“Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. (Products already on the market are known as “predicate devices.”) To placate the manufacturers, the FDA created the 510(k) premarket submission, which allowed manufacturers to skip PMA if they could prove the equivalency to a predicate device: Many claimed that their new products were “substantially equivalent” to products that were already on the market. The device manufacturers, however, fought back against the PMA process. There were many, MANY devices on the market before 1976, but those devices were grandfathered in, and could avoid PMA. It has been this way ever since 1976, when the FDA took over regulating medical devices. Class II devices fall somewhere in-between in terms of risk to the consumer. For risky devices (Class III), it could take years, and cost close to a hundred million dollars. For low-risk devices (Class I), this process may only last a few months. New medical devices, whether they’re new forms of tongue depressors or 3D-printed hands, must go through the FDA’s premarket approval, or PMA, process. A breakdown of the premarket approval (PMA) process vs. And much of that power resides in the loophole that is the 510(k) process. This is the group with more power than governments. The association’s goal is not to protect consumers or patients: it’s to get as many products approved as they can, as quickly as they can, in order to increase the profits of the companies they represent. They spent $3.6 million in lobbying efforts in 2017. By their own admittance, the group is dedicated to promoting policies which foster “ rapid product approvals” both here and abroad. Scott Whitaker, President and CEO of AdvaMedĪdvaMed is a medical device trade association – the largest in the world. “We have more power in this room, than most governments around the world.” If the movie teaches us anything, it is this: no one in the healthcare industry – not your doctors, not the FDA, not the medical device manufacturers – is looking out for you. It focuses on two separate issues: the dangerous medical devices that have led to tens of thousands of people across the country filing product liability lawsuits, and the Food & Drug Administration’s Premarket Notification 510(k) submission which allowed these devastating and deadly products to make it to market in the first place. The Bleeding Edge is one of those documentaries that could change the way we, as medical consumers, choose to protect our health. You might say that, since Bayer made its announcement a week before the film was released, that these two events are mere coincidence. On July 27, 2018, Netflix released a documentary titled The Bleeding Edge, a film about the $400 billion medical device industry – and which focused heavily on the women whose lives were ruined by Essure. On July 20, 2018, Bayer announced that it would finally stop selling Essure, a form of birth control that was supposed to cause permanent female sterilization, at the end of 2018.
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