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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.

Large 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.

FDA 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.

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$133 Billion
The size of the United States medical device market is expected to surpass $133 billion by 2016. At $110 billion, it is currently the largest medical device market in the world.

71% Failed
A 2011 study found that 71 percent of Class I medical device recalls (those deemed most likely to cause serious adverse outcomes or death) were cleared through the FDA’s 510(k) fast-track approval process. 1,190 Recalls According to a recent FDA report, recalls of defective medical devices nearly doubled from 2003 through 2012: 1,190 in 2012 compared with 604 in 2003.

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