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"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." 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