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Recommendations The heart of this issue comes from lack of regulation and lack of responsibility from multiple players including Synthes executives and employees, the Surgeons,

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Recommendations The heart of this issue comes from lack of regulation and lack of responsibility from multiple players including Synthes executives and employees, the Surgeons, the hospitals, the testing centers, and the FDA. In order to prevent situations like this happening in the future, there needs to be stronger regulations and better oversight on what is being used on patients and put out into the hospitals- UlJ'lu'l-U sly the company Synthes needs to be held accountable for their false labelling and unapproved rJinical trials, but something interesting in this study that didn't seem to get much attention was the lack of regulations on surgeons. Synthes went around the FDA guidelines by having the surgeons mix the cement before injecting it, but this seems like something that could have been avoided if the surgeons had more regulations place on the work that they do. Even in the Fortune article, it stated that the FDA does not regulate doctor's activity and they can essentially prescribe anything they want to, and a Synthes employee said a surgeon could llput a bowling ball in your bodyll if they wanted to \"times, 202D}- On top of that, surgeons often use devices in unapproved ways \"times, 20213]. If the surgeons are lacking regulation and using devices in unapproved ways, the safety of the patienE are at a much higher risk, so adding more regulations on them could decrease the amount of medical incidents in the future. "also wanted to talk about the hospitals - how did so many place incorporate these testing procedures and not back check the products at all1'I "also wanted to talk about the FDAs involvement, it seems like they need to be more involved, routine check ups that the restrictions they place are being followed because it would have been easy to see the mixig or off labelling if someone would have just looked into it Conclusion "sorry not finished at the end here

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