for refills for pain medications in the group. There was no reported incidence of Chronic Postoperative Inguinal Pain(CPIP). “
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To play “Angel’s Advocate” (not Devil’s) and support Ovitex use: I’ll list what appear to be strong positives for it.
1. The 5% permanent polypropolene polymer that is left after the bio liner goes away sure looks like it’s much better than
the big perm mesh. Dr Tomas in Fort Myers showed me a mesh—if that was what they all looked like—it was a lot of plastic.
I also found a hernia repair study and it basically said, the less mass/less material that is left perm inside you, the more likely you will not have chronic pain/ not have the feeling that there is something foreign inside you.2. It’s certainly more flexible, would feel more natural in there.
3. From Ovitex:
The biologic material, derived from ovine rumen, is optimized to reduce foreign body response, minimize inflammation, and enable functional tissue remodeling. The interwoven polymer helps provide long-term strength, along with improved handling and load-sharing capability.I look at Ovitex vs regular mesh and wonder, why isn’t Ovitex the majority product, why would anyone use the big mesh?
Anyone know what Ovitex costs?
I’m inquiring from long distance (FL), back to my home state (MN) about surgery and big hospital with daVinci said Ovitex is too expensive and not used for their surgeries.Ovitex looks like it would be a big improvement in making mesh surgery much better.
What are the downsides of it? Is it just that there is a very short track record with it??
Interested in hearing discussion, thanks
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