Posted On: March 19, 2012 by Montross Miller Muller Mendelson & Kennedy

Untested Medical Devices Compromise Patient Safety

mesh.jpgFor millions of Americans, medical devices have meant an improved quality of life. However, many of these people also suffer injuries from medical devices that were not tested adequately before they were implanted in their bodies.

According to a new report by Consumer Reports, there are an increasing number of American patients who live with some kind of medical devices. These devices range all the way from defibrillators to vaginal mesh. Many of these devices are untested. According to Consumer Reports, in many cases, manufacturers are getting their medical devices approved by the Food And Drug Administration by merely filing paperwork.

Getting a simple new medical device approved by the Food and Drug Administration costs just over $4,000. A company only has to pay this user fee to begin selling a medical product that can be inserted in the bodies of millions of Americans.

That is the approval procedure for low-risk products. There are other high-risk products that are also approved by the Food and Drug Administration through a less-than-rigorous screening process. Under the screening process, these devices are implanted, if they are reasonably similar to devices that are currently available on the market.

For years now, Indiana personal injury lawyers have been raising their voices against the pitifully low standards for the testing of medical devices at the Food and Drug Administration. The federal agency has limited resources for the testing of each and every medical device that it receives an approval application for. The agency receives hundreds of such applications every year, and does not have the resources to go through these devices and inspect them individually. As a result, the agency uses the fast track 501 (k) process to speed up the approval process for devices that are reasonably similar to devices already available in the market.

The investigation by Consumer Reports yielded a number of findings that are extremely disturbing to Indiana personal injury lawyers. The investigation found that there are far too many loopholes in the system for unsafe devices to slip through and injure consumers. When you buy a toaster, you will find a special and unique code by the manufacturer that allows you to identify the product. No system like that exists in the case of pacemakers or hip implants. These are highly complicated, sophisticated devices, but there are no unique serial numbers that can help identify potential problems and coordinate a recall.

Take the case of vaginal mesh. This mesh was designed to deal with urinary incontinence and pelvic organ prolapse. The mesh was passed through the fast track approval process. Thousands of women who have been implanted with the mesh have found themselves with chronic pain and a number of other complications as a result of the use of the mesh, which it is now clear, was not tested adequately before it was released into the market.