Students​: Kimberly Calero, Olivia Pennoyer, Roseline Simanjuntak Topics​: Legal & Medical Documentary​: the Bleed

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Students​: Kimberly Calero, Olivia Pennoyer, Roseline Simanjuntak Topics​: Legal & Medical Documentary​: the Bleed Students​: Kimberly Calero, Olivia Pennoyer, Roseline Simanjuntak Topics​: Legal & Medical Documentary​: The Bleeding Edge (2018) Section I. Genesis of Film- How it Came to Be The Bleeding Edge​ (2018), directed by two-time Academy Award winner Kirby Dick and co-produced by Emmy Award winner Amy Ziering, places the spotlight on the $400 billion dollar U.S. medical device industry and its lenient regulations (“About: The Medical Device Industry”). The film’s intent on uncovering deficiencies in a traditionally trusted system is not a new concept to either Dick or Ziering, who’ve both received critical acclaim for unearthing horrid secrets about other industries, like the scourge of unprosecuted rape within the U.S. military, ​The Invisible War​ (2012), and the problem of sexual assault among college campuses nationwide, ​The Hunting Ground​ (2015). This time, their endeavor is supported by the Shark Island Production company, an independent documentary company based in Sydney, Australia. The production company boasts a proud mission of “aim[ing] to educate, entertain, and make a significant social impact with [their] films” (​“Shark Island Productions: Documentary Production Company”).​ Known as “The Portfolio”, The Bleeding Edge​ is part of a consortium of other films created by teams of international filmmakers set with the intention to act as disruptors of the status quo (​“The Portfolio”).​ These films then receive support via long-term impact campaigns (focused in Australia) and access to a wide circle of film influencers to maximize influence and societal change. As with most films created by Dick and Ziering, they centered their focus on an area that no one else was talking about and brought that issue to the public. In an exclusive interview conducted by Zach Laws, Dick reveals it all began when numerous people reached out to them and told their horrible experiences with a variety of medical devices (​Laws, “Kirby Dick and Amy Ziering ('The 1 Bleeding Edge'): 'No One Is Told the Risks' of New Medical Devices’”).​ Then, once Dick and Ziering began to conduct their own research into the industry, they realized its associated problems were larger than they originally assumed and were told about. Both surprised and horrified about the truths they were learning, they spent the next two years simultaneously conducting research, interviewing victims, shooting, and editing to create the film. The Bleeding Edge ​first premiered at the Tribeca film festival on April 21, 2018 in New York as the “spotlight documentary” (​“The Bleeding Edge: Tribeca Film Festival”).​ Soon after, it was widely released on July 27, 2018. The film is only available on ​Netflix​, thus allowing it to be accessed by over 148 million paying subscribers worldwide alongside a large library of other popular films and TV shows. Featured with documentaries and dubbed as a “Netflix film”, it is also tagged with buzzwords such as “controversial” and “provocative,” thus drawing curious viewers with compelling marketing tactics and the allure of a dangerous, well-kept secret that will likely affect them eventually. Section II. Intent of Filmmaker(s) From the onset of film production, Dick and Ziering intended to create a cinematically compelling film that informed the public about the dangers of an industry that everyone was likely to come into contact with at some point in their lives. They hoped the film would create a baseline societal awareness about the issue, where people feel empowered to advocate for themselves and “ask the right questions” when they consider undergoing procedures. It was thus essential that the film presented accurate and accessible information to a large audience that encompassed society at large, policy makers, physicians, and people in the medical device industry. This suggests that Dick and Ziering wanted to not only increase knowledge about the deficiencies in the system, but also address the lax regulations and loopholes in the FDA medical device approval system via policy change. 2 In the same interview with Zach Laws, they confess that they “hope that in five years, [​The Bleeding Edge​] will put this issue on the map,” similar to how ​The Invisible War​ and ​The Hunting Ground​ helped usher the MeToo movement into fruition. They asserted that the same type of scrutiny society places on the pharmaceutical industry needs to be placed on the medical device industry. As a result, they hoped the film would inspire other filmmakers and journalists to “go into this territory and help change the landscape” about how society views the medical device industry. Section III. Methods Filmmaker(s) Used to Achieve Intentions The film portrays the monstrosity of the medical device industry through the provision of real-life cases of medical device installation failures. It creates parallel stories of the victims, including both surgical experts and commoners alike (e.g., the women affected by Essure), showing how poorly-tested medical devices have devastated people’s lives regardless of their backgrounds. This method stresses the urgency for collective action to discuss the adverse effects of medical devices approved by a lax regulatory system. The story about the hip replacement surgery of Dr. Stephen Tower (min 15:30), an orthopedic surgeon who experienced such medical failure, speaks to the lack of transparency about adverse effects of medical devices, even among experts.​ Although he uses medical language in his testimony, it is fairly understandable by the public in order to substantiate his reputation as both reliable, yet relatable. On the other hand, other doctors who are either apathetic or skeptical towards the maneuver are depicted as doubtful, inarticulate and distrustful towards science and evidence (min 52:38). The last doctor, whose cynical comments are screened extensively, is presented as an unprofessional figure through his lack of professional attire, which contrasts against Dr. Tower’s professional scrubs, neat 3 shirts or suits. Additionally, the high-angle shots used to film the cynical doctor made him appear small and vulnerable. This is opposite to the close-up shots used to film Dr. Tower, which establishes a more authoritative and trustworthy connection between the subject and the audience. Those juxtapositions skillfully encourage the audience to the side of medical professionals concerned for their patients’ safety. The story of Dr. Tower, and those of other victims, are also consistently developed in a systematic manner to add structure to the film. Each narration begins with the “normal-life” exposition of the victim in order to humanize and showcase their vulnerability. This is further emphasized by the presentation of the victims from different races and social statuses, which are either described verbally or elucidated through clips of their housing situations throughout the film. With each patient, the film presents commentary on the small discomforts they experienced that led to their decisions to install medical devices in their bodies. It then follows with visual representations of the medical procedures using 3D diagrams, actual surgical recordings, and photos. To bring each story together, it concludes with victims’ testimonies about how the surgical failures affected their professional and personal lives. By developing each story in a systematic manner, the storytelling feels more logical, while still managing to capture and hold the audience’s attention. The film also pits the viewer against FDA officials. It shows an FDA meeting that discusses the approval process of the Essure birth control implant (min 33:26), which depicts officials deliberately disregarding the possible adverse effects of the device raised. The film emphasizes that the FDA, the organization that is supposed to serve as the reliable protector of public health and safety, doesn’t care enough to ensure rigorous and comprehensive testing for newly invented devices. Thus, inserting the scene to into the film is meant to incite public reactionary protest; showing that indeed these problems 4 can happen to you anyone, including the viewer, because the FDA is capable of being so nonchalant and mockful with ​anyone​ and ​everyone’s​ safety. Section IV. Specific Outcomes After Film Release After the film’s release, viewers from across the globe praised the film’s brave and honest investigation into an often overlooked part of the corrupted healthcare system. The film received widespread critical acclaim, including a Peabody nomination (​“The Bleeding Edge”)​, the George Polk Award for Medical Reporting (Kilday, “'The Bleeding Edge' Doc Wins George Polk Award for Medical Reporting”), and a 100% rating on Rotten Tomatoes (​“The Bleeding Edge (2018)”). This recognition and support of ​The Bleeding Edge​ quickly led to changes in the medical device industry and a mobilization of patients, doctors, and concerned consumers. Essure, the controversial birth control device criticized harshly in the film, was pulled from the United States’s medical device market before the film even hit Netflix (“About: The Medical Device Industry”). Within a few months of the release, the Food and Drug Administration (FDA) also announced plans to redefine their device approval criteria (​Lim, “FDA Redefines 'Least Burdensome' as Critics Fear Chilling Effect on Reviewers”)​. More so, regulatory bodies in Australia, New Zealand, and the United Kingdom quickly banned vaginal mesh, another product scrutinized by the documentary (​“Vaginal Mesh Implants: Australia
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