In February 2011, federal legislators heard testimony regarding FDA regulations on the approval of medical devices to determine if changes should be recommended in order to keep defective medical devices from entering the market. Testimony from both medical device manufacturers and patient safety advocates provided conflicting information regarding whether the United States medical device approval process was too long, causing many patients to travel to Europe for treatments as the approval process there was much quicker.
Despite testimony from patient safety advocates who claimed that 70 percent of recalls between 2005 and 2009 were devices cleared through current fast-track methods, the FDA has updated guidelines allowing even more devices to be processed under less stringent requirements. Many patient advocates believe that this could lead patients in Iowa and other states to suffer significant injury from defective medical devices.
Large Number of Recalls
According to reports presented during the hearings, as many as 112 million units of medical devices were recalled during the five-year period reviewed. Many of these devices were cleared within 90 days, and more than 90 percent of all medical devices are cleared through the faster, 510(k) program. High-risk devices must be cleared through pre-market review, which requires human testing. Medical device manufacturers often avoid the more rigorous requirements as the pre-market approval process can take years and cost millions to complete. Therefore, many device manufacturers claim that the device for which they are obtaining approval is similar to one already on the market, even though the devices may be used for completely unrelated conditions.
Patient Safety Concerns
Many patient safety advocates in Iowa and other states are concerned that allowing even more devices to be processed through the 510(k) program will lead to defective medical devices that can cause significant injuries to patients. In 2011, there were more than 1,200 moderate to high-risk medical devices recalled and 50 high-risk device recalls. In 2010, only 751 moderate to high-risk defective medical devices were recalled, although recalls of high-risk devices remained relatively the same. However, recalls of high-risk devices in Iowa and other states has doubled since 2007, when only 26 were removed from the market.
Injured by a Defective Medical Device?
These statistics indicate why patient advocates are asking the FDA not to succumb to pressure from medical device manufacturers and weaken requirements for approvals of medical devices. If you or a loved one has been injured by a defective medical device, contact Attorney Group for Iowa to see whether a defective medical device lawsuit is right for you. We can help answer your questions in a free consultation, and connect you with an affiliated attorney if you decide to pursue a claim. Contact us today to learn more.