When Dr. Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was asking for, but what he knew wasn’t enough to protect him from a defect in the device.
Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.
Johnson & Johnson withdrew the ASR XL model from the market in 2010, but continued to sell another similarly problematic model, the Pinnacle, until 2013.
More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.
About 32 million Americans, or about one in 10, have at least one medical device implanted – from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.
Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.
Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.
Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.
With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.