Millions of Americans have some type of medical implant, from artificial joints to surgical mesh. These devices have come under scrutiny by researchers who published their findings in the Journal of the American Medical Association (JAMA). According to the research, the majority of medical implants studied fell short on safety information and FDA testing.
Lack Of Safety Information
The study looked at 50 new implants that included, among other devices, hip replacement implants and surgical mesh. Specifically, researchers reviewed the applications submitted to the FDA from the devices’ manufacturers. Out of the 50 applications submitted between 2008 and 2012, just eight applications contained the products’ safety data. In all 50 cases, however, the FDA approved the implants for use in patients.
Delays In FDA Review Of Postmarket Studies
In a second study performed by Pew Charitable Trusts, researchers also found that the FDA was slow to follow up with implant manufacturers regarding postmarket studies. These studies, which are mandatory, are typically carried out to make sure that a medical device or implant is functioning safely once it is approved.
Pew looked at 223 after-market studies performed between 2005 and 2011. Researchers found that, not only are the studies delayed, they are generally inefficient. Out of the 223 studies performed, just one device was removed from the market and 31 high-risk implants required labeling changes.
In many cases, the FDA waited six months or longer before pursuing information about a device’s performance after approval was granted. These delays can make it difficult for physicians and patients to become aware of adverse effects and defects associated with a particular implant.
This lack of FDA oversight can be frustrating for patients who have experienced health complications due to a defective or dangerous medical device. If you have been harmed by a defective medical implant, don’t delay – speak to a personal injury attorney as soon as possible.