Millions of people in the United States have some kind of medical implant, whether it be a surgical mesh or an artificial joint, such as a hip replacement.
Recently, several medical implants have been scrutinized by researchers who released their reports on these devices in the Journal of the American Medical Association (JAMA). According to their studies, the majority of medical implants do not receive enough testing before they are placed in people’s bodies.
Looking for further evidence to support these claims? Johnson & Johnson and its DePuy unit, which manufactured the metal on metal hip implants, were hit with a guilty verdict and ordered to pay in excess of $500 million to impacted patients.
Johnson & Johnson was forced to stop manufacturing these parts after patients experienced serious complications, including tissue death, bone erosion, and dangerously high levels of metal in their vascular systems.
In 2013, DePuy paid $2.5 billion to settle over 7,000 lawsuits related to its defective metal on hip implants.
How could this happen in a country where medical implant manufacturers are required to obtain approval from the Food and Drug Administration (FDA) before selling their products to the public?
According to researchers, the problem is that many of these devices are not put through enough rigorous testing before they make it to operating rooms.
Troubling Lack of Safety Information
The JAMA study took a look at 50 new medical implants that included, among other types of devices, hip replacements, and surgical mesh. Medical researchers conducted a thorough review of all the applications turned over to the FDA from the manufacturers of these devices.
In a four-year time span, just eight out of 50 applications included sufficient data about the devices’ safety. Shockingly, the FDA issued approval for every single application, which meant all 50 devices were approved for use in humans.
Delays in FDA Review of Postmarket Studies
In another study conducted by Pew Charitable Trusts, scientists also discovered that the FDA lagged when it came to following up with implant manufacturers about postmarket studies.
Postmarket studies are mandatory and are usually performed to ensure that any kind of medical device or implant that received FDA approval is actually performing safely. Learn more about this study here.
Pew researchers considered 223 after-market studies conducted between 2005 and 2011. Disturbingly, researchers learned that not only are the studies not performed on time, they are usually performed inefficiently.
Out of the 223 studies analyzed, just one resulted in the removal of a medical device from the market. An additional 31 after-market studies required manufacturers of high-risk implants to change their labels.
In several cases, the FDA delayed six months or more before asking for information about a device’s performance after the manufacturer was granted approval.
These delays can make it almost impossible for doctors and consumers to learn about negative side effects and defects before moving forward with a surgery to install an implant or medical device.
Armed with that type of information, it is fair to say many doctors and patients would choose an alternative.
The Need for Medical Registries
Experts who reviewed Pew’s findings say that one way to fight back against these types of delays and lack of information is to require medical device registries. These registries would track negative outcomes in a single database.
Hip implants can last anywhere between 15 and 20 years, but only require two years of clinical data to gain FDA approval; therefore, implementing such registries could revolutionize the way doctors evaluate patients before deciding to go ahead with a hip implant.
Tracking how a device performs over the long-term could be instrumental in keeping people safe for decades. Although some registries already exist, there is not one centralized registry or methodology for collecting this type of data.
These failures to test and follow up are understandably frustrating for people who have been seriously injured by defective medical devices. In the DePuy metal on metal hip implant patients, knowledge about the defects and adverse health consequences could have helped them make faster decisions about possibly removing the implants.
Get Help Today from a West Palm Beach Personal Injury Lawyer
As West Palm Beach personal injury lawyers, we see hundreds of people who have suffered greatly due to defective hip replacements and other medical implants.
You may be entitled to compensation for your pain and suffering, lost wages, medical bills, and other expenses. By consulting with a lawyer, they can determine how to proceed with your case to maximize that compensation and best benefit you.
If you have been injured by a defective medical implant or other device, such as a hip implant, you should get in touch with a West Palm Beach personal injury lawyer as soon as possible.
A delay could hurt your case and prevent you from getting the compensation you deserve. As these cases continue to come forward, it is important to act quickly.