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Fixing problems caused by new Onstep procedure
This paper was recently published describing how to fix what seems to be an inherent problem with the Onstep (Bard) device. The chaos continues with 510K devices introduced to market with no long-term data. to the surgeon it’s just another procedure, to the patient it’s months or years of life wasted.
Notice that there is no recommendation to avoid using the Onstep device because of this problem. Just keep using it and fix it later. The focus is on saving the product, not the patient.
https://pdfs.semanticscholar.org/345c/018e3c2e7c54e723ca8e6d6f99b74a696501.pdf
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4 Replies
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I can not agree more. Meshes are introduced with minimal research.
I wonder how many of the pigs complained of pain before the researchers had a BBQ.
Bill Brown MD -
Thank you for commenting Dr. Brown. It looks like Bard has already developed a new product, Modified Onflex, and introduced it to market, somehow. The 510k bypass process again. Overall, each patient with a problem is just an involuntary subject in the device makers’ experiments. It’s incredible that this is now normal. Validating new products is not even necessary anymore. All it takes is an idea and it can be implanted in patients as soon as it’s produced and delivered to a surgeon. It’s hard to read these marketing pamphlets without feeling sick to see how uncontrolled the market is. Complete abdication of responsibility from the FDA, and the community of surgeons that use mesh. Surgeons should be refusing to use these experimental products.
Here is the experimental justification for the new absorbable ring, copied below. Preclinical data on lab pigs. Results may not correlate to humans. But it’s for sale, ready for implantation. Amazing. Any surgeon who reads the fine print is guilty of malpractice I think, if they use this product without informing the patient that it is unproven in humans, even in the short term, let alone long term. Or they can plead ignorance and blame the device maker.
“These images are from a porcine study using Ventrio™ Hernia Patch which contains the same SorbaFlex™ memory technology.*
“* Preclinical data on file at C. R. Bard, Inc. Results may not correlate to performance in humans.”
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[USER=”2029″]Good intentions[/USER]
Only the ring is removed.
Most of the mesh was left in place.
Bill Brown MD -
If I ever decided to use a mesh, I think I’d use an Onstep. Even is there’s not much experience so far, studies published seem quite safe and that mesh looks much more sound than conventional meshes to me.
I had already read that article, and it’s positive to me that you can remove the ring after 6 months. I think I’d have it removed anyway after 6 months. Only problem is that they recommend general anesthesia.
Problem with medical devices is the same all over the world, not enough data requested and analyzed by authorities, and was recently disclosed by International Consortium of Investigative Journalists.
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