Medical Devices

Medical Devices Largely Unregulated, Recent Analysis Finds

Medical DevicesImplanted medical devices are increasingly commonplace in the modern world. In fact, approximately one in ten Americans have at least one medical device implanted in them, including artificial joints, cardiac stents, pacemakers, defibrillators, nerve stimulators, surgical mesh, replacement eye lenses, heart valves, and birth control. With medical devices so frequently in use, and with the potential risk of health complications, one might imagine that they would have undergone rigorous safety testing before entering the marketplace. A recent analysis in the New York Times, however, found quite the opposite: the medical device industry remains largely unregulated by the federal government.

Third-Leading Cause of Death

Roughly 32 million Americans, or about ten percent of the population, have implanted medical devices. While these devices help millions of people and even save lives, many of them have proved harmful to patients’ health.

In fact, medical interventions are now the third-leading cause of death in the United States, with medical devices playing a significant part in that statistic. Nevertheless, the majority of medical devices undergo little or no safety testing before entering the marketplace.

Shorter Approval Process than Drugs

The Food and Drug Administration (FDA) is the federal agency tasked with regulating drugs and medical devices. Before they are released to the marketplace, drugs have to undergo a lengthy approval process to determine whether they are safe for patients to take. This process usually calls for two randomized, controlled clinical trials.

Medical devices, on the other hand, have a much weaker standard for approval – some would say virtually no standard, with most undergoing no clinical testing.

Regulatory Loopholes Widespread

The FDA first gained regulatory control over medical devices in 1976. At that time, the agency grandfathered in all medical devices that were already on the market under a provision known as 510(k). This rule allows manufacturers to sell most new medical devices without required clinical testing as long as the manufacturer claims that the new device is “substantially equivalent” to a device that already exists.

In addition to utilizing the 510(k) loophole, manufacturers may also avoid clinical testing through the “supplement pathway,” by which they inform the FDA that they simply made minor changes to a previously approved device.

The use of such regulatory loopholes to avoid clinical testing is widespread. For example, one 2009 study in the Journal of the American Medical Association found that only five percent of high-risk implanted cardiac devices even partly met the standard for drug testing.

Tested Devices with Known Dangers Approved

Even medical devices that have undergone clinical testing have been approved despite dangers uncovered during the testing process.

In 1997, a vagus nerve stimulator made by the company Cyberonics to treat epilepsy underwent FDA-monitored clinical trials. Following these trials, an FDA advisor “voiced concerns” about the high death rate noted in patients with the device. Despite this high rate of mortality, the FDA still awarded the device “conditional approval,” meaning that Cyberonics was required to conduct safety studies after it went to market.

However, Cyberonics was not required to inform patients that there were known concerns about the product’s death rate or that they were effectively serving as test subjects in a clinical trial. And when Cyberonics finally released five studies to the FDA that the company claimed proved the product’s safety, none of these studies included any death data, a curious omission that the FDA nevertheless defended.

Recalls of Medical Devices Skyrocketing

The lax approval process for medical devices, which allows for unsafe or unproven medical devices in the marketplace, may have caused product recalls to skyrocket in recent years.

In 2003, the FDA announced eight Class 1 device recalls, which are defined as recalls in which there is a “reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, by contrast, there were 117 Class 1 device recalls, affecting hundreds of thousands of patients.

Medical Device Lawsuits

Given the system in place, it is perhaps unsurprising that there have been multiple high-profile lawsuits against the manufacturers of dangerous medical devices.

To consider only one recent example, more than 9,000 patients have filed suit against Johnson & Johnson over harms caused by the company’s ASR XL and Pinnacle metal-on-metal hip implants, which were taken off the market in 2010 and 2013, respectively. On November 16, 2017, six New York plaintiffs were awarded a trial verdict of $247 million from the company for damages resulting from the implantation of the devices and for its failure to warn doctors and patients about their dangers.

Placing Profits Over Safety

Critics of the FDA argue that the agency is placing company profits over patient safety and that a change in the process of appointing FDA commissioners has made the agency too “business friendly.” Prior to 1988, FDA commissioners were career civil servants. President Ronald Reagan changed them to political appointees. With rare exceptions, presidents have been appointing commissioners favorable to the industry ever since.

This trend extends to the present moment. President Trump’s appointees to head the Department of Health and Human Services and the FDA have been advocates of deregulation who argue that it is necessary to speed “lifesaving” medical devices to market. Critics, however, counter that such faith in a deregulated medical device industry is misplaced, ignoring ample evidence to the contrary and putting the health of the public at risk.