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Medical Devices
The Bleeding Edge is a Netflix film that examines the $400 billion medical device industry, which produces and markets highly complex apparatuses that are implanted into human bodies (Dick, 2018). The documentary was carried out on the premise that more than 70 million Americans have been outfitted with internal medical devices. While there are numerous medical devices that help uplift and save people’s lives such as corneal transplants and hip replacements, the film mostly focuses on some medical devices that have harmed people. Through this expose, the Netflix film provides shocking revelations regarding medical devices that are implanted in people’s bodies in attempts to enhance their health and wellbeing.
One of the medical devices discussed in this film is hip replacement, which has traditionally been a terrific medical device. This medical device is implanted in an individual’s body to help restore mobility and relieve pain brought by hip diseases or injuries like arthritis. However, the conventional hip replacement medical device has been improved to help enhance its effectiveness. The improvements have in turn been characterized by some side effects such as leakage of cobalt into people’s body, which in turn generates physical and...
The Bleeding Edge also discusses Essure, which is a contraceptive used for birth control. This medical device in inserted by an Essure trained doctor through the natural pathways of the body such as cervix and vagina into the fallopian tubes. Essure is associated with side effects of excruciating pain, which in turn contributes to difficulties in working due to complications. The other medical device mentioned in the movie is transvaginal mesh produced by Johnson and Johnson. This device is used for pelvic repairs through implanting into the vaginal wall. The side effects and potential harm of transvaginal mesh include pelvic pain, bleeding, organ perforation, and pain during sexual intercourse.
The film indicates how the system for approving medical devices in the United States is relatively flawed. The first step in this process is pre-market approval (PMA) in which device manufacturers are required by federal law to give a notice of intent to the U.S. Food and Drug Administration at least 90 days before marketing (Van Norman, 2016). PMA is the strictest device marketing application that is required by this agency for any new medical device before it enters the market. PMA is significant in this process since it’s used to demonstrate…
References
Dick, K. (Director). (2018). The Bleeding Edge [Motion picture]. USA: Netflix.
Gleiberman, O. (2018, July 27). Film Review: ‘The Bleeding Edge.’ Retrieved February 11, 2019, from https://variety.com/2018/film/reviews/the-bleeding-edge-review-kirby-dick-1202887859/
Van Norman, G.A. (2016, June). Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. JACC: Basic to Translational Science, 1(4), 277-287.
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