Some women said the coils came loose, causing severe bleeding and the need for surgeries, including hysterectomies. Many of these women have banded together online in Facebook groups, and the documentary follows several of the women who have been affected. More than 16,000 lawsuits have been filed against Bayer over Essure, with women citing complications like migraines, hair loss, organ perforation and even unintended or dangerous pregnancies, according to. Just a week before Netflix released The Bleeding Edge, Bayer, the pharmaceutical company behind Essure-a controversial, permanent form of birth control that, when placed inside the fallopian tubes, creates scar tissue that prevents pregnancy-announced it was dropping the product. One of the devices targeted in the film for not undergoing enough pre-market testing or oversight has also recently come under fire. In June, the Trump administration released its proposed plans for an FDA reorganization, which would limit the agency’s purview, rather than expand it. The topic is a timely one, and there are signs that oversight is weakening even further. “ became the rule, so that the vast majority of devices today regrettably are regulated under this framework.” David Kessler, a former FDA commissioner, in The Bleeding Edge. “That provision, which was meant as an exception, in essence a loophole,” says Dr. The problem, the film argues, is that while that pathway was supposed to be an exception, it’s become a common way devices are approved for sale, and sometimes, it creates an approval chain of devices that are on the market without recent testing. To address that, a provision called the 510(k) pathway was created, whereby a manufacturer can also obtain approval if they can prove that their device is “substantially equivalent” to another device already on the market. Yet because so many new devices are brought to market, including new iterations of already approved devices, some medical companies argue that it’s too expensive to send each device through massive amounts of clinical testing. New devices are supposed to go through a pre-market approval process similar to a new drug, which requires that the device be tested in humans to show it’s both effective and safe. Their main concern is a loophole which allows many devices to reach the market without much clinical testing. Little has changed about the process since then, but the devices have: critics in The Bleeding Edge argue that medical devices today have become much more complex, and testing requirements haven’t evolved along with them. The FDA began regulating approvals for medical devices in 1976. However, medical devices often escape scrutiny on their path to the American market, the filmmakers say, and demand more research and testing than they currently have. It’s normal for medical devices to come with risks for adverse reactions, and it’s a physician’s responsibility to discuss those risks with their patients.
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