When a doctor prescribes a medicine to a patient in Massachusetts, the patient often asks a number of questions about the side effects of the drug and how it can impact their life. This is despite the fact that medicine is often thoroughly tested in humans and tightly regulated by the Food and Drug Administration. In order to be approved, manufacturers need to compile data and get approval from a panel of FDA scientists. Only then does a medicine go on the market and even then people are highly skeptical of it.
The same skepticism does not exist when it comes to medical devices, however, and this discrepancy is one pointed out by a Netflix documentary focusing on medical errors and surgical mistakes. Titled “The Bleeding Edge,” the documentary highlights the lack of regulation on medical devices in the industry. To be approved, a device only needs to be comparable to one already available in the market, even if the compared device is being recalled.
The documentary profiles a few people whose medical experienced have gone awry, including that of an orthopedic doctor himself. After developing a tremor, he found himself having major psychological issues including writing on the walls of a conference hall using soap as ink. He found elevated levels of cobalt in his urine and blood — metal sludge was seeping from his metal-on-metal hip replacement. He had the device removed and was soon stable. Another commonly used medical implant, a coiled birth control implant, was shown in the film to have caused unintended pregnancies, bleeding and persistent pain. Its manufacturers have claimed they will stop selling the product by the end of this year because of misleading publicity about it.
Asking questions about the medical device, its necessity and its possible side effects are important steps patients should take when visiting their doctors. A surgical mistake or error can give rise to a medical malpractice suit that, if successful, could provide compensation to cover medical costs associated with a worsened medical condition.