So-called “state–of–the–art” medical devices can kill just as swiftly as they heal. Faulty medical devices claim the lives of, at the very least, 3,000 Americans per year. And the scary thing is: In reality, that figure is likely much higher because many deaths caused by devices are never recorded as such. The most frustrating part? These deaths could be more easily avoided with better federal regulations.
Worse still, some of the less morally sound companies, like Johnson & Johnson, release products into the market that they know are defective. And consumers need not look far to find examples. Over 170,000 patients received J&J’s Hip Replacement® and many of those patients suffered blood poisoning as a result. Johnson & Johnson knew their hip replacement could cause such poisoning, but sold the product anyway. C.R. Bard, the manufacturers of faulty IVC filters, allegedly forged their FDA approval application altogether.
If one can’t really count on the billion-dollar corporations to provide the public with sound, safe, and reliable medical devices, who, then, can they count on?
You would think that the Food and Drug Administration (FDA) would have some air-tight processes in place for monitoring the risks of medical devices in order to avoid large-scale tragedies. But, in reality, that’s not the case. Instead, the federal regulatory system is outdated and ineffective. Why? Because as it stands now, the system largely depends on corporations self-reporting their own defective products to the FDA. But relying on the companies of Big Pharma to do anything other than serve their own financial gains can only lead to disappointing results.
Greedy Medical Companies Exploit Poor Regulations for Money – Example? Bayer’s Essure®
Without a quick system for tracking the risks of medical devices, the FDA bases its approval decisions on studies conducted and self-reported by manufacturers. Looking toward the recent news cycle for an example of how this can – and does – go wrong, one will find Bayer AG, the maker of the Essure® Birth Control System.
When it comes to Essure, the device has caused severe side effects in well over 27,000 women – a number that is likely still growing. Even before Essure was on the market, Bayer altered and downright falsified reports that were used to secure pre-market approval for the birth control device. Bayer’s researchers conducting the study asked patients how they felt while using the birth control system, and then, in preparing their reports for the FDA, literally crossed out the patients’ answers if they were “negative” in tone. In several cases, Bayer’s researchers wrote in entirely new answers that made the device seem safer.
Crossing out an answer with a pen seems like a pretty amateur way to commit fraud, and yet, it was enough to get Essure through the FDA and into the market. While pharmaceutical companies are the ones committing crimes, the FDA has also failed to regulate them.
The agency has admitted as much, describing the data it collects from manufacturers and institutions as potentially “incomplete, inaccurate, untimely, unverified or biased.”
When a federal regulatory agency admits that it is potentially failing its citizens in its own regulatory process, it’s pretty scary. And when it comes to drugs and medical devices – the actual, physical things that people put into their bodies to help them survive or improve their health? It’s downright frightening.
Better Record Keeping Can and Will Save Lives – Thousands of Them
When there’s no easy way for regulators to track the side effects of a product, medical device manufacturers can simply sweep patient deaths right under the rug. It’s all too easy for these companies to hide the risks of fatal products – even for years at a time.
C.R. Bard, the manufacturer of inferior vena cava (IVC) blood clot filters, did just that with its defective blood clot filters. First, Bard sold its Recovery filter for 3 years, despite knowing they had serious flaws. After the filter killed 30 people, Bard replaced it with the G2 series – not because the FDA forced it to, but to avoid bad press. The G2 filters were also defective, but Bard didn’t report this and sold the filter for 5 more years, killing 12 more people, injuring thousands, and making nearly $6 Billion in the process.
Had there been any way to more easily track which brand or model of filter was going into each patient, researchers might have more easily spotted the faulty product before it took 50 lives.
21st Century Solutions
One of the first big steps towards preventing tragedies like these is to include medical devices in a database known as The Sentinel Initiative. Made up of 18 major health organizations, the Sentinel Initiative has a huge pool of data, with files on 178 million Americans – more than half the entire population of the country.
Former Department of Health and Human Services Secretary, Mike Leavitt explained the initiative would "help monitor medical products throughout their entire life cycle” – or, in other words, track their use and side effects over time.
Such tracking is essential, but requires that medical devices be equipped with special identifying codes that aren’t currently required by the law. The good news is that health organizations, including the FDA, are working on a plan to introduce what they call Unique Device Identifiers (UDIs). These identifiers, alongside a project called the Medical Device Post-Market Surveillance System, may eventually provide the kind of information regulators need to keep patients safe.
The question is: How long will it take? Policymakers and health experts are in a frenzied debate about the high cost of these new systems, which will reach about $50 million a year. But, as health economist, Austin Frakt argues, if better data collection saves only 10 human lives a year, the systems will be worth it.
And Frakt is right. With any luck, such much-needed scrutiny would not only hold medical device manufacturers more accountable for the dangerous side effects of their faulty devices, it would also take the U.S. regulatory process out of the dark ages.