News & Resources

Category: Unsafe Medical Devices - Page 3

February 8, 2016

Transvaginal Mesh Products Are High-Risk Devices According to the FDA

At last, the FDA has finalized its proposals from April of 2014 to reclassify certain transvaginal mesh implant devices from Class II medical devices to Class III devices.  Class III medical products are “high risk” devices that require pre-market approval.  This is a process that requires manufacturers to provide the FDA with clinical data to demonstrate safety and efficacy of a product before it can be sold.    The reclassification only applies to transvaginal mesh used to treat pelvic organ prolapse (POP) and does not include transvaginal mesh sling products implanted for the treatment of stress urinary incontinence. 

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September 14, 2015

Over 50 Medical Devices Recalled in 2014 Alone

A medical device failure can leave individuals facing major surgeries or even death. A Tampa defective medical device attorney at our firm has seen families deal with the devastating consequences of unsafe and defective medical devices. While patients cannot always escape injuries, they should educate themselves when possible to better understand the risks.

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