Good intentions
Forum Replies Created
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Another fairly recent article about changing the 510(k) process. It’s not really clear who will benefit though. Seems to be more short-term based.
https://www.cnbc.com/2018/11/26/fda-to-overhaul-510k-medical-device-approval-process.html
And it looks like the head of the FDA has been pushed out. Wants more family time after just two years.
https://spinalnewsinternational.com/scott-gottlieb-resigns-fda/
This is why we can’t depend on the FDA to save us. If they can help, that’s great. But nobody should expect the help.
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About one year ago there was an effort to increase the dialogue between the FDA and the affected parties. Not clear what ever came of it.
https://www.herniatalk.com/6583-dear-patient-advocates-seeking-feedback
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quote DrBrown:Dear Good Intentions.
Your comments and information in this forum are a start, but I agree it would be very helpful if the FDA would acknowledge the problem. Many surgeons that use mesh do not realize that their patients have serious problems with mesh, because the patient goes to another surgeon to have the mesh removed (i.e. Myself and Dr Towfigh)
I appreciate your effort to keep attention focused on Mesh.
Regards
Bill Brown MDThank you Dr. Brown. As you can see from the FDA’s own web site they are aware. But they seem to be deflecting any responsibility for action, even suggesting that the problems they list have all been removed from the market, by recalls. Even as the lawsuit ads on the mainstream media channels become more prevalent. It really looks like the device makers have got to them and are running the show. The FDA expects the device makers to recall their own products, seemingly not realizing that self-recall means self-blame which means liability. The FDA does not seem to understand their role.
From the FDA:
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”
They put all of the responsibility on the surgeon, and the patient. Surgeons make fun of “Dr. Google” but Dr. Google seems to be necessary.
“The FDA wants to help patients make informed decisions about their health care and to facilitate a discussion between patients and their surgeons.”
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Thanks for posting this. I found the link to the full review, it’s free for viewing, below. It looks very comprehensive, it will take some time to work through.
Download choices are in a column on the left.
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Thank you for the reply Dr. Towfigh.
Of course, I meant an open forum with presentations, at one or more of the national meetings, similar to the presentations about how to implant mesh. As the patient becomes more responsible for the decision about how to repair their hernia, the patient needs good information. The closed door meetings between surgeons and others don’t help the patient learn anything. They actually make the patient more suspicious that something is being hidden. In the long run, the closed door meetings might even be making the participants of the meetings more liable for future problems.
It would be so much better to just have an official acknowledgement of the problem, with some level of quantification, and some shared information about how to deal with it. My surgeon delayed and denied for almost a year and finally said that he was going to seek outside help. He should have had an answer immediately and recognized the symptoms. He was fully up to speed on how to implant mesh, training and certifying people in laparoscopic techniques, but apparently clueless about mesh removal. He was either pretending, or he really did not know what to do. Both are bad.
Unfortunately, there is a growing gap between what the doctor needs to do for their profession, and what the patient needs to do to heal and get back to a full life. I think that this also plays in to the burnout and depression among doctors that mentioned in my other topic. The doctors need patients to push back, for the health of all involved. Expose the bad side of hernia repair so that people can be ready to deal with the failures.
I think that in today’s world it is inevitable that mesh removal will eventually be fully exposed. Better to be ready for it and ahead of it. It would make a great 60 minutes story.
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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
….
• 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
….
• 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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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”.
The speed to market on almost no data is incredible. It seems that just replacing old products with products that look different is the business model. Lightweight from heavyweight, bioscaffold – synthetic hybrids… long-term results don’t matter. Just keep implanting new stuff but don’t keep track of results.
This is from October 2018.
“Nonhuman primate studies have shown that following im-
plantation OPRBS rapidly repopulates with cells and new
blood vessels, and subsequently remodels into a morpho-
logically functional collagen layer. -
I’m not sure if the surgeon from the paper above above realized that he left an “out” with his use of the word “or”. Non-disabling pain beyond three months is still a possibility.
“In this small series no patients reported any postoperative pain that was either disabling or lasted beyond three months. ”
He does recognize the weakness of the work, re long-term results, below. But TelaBio doesn’t care. They’ll use the good news. That’s enough.
“To confirm these results, as well as evaluate the effect of RBS on late-onset CPIP, a larger prospective series should be studied with longer follow-up.”
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And this is the ad copy on their main web page. It’s available for usage, apparently, based on primate studies, non-talking I assume, and a 3 – 18 month 31 patient human study. Thousands of implantations, surgeon-recommended. Chronic pain is the supposed impetus, but only 31 short-term
This is how new products get introduced.
” [h=3]A COMPREHENSIVE SOLUTION BACKED BY EXTENSIVE PRECLINICAL TESTING AND EVALUATION OF ONGOING CLINICAL OUTCOMES[/h]
Building on extensive preclinical testing in a non-human primate model, TELA Bio is committed to evidence-based medicine and investing in clinical data collection. Following thousands of implantations, surgeons have acknowledged OviTex as a comprehensive solution in hernia repair and abdominal wall reconstruction. Additionally, our multicenter, post-market, single-arm, prospective study (the BRAVO* study) evaluating OviTex performance in ventral hernia repair is currently enrolling patients.*BRAVO: Bioscaffold reconstruction of abdominal wall and ventral hernia defects with open or laparoscopic repair.
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“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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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.”
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Here is the link, and excerpts.
http://www.telabio.com/ovitex.html
This is the paper, next post, 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.
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Minnbobber I just dug into what Ovitex is and it does not appear to be a resorbable or absorbable material. It uses sheep stomach along with polypropylene. The material stays in the body, it’s not absorbed. It’s just not synthesized like polypropylene.
“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. RBSs are purposefully designed for hernia repair and abdominal wall reconstruction and are constructed by embroidering layers of biologic material derived from ovine (sheep) rumen with polymer. “
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“da Vinci” or robotic surgery just offers more potential to get the very fine details right. There is really nothing that special about it otherwise. A good surgeon with steady hands can probably do just as well as a surgeon using a robotic method, for a typical hernia repair. I would not read anything special in to robotic methods for placing mesh. Mesh placement is a fast way to cover a lot of area, without having to deal to much with the fine details of a typical suture-based repair. Mesh placement is probably the crudest way to repair a hernia. Placing a large patch over a relatively small defect.
Ovitex is a new material, introduced to market in 2016. They are using results generated in 2016 to “sell” the product, based on a 3 – 18 month follow-up exam, see the link and click through to “Experience in Inguinal Hernia Repair”. They used the Lichtenstein repair method, an open surgery, focused only on the inguinal canal. I may be wrong, but using da Vinci for a Lichtenstein repair would be unusual.
http://www.telabio.com/ovitex.html
The surgeon for the paper that they are using to sell the product is a consultant for TelaBio.
Overall, you’re asking about a new and unproven, no long-term results, product to be placed via a new robotic technique. You would be an experiment. If you are healthy, except for the hernia, find a surgeon with a long-term track record for repairing hernias. Don’t be a lab animal. Ovitex is a choice for difficult situations but has no data supporting its use for a normal hernia repair, if long-term success is the goal.
” [h=2]Conflict of interest statement[/h]
Consultant for TelaBio.
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Also, sometimes you can just change a few words and try again and it will work. Not clear why. I try to remember to copy a post before hitting “Post Reply” so I don’t have to start over.
[USER=”1041″]WasInTN[/USER]
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I just got blocked in my reply. Dr. Towfigh will probably clear these up soon. She is the moderator.
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quote pinto:While I sort out how to ultimately get repaired, I am concerned how to live with it. It seems I must do trial-an-error about my living activities, etc. I have been out hip hop dancing a few times and do fitness training with no apparent damage but unsure about practicing golf swings. I don’t even think about playing basketball. Yet fearful to stoop picking things up from the floor. I fear making my situation worse while I eventually make repair plans.
Hello pinto. I was advised by a good friend, who is a surgeon and had his own hernia repaired, that I could continue my sports activities while I waited to have surgery. But I am pretty sure that my rigorous activities made it larger. It went from a small distinct bump to a long bulge. I don’t know if it was more material pushed through a small hole or if the defect itself got larger. So I think that your concerns about activity are valid. It’s a matter of degree. If you weren’t very active in general then a moment of strenuous activity caused the hernia, that would be different than if the hernia occurred during your normal activities, I think.
If you are considering a non-mesh repair I think that it is more effective to repair a small defect than a large one. Mesh is used to cover large areas, but even then the surgeons might change to a different mesh or cover more area if they are concerned about the size. From what I’ve read on the internet.
I’m not sure that you can do “trial and error” with a hernia and your activities. Each tear or increase in hernia size is permanent and there is no warning that it is about to happen. Just like the initial rupture.
Good luck. Be careful.