Netflix is now showing a new documentary which might qualify for some as a horror film. The movie, entitled The Bleeding Edge, takes a closer look at the medical device industry. Medical devices can include anything from birth control implants, to knee and hip replacements, to pacemakers. The documentary is not comforting to anyone who has, or is considering getting an implant of any kind to improve their health.
Regulation And Its Limitations
Businesses in the pharmaceutical industry regularly complain about the expense and difficulty involved in getting a new drug approved. That complaining hardly seems justified, as there has been no shortage of drugs pulled off the shelves after patients discovered new, sometimes deadly side effects. The regulation of new medicines is far from foolproof. Unfortunately, it is also far superior to the regulation of medical devices.
Getting a new device into the market is relatively simple. Any device manufacturer can gain approval by demonstrating that their new tool is equivalent to any other device that has already been approved. This can easily allow devices made of substandard materials or carrying non-obvious design flaws to reach patients. These patients assume they are getting a fully tested, reliable device, but in truth they are acting as lab rats for a completely unproved technology.
Defective products of all kinds can lead to serious injuries. Defective medical products carry perhaps the greatest potential of all to hurt consumers. The luckiest recipients of a defective device will likely still need to undergo additional surgery to remove the implant. The less fortunate could suffer a host of traumatic injuries and even death, depending on how the device in question fails. Given the severity of the problem, it is fair to question the current regulatory practices in place for medical devices.