Since 1976, the FDA has been using the 510k process to approve most medical devices. This pathway once was the exception to the rule has now become the bypass standard. Facing growing pressure from the public, the agency says it will now look to overhaul the system but insists it still works.
About the 510k Medical Device Approval Process
Most people assume that medical devices undergo comprehensive testing with human subjects. However, a majority do not. These studies can be costly and lengthy; therefore, to help push life-saving measures through the approval process, Congress passed the 510k provision. This pathway allows manufacturers to apply for approval clearance when a new device exhibits roughly the same safety and effectiveness characteristics as a device already on the market. If approved, the FDA requires no other testing or information. This means that the manufacturer can go straight to market without passing through the Premarket Approval (PMA) process. PMA requires clinical trials and other stringent studies of the device’s uses, safety, and possible risks.
Because the 510(k) clearance allows the manufacturer to skip the PMA process, devices given 510(k) clearance are not FDA- approved and cannot be referred to as such. However, legally, manufacturers can still sell them in the U.S.
Pressure to Change a Faulty System
The 510k process started as the exception, but now it is the rule. Out of all the devices on the market, 98% are from the 510k process. Now, the public is sick of constantly being injured by defective devices, which steam from a broken medical device approval process. Defective devices cleared through the streamlined system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.
Just this week, a global investigation into medical device safety by more than 50 media organizations, including the Associated Press released their findings. Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the FDA over a 10-year period.
The new generation of devices, which received 510k clearance, barely resemble decades-old precursors as applications claim. Devices cleared through this system include imaging scanners, computerized drug pumps, artificial joints, and spinal implants. These were definitely not around before 1976.
In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.
Last year, the FDA cleared 3,173 devices through this system, or 82 percent of the total devices cleared or approved, Gottlieb and Shuren said in their statement. Nearly 20 percent of products cleared through the 510(k) pathway is based on a predicate device that’s more than 10 years old, they said.
FDA Sides With Big Pharma
Now, the FDA has changed its tune and insists that their new guidelines will be in place in the coming years. However, it is hard to believe the agency is telling the truth since it has a long history with siding with the large drug companies. In fact, pharmaceutical companies are not content with the loopholes the 510k process gives them. They keep pushing for fewer restrictions. They can achieve this since these companies fund 70% of the biomedical research. Long gone are the days of the government funding independent studies. Big Pharma will stop at nothing to increase their profits even bribing doctors. In 2016 alone, doctors received $2 billion in kickbacks.
No one is regulating this since even the FDA director is a cog in the Big Pharma machine. Before becoming the director, Scott Gottlieb worked at a venture capitalist firm. His firm helped fund dozens of medical devices like Essure. When he became the director, he agreed to recuse himself from decisions in companies he was involved in for only the first two years. His first act as FDA director was hiring a new lead attorney for the FDA. The new attorney used to represent Bayer in victim lawsuits.
Also, it is hard to receive help from the government itself not only since Big Pharma greases the FDA, but also due to executive orders that hurt America but help these multi-billion dollar companies. In February 2017, President Trump signed the executive order “Two-For-One”. In this order, the FDA cannot create any new regulations without eliminated two old ones. This approach isn’t new. In fact, President Carter attempted to start this push. But, this approach only takes costs in mind not the welfare of the American people. Each regulation could possibly save a life. Isn’t that worth it?
Help Us Fight Back
This is why it is incredibly important that when a medical device injures you, you need to come forward. The more people who speak out against a device, the better chance we have that pharmaceutical company either will attempt to fix or recall it. If the FDA won’t protect us, then we need to rally and protect each other. Lawsuits can have a bad reputation, but these legal pursuits shine a light on the pain and suffering of thousands. It makes the media and Big Pharma listen. Since Big Pharma only cares about money, filing a suit against them and threatening to take their bottom line makes them pay attention. It creates change.
Therefore, take a second and look at this long list of medical devices. It is just a small fraction of those currently on the market injuring Americans. However, if you have any of these devices and are experiencing the side effects listed, contact us. Join the fight. Let your voice be heard. Let’s demand accountability for a flawed approval process, and an agency who just does not care to listen.