11/3/2022 0 Comments Bleeding edge documentary![]() ![]() "The Bleeding Edge" filmmakers respond to Bayer: This does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device. The film also relies on many conflicted sources without disclosing their potential biases. BLEEDING EDGE DOCUMENTARY FULLThe film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the Food and Drug Administration’s (FDA) determination that Essure’s benefits outweigh its risks and disregarding the appropriate warnings that accompany the device. In contrast, the portrayal of Essure in The Bleeding Edge lacks scientific support, despite the fact that Bayer provided the producers with extensive scientific information on Essure before the completion of the film. Since that time, a number of large-scale studies have generated new data addressing many of FDA’s questions and provided further reassurance about the safety and efficacy of Essure.Īs a leader in women’s healthcare, Bayer believes strongly that women and their physicians should make reproductive health decisions based on sound science. After completing its review, FDA confirmed that the benefits outweigh the risks associated with the device, but did request a new study to evaluate the comparative risks of Essure and tubal ligation. In 2015, the FDA conducted a thorough review of the reports related to Essure and held an Advisory Committee meeting to discuss those reports. Such questions can only be answered through evidence-based medicine, including clinical trials and observational studies. While such reports can raise questions about potential issues with a product, they do not provide answers. It is important to understand, however, that anecdotal reports have limitations. The concerns raised about Essure are based primarily on anecdotal reports from individual patients. Over the last few years, Essure has been the subject of conversation on both social and mainstream media platforms. There is no reliable scientific evidence of any new safety issues related to Essure. Like all medical products, Essure use is associated with certain potential risks, which have been appropriately communicated in the label to doctors and patients. FDA also has maintained that Essure’s benefits outweigh any potential risks. The data demonstrates Essure’s positive safety profile as confirmed by highly respected medical organizations such as the American College of Obstetricians and Gynecologists. More than 40 studies, involving more than 200,000 women, have been conducted to evaluate the safety and efficacy of Essure. Essure has been on the market for more than 15 years and has been successfully used by hundreds of thousands of women.Īny effort to protect and promote women’s health must be rooted in science. Our decision was not based on concerns about the safety and efficacy of Essure. In recent years, however, the demand for Essure has decreased due to a number of factors, including decreased use of permanent contraception overall, the increasing popularity of long-acting, reversible birth control options, and inaccurate or misleading publicity about the device. Since its approval, Essure has been an important option for women seeking permanent birth control, offering a less invasive alternative to tubal ligation. According to a statement provided by the company: UPDATE: Bayer announced on July 20 that it would stop the sale of Essure at the end of 2018. ![]() Angie became an activist, seeking out other women who suffered medical problems, such as Ana, a Latina mother of four, who began bleeding profusely after the Essure device was inserted. ![]() (It sterilizes women by blocking the fallopian tube). They investigate women who say they were harmed by Essure, a device that is used to provide permanent birth control. In their latest effort, “The Bleeding Edge,” Dick and Ziering explore the ramifications of medical devices that cause harm rather than do good. military cover up of the rape of soldiers in “The Invisible War” and how college campuses cover up rape crimes in “The Hunting Ground.” These Oscar-nominated truth tellers exposed closeted politicians voting against gay rights in “Outrage,” the U.S. ![]() Kirby Dick and Amy Ziering make investigative documentaries that tackle hypocrisy. ![]()
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