The growing of Netflix is enormous from Oscars to unearthed and proclaim real world truth in the form documentary. The documentary called ‘The Bleeding Edge’ unveil the industry back door to get the product approved leading to catastrophic impact on patients body.
USA remains one of the growing markets in the world. As per Moody’s report, the medical device industry should see a standout year in 2019.
A film by Kirby Dick and Amy Ziering, that shows how big the industry with 300 billion-a-year industry which is somewhat parallel to the drug industry. The film also showed that the over the past 10 years, nearly 70 million American have been implanted with medical devices.
A quote from the documentary explain the importance of medical device “Before you born, they use the medical devices to find out when you’re gonna be born. When you’re born, they use medical devices to find out how healthy you are. Medical Devices are a way of life. People think pharma’s got power. But the device industry has more power than pharma.”
“A wide range of people know about the problems with pharmaceuticals, but very few people know about the medical device industry and the fact that it is even less regulated than pharmaceuticals,” director Kirby Dick told the Guardian. “We felt it was very important that the public, doctors and policymakers know about this because right now medical device companies can get away with just about anything.”
The devices profiled in this documentary have showed unknown effects to patients which is the completely different scenario from the results of clinical trials. The device like Essure, metal-on-metal cobalt hip replacement, hernia mesh and the famous Da vinci system.
It highlights the major problem of FDA 510(k) pathway and how most moderate and high-risk devices are skipping the necessary norms and regulation. The FDA 510(k) process came into existence after industry argues about the innovation they bringing to products every year is costing more money to test in humans. Hence, the govt came up with the solution 510(k) process.
A 510(k) or premarket notification, is one of the major pathways for bringing device to market and it is referred to as a 510(k) is because it actually refers to the section 510(k) of the Federal Food, Drug and Cosmetic Act. Class I devices (low risk) are exempt from the premarket notification process, class 2 (moderate risk) and class 3 (high risk) basically move for premarket notification.
The problem arises with “Substantial Equivalence” means any new device that is similar to the predicate device or product that is already available in market with same technology, intended use does not require any approval.
Dr. David Kessler Former FDA Commissioner, 1990-1997 said in the documentary that, “That provision which was meant as an exception, in essence, a little loopholes. Moreover, that exception became the major rule. Hence, the vast majority of the devices today, regrettably, regulated under 510 (k) pathway”. The sad part is even the device are recalled, such device too can be applied under substantial equivalence.
Dr. Stephen, orthopaedic surgeon who underwent hip replacement of metal-on-metal of Depuy Synthes (company of Johnson and Johnson) faced several psychological and health issue like tremor, memory and similar symptoms of Alzheimer’s and Parkinson. He explains how an orthopaedic implant is causing neurologic problems, and later when the hip was redone and choosing a different model of plastic – ceramic head, all symptoms were magically disappeared. He started to notice similar problem with his own patients, and it’s not just metal-on-metal but metal-on-plastics, too. Till this date, the industry still recommend hips containing cobalt and more than ten million people who currently have hips, knees and shoulder with cobalt.
Experts also commented that event FDA PMA that is the most rigid and tough pathway to get a product approved, is less rigorous than the process of drugs. With one study and less patient number riskier the device safety and efficacy statement.
After the release of the movie, Bayer has stopped selling Essure in the US at the end of 2018.
Key take away from this documentary: