The FDA has recently been receiving a lot of attention for something other than a recall or warning; the health experts are facing pressure on approving medical devices at a faster rate. The majority of approvals can take years, and when life threatening or extremely painful health problems are at risk, that wait can be too long. However, other health experts and administrations fear that a faster approval rate of medical devices could also decrease the safety of the devices.
An article from the Huffington Post states the possible new agreement hopes to "double the user fees paid by device makers to the Food and Drug Administration; the fees help fund the agency's review of their products. In exchange, the industry wants to speed up the approval process, claiming that crucial devices to help treat suffering patients are being needlessly delayed in FDA bureaucracy." (read full article)
However, this agreement is not supported by all. Many health experts are arguing that administrations need to focus on the high number of medical device recalls just in 2011, the average number of recalls was doubled compared to previous years. Adjusting to a faster approval rate would only spike those numbers even more. Looking back at the thousands of DePuy Hip System recalls and the several vaginal mesh lawsuits, the idea that devices would be approved even quicker only frightens patients, lawyers and doctors. After thousands of patients suffered from severe pain and multiple revision surgeries due to failed medical devices, patients are very hesitant on devices being approved faster. Many of them believe health experts and administrations need to put more focus on approving the devices, rather than speeding up the process.
The debate appears to be an ongoing controversy that looks as if it will take time to solve. At McGartland & Borchardt LLP, we hope that no one has to ever suffer from failed medical devices and that they receive the attention they deserve in a timely manner. However, we have seen and dealt with several failed medical device cases and feel the work we do will continue to protect future generations of Texans. If you or a loved one have ever suffered from a failed medical device, don't hesitate to contact an attorney to discuss any legal compensation you might have. Feel free to give us a call.
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