Medical devices sustain and improve the quality of life for millions of Americans. But as the over $100 billion-a-year industry pushes thousands of devices to market every year, reports of faulty devices, repeat surgeries, and recalls have increased. The FDA and the industry maintain that a speedy approval process gives patients faster access to life-saving devices. But critics say that unlike drugs, a substantial number of risky devices are cleared without clinical testing, and receive almost no oversight once on the market.
We've taken a closer look at four types of implantable medical devices that have drawn the most criticism.
Hundreds of thousands of people with advanced arthritis get total hip replacements each year, surgically replacing their hip joint with a prosthetic. Typically, implants are made up of a metal head that rotates inside a plastic cup. But in 2005, Johnson & Johnson's DePuy Orthopaedics introduced a new all-metal design. Maintaining that the new device was substantially equivalent to older models, DePuy got clearance for the hip device without conducting any clinical trials to test how it would perform in patient's bodies. The company was able to do that through an FDA process called 510(k), which doesn't require clinical data as long as manufacturers can show that their new device is "substantially equivalent" to one already on the market.
2009 Government Accountability Office Report on High-Risk Device Review Process
In the case of DePuy's hip implant, that testing began once the implants went to market.
According to the British Hip Society, the failure rate of the DePuy implant was so high that almost half of all patients who got the implant required surgery within six years to fix problems. The metal was eroding, releasing metallic particles into the blood and surrounding tissue of the joint and causing tremendous pain (the New York Times has an explanatory graphic of this failure.) After thousands of complaints and lawsuits, the device was recalled in 2010, after it had been implanted in almost 100,000 people. DePuy said the company continuously reviewed data about the hip implant while it was on the market, and initiated the recall as soon as new information confirmed a problem.
Last year the Institute of Medicine reviewed the clearance process for medical devices and called for the 510(k) process to be eliminated altogether because it could not guarantee safe devices. They found that from 2005 to 2009, three out of four recalled high-risk devices had not been approved with clinical data, but rather had gone through the 510(k) clearance process or had been exempt from review altogether.
2011 Institute of Medicine Statement on the 510(k) Clearance Process at 35 Years