Netflix recently released a documentary, called The Bleeding Edge, which exposes some aspects of the medical device industry. The main purpose of the film was to call out the U.S. Food and Drug Administration (FDA) for being lax about what devices hit the U.S. market. Doctors and patients alike participated in highly-personal interviews, describing their frightening and sometimes devastating experiences.
Cobalt-based hip replacements, robotic surgery devices and vaginal mesh were all problematic medical devices that fell into the spotlight. These devices failed their human carrier immensely, yet remained on the American market.
Medical devices do fail. It’s the risk of technology. However, the major concern centers around supposed loopholes companies jump through when going through the FDA.
Have FDA regulations become lax?
The FDA plays a crucial role – if not the only role – in controlling what enters the market and our bodies. The FDA’s system requires new devices go through a pre-market approval process and thorough clinical testing. It’s questioned if the regulations are really keeping up with new technology, or even enforced.
Spreading awareness and making changes
Since the film, awareness has expanded and policies are starting to change. It’s an important reminder that problems will keep occurring unless the people who are harmed tell their story.
Unfortunately, sometimes even doctors don’t fully know the dangers of some medical devices. Additionally, it’s impossible for patients to be all-knowing of the medical devices they utilize.
It’s up to companies to ensure their devices go through trials and testing. At this time, it’s important that people advocate for themselves. Research the devices, look to social media for authentic reviews and ask questions. If you are harmed by a faulty product, it may be time to fight for justice.