Bleeding edge documentary how to#
Bleeding edge documentary trial#

Tower thought it might be related to his metal-on-metal hip replacement and had it redone. So, Tower studied himself until he found the answer in a blood and urine sample: his levels of cobalt, a metal used in rechargeable batteries, were more than a hundred times higher than normal. Tower, his friends and family knew he was in the throes of mental health crisis, but no one was sure why. Stephen Tower, an orthopedic doctor profiled in the film, had developed a tremor and was having a hard time thinking when he decided to scrawl all over the walls and ceiling of a hotel room during a medical conference, eventually using soap as ink. Doctors, too, come forward afflicted by the unknown effects of some of these devices. Most importantly, it succeeds as a documentary because it leaves people questioning the safety of the medical devices in their life.Dozens of people speak about issues that followed procedures involving medical devices, including women whose intestines fell out of their bodies after robotic surgery. Through examples like Essure and Cobalt-hip replacements, The Bleeding Edge demonstrates the FDA’s inadequacies and the need for immediate change. Though The Bleeding Edge may feel a bit rushed at moments, it ultimately presents a comprehensive examination of one of America’s most unregulated industries. While it is made evident that it is not a good device, the documentary provides little explanation for how it came to the market and what can be done to avoid its use. The documentary, similarly, spends too little time explaining the issues with vaginal mesh.

Bleeding edge documentary how to#

The brevity makes the argument against this technology slightly confusing because the documentary only provides extreme examples of post-op complications and assigns the blame to the doctors for not knowing how to properly operate the machinery. The Da Vinci surgery method, especially, appears almost randomly in the last third of the documentary for about ten minutes and then is never brought up again. Both receive little screen time and explanation. While the documentary’s choppy style parallels the chaos of this industry, it hinders the strength of the vaginal mesh and Da Vinci surgery examples. The documentary does not include any other cases of this phenomena, which contradicts its central argument throughout the film: that research must be thorough and comprehensive, not dependent on a singular case study. The only issue that arises with this example is it’s limited scope. Tower’s miraculous recovery upon having the replacement removed casts aside any speculation that his deranged mental state was a result of something else. Stephen Tower, a doctor himself, received a Cobalt-based hip replacement that practically drove him to insanity. The documentary spends less time discussing the issues with Cobalt-hip replacement, but this example still successfully conveys their message because of its extreme nature. Moreover, the documentary builds its pathos by spotlighting the Facebook advocacy group lobbying for a ban of this product.

Bleeding edge documentary trial#

The documentary shines as it exposes how even with these standards in the mind, Essure had only undergone one small trial before becoming available on the market. Providing this background highlights how products like Essure, which was considered to be one of the most regulated medical devices on the market, can still be unsafe. Either devices must be thoroughly tested, or they must have a predecessor that had already been approved by the FDA.

The documentary explains how the FDA has two standards of regulating medical devices. The emphasis on Essure is particularly effective because it epitomizes the problem with the FDA. In particular, Essure, a form of permanent birth control that has resulted in numerous medical problems, dominates the documentary’s focus. The documentary cuts between these four cases to highlight some of the largest holes in the FDA’s medical device regulation system. The Bleeding Edge focuses mainly on four examples of the FDA’s inadequate regulation: Essure, vaginal mesh, Cobalt Hip-replacement, and the Da Vinci method of robotic surgery. That’s the FDA’s job, right? Netflix’s documentary The Bleeding Edge examines this grave misconception and attempts to expose the corruption present in the medical device industry. BY ISHAN VAISH – When most people go into the operating room, they do not question the safety of the procedure they are about to undergo.