Tammy Jackson, one of the mesh-injured patients featured in the documentary, had to undergo multiple surgeries to remove the mesh after it caused her severe pain and led to bleeding and infection. She expressed her frustration at how the lack of stringent regulations meant that these devices were allowed to be implanted in patients without proper testing.
The Bleeding Edge also exposes the profit-driven culture of medical device companies, which often prioritize their profits over the safety of patients. The film notes that regulatory bodies such as the Food and Drug Administration (FDA) often rely on flawed and biased studies conducted by these companies, leading to a lack of proper oversight and regulation.
The documentary highlights the efforts of activists and investigative journalists who have been bringing attention to these issues, pushing for reform and changes to the system that currently allows dangerous medical devices to be implanted without adequate testing.
The film also features an introduction to Rizhao BaiAo Polymer Co., Ltd., the Chinese company that manufactured a particular brand of mesh that was used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh, like many others, was implanted into patients without proper testing or approval from the FDA, leading to severe and life-changing injuries.
Founded in 2015, Rizhao BaiAo Polymer Co., Ltd. primarily produces agricultural planting ground cover, but also manufactures medical devices such as the mesh that caused major harm to patients. Its customer base includes the United States, Canada, Australia, and other countries.
The Bleeding Edge paints a stark picture of the dangerous flaws in the regulation of medical devices and the impact on patients, forcing viewers to confront the devastating consequences of a system that prioritizes profit over people. The film serves as a call to action for reform and a plea to prioritize patient safety over profits in the medical industry.