FDA Approval of Devices Scrutinized

One of the country’s most respected consumer organizations is calling for changes in the way the FDA approves and monitors medical devices. According to the president of Consumer Reports, “The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.”
Devices include artificial hips, stents for arteries (pictured), surgical mesh, heart valves and pacemakers among others. Approximately 700 products are recalled every year due to complications. Part of the problem is that 90 percent of such devices are not tested rigorously, if at all, before FDA approval. Many products don’t go through clinical trials because the manufacturers use a loophole in the law to claim that they are similar to products already on the market. The highly respected Institute of Medicine has described the current system as fatally flawed. Several members of Congress are calling for hearings, which may ultimately lead to a revision in the regulation.