We discussed problems at the FDA regarding medical devices in The Origin of Disease: The War Within. This article from the Washington Post contains appalling admissions regarding the approval of medical devices by the FDA. The FDA approves dangerous devices when it is convenient, expedient, or in response to political pressure. The FDA does not follow its own regulations regarding medical device approval for 510k products. The FDA exceeds their authority at will to protect industry from claims of harm from patients. The FDA believes industry is their customer, instead of the public. Profit on medical devices can be as high as 1000%, and even when removed from the market due to the harm caused, industry retains that profit. Carolyn represented clients injured by most of the devices listed in the article and more, including defective keratomes, jaw implants, and IUD’s. The impact of defective medical devices is devastating for patients and significant for society. Buyer beware before agreeing to any surgery involving a medical device, particularly implantable medical devices.
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