Clifford Law Newsletter – Winter 2016
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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. 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…
Interesting Statistics You Should Know About Defective Medical Devices
You Should Know Newsletter $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…