Not So Fast: Examining the FDA’s Medical Device Approval Process

Most of us pay them little mind; and, if they’re working correctly, medical devices implanted in the body are supposed to work behind the scenes. When a device malfunctions, however, the results can be life altering and even deadly. If you’ve been affected by a faulty medical device, you need to contact an attorney to learn your options.

A recent Wall Street Journal article pitted three experts in a debate over the validity of the FDA’s current medical device-approval process. The piece raised some interesting issues, including the increasingly complex nature of these devices as well as the fast-track process through which most of these devices are approved. According to the FDA, there have been seven major recalls of medical devices so far this year — for reasons ranging from volume failure to leak risks. In 2014, there was close to 60 recalls.

The bottom line is that this isn’t a toaster or a blender we’re talking about; it’s something that you’re relying on to sustain your life and, in many cases, something that you will be putting in your body. While these devices can help us live longer and enjoy a better quality of life, we’ve seen case after case of their malfunction.

Perhaps it’s time modify or at least revisit the approval process to ensure manufacturers get it right the first time? In any case, be sure to talk to your doctor about the benefits and risks involved before electing to utilize one of these tools.

If you’ve been a victim of a defective and malfunctioning medical device, talk to a lawyer that can help you get the damages you deserve. Accidents happen, but that doesn’t mean you have to pay for them with your health or your livelihood.

The Sugarman Law Firm possesses decades of experience helping clients who have been the victims of faulty medical devices. Call us today to get justice and peace of mind.