A gaping loophole in the laws that govern the testing of medical devices may be causing deaths and injuries across the nation.
According to a report by Consumer Reports and another report by CBS news, the recipients of hip replacement implants are suffering conditions that result from defective products and lax testing requirements. In a report by Dr. Steven Nissen of the Cleveland Clinic, cited in the CBS report, almost 3,000 people died in 2006 because of the faulty devices.
The implants mentioned in the CBS article are manufactured by DePuy; artificial hips that are made completely out of metal. These hips were recalled, totaling 93,000 of the devices and causing some people to go through the same painful surgery that they had endured to replace their hips twice. The threat from these devices is particularly disturbing.
Metal in the Blood
The recalled DePuy hips are believed to cause metal fragments to pass into the bloodstream. These metal fragments can cause problems with the eye, can increase the risk of cancer and cause problems with hearing, according to the CBS report. There are other issues that are believed to be caused by these implants, as well, and doctors and consumer advocates are concerned.
The Testing Isn’t There
According to the Consumer Reports writer cited in the CBS article, FDA approval may not ensure that these devices are entirely safe. She said that loopholes allow the manufacturers to get their devices approved without any real testing. If the device is somehow similar to another device that was approved, the new device can be grandfathered in an immediately approved with no human testing done at all.
Pain and Suffering
Any surgery is dangerous and potentially deadly. The patients who were implanted with these devices may find themselves needing more painful and dangerous procedures due to having been implanted with a faulty device.
If you’ve been implanted with a device that has proven defective, consider contacting a medical implant attorney. Sometimes, there are class action suits filed over these cases and sometimes these cases are handled individually. Either way, the civil courts provide you with a way to seek material compensation for what you’ve been put through. If you’re suffering due to an implant that wasn’t tested and that has proven to be a threat to your health, it’s important to act soon so that you don’t miss the time limitation on these lawsuits.