With medical devices so ubiquitous in our modern lives, it is easy to forget they are regulated technologies. Or are they as regulated and tested as much as we think? Mariela Ticas dives into the Netflix Original The Bleeding Edge (2018) and explores the world of medical devices and technology.
The Bleeding Edge Exposes the Bloody Truth
When we hear a family member, a friend, or a colleague has had a medical device implanted, we don’t question it. When we hear a suggestion from a doctor to get a medical implant device, we don’t question it. In fact, do you ever stop and wonder about how medical devices passed safety inspections or trials? Didn’t think so, and you’re not alone. Next time you, or someone you know, choose to place trust in doctors or the newest “revolutionary” medical device, make sure you think twice and ask plenty of questions.
The Netflix Original Documentary The Bleeding Edge is a new film by Kirby Dick and Amy Ziernig. During the 1 hour and 39 minute run-time, they dive into the industry of medical devices and technologies. This is an industry worth an estimated 400 billion dollars. During the film we meet Stephen Tower, an orthopedic doctor, who suffered a psychotic breakdown due to a medical implant. He says perhaps the most memorable quote in the film, “New equates to unproven.”
In the film we learn of a provision called the 510(k) pathway. Within this provision, a manufacturer can obtain approval for a new device if they can prove it is “substantially equivalent” to another device already on the market. This creates a loophole with a perpetual and dangerous cycle, leaving patients in everlasting danger. There is no mandatory testing for new devices if companies use the 510(k) pathway!
That’s right! This means that if “The Vaginator” is for ‘safely’ removing the female’s reproductive organs was recalled, it would make it totally ok for a different device to be manufactured and be called “The Terminator” to do a very similar job with no obligation to undergo testing for safety. Sick!
Essure and the FDA
By far the most memorable topic of the film is the birth control implant Essure. This implant is a metallic coil, small enough to be inserted inside the fallopian tube to prevent unwanted pregnancies as a permanent method. However, it didn’t come without very serious complications. Many thousands of women have reported all sorts of horrific side effects.
On July 20, a month before the film was released, Bayer announced that Essure will no longer be available in the U.S. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” Bayer said in a statement. However, is this truly a shock?
Like Woody Harrelson mentions in the documentary Ethos Genesis (2015), the power of your dollar is more powerful than a vote. America runs on free-market capitalism. Choose wisely how you spend your dollar and on what. Doing so sends a direct message to these corporations. As we see in The Bleeding Edge, cries and concerns of safety fall on deaf ears to those money driven behemoths. The decline in sales certainly sent tremors quaking throughout Bayer and their CEO.
Perhaps the most barbaric practice among these doctors was how they treated the women who dared speak up for their bodies. After reporting negative side effects, doctors called these women crazy and told them it was all in their heads. The victim was being victimized over and over again while families were being broken. And how is this not victim shaming? All the while the bullies are the doctors with a license to kill — literally. And the fight is far from over.
Walking With Propoganda
Just the other night, I curled in bed to watch a TV show and a medication commercial came on. This medication was to help you obtain clear skin, but the possible side effects were a chance of cancer and suicidal tendencies. These were listed while hypnotizing images of living the perfect life flashed on screen without any hint of how your life would actually look during a life-or-death battle with cancer.
Recently, there was an over-the-counter emergency contraception being advertised as something you can purchase at your local drugstore. Immediately this raised concerns in my mind, because when I worked in the medical field years ago (specifically the department of family planning) emergency contraception was prescription ONLY. And for good reason! If our records showed a patient had taken the EC pill more than three times and at least twice that same year, the doctor wouldn’t prescribe it. This was because of the risk of irreversible liver damage and infertility!
Even more frightening, the FDA has now approved this for over the counter use for anyone of reproductive age! This means the FDA trusts your teenage daughter to purchase this product, but no longer wants it to be regulated by a physician. My “strange theory” is that because it was so highly regulated sales went down. As seen in The Bleeding Edge these companies will do whatever it takes to increase sales.
We see these companies spreading their propaganda everywhere. Unfortunately the greed and pressure to make sales has become an illness in itself. These companies should be fighting for the health and wellbeing of people, not leaving patients to fend for themselves. But who takes the blame and who should be held responsible for the hundreds of women whose lives have been forever affected? Where do we go from here?
It seems like the fight must come down to us. It is up to us to heal and move forward. We must question the status quo and encourage survivors to never stop fighting. The sad truth is that not everyone will find the justice they deserve, but hope and faith do always finds a way. While some women have expressed feeling robbed of what makes them women, they have something deeper these companies can never take. They possess grace and poise in one of the toughest scenarios imaginable.
My hope is that these words can help someone who has been affected — never stop fighting.
Mariela Ticas lives in Los Angeles, CA. and is a regular contributor for ATRP. She is a podcast personality/co-host/blogger for The Strange Kamelion Show on iTunes and is an active member of Sag-Aftra as a performer. She has always been a writer at heart and got her start writing poetry as a teen. Mariela got her start in the entertainment industry back in 2012 and is now currently working on her first children’s book! In her downtime, she’s a volunteer member of the Motion Picture & Television Fund. You can follow Mariela on Instagram, keep up-to-date with her on the podcast blog, or scope her IMDb for upcoming features.