Right now, nearly 70 million Americans have been implanted with metal or plastic medical devices. We trust that these devices are all safe, but are they?
When it comes to our health and the health of our family members, we want the absolute best. Innovation is needed to move our society forward and save lives, but at what cost? It took over 40 years to determined that Teflon was toxic, but before that, we placed it into our bodies and prepared our food on it. How long will it take to find out if the new non-stick ceramic coatings, such as Sol-gel are safe or toxic? When it comes down to our health, taking a look at what we are putting into our bodies is critical. From the medical industry, we can see how fast-paced innovation without extensive testing has had dangerous consequences, and as a society, we need to be more aware of the dangers that exist with compounds and devices that we put into our bodies. What may appear or be marketed as safe with doctor recommendations or statements can be the result of a product pushed towards approval with little or no research or 3rd party or double blind testing.
Medical devices are a way of our entire life, even before we are born. As a parent, I have seen my unborn son on the ultrasound machine and heard his heartbeat. It is incredible what medical devices can do. Unfortunately, we often do not question the science that goes behind products that are marketed or recommended by doctors. There is a level of unwavering trust that we have towards believing that the medical devices used on us are safe.
Medical devices have been developed to improve our health, create artificial limbs, improve sight, heart rhythm, and save lives. Innovation is not the problem, but it is our rush to solve problems and also get new products to market that sometimes leaves us in a worse position. You hear much about large pharmaceutical companies having the power, but the medical device industry has much momentum and has been expanding quicker than the science behind them.
Regulatory Concerns
Devices are far less regulated than pharmaceuticals. Surprisingly, manufacturers did not have to prove that their products were safe or effective before being used in patients until 1976. At that time, the 94th Congress of the United States enacted the Medical Device Regulation Act amendments. Even with this passing, due to industry push back, devices in use before the amendment did not have to go through the battery of tests.
Even with the amendments, the testing standards have not managed to keep up with the rapid pace of medical device advancements. This progression has left the testing standards antiquated and open to interpretation. What is even more shocking is the use of the 510(K) process that was passed by Congress. The objective was to speed up medical devices reaching the market without any testing as long as the new device designed is essentially equivalent to a previously approved device. A dangerous chain was created since all a manufacturer had to do was cite that it was an updated version of a previous device. It gets even more concerning because a manufacturer could even cite a product that was recalled from the market and still get approval under 510(K). A device could be recalled, and with no testing, a new medical device was ready to be marketed as long as it was essentially equivalent to the recalled device.
Example 1: Essure
Bayer Health went through the medical device approval process with the FDA in 2002 for their new birth control device that would be implanted into the fallopian tubes. Their primary focus and selling points were that the product was 99% effective at sterilization and that the procedure was minimally invasive.
The study for approval only lasted a year and a half for a device implanted into a woman's body for the rest of her life. Only a handful of patients were used in the study. Compare that to a pharmaceutical approval process, which requires two studies and hundreds of patients before receiving FDA approval.
Many of the women implanted with this device had their lives forever changed. In the more extreme circumstances, there were over 800 pregnancies that failed because of the product and a large number of women were required to have a hysterectomy. Cramping and continual bleeding were among most of the typical patients' symptoms, which then progressed until surgery was the only option. Often doctors would attempt to remove the device, but by design, it generated scar tissue, which caused fragments of the device to break off into their body. This often led the patient back to surgery for a hysterectomy or auto-immune issues. These auto-immune disorders took years to be linked to the metal fragments from the device. Even women without those initial complications still had to deal with the metal fragments of the device being released into their body over time.
As of a 2017 report, more than 3,700 women have filed lawsuits against Bayer and the losses because of it in 2016 were $413 million.
Example 2: Metal on Metal Hip Replacements
There are a variety of different types of hip replacements to form the joint. There are a variety of hip replacement devices including ceramic on ceramic, ceramic on plastic, metal on plastic and metal on metal. Through the 510(K) process, metal on metal implants was approved with no testing on the implications because it was deemed equivalent to other methods. The company’s marketing the metal on metal hip replacements were strongly focused on highly active individuals.
We talk a lot about the dangers of metal toxicity in the body, and this is no exception. Chrome cobalt is the metal that is often used for joint replacement. As the patient used the device, metal fragments of cobalt was being released into their body as the hip replacement ground its two parts together. For the active individuals it was highly marketed for, higher levels of activity would quickly wear down and release more cobalt into their bloodstream.
Cobalt poisoning is a very serious thing that can cause cardiomyopathy, deafness, nerve issues, tinnitus, and issues with memory. What is so shocking is that we surgically implanted a medical device that contained high quantities of cobalt with no medical testing. It was sold as the next best thing. One patient that had a metal on metal hip replacement saw cobalt levels in his blood 100 times higher than normal. He was experiencing all of those symptoms of cobalt poisoning and eventually had the hip replacement removed and replaced with a ceramic on plastic device. During the surgery, doctors found that the metal on metal implant had worn itself down and had been releasing the toxic element into his blood. Shortly after removing the device, the symptoms went away and cobalt levels in his blood returned to normal.
What is concerning about this issue is how many people with metal on metal hip implants misdiagnosed as having neurological issues that are permanent, rather than reversing the high levels of cobalt in the blood.
Towards the end of last year on December 9th, 2018, Johnson & Johnson settled a series of lawsuits for $413 million. Pinnacle, another company that made these devices has paid over $1.7 billion in damages from the metal poisoning caused by these devices.
Example 3: Vaginal Mesh
Johnson & Johnson had a mesh that was often used in hernia operations, which some doctors would cut and use portions to support weak tissue for pelvic floor treatments. Since the mesh product was already an existing device, the new vaginal mesh implant devices were approved through the 510(K) process with no studies on humans before it went to market.
These devices essentially create scar tissue to strengthen surrounding body tissues. The problem is when it is surgically placed on the pelvic floor; the scar tissue begins to harden and create a structure in the pelvis, which is an area that needs flexibility. Patients that had this device implanted frequently experienced complications including chronic pain, infections, bleeding, and urinary problems. The unfortunate problem with this device is that it is nearly impossible to remove in its entirety and even with attempts at removal the hardened scar tissue remains.
Over $300 million has been paid out by Johnson and Johnson on settlements.
An Observation on Innovation and Health
Medical innovation is not a bad thing, but without proper vetting and testing of these devices, we put ourselves and our families at risk. Marketing dollars and for-profit companies are often the drivers to get these new innovations to the market as quickly as possible, with indifference towards success or long term patient health. New medical devices are the same as unproven devices, promoted by marketing with the objective for generating profits rather than developing a healthier world.
Moving Forward
At Xtrema, our focus is on health and our products are designed specifically for that reason. What we put in our bodies surgically or through the food we eat has an impact on our health as a whole. Ceramics have been in development for over 10,000 years. It is a product proven to be safe and protect against metal toxicity or toxicity from other chemical compounds. When new non-stick coatings are invented for metal cookware, how long do we have to wait to find out that they are might be toxic? It is important to do your research and choose products that have been thoroughly tested and not simply rushed to market under the smokescreen of innovation.
