Medical Device Failures Are Nothing New

Just Because A Device Makes It To Market Doesn’t Mean It's Safe

Rebel is not just a TV show, it’s about mainstreaming strong female characters of all ages that are willing to stand up for what’s right. It portrays women working together for a greater cause and having fun.

It’s a fictional show, but it is inspired by my life and from real causes out in the world. I think these conversations are important so that more people can see what’s happening behind the curtain.

These stories matter to those who feel alone.

When you are dealing with a water issue or a medical crisis, it’s easy to think that you are in it on your own. If you are willing to speak up and reach out for help, many times you will find a whole community to support you. When you are able to open up and discuss what has happened, you can become empowered to take control over your situation and speak out to change something.

The Story of E-Sisters

Back in 2013, I started receiving emails from hundreds of women, who had been dealing with issues related to Bayer’s Essure device, a non-hormonal coil-shaped insert implanted in the fallopian tubes designed to permanently prevent pregnancy. The device, approved by the Food and Drug Administration in 2002, was intended as a cheaper, easier alternative to tubal ligation with a quick 10-minute procedure that could be performed in a doctor’s office.  

But the emails detailed all kinds of problems including severe cramping, constant bleeding, perforated organs, chronic pain, debilitating headaches, and even pregnancies despite the implants.

Together, we launched a campaign and an online petition for women to share their stories, inform one another, and spark change. Many of the women involved called themselves e-sisters.

In 2014, more than 800 women had filed adverse event reports with the FDA about Essure birth control. By 2018, more than 35,000 women across the U.S. had joined the fight urging the FDA to take Essure off the market. That same year, Bayer removed the product from the market.

Now, that’s power!

But Essure is just one of many medical devices that has sparked controversy and health concerns. The almost $500 billion medical device industry is BIG business with sales expected to reach $800 billion by 2030. Just because a device makes it to market doesn’t mean it’s safe.

A 2018 documentary called “The Bleeding Edge” detailed the risks and unforeseen consequences of medical devices in real people, discussing how medical interventions have become the third leading cause of death and that the overwhelming majority of high-risk implanted devices never require a single clinical trial.

And when Rebel came out, I saw this tweet about another medical device scandal involving defective heart valves.

Talk about art imitating life!

The series follows the fight for victims of a heart valve implant causing a life-threatening autoimmune disease.

In real life there’s Dr. Nalini Rajamannan, a cardiologist and heart valve expert, who first reported experimental surgeries happening without patient knowing about it, while working at Northwestern University Feinberg School of Medicine. She accused her colleague, Dr. Patrick McCarthy, of implanting a ring, formerly called the Myxo ring, that did not yet have FDA approval in patients without consent. And it lead to a Congressional investigation.

You can read all about it in this piece from The Daily Northwestern and Dr. Rajamannan’s own account of what happened here.

People’s health and livelihoods can be ruined from faulty medical devices, while large medical companies rake in the dollars with zero accountability.

We all have strong voices that can create change and not only help ourselves, but educate and help others too.

Sound off in the comments below if you or someone you know has been impacted by a medical device gone wrong.