The Houston medical device injury lawyers at Denena & Points realize that you might know that most medical devices that get introduced to the U.S. market receive approval under the FDA’s expedited 510(k) approval process. Under the 510(k) expedited approval process, a medical device will receive approval so long as it is “substantially equivalent” to a medical device that already received approval to enter the market. This remains true even if that earlier, substantially equivalent product was recalled for defects still present in the later product. Medical devices approved under the 510(k) process do not require additional testing or clinical trials in human subjects.
The Institute of Medicine in 2011 recommended to the FDA that it replace the 510(k) approval process with a new system. The Institute indicated that the 510(k) process couldn’t properly assure the safety or effectiveness of a medical device before it enters the market. And a study found in the Archives of Medicine determined that fully 71% of dangerous recalled medical devices from 2005 to 2009 received their approvals through the 510(k) expedited approval process.
Earlier this year, Congress introduced a bill that would allow the U.S. FDA to reject a medical device application where that new device was substantially equivalent to a product already determined to be harmful. Yes, it’s shocking that Congress has to introduce additional legislation to give the FDA that authority. It should already have that authority. Our Houston medical device injury lawyers mention that the bill has not yet cleared Congress.
So two Congressmen, Representative Edward Markey (D, Massachusetts) and Senator Jeff Merkley (D, Oregon) have sent a letter to the FDA requesting some answers about the agency’s willingness to assume the additional authority needed to help ensure your safety. These two Congressmen actually don’t ask for much in the way of real change.
They only want the FDA to make changes to the 510(k) database that would indicate the devices that were recalled for design flaws, and include and clearly mark past medical device recalls. The Congressmen would also like the FDA to update the database within 30 days after reviewing a manufacturer’s root cause analysis and determining that a flaw leading to a recall was serious; and to notify the public when a new medical device includes design flaws that led to an earlier product’s recall.
Our Houston medical device injury lawyers note that even if these changes are implemented, the safety of the public remains at risk from medical devices approved under the expedited 510(k) process. And realistically, how many of you would go to the FDA database to check on the design flaw and recall notes relating to a medical device your doctor has recommended? When your health or the life of a loved one is threatened, even a flawed medical device that promises hope likely seems better than no device at all.
The real answer would be to require extensive testing and clinical trails of all medical devices before they reach the market. But manufacturers view both the cost and the time delay required by such testing as prohibitive and a deterrent to research and development.
Ultimately, solutions will continue to be balanced between the medical needs of a population with poor health and the needs of the manufacturers that produce the medical devices and products promised to save them or alleviate their suffering. Yet our Houston medical device injury lawyers strongly believe that some better oversight of the 510(k) expedited approval process is necessary.
As a glaring example stands the transvaginal surgical mesh that has led to so much suffering for so many women. Use of the mesh to repair extensive internal organ prolapses was approved under the 510(k) expedited process based on its substantial equivalency to the mesh used to repair hernias. Our Houston medical device injury lawyers emphasize that even if the mesh itself might have been substantially equivalent, the intended use clearly was not. A prolapse repair is a far more invasive and extensive procedure, with much higher risks, than a simpler hernia repair.
At the very least, some modification of the 519(k) approval process should be made to catch these types of cases where a novel use of a substantially equivalent product deviates so diametrically from the product’s prior use that unanticipated risks and errors could occur. In such cases, the medical device should undergo additional testing and clinical trials relating to its intended novel usage before it is released into the U.S. market and installed in the bodies of unsuspecting patients.
Our Houston medical device injury lawyers have taken some pains to learn about the intricacies of transvaginal surgical mesh prolapse repair in order to help our clients that were injured by the product. In doing so, we’ve acquired an in-depth knowledge of the strengths and weaknesses of the FDA medical device approval processes as well.
If you or a loved one are suffering because of a defective medical device, give us a call to schedule a free case evaluation consultation. Our Houston medical device injury lawyers could familiarize you with the law that applies to your specific situation and help you understand your options for winning a full financial recovery for the harm you’ve received. Money can never replace the health and well being that you’ve lost to a defective medical device. But it can help you meet your future medical costs as you struggle to recover from the injury and your lost wages if you can no longer work. Let our experience and knowledge help you recover.