In recent years, Nashville area residents have been involved in some high-profile medical device recalls. From defective hip implants to infusion pumps, there have been numerous products that have made it into the medical marketplace and gone on to be implanted in patients only to be recalled. Many patients then have had to undergo surgeries to remove the dangerous devices.
Medical device recalls are on the rise, according to the U.S. Food and Drug Administration. From 2003 to 2012, the total number of safety-related medical device recalls almost doubled. Class 1 recalls, those that involve the most dangerous devices, increased tremendously during that time period. Just 1 percent of the recalls issued during 2003 were Class 1 recalls, and by 2012 this number soared to 5 percent.
However, the increase in Class 1 recalls is due at least in part to the FDA's focus on improving certain devices that have historically been problematic--such as ventilators and infusion pumps. The medical device industry has also focused efforts on this area.
For example, in some cases a recall may not necessarily be issued because a device is failing or defective, but because the FDA or device manufacturer has learned of a way to improve the device and prevent negative outcomes.
Nonetheless, the statistics that the FDA has reported are still troubling. The rise in the frequency of recalls does mean that there are far too many people here in Tennessee and across the country who may have suffered injuries due to dangerous medical devices. It is critical for medical device companies, as well as the FDA, to catch patient safety problems before these devices are prescribed.
When people are harmed as the result of a dangerous medical device, they may not know where to turn. It is important to seek legal counsel if you are involved in a medical device recall. It may be important to hold the medical device company accountable for product liability, and this can result in compensation for your medical expenses and injuries and other damages.