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One company’s mesh development process
I’ve come across some interesting stories that shine a bit of light on how strange this mesh device field really is. Here is a company that devised a way to apply a food supplement to their polypropylene mesh product, and get it approved via the FDA’s 510(k) process (substantially equivalent to existing products), and now is, apparently, suffering the consequences. Overall, the story is almost absurd, applying a fish oil that was originally meant to pass through the digestive system to a device that will come in to direct contact with the inside of the abdomen and its contents. It seems like what a small child would imagine is possible. The food ends up in the tummy so placing it their directly will be okay. They also add Vitamin E, another food supplement, to the coating.
Anyway, here are the stories and some links to Atrium’s devices page, several of which are strange in their own ways, without the fish oil.
http://www.nhbr.com/February-2-2018/Hernia-mesh-litigation-mounts/
http://www.atriummed.com/en/biosurgery/cqur.asp
Here is a device that looks like somebody got frustrated and made a joke and they decided to go ahead and manufacture it. It’s just a bundle of polypropylene fibers.
http://www.atriummed.com/en/biosurgery/proloop.asp
Here is a link to the patent and an extract from the patent. They talk about partially “curing” the fish oil. Curing would mean crosslinking, or bonding the individual oil molecules together. When you do that, it’s not fish oil anymore. It’s a completely new material. Not “substantially equivalent” to anything. The product was never tested in humans before its release to market.
https://patents.google.com/patent/US20080118550
“In accordance with further aspects of the present invention, the coating additionally includes vitamin E. The coating can be in at least a partially cured state prior to application of the coating on the mesh. The coating may also be subjected to curing conditions subsequent to application of the coating on the mesh, such that the coating is resident on the mesh in at least a partially cured state. Curing with respect to the present invention generally refers to thickening, hardening, or drying of a material brought about by heat, UV light, chemical means, and/or reactive gasses.”
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