By Judith Garber, MPP
By the time I finished watching The Bleeding Edge, a new documentary about the medical device industry and regulation, I never wanted to hear the word “innovation” again.
Filmmakers Amy Ziering and Kirby Dick do an amazing job of juxtaposing the optimistic, Silicon Valley-style language used by industry leaders, with the very real consequences that unrestricted innovation has on people using medical devices.
Viewers meet women who suffered debilitating, life-changing side effects from the Essure sterilization device and vaginal mesh, survivors of robot-aided surgeries gone awry, and a surgeon who was enthusiastic about metal-on-metal hip implants — until he had one put in himself.
This demystification of “innovation” is essential, because for many years the power of this buzzword has allowed industry to dodge regulations by saying they will “stifle innovation.” But as UCSF professor of medicine Dr. Rita Redberg says in the film, “Putting untested devices on the market is not innovative.”
By going through the history of medical device regulation and exposing the system’s many weaknesses, the filmmakers force us to rethink our assumptions that “approved means safe” and “newer means better.”
Those familiar with the Lown Institute may recognize some of the experts in the film. Featured along with Redberg are Dr. Martin Makary, professor of surgery and health policy at Johns Hopkins School of Medicine and journalist Jeanne Lenzer, author of the recent book, The Danger Within Us about medical devices. You may have heard Lenzer and Redberg speak at the Lown Conference this year, and you may think, “I know all about what’s wrong with devices. Nothing in this film will surprise me.” You would be wrong.
Be prepared to be shocked. Be prepared for raw, incredibly sad stories, and uplifting, hopeful ones. Be prepared to have the urge to call your friends and tell them to watch this film now.
What impressed me the most about the film was not the arguments and facts, but how the survivors’ stories put you in their shoes for a moment. The stories made me think about the long-term costs of these devices in ways I had not previously thought of — for example, how would the side effects impact relationships with your partner or your kids?
I also appreciated that the film touched on the ways in which race and class intersect with health. For a white woman who had financial resources and property, having Essure devastated her physical health, but her marriage, job, and finances remained intact, and she was able to become a patient advocate. For a Latina woman with less of a financial buffer, the physical effects of Essure – combined with refusal by doctors to believe her symptoms – threatened every aspect of her livelihood in a tragic snowball effect.
As with most documentaries, the filmmakers want to show a certain point of view, which leaves some holes in the stories. The documentary does not interview patients who have been helped by these medical devices, it only briefly touches on the role of doctors in device overuse, and doesn’t mention that the backlash toward industry can also be corrupted. I hope these omissions don’t distract from the film’s larger message – that the entire device regulatory system is broken, and urgently needs change.