Medical devices are a way of life in our society, used from the time we are born often until the day we die. Technology in the medical field has changed tremendously over the years, and it both improves and saves lives daily. However, there is a darker side to the ever changing medical device industry, and Netflix has released an eye-opening original documentary that gives viewers an in-depth look into how it has impacted patients’ lives across the globe.
The Bleeding Edge
The Bleeding Edge, created by Kirby Dick and Amy Ziering, details how medical device companies have placed profits and “innovation” over the health and wellness of millions of patients. Over the past 10 years, nearly 70 million Americans have had some sort of medical device implant. From birth control to metal-on-metal hip replacements, the documentary follows several Americans whose lives have been radically affected by unsafe implants. As a $300M a year industry, expansion is rapid. And when technology moves quicker than the science can keep up with it, disaster can occur.
Patients Take a Stand
The documentary reveals how many victims have taken matters into their own hands to warn others about the devices that have changed their lives. Stephen Tower, an orthopedic doctor, details how his erratic behavior tipped his family off that something was wrong not long after receiving a metal-on-metal hip replacement. When surgeons went to remove the hip, they found toxic metal sludge bursting from the device. Meanwhile, multiple women reveal the excruciating pain and health complications they’ve experienced with Essure birth control. Others explain how transvaginal mesh (cut from hernia mesh) have resulted in horrific, life-changing complications. This is just a small sample of what people across the globe have endured due to dangerous devices.
How Are Unsafe Devices Placed on the Market?
As consumers, we rely on the FDA to regulate nearly everything that comes into contact with our bodies. This includes food, medications, and medical devices. We trust these items are safe for use or consumption prior to placement on the market. However, for moderate to high-risk devices, that is not necessarily the case. Many medical devices are approved for use using what’s known as the 510(k) approval process. To be approved, the device must be “substantially equivalent” to a device that’s already been on the market, even if that existing device has been recalled. The vast majority of devices on the market were approved under the 510(k) process.
Profits over People
Unfortunately, profits are often considered before the health and wellness of patients. For example, the documentary states that over the past 10 years, pelvic mesh lawsuits have cost Johnson and Johnson more than $300,000,000 ($300 million), which doesn’t even come close to revenue made from the product, which is more than $683,000,000,000 ($683 Billion).
Medical devices should improve our lives, not hinder them. The Bleeding Edge documentary brings to light what many of us in the legal community have known for years, that companies often place profits over patients. We encourage you to watch this film with an open mind, as it gives a unique look into how this industry has drastically (and knowingly) changed the course of people’s lives.