-
New material – Ovitex
I wrote a small book’s worth of stuff but it just disappeared so will try again in smaller chunks.
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 had good words about 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 part of an experiment.
Links follow.
-
6 Replies
-
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.”
-
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.
-
“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. ”
-
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.”
-
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.
Log in to reply.