Medical devices need more FDA oversight to protect public from injury

 Medical devices need more FDA oversight to protect public from injuryAs an orthopedic surgeon specializing in complex hip replacements, Stephen Tower knew enough about the devices to ask his own surgeon specifically for a metal-on-metal hip implant called the ASR XL, made by Johnson & Johnson subsidiary DePuy Orthopaedics, when he was due for hip replacement surgery. The newly approved medical device appeared to be more durable and longer lasting than traditional implants made from other materials.

But five years after his surgery, Tower was in so much pain that he underwent revision surgery to remove and replace his device. When his surgeon cut into his hip, he found a mess. The cobalt and other metals from the device had leached into his bloodstream. The tissue surrounding the implant was black from damage to nearby muscle, tendons and ligaments, a condition called metallosis. The heavy metals from the device were coursing through his body, including his heart and brain.

Tower warned his colleagues about the defect with the metal-on-metal hip implant, and even warned Johnson & Johnson. But the company continued to market the device, ultimately withdrawing the ASR XL model in 2010 citing slow sales. But it continued to sell a similar brand, which proved to be just as problematic.

Tower’s case highlights the need for closer oversight of medical devices, according to Jeanne Lenzer, in an opinion piece published in the New York Times. She is author of “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.”

Tower’s hip implant was approved by the Food and Drug Administration (FDA), a rating that many people assume means a device has been shown through testing to be safe and effective. But most high-risk medical devices on the market, including hip implants, have not been clinically tested. That’s because medical devices did not fall under regulatory control by the FDA until 1976. At that time, devices already on the market were grandfathered in. New devices that followed did not require clinical testing if they were “substantially equivalent” to an existing device.

This has resulted in catastrophic consequences to patients, not only recipients of metal-on-metal hip implants, but other types of devices as well, from contraceptive IUDs to heart defibrillators to anti-epileptic stimulators.

Lenzer says one step toward better protecting the public is to return to a system in which the FDA commissioners are civil servants. In 1988, she said, President Ronald Reagan changed the position of FDA commissioner from a civil servant to a political appointee.

But this step “needs to be the first of many,” she says. “As a government agency, the FDA is supposed to serve as a bulwark between corporate profiteering and the public welfare. Its continued allowance of regulation loopholes … despite the significant demonstrated cost to public welfare, calls into serious question the agency’s fulfillment of its stated mission to protect public health by ensuring safety, efficacy and security.”

Source: New York Times