Cardiac devices substantially different from those originally approved

Many medical devices in use today took several years to develop and perfect. Manufacturers had to be able to demonstrate that the devices worked as intended, and did not subject any individuals to unnecessary health risks before they would be allowed on the market. Such a rigid screening process was designed to ensure that only the most effective and safe products would be permitted to be used on individuals who needed these devices to be able to return to health.

Manufacturers of certain cardiac devices submitted their products to the Food and Drug Administration's (FDA) premarket approval process (PMA). This meant that the companies had to supply data that showed the devices were successful in clinical trials. The FDA could then approve the products for use in patients based on these results.

A new study by doctors at Brigham and Women's Hospital in Boston examined some of the products that have went through this process to learn if the system may have allowed defective medical devices to place patients at risk. They learned that 77 cardiac devices were approved from 1979 to 2012 using the premarket process. These 77 products led to an additional 5,829 later PMA petitions for modifications to the original designs.

This is an important fact because in many cases, these later petitions would not necessarily require additional testing before they would be approved. Because the manufacturers had supplied data with the first application, the later applications fell under those original requests.

Two devices approved in this manner had to be recalled after later problems were discovered. The Medtronic Sprint Fidelis and St. Jude Medical Riata ICD leads both were approved by the FDA through supplemental applications, meaning that they had not underwent significant testing prior to their introduction.

The study expressed concern over the many supplemental applications that often flowed from those devices originally approved. In some situations, the make-up of the device changed substantially from the time it was introduced. This could be placing many patients at risk due to devices that manufacturers have not studied extensively prior to placing on the market.

If you believe your condition has been worsened due to a defective medical device, you should speak to an experienced medical malpractice attorney about your ability to recover compensation from the responsible parties. Because of the complex issues involved, including very detailed scientific testimony regarding your injuries, it is important that you work with someone that knows how to investigate and present these types of claims. You attorney will be able to answer any questions that you may have, and demonstrate how your injuries have resulted due to devices being used.