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Is Your Medical Device Really Safe? Here are Some Stories of Which You Should Know About FDA Approval

You Should Know Newsletter

Routine Surgical Device May Spread Cancer

Many surgeons use a device called a morcellator as a way to do noninvasive hysterectomy surgery. Amy Reed, a doctor herself, says the morcellator used in her 2013 hysterectomy spread cancer all over her stomach. View video.

GuardrailsLarge Portion of FDA-Approved Devices Lack Safety Evidence

A recent study from the Wall Street Journal  shows the majority of moderate- to high-risk medical devices approved by the FDA lack scientific evidence to verify safety and effectiveness with patients. View video.

Fatal CrashFDA Knew Device Might Expose Patients to Deadly ‘Superbug’

Experts say the FDA has known since at least 2009 that the medical devices involved in a superbug outbreak that infected 179 patients in Los Angeles could transmit lethal infections but did not require more stringent safety standards. View video.