"There is a system for reporting complications, but there’s tremendous underreporting because it’s a voluntary system," Kessler said. But the agency's Manufacturer and User Facility Device Experience (MAUDE) system, which houses adverse events for medical devices, is based on self-reporting. When there's a problem with a medical device, companies are required to report it to the FDA. They stated that their reported experiences with the permanent birth control device had been altered in the trial results, making the device appear safer than it is.Īnother issue is the reporting of medical device adverse events. ![]() The film illustrates this with the case of Essure by interviewing women who were a part of the clinical trial. In the film, it's suggested that manufacturers have an influence on the outcome or perception of the trials. ![]() However, 70 percent of biomedical research is funded by the manufacturer. With a PMA, medical devices are regarded as a new product and clinical testing is required. “It became the rule, so that the vast majority of devices today regrettably are regulated under this framework.” “That provision, which was meant as an exception, in essence, is a loophole,” Kessler said. But it can still be used as a basis to allow another device to enter the market. When a 510(k) process is used, the predicate device may have failed. Substantial equivalence indicates the devices don't need clinical testing. The vast majority of devices are approved through the 510(k) process, meaning they're regarded as substantially equivalent to other devices. “When it comes to medical devices, we built a system that doesn’t work,” Kessler said in "The Bleeding Edge." Medical devices are approved through two processes: a post-market approval (PMA) or a 510(k) clearance.ĭavid Kessler, the former FDA commissioner from 1990-1997, is a former agency staff member speaking out to highlight the issues in the regulatory process. Food and Drug Administration, with a dedicated division specifically intended to regulate the safety of medical devices. In 1976, the Medical Device Regulation Act, also known as Medical Device Amendments, ushered in the modern method of medical device regulation. The Bleeding Edge outlines the current system and shows how the outdated process doesn’t work well for medical device regulation. Medical Devices Are Poorly Tested and Regulated The film explores the under-representation of women in positions of authority and challenges what it means to be a powerful woman.Here are MedTruth's major takeaways from "The Bleeding Edge" documentary: 1. 5. Miss RepresentationĪs reported by IMDb, Miss Representation is all about the skewed portrayal of women in the media. Directed by Luis Lopez and Clay Tweel, the film follows the race to perfect and distribute this revolutionary tech. Print the LegendĪccording to IMDb, Print the Legend chronicles the rise of 3D printing technology. The film examines lackluster regulations, corporate deception, and the risks of certain advancing medical techniques. The Bleeding EdgeĪs told by IMDb, The Bleeding Edge investigates the repercussions of utilizing advanced technology in the medical field. The documentary includes interviews with various people involved in the leak, such as journalist Carole Cadwalladr and Brittany Kaiser, a former employee at Cambridge Analytica. The Great HackĪs reported by IMDb, The Great Hack delves into the Facebook–Cambridge Analytica data scandal, a data leak that allowed millions of Facebook users’ personal information to be harvested without their knowledge or consent. Icarus won an Academy Award for Best Documentary Feature. However, his partnership with a Russian scientist turns Fogel’s personal journey into a dangerous political quagmire. ![]() ![]() The film is invigorating, informative, and while you’re watching you get the sense that you’re skimming the surface of some very sinister waters.Īs reported by IMDb, the film follows filmmaker Bryan Fogel as he attempts to learn the truth about doping in sports. I cannot say enough good things about the investigative documentary Icarus. Here are 5 documentaries on Netflix that you can watch if you liked The Social Dilemma. If The Social Dilemma left you hankering to watch another great documentary, then look no further. A new documentary called The Social Dilemma premiered on Netflix earlier this month, and people can’t stop talking about it.Īs reported by IMDb, the film explores the rise of technology and social media in society and the potential consequences of its all-consuming popularity.
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