Understanding Medical Devices
Over the years, medical practitioners and firms have invented and innovated different medical devices that improve the lives of patients in need. Medical devices are products or equipment for doctors and physicians to use medically. The Bleeding Edge is a 2018 Netflix documentary produced by Kirby Dick and Amy Herdy that focuses on different medical devices and how they affect the life of patients after use as well as educating about the US medical device industry (Nowakowski, 2019). It also shows the role of the Food and Drug Administration (FDA) ‘s role in approving medical devices.
Challenges Facing the Medical Device Industry
The documentary presents some significant problems with the medical device industry in the United States. First, the industry is no longer doing things to benefit an ordinary citizen’s life but to benefit the industry. The government no longer carries out research or funds the production of medical devices; the industry and big corporations do it. This makes it hard to monitor the type of medical devices created and their usefulness, as some major shareholders lead the regulation boards in the industry. Additionally, there is the problem of having greedy people in the system, causing it to have a system run on profits and numbers rather than caring about the safety of patients.
The medical device industry’s second problem is the lack of proper regulation and testing of devices before releasing into the market. Some medical devices are not required to undergo human testing before they are approved, so one may not know their effect after use. For example, according to Heneghan et al. (2017), devices such as the vaginal mesh did not require to be tested on humans before they were marketed. This led to them being used on patients without knowing the possible harmful effects they may have in the future.
Lastly, there is the problem of approving medical devices without proving their safety and effectiveness to the user. Some marketed devices lack adequate data on their usefulness and possible outcomes. Due to the lack of human testing, it is sometimes impossible to tabulate whether a device’s advantages outweigh the risks involved. Furthermore, human-tested devices do not collect enough data to prove their success as they are collected over a short period compared to the device’s long-life use.
Key Medical Devices Featured in the Documentary and Their Negative Side Effects
Some medical devices highlighted in the documentary are diverse medical devices in the industry, such as hip implants made of metal, da Vinci surgical system, vaginal mesh, and Essure birth control implants. The significant side effects of Essure birth control include excessive bleeding, miscarriages and premature deaths of babies, cramping, fevers, and severe headaches. Other side effects from different devices include high levels of cobalt in the body due to metal hip implants, leading to physical and mental disorders. For patients who underwent the da Vinci surgical procedure, there was the issue of internal damage, with some reporting their intestines falling. Numerous complications also occurred, with other patients requiring multiple surgeries for treatment.
The Relationship Between the Medical Device Industry and the FDA
The relationship between the industry and the FDA is that the FDA regulates the sale of medical devices in the United States. It is also supposed to monitor device safety, thus acting as a consumer protection agency by shielding citizens from unsafe devices. However, this is not the case, as some harmful devices still get released into the market due to the hassle-free and profit-oriented approval of products.
References
Heneghan, C. J., Goldacre, B., Onakpoya, I., Aronson, J. K., Jefferson, T., Pluddemann, A., & Mahtani, K. R. (2017). Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ open, 7(12), e017125.
Nowakowski, A. X. C. (2019). Film Review: The Bleeding Edge.