A Netflix documentary shares certain dangers that have been found within the $400 billion-dollar medical device industry, where they have existed for decades.
The documentary looks at industry products, including robotic surgeons and hip implants, which have negatively impacted the lives of thousands of patients for years.
What many are unaware of is that the medical device industry is not as regulated as the oft-criticized pharmaceutical industry. The film director explained that currently, it seems that the medical device industry is able to get away with just about anything – especially because the risks of the industry are not commonly known to the general public.
While these devices are a progressive means of aid, intended to move along production within the medical industry, many of them continue to do more harm than good.
Patients have shared horror stories, including those from female patients whose intestines reportedly fell out of their bodies after receiving robotic surgery.
In the film, an orthopedic physician had begun experiencing a tremor, difficulty thinking, and was in the midst of a mental health crisis, though no one around him could seem to figure out why. After studying himself, he found that his body continued a much higher level of cobalt than is normal.
Cobalt, a metal that is found in rechargeable batteries, was in fact more than one hundred times higher in his blood stream than it should have been.
Thinking that it could potentially be related to his metal-on-metal hip replacement, he had the surgery redone. While being operated on, his surgeon discovered that there was metal sludge that had been seeping out of the device. Less than a month later, his psychological symptoms had greatly improved.
The discovery was a shock for the physician, who never knew that his temporary poor mental health could be the result of an orthopedic device. He now tests the cobalt level of his patients, should they begin to exhibit or complain of specific symptoms.
According to a 2012 joint investigation by the British Medical Journal and BBC Newsnight, it appears that he was not alone. Hundreds of thousands of patients have been exposed to high levels of toxic metals from metal-on-metal hip implants.
For the film’s producer, the best benefit and hope for its viewers is that they be much more aware of information and research surrounding medical devices.
While the approval of prescription drugs often hinges on their testing on humans, compiled data, effects compiled by manufacturers, and final approval by FDA scientists, medical devices are not subject to anything of even remote similarity.
All that is required for manufacturers is a demonstration that their device is the same as another device already on the market; however, this does not matter if the comparison-product has been recalled.
After just one week of the film being released, it had a very real impact on manufacturers. By the end of 2018, Bayer has already committed to stopping its sale of Essure, a type of birth control implant that was featured in the film, which has been known to cause negative health consequences.
If you or a loved one in has been injured by a defective medical device, you may be entitled to compensation. A Pennsylvania defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler has the experience to help you. Call 215-569-4000 or contact us online for a free consultation.