![]() ![]() The film explains that many devices aren’t even human tested anymore- due to a loophole that allows for ‘similar’ devices to get approved. Meanwhile, ‘Essure’ was not even marketed or tested properly on women. After going to a doctor’s visit, she was told that “because she was Latina” she naturally had heavier periods, and that nothing was wrong with her. Out of all of the people in the film, her story is one that stays with you because you realize nobody believes her or listens to her in the way that other upper-class white women were. Due to chronic bleeding and constant surgeries from the insertion of her ‘Essure’ device, she lost her job and eventually had to give up her children. Many women were affected by Essure, but what makes Ana’s case so tragic is her economic situation and how her health affected it. As there was no method created to take the device out, doctors trying to remove ‘Essure’ ended up breaking them inside the uterus. As explained in the documentary, ‘Essure’ was a device alternative to women who wanted to get their tubes tied (sterilization), however, it was untested and led to many horrible side effects such as chronic pain and bleeding. ![]() Ana Fuentes is a single mother with younger children who struggles to find employment after her ‘Essure’ device caused chronic bleeding. One of the survivors of malfunctions with their medical device in the film is named Ana Fuentes. ‘The Bleeding Edge’ then follows several different people and their experiences with medical device failure and then follows up with information about shady business practices at the FDA. #BLEEDING EDGE DOCUMENTARY MOVIE#The movie informs us that the medical device industry is incredibly lucrative- a 300 billion per year industry. One expert referred to medical devices (for example, pacemakers, cataract lenses, birth control implants, etc) as a “way of life in America” because of how widely used they are. Their seemingly favorite slogan, “innovation to improve and save lives”, is reiterated over and over again throughout their advertisements and meetings. ![]() The medical industry in the past 10-20 years has been evolving rapidly. ‘The Bleeding Edge’ begins by giving us insight into what the current medical device industry portrays themselves as. However, the documentary is not explicitly anti-doctor either, with an expert explaining, “it’s not the doctor’s job. (This documentary is biased in favor of the victims throughout the film, and critiques doctors who are in favor of putting new untested devices in patients for monetary gain. Directed by Kirby Dick, best known for the documentary: “The Hunting Ground” (2015) ‘The Bleeding Edge’ (2018) shows the life-altering reactions of thousands of people to some of the new industry’s devices, exposing how dangerous they are. Some women said the coils came loose, causing severe bleeding and the need for surgeries, including hysterectomies.‘The Bleeding Edge’, (a play-off of the saying: ‘the cutting edge’ as in the arrival of new technology) is a documentary that seeks to expose the medical device industry. 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. ![]()
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