How can a country with the most technologically advanced healthcare system in the world approve the sale and use of medical devices that haven’t even been tested for safety? This is precisely the issue “The Bleeding Edge”—a new documentary about the U.S.’s failure to regulate the medical device industry—attempts to uncover.
One of the most compelling stories in the film comes from Angie Firmalino, a mail carrier in upstate New York who suffered painful complications from Essure, an implantable birth control device that was approved by the U.S. Food and Drug Administration (FDA) in 2002.
In the film, Firmalino describes the intense pain and bleeding she experienced after the procedure, which she says was like something out of a “horror scene.” Distraught by her situation, Firmalino went on to form a support group for women who experienced health problems after Essure implantation.
Unfortunately, Firmalino’s case is just one of many. As of early 2018, thousands of women across the U.S. have filed Essure lawsuits in an attempt to get compensation for complications and injuries resulting from implantation of the device, which have included:1
- Perforation of the uterus and/or fallopian tubes
- Migration of Essure to the abdominal or pelvic cavity
- Persistent pain and bleeding
- Dislodgement of the device
- Difficulty inserting or removing the device
- Suspected allergic or hypersensitivity reactions
Thousands of women using Essure have also reported headaches, fatigue, mood changes (including depression), hair loss, and weight changes, which may be related to the device.1
To add insult to injury, rather than pulling Essure off the market completely after receiving these reports, the FDA announced in April 2018 that it would simply issue an order requiring new package labeling warning women of the risks and benefits of the device, and limiting the sale and distribution of Essure to healthcare providers who agree to inform patients of the risks and benefits and complete a “Patient-Doctor Discussion Checklist.”1,2
Beyond being woefully inadequate, these guidelines are non-binding and not legally enforceable.
What’s clear from all of this is that, in their decision to keep Essure on the market, the FDA—a government agency created to protect consumers—is choosing to protect Big Business.
A Widespread Problem
Unfortunately, the Essure debacle is not an isolated incident. Tens of thousands of people file medical device lawsuits every year, as defective devices are common.
In 2017, alone, there were more than 30 devices recalled by the FDA—everything from a faulty intra-aortic balloon pump (used during heart surgery) that could lead to complications and even death to a faulty catheter that has been known to break apart during use, leading to possible blood clots or death. Medical device recalls are already at an all-time high in 2018.
Not only have medical device manufacturers, in many instances, failed to perform adequate clinical trials to ensure the safety of their devices, in some cases, they’ve actually covered up side effects reported by clinical trial participants, as revealed in the documentary.3
An Industry Run Amok
The medical device industry is massive—a $400 billion powerhouse, which the documentary suggests is even more powerful than Big Pharma. That’s saying something, considering the many tens of millions Big Pharma spends on lobbying each year to influence government decision-makers.4
Among the many disturbing revelations in the film is how device manufacturers use an FDA loophole from 1976 to sell devices without first testing them. A clearance process called the 510(k) gives medical device manufacturers the green light to put their products on the market without a single clinical trial and with very little oversight, as long as the devices are “substantially equivalent” to devices already on the market.
In other words, the FDA’s rationale is that if a device already available to consumers is considered safe, new devices that are very similar must also be safe.
Not surprisingly, unscrupulous medical device manufacturers are taking full advantage of the 510(k) loophole.
Not only does the 510(k) clearance process seems absurd on its face, it also doesn’t work.
Researchers have found that devices cleared through 510(k) are more likely—11.5 times more likely—to be recalled compared to devices that are subject to the FDA’s more rigorous premarket approval (PMA) process, which requires clinical and laboratory studies to determine a product’s safety before it can be brought to market.
Medical devices hastily approved by the 510(k) clearance process often haven’t even been tested for the purpose they’re sold or tested in the patient population they’re designed to serve.
Former FDA commissioner Dr. David Kessler sums it up best in the documentary when he says, “When it comes to medical devices, we built a system that doesn’t work.”
“The Bleeding Edge” May Shed Light on FDA’s Failures
The hope is that “The Bleeding Edge,” which will soon be released on Netflix, will help sound the alarm about the FDA’s failure to properly regulate the medical device industry.
Unfortunately, it’s not just medical device manufacturers that patients have to worry about. The film’s director, Kirby Dick, pointed out that most people trust their doctors without question when it comes to device recommendations.
However, he says, this is a mistake since even doctors don’t always know how medical devices are regulated.5 Worse, they don’t always believe or take patients seriously who come to them with complaints about a medical device. Ultimately, though, doctors are victims of the failure to properly regulate medical devices, too, says Dick.
The unfortunate reality is that, until the FDA steps up its game, patients must be diligent about questioning their doctor’s recommendations—not an easy thing to do, considering the power imbalance between patients and doctors.
How Consumers Are Fighting Back
As we’ve seen, the medical device industry is weakly regulated, yet a staggering 70 million have a medical device implanted in their body, whether it’s an artificial hip or a stent to keep an artery open in the heart.
If you’ve been injured by a defective device, you’ve had to undergo one or more additional surgeries as a result of the faulty device, or you’ve lost a loved one to a faulty device, a medical lawsuit may help you recover some of your damages.
While a damage award can never truly replace what was lost, it can help ease the financial burden so often associated with medical injuries. It can also bring some sense of justice for individuals and families who have suffered a permanent injury or who have lost a loved one from a device that was improperly tested or labeled.
The expert defective medical device lawyers at Saunders & Walker P.A. can help. Our skilled attorneys have experience with both individual and class action cases against medical manufacturers in both local and federal court.
Call us today at 1-800-748-7115 for a free case evaluation. Since 1987, we’ve made it our mission to get justice for people who have been wrongfully harmed or killed by corporations, insurance companies, and manufacturers.