9 August 2018

Examining Problems with the Medical Device Industry in the US

The Bleeding Edge documentary on Netflix provided in-depth insight into the health risks, pain and suffering the medical device industry is causing consumers with products like Essure, pelvic mesh, and cobalt joint replacements. As expected, the documentary received significant push-back in responses from leading manufacturers like Bayer and Johnson & Johnson. According to the directors, the documentary was not as much about the defective products, but the flawed system at large.

How the Medical Device Industry Works

Medical devices may refer to any technology that interacts with the human body, such as hip implants, ultrasounds, x-ray, and cat scans, among others. According to the directors, the medical device industry has been able to keep regulation at a low with their lobbying power. Around 98 percent of all medical devices are currently being approved for sale without going through any clinical studies. The case studies that are produced are often privately funded and biased.

In addition, many of the devices like implants are permanent, but the studies typically only last for less than two decades. Even as Bayer halts sales of Essure over weak sales and bad publicity, the medical manufacturer stands by the safety profile and quality of its permanent birth control implant. Both Bayer and Johnson & Johnson have already been targeted by thousands of lawsuits suing for millions in damages over their defective medical devices.

The medical device industry generates approximately $300 billion in the US every year. Over the past decade, close to 70 million people in the US have been implanted with a medical device. There are currently over 10 million patients around the world who have shoulder, knee or hip implants composed of the cobalt covered in The Bleeding Edge. Since 2002, more than 750,000 women worldwide have received Bayer’s Essure implant.

The FDA’s Role in the Medical Device Industry

The 2002 pre-market approval meeting with the FDA panel demonstrates Bayer’s ability to get Essure approved without answering all the panel’s questions or providing the data requested. While approving Essure, panel members could be heard joking about how they could be held accountable one day in the distant future for approving the controversial implant. In their announcement to halt Essure sales, Bayer attributed the decision to weakening sales and bad publicity but never acknowledge the lawsuits.

One former FDA commissioner says the agency is organized by centers, but that the medical device center is the most broken within the system. Some say that the medical device industry is more powerful than big pharma. Many say the system for reporting adverse events is also broken because physicians are not required to report them to the FDA. Experts estimate that only 3 to 4 percent of all adverse events are reported to the agency.

One John Hopkins surgery professor says the core of the problem is the massive adoption of technology with too little evaluation for the potential outcomes. While many consumers expect medical devices to undergo adequate testing, this is rarely the case with many moderate and high-risk products. In its response to The Bleeding Edge, the FDA even acknowledged that all the information on risks and benefits associated with these products is rarely understood before they are approved.

The pre-market approval process Essure was approved through only accounts for 2 percent of all medical devices. The other 98 percent not subjected to human trials are approved under the 501(K) provision. The 501(K) provision was originally established as a loophole, but it eventually became standard practice in the industry. Under the 501(K) pathway, all the manufacturer has to do to bypass human trials is show that their new device is substantially equivalent to an existing, or predicate, device.

However, even if the product is dangerous, failing or pulled from the market, it can be used as a predicate to help a new device bypass human trials. In addition, you can end up with a daisy chain of FDA approvals for devices that sought approval based on predicate devices designed after failing and dangerous devices, which is what allows products like the cobalt implants to make it onto US markets.

Flaws in the Medical Device Industry

It’s also worth noting that around 70 percent of all biomedical research is currently privately funded, but 20 to 30 years ago government agencies were the ones funding 70 percent of this research. At this point Dr. Kuo of Stanford feels that consumers cannot trust device manufacturers to operate with their best interest in mind and the FDA cannot be trusted to properly regulate the medical device industry.

For the most part, physicians don’t really understand how medical devices are regulated because that’s not their area of expertise. Many surgeons trust or assume the devices have been thoroughly vetted by the FDA and tested on humans, but this is not the case. When the science and marketing don’t match up, the marketing division for many of these device manufacturers ultimately wins out.

Technological innovations are providing the medical devices industry with the fastest expansion right now. Many experts say the tech innovations are outpacing the science and research needed to properly assess the potential safety risks. The truth is, a medical device can be approved by the FDA and be on the market for years causing a number of injuries and deaths before the public actually hears about it.

Corruption in the Medical Device Industry

If the accessibility to highly profitable devices is challenged from within the agency or organization, there is often push back from management or other corporate leadership. Concerns may be ignored altogether or employees may even be retaliated against. Within the FDA, scientists claim they’ve actually had their keystrokes monitored by the agency after voicing concerns about popular products like CT scans. The foremost lobbying group for the medical device industry, AdvaMed, has been fighting to reduce regulations for years.

The medical device industry relies heavily on lobbyists to influence politicians into adopting more lenient legislation for their products. The industry also uses advocacy groups and think tanks to help sway politicians in their favor. In addition, many of the former FDA commissioners were formerly employed in the medical device industry and go back to help these same companies circumvent the system once their time in office is over.

Current FDA commissioner Gottlieb actually headed the company that funded the controversial Essure implant manufactured by Bayer. The new FDA lead attorney Gottlieb hired formerly worked as a representative for Bayer defending the manufacturer against patients harmed by their devices. The Bleeding Edge makes it clear, controversial devices like Essure and cobalt joint replacements are just symptoms of more systemic problems within the medical device industry.


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