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Registries, Ethicon, and Marketing
In studying why more registries aren’t used to track the successes or failures of the multitude of mesh products out there I came across what looked very promising – an international hernia mesh registry. After digging in to what it was though, I find that it looks more like a large number of clinics have been roped in to providing marketing data for Ethicon. That’s the most reasonable conclusion I can come to when I look at the history.
Here are some relevant link’s with some short comments, below. You might have to look through these several times to get a real feel for what has happened and is still happening. But the truth will become more clear, hopefully, in December 2021 when the study is to be completed. In the meantime Ethicon is using preliminary data to sell their products, using vague statements about “baseline” comparisons from the registry. For example – “reported significant improvement in pain and movement limitations from baseline at one year postsurgery9,10 § //” referring to the IHMR. But somehow missing major problems with Physiomesh. Luckily other registries caught these problems before more damage was done. See the The_Importance_of_Registries_in_the_Postmarketing.32.aspx link below.
It’s hard to comprehend what is shown here, and even harder to understand how there aren’t more surgeons asking questions of these medical device makers. Ethicon is a subsidiary of Johnson & Johnson. A huge player in the mesh market. The data, over time, also seems to show that the Carolinas group is essentially a subsidiary, or marketing arm, for Ethicon.
https://clinicaltrials.gov/ct2/show/study/NCT00622583?show_locs=Y#locn
Read the subscripts closely. I will attach some pictures in my second post.
https://www.ethicon.com/na/products/hernia-mesh-and-fixation/hernia-mesh/ultrapro-hernia-system
https://www.ethicon.com/na/products/hernia-mesh-and-fixation/hernia-mesh/ultrapro-advanced
https://www.ethicon.com/na/products/hernia-mesh-and-fixation/hernia-mesh/proceed-surgical-meshhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4585075/
https://www.ncbi.nlm.nih.gov/pubmed/26137464
https://www.ethicon.com/na/products/hernia-mesh-and-fixation/hernia-mesh/ethicon-physiomesh-open-flexible-composite-mesh-device -
7 Replies
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The study is incomplete but Ethicon has no problem pulling out anything that helps sell the product. The study started in 2007, it’s 2022, and they use one year as the evidence for their statements. The statement itself is vague, what is “baseline”? Just marketing stuff.
https://www.jnjmedtech.com/en-US/product/ultrapro-mesh-ethicon
“ULTRAPRO® Macroporous Partially Absorbable Mesh offers strength with reduced foreign body mass1,5 and may reduce the risk of patient complications compared with mircroporous mesh.2,6 In a study of patients from the International Mesh Hernia Registry (IHMR), patients demonstrated low rates of intra- and postoperative complications, such as seromas, and recurrence (<1%) after 1 year.2-4,7-12 In the same study, patients reported improvement in pain and movement limitations from baseline at 1 year postsurgery.2,3,7,8 ULTRAPRO Mesh withstands more than 2x the maximum abdominal pressure in healthy adults.13,14”
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I just stumbled across the Ethicon IHMR site again. The study completion date has been pushed out again, to March 2024. And they are still using data from the study in their marketing literature to promote the mesh as “pain-free”. The people that sell mesh have no connection to healthcare. They are just selling a product.
https://www.clinicaltrials.gov/ct2/show/NCT00622583
Official Title: A Two-Year Follow-up, Post-Implantation, Multi-center, International Hernia Mesh Registry
Actual Study Start Date : September 1, 2007
Actual Primary Completion Date : April 24, 2019
Estimated Study Completion Date : March 31, 2024 -
I just checked, and Ethicon’s “Two Year Study”, started in 2007, is still pending. It’s a good example of an industry-managed registry.
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Here is a post about a recent study using data from a “real” registry, not a company created and promoted pseudo-registry.
https://herniatalk.com/forums/topic/lightweight-vs-heavyweight-mesh/
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Here is the Ultrapro link to what I posted above.
https://www.jnjmedicaldevices.com/en-US/product/ultrapro-mesh-ethicon
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Ethicon has delayed the publication of the report again, to December 2023. But they’re still using the suggestion that the study supports their products.
“Estimated Study Completion Date : December 31, 2023”
https://clinicaltrials.gov/ct2/show/NCT00622583
“ULTRAPRO Partially Absorbable Lightweight Mesh offers strength with reduced foreign body mass1** and may reduce the risk of patient complications compared with heavyweight mesh.† In a study of patients from the International Mesh Hernia Registry (IHMR), patients demonstrated low rates of intra- and postoperative complications, such as seromas, and recurrence (<1%) after 1 year.2* In the same study, patients reported improvement in pain and movement limitations from baseline at 1 year postsurgery.2*”
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I have found a recent update to Ethicon’s marketing literature. They have put the “Registry” at the forefront, highlighting it at the start of their brochure. Even though, the report is not out yet, and the study is, supposedly, not complete. The finish date has been pushed out, it might never be published and available. but the “results”, whatever they might be, are still being used by Ethicon, A Johnson & Johnson company.
Click on Clinical Support in this link and a pdf file will open.
https://www.jnjmedicaldevices.com/en-US/product/ultrapro-plug
Excerpt –
“Ethicon Hernia
Dedicated to evidence and long-term patient outcomesFor more than 80 years, Ethicon has been a trusted partner, leading the industry in providing outcomes-based solutions for our customers. An example of this commitment is our sponsorship of the largest hernia registry in the world, the International Hernia Mesh Registry (IHMR).
Ethicon began sponsoring the IHMR in 2007 through a grant program
so we could play a significant role in providing large-scale evidence of the safety and Quality-of-Life outcomes for hernia-related products and procedures. This repository includes postoperative hernia data on all synthetic meshes and techniques – both Ethicon’s and our competitors’.
Many Ethicon products—including ETHICON SECURESTRAP®
Absorbable Strap Fixation Device, ULTRAPRO® Partially Absorbable
Lightweight Mesh, and PROCEED® Surgical Mesh—are tracked and
measured in IHMR for continuous assessment of outcomes data. This
illustrates our dedication to advancing hernia repair and commitment to evidence generation.”
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