In today’s society, we are all so obsessed with keeping up with what’s new. We all try to keep up even if our lives depend on it. In recent years, there has been an increase of medical “innovations” that actually may do more harm than help. The medical industry is evolving too quickly for its own good and the Food and Drug Administration (which is supposed to regulate approval of medical devices) isn’t making the situation any better. The former commissioner of the FDA, David A. Kessler, has even stated that the FDA has “built a system that doesn’t work.”
The process of getting medical devices approved is a shady one. From the 1920s to the 1940s, there was a boom of medical devices being developed — most of which were fraudulent. It was not until 1976 (which is fairly recent) that the FDA gained control of regulating the approval of medical devices. In general, the process requires premarket approval which is not that strict, but it is in place to determine if the product is safe enough for commercial use. Premarket approval requires the submission of clinical trial data to prove that the device does not pose a threat to the health of potential patients. Most of these clinical trials are very short and small with some as small as only 50 people. Additionally, the trial participants are not followed up on for long. Therefore, long term effects of the devices are not properly assessed. The government did not want to spend too much money on testing devices that were already approved, so congress created the 510(k). The 510(k) allows any medical device that was approved prior to 1976 to stay on the market without testing. This inadvertently created a loophole — newly developed models that are designed similarly to the original untested device are now able to be approved without testing. Now, anything that is similar in design to the new untested device are able to be approved without testing, and it keeps happening and creates a vicious cycle. The scary part is that about 90% of medical devices on the market are approved via 510(k) while only 10% are approved via premarket approval. This means that most of the medical devices that have been recently approved are on the market have never been tested, but doctors still use them on patients.
Doctors still recommend these services even though they don’t have a clue if they are actually safe. Doctors are not even offered proper training on how to use the new devices. They are often shown a video on how to do the procedure and are further informed by the sales rep from the company. These sales reps are not doctors, but they are the ones giving these doctors information. Most doctors try to do right by the patient by offering something new and better, but in reality they aren’t doing enough research. There is a system to report adverse effects of medical devices, but it is self-reported meaning the patient I has to report it. Most patients are not made aware of this. The FDA doesn’t even keep data, so they can recall and report issues to the manufacturers. When a manufacturer is aware of an issue with their device, only about 3-4% report the problem to the FDA. The more severe the adverse effects are, the less likely it is to be reported to the FDA. By the time a medical device is recalled it has been several months, years even, since the initial problem has been reported. In this time frame hundreds and thousands of other patients has already had procedures done involving these harmful medical devices.
Often hospitals and doctors are offered incentives to use new medical devices by the companies that develops these devices. It has been reported that the medical device industry has spent about $2 million in “grants” for hospitals that push procedures using their devices. That is a small price to pay for a $300 billion industry. Medical professionals are not the only ones who receive financial compensation for these questionable devices, FDA officials are as well. A lot of FDA officials own stock or some sort financial tie to these medical device manufacturers. Of course they’ll disregard public safety for their own personal gain. Who cares? It’s not like these companies are unaware of the adverse effects of their products they just don’t care. Some infamous medical devices that are known to cause problems (some of which are still on the market) include: Essure from Bayer Health, pelvic mesh from Johnson and Johnson and Attune from Depuy. All of the previous mentioned have resulted in devastating effects that changed people’s lives forever and all resulted from procedures for common health concerns.
Unfortunately, all this tells us is that medical professionals and government officials don’t always have the public’s best interest in mind. The next time you go to the doctors and you’re considering getting a procedure done, do your research. Do not be afraid to advocate for yourself because, if you don’t, who else will?