Of all medical devices, according to an article by the Consumers Union, cardiac devices dominate the list of reports to the U.S. Food and Drug Administration of deaths and injuries.
The report spotlights IVC filters, which are placed in the vessel that returns blood from the lower body to the heart to prevent pulmonary embolism — a life-threatening condition caused by blood clots breaking loose and traveling to the lungs. According to the report, about 200,000 people get the filters implanted each year.
Although many filters should be removed once the danger of clots has passed, they often aren’t. The report cites a study published in Nov., 2010, in the Archives of Internal Medicine, in which Pennsylvania researchers found that pieces of the Bard Recovery filter had broken off and migrated elsewhere in the body in 25 percent of the study patients. One patient needed open-heart surgery as a result.
In an article accompanying the reported results of that study, cardiologist Rita Redberg, M.D., of the University of California, San Francisco, wrote that the FDA classified the filters as “Class II,” the same risk category as mercury thermometers, and approved them without any clinical data of safety and effectiveness.
The report quotes Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, as saying: “The devices were being used inconsistent with their FDA clearance. We don’t have authority to do something about that.”
Consumer’s Union notes that tens of millions of Americans live with medical devices implanted in their bodies, and most of them probably assume those devices were tested for safety and effectiveness. But that’s rarely the case.
Most implants and other high-risk devices make it onto the market after their manufacturers have done nothing more than filing paperwork and paying the FDA a user fee of roughly $4,000.
“Often, the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients,” the report states.
If you’ve received an IVC filter, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a IVC filter lawyer to discuss your legal rights.
See the report here:
