I had five screws implanted in my back at age 13. Then I learned of spinal implants improperly tested. Can we know if medical procedures are safe?
Photo illustration of a doctor examining a woman’s spine. (Credit: Albina Gavrilovic)
This article was authored by a student at Realgymnasium Rämibühl in Zürich, a News Decoder school partner, who asked that their name not be published. Learn more about how News Decoder can work with your school.
It has taken a while, but I’m gradually getting used to the fact that I will live the rest of my life with a medical device in my back.
Three years ago, I received a spinal implant. It’s composed of a titanium rod, to which five screws are attached that have each been drilled into a segment of my spine to help stabilise it.
As time passed after the operation, I was surprised to find that I couldn’t feel it at all. The only sign of it being there is that I can no longer bend my lower back, which has proven to be less of an issue in my life than originally expected.
I was 13 at the time, and most of the decisions were made by my parents and the medical professionals involved. Often, the condition I have called scoliosis can be dealt with by doing physiotherapy and/or carrying a back brace.
In my case, the scoliosis — a curvature and rotation of the spine — was already too far advanced. Unusually for such cases, I didn’t feel any pain. This may have contributed to the fact that it was noticed so late on in its development. At the time I didn’t quite realize it, but looking back, I was lacking a lot of information surrounding the whole procedure of the surgery and implant involved.
Spinal implants can improve quality of life.
I was lucky to receive high-quality recommendations from various professionals that had my best interests at heart. Even though I have had a hard time accepting myself due to this condition, over the years, I have come to appreciate the uniqueness the implant has given my body and how I am able to live a healthy life due to it.
Recently, I discovered not everyone is as lucky as me. I learned of an implant scandal regarding the Cadisc-L medical implant. It varies from mine in shape and material, as the two have opposite functions.
While mine was used to pull my spine into a straighter position, leading to me not being able to bend my lower back, Cadisc-L is a spinal disc implant designed to aid spinal mobility and was first implanted around 2010. It was made of synthetic materials, and consequently eroded in the bodies of the carriers. As a comparison, my implant is made of titanium, which is a metal resistant to erosion.
“You cannot make compromises on people’s safety,” said Bart Volckaerts, a medical device professional who explained the standard processes during the development of an implant.
Unfortunately, this is not the case everywhere. The Implant Files, an investigation by the International Consortium of Investigative Journalists (ICIJ) reported on the damage brought on by medical devices that have undergone insufficient or no testing at all. It found that several governments in Africa, Asia and South America don’t regulate medical devices. Instead, they rely on European regulators or the U.S. Food and Drug Administration. Defective implants can range anywhere from defibrillators to hip replacements, breast implants and mesh products.
Investigative journalism and medical devices
The ICIJ published the Implant Files in 2018 to push for transparency in the field of medical devices, something I consider important from personal experience. When you aren’t a specialist in a field, you rely on professionals to give you the best advice and medical treatment possible, and this is only possible through transparency between the medical professional and the patient.
Swiss patients were among those who received Cadisc-L devices. Switzerland is not one of the world’s more corrupt nations, according to the CPI (corruptions perception index) and it has a high overall healthcare system score considering its small size, so it’s unsettling to hear that something like this can happen even in such a developed country.
According to Swiss Newspaper Podcast “Apropos”, Max Aebi, a Swiss spine surgeon, was one of the leading professionals in the development and production of the Cadisc-L device. A report by one of the surgeons involved reveals that baboons used as laboratory animals were the first victims.
Apropos disclosed that after implantation, the baboons were euthanized and their cadavers scanned in a computer tomograph, revealing shocking results; the implant itself cracked and shifted, and erosion took place around the spine.
As reported by the podcast, after a meeting with the company Ranier Technology, a British company trying to bring Cadisc-L onto the market, it was nevertheless decided to start a case study with 29 people according to the Guardian newspaper which reported having seen documents. Testing on humans lasted eight months, when usually the testing period for a product like Cadisc-L requires at least five years until one is able to say anything long-term.
“A lot of elements need to be clarified before you go to the final test on humans,” said Volckaerts. An example for this is biocompatibility testing. This ensures there won’t be any allergic reaction or skin irritations cause by the materials. In the framework of biological safety, information must be gathered in both qualitative and quantitative forms about the components of the devices.
Animal testing in medical research
Apropos reported that the humans in the study showed the same results as the monkeys. However, the implants stayed longer inside humans, and with time, the problems for the affected patients kept worsening.
Even though testing on monkeys, as well as on humans was unsuccessful, the medical device was approved by a private examination board, rather than by a state authority. And it received the CE safety mark which allowed it to be marketed throughout Europe.
“All the standards that we are complying to are contributing to give us as developers the confidence, that indeed, we are delivering a safe and performing product,” Volckaerts said. “It’s unethical to bring something on the market that you know already will not perform or will be unsafe.”
According to the podcast, Cadisc-L got implanted up to 200 times in Germany, as well as in other European countries and reports about it never surfaced until the company hired new employees in 2014. The employees collected the complaints and published them, leading to the company to withdraw the product from the market. Of the 200 victims, around 80 patients had to have their implants removed.
“At the end of the day, when you have a device that is not addressing all those requirements, it will hit you much more severely than actually spending another few months designing and having a successful product,” Volckaerts said.
Money in the market for medical impants
More than 1.7 million injuries have been identified by the ICIJ in data analysis from the United States that may be related to medical devices. According to Fortune Business Insights and Grand View Research, the worldwide medical device market in 2022 was estimated to be worth $495 billion, whereas the global spinal implants and devices market is worth $12.8 billion. Both these numbers are expected to increase.
A cost analysis study published in 2019 revealed that direct costs of primary single-level lumbar fusion procedures ranged from just over $8,000 to almost $74,000. Surgical supplies made up around 44% of the costs and the spinal implants accounted for nearly 85% of those surgical supplies.
It would make sense that the more levels you add, the pricier the direct costs get. To put this into perspective in a real-life scenario, while this study was made on people getting a single-level lumbar fusion which includes two screws, I had five, making it a four-level lumbar fusion as there were four gaps between the five screws.
Making a calculated assumption, my spinal implant’s cost would be somewhere around $25,000.
This goes to show how the expenses of spinal and overall medical implant surgeries vary greatly. And while one must consider different costs based on each individual surgery, it demonstrates that money will always be a leading driver for device makers rushing products to market.
Medical research must prioritize safety.
So, how can people around the world like me be sure that their implants are safe? How can we be sure these implants will improve our life instead of impairing or even ending it. The answers are not always black and white. It helps to know the backgrounds of the devices, how they are made, how they affect people and how important safety is to the developers.
“The regulator is also a strong voice in the process,” Volckaerts said. “They are defining to which standards the device needs to comply.”
The first phase of a project involves defining the specifications and requirements of the final product. Once this has been approved, the designing process of the project starts. Different concepts are developed and compared.
“We are looking into which concept is following most and addressing most of those requirements,” Volckaerts said.
Verification involves testing in the lab while validation requires testing on patients, he added. In both cases, certain standards must be followed.
“Then we need to gain regulatory approval, we go to the regulators and ask whether they are fine with us bringing this to the market,” Volckaerts said. “And they are evaluating the design file, from the first phase to the last and checking whether indeed we are complying to all the standards they are expecting us to.”
With proper protocols implants are safe.
I was relieved to hear that the safety and performance of the device is prioritized.
Only when every phase the product goes through is carefully analysed and approved can the product be released on the market. From the user needs to the design input, process and output, as well as the final medical device, all the steps are reviewed, verified and validated as they all influence each other. These are standard processes implants go through to ensure maximum safety and performances on a high level.
“Everything that counts to me is, again, the customer,” Volckaerts said.
Hearing this process from someone dedicated to developing a safe and life-improving device satisfied my doubts about implants. They’re complex devices, able to improve or lower our quality of life. Despite some frightening cases, there are still people like me, whose implants have led to an improved and healthy life with no complications.
As they are meant to.
Three questions to consider:
- Why would a medical device maker rush a project to market when safety has not been proven?
- How can a patient know if a medical device is safe before agreeing to have it implanted?
- What steps can be taken to make medical devices safer?
This is a really helpful article. We all know people with implants and the impact that those have in their lives. Your experience and comments are extremely valuable to other people. Thanks for sharing them, and thanks for writing such interesting article