What it's about: The U.S. Food and Drug Administration is charged with the oversight of medical devices with an approval process involving scientific study. In comparison to the approval of food and drugs, however, the process of testing and approving medical devices is incredibly limited. From birth control instruments to hip replacements, putting foreign objects into bodies is a scary proposition that has become a medical norm. While there have been thousands of successful breakthroughs involving medical devices, horror stories are out there, too, problems that may have been avoided.
Unorganized thoughts [New Father Edition]:
The Bleeding Edge is as scary a body horror film as I've ever seen, a rare documentary that transcends its form. There are stories told that are so incredibly devastating that I had visceral reactions to them -- we're talking like colons falling out of bodies, sexual organs becoming lacerated during intercourse, terrible, horrible, nightmarish stuff.
It takes really exciting, innovative technology and lifts the veil, showing the dangers of scientific achievement without proper oversight.
It isn't unusual for a documentarian to become [for lack of a better term] pigeonholed by specific subject matter and with her previous two films, it seemed like maybe that could happen to Kirby Dick. The Hunting Ground and The Invisible War, both films about rape and sexual assault in two different areas of the world [college campuses and the military, respectively], are both extraordinary films. The Bleeding Edge is a turn into new territory, but what Dick shows is that he is one of the most empathetic documentary storytellers working today.
Even before getting to the painful personal stories, director Kirby Dick properly sets the stage by thoroughly describing the complicated procedural background that created a wild west environment. He has two major focuses: first, the grandfathering in of devices before a 1970s law set the approval procedures because reviewing every device already on the market would be far too costly; the second emphasis is on something called a 501(k), an exception for new medical devices to be approved if they can argue they are similar enough to a device that has already been approved -- this includes these grandfathered devices that haven't gone through rigorous scientific testing AND devices that are similar to devices that have been shown to be ineffective or dangerous.
The bulk of the documentary revolves around a permanent birth control device called Essure, a small metal instrument that closes the Fallopian tubes. After going through a short trial, the device was put on the market. In the coming years, many women began experiencing intense pain and chronic pain. In some women, the device broke or inadvertently entered the uterus. When devices were removed, more complications occurred. In many cases, the pain and complications led to hysterectomies in women as young as 30 years old. The Bleeding Edge follows a group of women that started a Facebook support group that bubbled into a large organization that have put the pressure on the manufacturers of Essure.
The documentary is thoroughly researched and presented through talking heads spanning from medical professionals, patients, in one case a medical professional who was also an implantee, former FDA representatives, medical researchers, and even medical device lobbyists.
While not explicitly doing so, The Bleeding Edge is a call for more scientific study in a political environment that is moving toward de-funding scientific oversight that will only make these problems more prevalent. Unfortunately, the onus is increasingly put on healthcare providers who aren't experts in studying the devices they are using and the healthcare recipients who implicitly trust their healthcare providers.
The Bleeding Edge is incredibly provocative for examining a field that most people would be in favor of -- who doesn't want science and technology to improve basic life? A similar spotlight has been put on pharmaceutical drugs for decades, exposing the corporate greed and bureaucratic issues. But there is something about the shiny new nature of science-based medical devices that has escaped the same widespread public criticisms.
The Bleeding Edge unravels in a way that seems pretty familiar as a public awareness documentary. But because of the specificity of its subject matter and especially the incredible stories told by its profiles, it is something essential.