Medical implants were meant to save lives. Now the FDA might have to stop them

Even those with the most basic knowledge of the pharmaceutical industry know that clinical trials are vitally important. No one would want to take medicine that hadn’t passed rigorous safety tests. Yet a recent investigation from The Guardian found that a staggering number of medical implants hit the market without proper testing, and in some cases without any kind of clinical trial at all.

The consequences have been disastrous. 83,000 patients have died in the US, 1,004 in the UK. Millions more have suffered harm. The FDA is already moving to tighten its approval process, but for many the damage has already been done.

What went wrong?

Vocal critics of “Big Pharma” have been prominent throughout the 21st century. In the US, particularly, pharmaceutical companies are often seen as preying on the vulnerable to make astronomical profits. This perception is not unfounded; the opioid epidemic—which takes approximately 115 lives every day across America—was driven in part by pharmaceuticals firms aggressively marketing OxyContin despite the clear risks posed by overprescription.

In the US, then, the faulty implant crisis could be seen as an extension of this “profit over people” business model. But the problem goes further than this. It’s not simply a case of these devices’ manufacturers trying hard to sell the implants. To return to the opioid analogy, OxyContin can be safe when prescribed reasonably, but these devices cannot. For manufacturers to even reach the point of overmarketing, they have to get their products on the market. So this is about more than Big Pharma. This is about regulatory bodies.

Since 2008, the FDA has allowed faulty spinal-cord stimulators to create 80,000 injuries, and faulty insulin pumps and hip replacements have caused even more. Responding to an Associated Press report on these findings, the FDA said, “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market.” This statement may come as a surprise to those who thought the purpose of the FDA’s testing was exactly that.

Without insider knowledge of regulatory practices (which are often kept a secret on both sides of the pond), it is difficult to determine exactly how so many dangerous implants slipped through the apparently cavernous cracks. The Guardian report, however, quotes a German MEP pointing towards lobbying in the industry as a possible cause. Manufacturers lobby governments to make sure regulations are to their liking. Perhaps this is what led to such lax testing standards. Either way, it’s clear that something needs to change.

Can new reforms make a difference?

Along with the above statement, the FDA promised to overhaul its 40-year-old regulatory practices. Currently, manufacturers can gain accelerated approval for new devices if they can show that they are based on older technology. Under the new system, this will only apply for devices which are based upon tech that is no more than 10 years old. Though this does sound like a step in the right direction, perhaps abolishing the accelerated approval track altogether would allow for more careful consideration before any potentially dangerous devices hit the market.

The EU is due to introduce rules making it tougher for medical devices to get approval in 2020. Whether or not they are effective, reforms like these have come far too late for those who have already fallen victim to one of these oversights. Many have had to take manufacturers to court in order to win damages as compensation—often used to pay for medical bills stemming from the very problems faulty implants caused in the first place. Nova Legal Funding has set up a service to provide lawsuit funding against defective medical devices, specifically helping out victims in the US who need money to take their cases forward.

As these new laws come into effect, those who need implants in the future can only hope that they have an impact. Otherwise, the courts could be flooded with faulty implant lawsuits, and patients might continue to miss out on the care they need.

This article does not necessarily reflect the opinions of the editors or management of EconoTimes.