FDA Approving Medical Devices Too Quickly With Little to No Research
The Food and Drug Administration (FDA) is under scrutiny by several groups for approving medical devices too quickly, allowing them to go to market with little to no testing. The concern is for patients who rely on these devices and end up dead or severely injured due to lax medical device regulations.
The Government Accountability Office has criticized the FDA for approving 99 percent of medical devices to be allowed on the market without any clinical testing at all. A rule that allows devices that are similar to ones already approved to skip testing is one of the many loopholes used by medical device companies.
The remaining one percent are considered “high-risk” devices, and do require some testing before being approved. These are mostly devices that either directly support life, or require surgical procedures to implant within the body. However, a study by Yale University found that it only takes one major study to get these high-risk devices approved.
While none of the high risk devices studied in the latest research were blamed for any patient’s death, many approved medical devices are later recalled or discontinued due to complications discovered after they are already being sold. For example, DePuy Orthopedics, Inc. is being sued by thousands of patients for a defect in their Pinnacle Complete prosthetic hip system. This implant may leak dangerous metal ions into the blood and cause excruciating pain.
More Information on the Medical Device Study
A team of Yale researchers looked at 28 high risk medical devices that were FDA approved in 2010 and 2011. They found that most devices typically were subjected to only two major tests per device prior to receiving FDA approval. Most of the time, these tests critiqued the device mechanics instead of long term clinical impacts.
While the FDA conditionally approved these devices, the device manufacturers were supposed to conduct extra tests after the devices were released. The research team discovered that only six of 33 tests were finished to date.
If you or a loved one has been injured by a faulty medical device, contact Peterson & Associates, P.C.™ today. We will work to ensure you get the maximum compensation you deserve.