Do not think that the medical device–be it an artificial hip, a pacemaker or mesh–your doctor proposes to implant is safe because the Food and Drug Administration (FDA) has approved its use. As I’ve written before on Just Care, there is a fair chance that you could be at serious risk. Fred Schulte reports for Kaiser Health News on the 28,000 lawsuits against medical device companies for selling faulty products, misleading providers about their products, failing to disclose product defects as required by law, paying physicians illegal kickbacks, and more.
You rarely read or hear about medical device companies, but many are multi-billion dollar businesses. Like pharmaceutical companies, they are operating in a health care market that allows them to charge exorbitant prices for products that sometimes add little value or worse, cause serious harm. Despite the need for a more stringent FDA approval process of certain devices and a registry to ensure awareness of dangerous medical devices, the industry has done a brilliant job of keeping this from happening.
One reason dangerous devices are in use lies with the FDA’s approval procedures. It allows medical device companies to design and distribute many new devices without testing. If they are substantially equivalent to another product already approved, they do not need to go through an approval process. But, the line between substantially equivalent and different enough as to be defective is blurry.
It’s also often hard to know whether a device is safe even though there is a public database that is supposed to store information about faulty medical devices. The problem lies with the FDA, which also keeps a private database of information on medical device malfunctions and injuries that for some reason it does not deem fit for the public database. It literally keeps hundreds of thousands of incident reports secret. Consequently, doctors keep using these dangerous devices–artificial hips, pacemakers, mesh, etc.–on unsuspecting patients.
And, physicians often rely on medical device salespeople when implanting a device. They often work in tandem with medical device salespeople to learn about them. While that might make sense in theory, it can be harmful to patients if the physician is not super sure of what he or she is doing. The sales reps are not legally required to have medical training or credentials.
In one case, a surgeon relied on a Life Spine rep’s assurance that the surgeon would have the implants he needed mid-surgery to address a spinal issue, but he did not. The patient is claiming that, as a result, the surgeon implanted the wrong device and she suffered physical harm. Meanwhile, Life Spine, the sales rep and the surgeon are pointing fingers at one another, refusing to take responsibility for the harm.
It’s still not possible to do the needed research to determine the frequency with which implants cause harm or which implants are dangerous. It’s also not possible to know which implants are the safest. A public FDA website at which reports of serious injuries from a medical device are posted has the following caveat: It could include “incomplete, inaccurate, untimely, unverified, or biased data.”
Now, six multi-district federal cases have consolidated the more than 28,000 patient suits charging that medical devices caused injuries. For the health and safety of Americans, the federal government should be putting in place a smart and wholly transparent way to track injuries, a more robust approval process for devices, and a means of removing defective products from the market swiftly.
Here’s more from Just Care: