As American consumers, we come to trust that our governmental agencies have our best interest in mind. But, what is becoming more apparent is that more large pharmaceutical companies are infiltrating the Federal Drug Administration with the sole process of watering down the approval process. This means that regulations and strict processes before a medical device is FDA approved are slowly dissipating as lobbyists grease the palms of doctors and commissioners in the FDA itself. These efforts are just to profit on American pain.
510K Approval Process Does Not Work
When the FDA started implementing stricter regulations on medical devices, the agency grandfathered in any device used prior to 1976. Then, medical devices used after 1976 had to go through a rigorous Pre-Market Approval (PMA) process. Researchers had to test the device on humans, and the study had to have appropriate data compiled for FDA approval. However, pharmaceutical companies started lobbying Congress about the cost and length of human trials. Therefore, Congress passed the 510k approval. This new process meant that a manufacturer only needed to establish that their device is substantially equivalent to one already on the market through PMA. This 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, these unstudied medical devices are injuring thousands of people.
Deadly Medical Devices
There are 70 million Americans living with medical devices. Some help people live longer lives and have a better quality of life. However, for many, these devices made their lives almost unbearable to be alive.
Essure
Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. A doctor inserts one Essure coil into each fallopian tube. Scar tissue will form around the coil to obstruct sperm from fertilizing an egg in the fallopian tubes. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Bayer, the manufacturer of Essure, claims it is nearly 100 percent effective at preventing pregnancy and is perfecting safe; however, thousands of women disagree.
Essure Side Effects
Within 10 years of Essure being on the market, thousands of women began experiencing continual bleeding, headaches, device migration, device fracturing after it migrates and then sets off an autoimmune response. Not to mention that over 800 women experienced a failed pregnancy after using the device. The babies born had pre-term labor issues, problems with the amniotic sac and a slew of health concerns. If Bayer decided to perform their initial study longer, many women would have been spared. Instead, they only followed women for a year and a half. Plus, the researchers swayed the satisfaction results while interviewing clinical participants. As long as the women did not get pregnant, then they changed their responses to “Extremely Satisfied”. Many women even noted the pain they were in, but researchers crossed out those answers.
Still, the FDA approved the device. Could it be because the lead FDA investigator admitted to owning stock in Essure? Even as other countries banned the device, the United States kept it on the market. Then, it was revealed that the current FDA director funded the development of Essure. This organization is keeping unsafe products on the market to get rich off of American pain.
Transvaginal Mesh
Doctors use transvaginal mesh patches to combat the effects of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the pelvic muscles weaken, causing the pelvic organs to descend from their normal place and bulge through the vaginal wall. The popularity of surgically implanting transvaginal mesh patches to hold organs in place has increased since the device’s 2001 approval, but unfortunately, adverse reports link this device to painful and serious complications.
Profiting From Pain
Vaginal mesh is actually modified hernia mesh. Pharmaceutical companies took a hernia mesh composite, recut the $25 piece of material, then started selling it for $2,000 to women with POP. All vaginal mesh devices went through the 510k process. The FDA did not require a single one to have an independent study. So, no one took the time to see what happens to women after doctors implant the mesh. The outcome is a disaster. As the mesh hardens and creates scar tissue, it sets off dozens of problems. These include perforation of the bladder and other organs, bleeding, infection, incontinence, and extreme pain during intercourse. One husband admitted that the device cut his penis during intercourse.
Johnson & Johnson trained surgeons how to put the mesh in, but the company never instructed doctors on removal. Once vaginal mesh scars into place, it cannot come out in one piece. The documentary, Bleeding Edge, shows a Johnson & Johnson researcher admitting that the company knew that retraction could lead to pain and invasive operations. However, they ignored the risks for profits.
FDA Sides With Big Pharma
Pharmaceutical companies are not content with the loopholes the 510k process gives them. In fact, 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 that 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 who used to represent Bayer in victim lawsuits.
Also, it is hard to receive help from the government itself not only since the FDA is being greased by Big Pharma, but also do 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.