Documentary Film Analysis: The Bleeding Edge The Bleeding Edge is a Netflix

Documentary Film Analysis: The Bleeding Edge

The Bleeding Edge is a Netflix documentary film which mainly follows the stories of several people with years of medical problems following procedures where faulty medical devices were implanted into their bodies. The film sheds light on the issue of negligence in the medical device industry of our healthcare system. More specifically it exposes the negligence in the approval processes that is present for the reason that our system is so corrupt it prioritizes financial gain over ensuring the health and safety of its patients it is supposed to be helping. Some of the medical devices which were implanted included a female sterilization device called Essure, a vaginal mesh meant to help with pelvic floor dysfunction, and a hip replacement made of cobalt-chrome. Besides these implantations, issues with a robotic surgery system known as the Da Vinci Surgical System were also addressed.

Pre-Market Approval Process

With Essure, women who had this device implanted experienced symptoms of pain, headaches, and heavy bleeding immediately after the procedure and continuing afterwards. The device was implanted into the fallopian tubes, but there were instances where it would fall out and end up in the uterus, adding to unpleasant symptoms. The device could not even be removed safely or properly due to the material it was made of and fragments of metal would stay inside the body when this was attempted, leading to even more health conditions. Essure was approved on the basis of Pre-Market Approval, also known as PMA. When this process is done for medical devices, it is usually studied on a small group of people and the data collected from this study is presented to the FDA. The study done for Essure was not done for long enough or on a large enough group of women for it to produce reliable evidence. The lead investigator who presented data at the approval hearing for Essure to the FDA happened to own stocks in the company, insinuating this was financial motivation for trying to get the device approved with such little research. The device was approved even though so many questions about its safety were left completely unanswered by the members of the panel.

510 (K) Approval Process

In the case of the vaginal mesh, the device was approved through 510 (K), which is seen as a loophole for having products tested for safety at all. With 510 (K), products do not have to be tested before hitting the market as long as they are “substantially equivalent” to prior products, even if the prior device was recalled because it was discovered to be unsafe. Alarmingly, most medical devices are approved by the FDA through this method. The mesh led to debilitating, chronic pain caused by constriction of organs inside the body alongside devastating sexual issues. Another product approved through 510 (K) was the cobalt-chrome hip. This product caused neurological problems for patients due to cobalt poisoning in the body. The metal would liquify and cause damage to the nearby tissue where it was placed.

White-Collar Crime?

In most of these situations, manufacturers followed legal guidelines for the approval of their products and no laws were actually broken, so no white-collar crime or organizational crime actually took place. However, fraudulent activity and negligence still occurred. This is because manufacturers wrongfully introduced devices to the public without adequate research on their safety haven been done. 510 (K) is dangerous because of the lack of study on a product done, and because the product it should mimic may have already been proven to be unsafe. PMA is dangerous because of the inadequate research required for a medical device. However both of these routes are valid in accordance with the FDA. Manufacturers failed to consider the safety of patients and the approval process was rushed all for the purpose of monetary gain for their company. This was all technically legal but calls into question the morals of the FDA and medical device manufacturers, as well as the legitimacy of every product that hits the market. How can people have faith they are properly being taken of knowing the regulations for medical device approval are so lax and potentially dangerous? These practices for approving medical devices are still the perfect opportunity for fraud and negligence despite their legality. Those at fault for these actions include the manufacturers of products as well as the FDA.

One instance of actual crime depicted in the film falls under the category of organizational crime on behalf of Johnson & Johnson, the manufacturer of the vaginal mesh. The CEO, Alex Gorksy admitted to having prior knowledge that the mesh was unsafe and would lead to complications for its users before the product hit the market. The developers of the prototypes for the mesh had tried to warn Johnson & Johnson of the dangers of the mesh but Johnson & Johnson chose to ignore this information. Instead they promoted the product to potential consumers by telling them how safe it would be with no grounds for saying so. This was fraud not only because it was wrong but also in legal terms.

White-Collar Crime Theories

Although the FDA and manufacturers are not doing anything illegal with their approval processes for medical devices, criminological theories can be applied to their actions, as well as to Johnson & Johnson’s criminal acts. These are conflict theory, neutralization theory, and institutional anoime theory. Conflict theory explains how powerful groups of people are protected by the law and these powerful people are able to use the law to oppress minority groups. The way that laws are developed are described by this theory as a way for powerful groups to increase the amount of power they have over less powerful people. The FDA is getting away with approving medical devices through illegitimate means, and the manufacturers who designed these devices are getting away with introducing their products to the public through these means. In the end, consumers are harmed. The very fact that these means for approving products is perfectly legal goes to show how our justice system is designed to protect large, powerful institutions. “Consider that many types of white-collar offending are not typically defined as criminally illegal. Doctors, for example, do not go to jail for making medical errors. Corporate executives are not sent to prison for creating unsafe products” (Payne, 356). Conflict theory might explain the behavior of the FDA and device manufacturers for the rea

Neutralization theory can be applied to