Registries, Ethicon, and Marketing

[Good intentions]

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 postsurgery^{9,10 § //”} 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-mesh

https://www.researchgate.net/publication/263238379_International_Hernia_Mesh_Registry_IHMR_-_An_Ongoing_Global_Source_of_Real-World_Outcomes_on_Hernia_Mesh_Repair

https://journals.lww.com/annalsofsurgery/Fulltext/2018/12000/The_Importance_of_Registries_in_the_Postmarketing.32.aspx

https://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

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6250300/

[Good intentions]

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 outcomes

For 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.”

[Good intentions]

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*”

[Good intentions]

Here is the Ultrapro link to what I posted above.

https://www.jnjmedicaldevices.com/en-US/product/ultrapro-mesh-ethicon

[Good intentions]

Here is a post about a recent study using data from a “real” registry, not a company created and promoted pseudo-registry.

Lightweight vs heavyweight mesh

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