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What’s in That Mesh? – article about what should have happened 20 years ago
This looks like a summary of Dr. Eric Pauli’s presentation at the recent Costa Rica 2022 International Hernia Collaboration meeting.
He covers most of the problems with mesh and seems very informed, with lots of relevant detail. His predictions about the future seem hopeful though. Much of what he discusses has been known for years or decades, and nothing has happened. The references shown range from 2010 to 2016.
His prediction of greater barriers to new meshes does not address at all the removal of known bad meshes. Perfect for the mesh producers, the competition to existing bad products will be reduced, but their bad products will be “grandfathered” in. He probably does not realize that. Good luck to him though.
https://www.ormanagement.net/Clinical-News/Article/09-22/What%E2%80%99s-in-That-Mesh-/68110
His parting thought –
“Looking Ahead
Dr. Pauli predicted that government regulation of hernia mesh products will change. Currently, most meshes reach the U.S. market through the 510(k) clearance process, which requires only demonstration that the new product is substantially equivalent to a previously approved device. As such, mesh products may enter the market with a minimal amount of clinical data on their safety and long-term effectiveness.
“ “I think we’re going to enter a new era of government regulation that says if you’re going to put a new mesh on the market, you can’t simply tell us that it is the same as some other product,” Dr. Pauli said. “You’ll have to present us with the data that shows it is safe and provides effective outcomes.” “
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3 Replies
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Hello William. My point was that the problems have been clearly identified but no action is being taken to remove them. The bad products are still for sale all over the world. Dr. Pauli explains how the bad products got in to the market, through the 510(k) program, then describes how it will be harder to introduce new products. In sum, the bad products will remain and product development will be hindered. The horse is out of the barn, they closed the door, and they’re happy to let the bad horses run free, making everybody money, from implantation to pain clinics to explantation.
But no attempt to prevent the problems by removing the bad products or procedures. Lots of talk, the same things repeated over and over, very supposedly conscientious, but no actions taken. Nobody is brave enough to criticize an actual mesh product and push for its removal from the market. The most direct that I’ve seen is “plugs are evil” from a Dr. Novitsky tweet in response to a Dr. Towfigh tweet about a plug removal and all of the damage that the plug caused. Plugs are still being promoted, markets being developed, in foreign countries.
The large organizations like SAGES are more focused on fostering tech entrepreneurs. It’s all very commercial and corporate. Like it’s all a popular cable TV show. Better faster technology to implant the bad mesh products faster and more profitably.
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This is the current situation at Europe and also with pelvic mesh in US. We predict FDA will do same in US.
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Yes good for him bit doesn’t it more or less go along with what I posted that some meshes are better than others and mesh does work for some people.
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