Bleeding Edge 2018 is a documentary produced by Kirby Dick and Amy Herdy, giving insights into the US medical device industry. The film shows the lack of regulation and testing of devices implanted on patients. It opens with a clear message about medical innovation and the future of medical care centered on saving lives. The major problem documented is that the device industry funds the Food and Drug Administration (FDA). Therefore, most medium and high-risk medical devices are never tested in humans despite the approval to be used in health care. Kirby and Amy review several products that have harmed different victims who had trusted to use them. The film’s end presents facts about companies that manufacture these medical devices and why they refused to interview the filmmakers.
According to the FDA, medical devices are products, reagents, test kits, implementers, implants, or machines included in the vitro diagnostic (Nowakowski 76). These are intended by the manufacturer to be used alone by human beings or combined for specific purposes. Despite the advancement and technology use, the medical device industry has various problems. A considerable challenge is ensuring the quality of the product released to be used on human beings. In addition, there is a problem in getting regulatory compliance and government support that has led to many substandard and devices not approved being used. There is a lack of transparency from the approving bodies and the device manufacturers on the product specifications.
The first device discussed in the film is a hip replacement that worked well 30 to 40 years ago. It is made up of cobalt and involves minor surgery to implant. The adverse side effects of the device are that it began to leak cobalt into the human body. This caused all sorts of breakdowns, including mental and physical explained by Dr. Tower in the film. Dr. Tower is a victim of a cobalt hip replacement who falls apart after the surgery. This device was tested nominally by FDA, which raises a question regarding its approval by the regulatory authority.
The second device is the Essure insert deeply analyzed in the film. It is a non-hormonal birth control device for women marketed by Bayer. It is a coil that functions by causing a scar to the uterine tube, leading to permanent blockage. It is inserted through the uterus to the fallopian of the female reproductive system. The side effect of this birth control device is that it causes a lot of destabilizing and physical distress, affecting lives. Angie Firmalino is a victim of Essure birth control who suffered an autoimmune disease after the implant. Another victim is Ana Fuentes, whom we learned through the Facebook page launched by Angie. Ana suffered chronic bleeding and was unable to work for herself. The documentary reviews the vaginal mesh implanted on Tammy Jackson, causing undesirable effects to her. Doctors had zero training on mesh removal, which ruined her sex life and cost her several operations.
The relationship between the device industry and the FDA is that FDA regulates the sale of device products and monitors its safety in the US. The US multi-billion medical device industry funds the FDA, meaning approval of its products is hassle-free. This relationship creates a nightmare in medical care as the industry is profit-driven and does not care about the patients.
Works Cited
Nowakowski, Alexandra. “Film Review: The Bleeding Edge.” Teaching Sociology, 2018, pp. 78–81.