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Australia – just like the rest of the world
Here’s an article from Australia, from just a few days ago. It looks very similar to many past articles from other parts of the world. If you can find humor in the whole situation one of the last comments is pretty funny. The hernia repair mesh situation was analyzed and mesh was reclassified from medium-risk to high-risk. The solution for the repair industry was to print a leaflet, passing responsibility on to the patient for taking that high risk.
“We have a problem here, what should we do about it?!” “Make sure that the patient takes more responsibility for the risk.”
“In December 2018 all surgical mesh – including hernia mesh – was reclassified from “medium risk” to “high risk”, increasing both pre-market scrutiny and post market scrutiny, the spokesperson said.
All patients having surgical mesh operations must now be given a leaflet and implant card warning about potential risks of the device, the spokesperson said.”
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1 Reply
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Hopefully the leaflet will be printed on a piece of mesh.
I wish our FDA would pay attention.
Bill Brown MD
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