It’s 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 medical spinal implant to help stabilize my spine. It’s composed of a titanium rod, to which five screws are attached that have each been drilled into a segment of my spine. 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 taken by my parents and the medical professionals involved. Often, the condition I have called scoliosis can be dealt with physiotherapy and 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. However, 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 was made aware of an implant scandal regarding the Cadisc-L medical implant. This implant varies from mine in shape and material as the two also 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 comparison, my implant is made entirely of titanium, which is a metal resistant to erosion.
„You cannot make compromises on people’s safety,“ stated Bart Volkaerts, a medical device professional who explained the standard processes during the development of an implant to me in an interview. The subject of safety is the most stressed point when developing a medical implant. Unfortunately, this is not the case everywhere, as the implant files, an international investigation that monitors the damage brought on by medical devices that have undergone insufficient or no testing at all that, show. 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. These defective implants can range anywhere from defibrillators to hip replacements, breast implants and mesh products. The implant files project was published by the International Consortium for Investigative Journalists in 2018. Their goal is to increase transparency in the field of medical devices, something I consider a key element to a successful implantation 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, and 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 the leading professional 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, they were euthanized, their cadavers scanned in a computer tomograph, revealing shocking results; the implant itself cracked and shifted, erosion took place around the spine.
As reported by Apropos, 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 which the Guardian claims to have seen documents of. Testing on humans lasted 8 months, when usually, the testing period for a product like Cadisc-L requires at least 5 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,” explained Bart V., 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.
Apropos stated 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 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,” expressed Bart V., “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 withdrawing their 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.”
Even though this scandal happened on a smaller scale than others already have, 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. 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. Being informed about the backgrounds of the devices, how they are made and how they affect people is essential knowledge that must be acquired before deciding whether one should consider getting it implanted. Knowing how an implant is developed may provide the patient with the reassurance needed to determine whether they are comfortable with carrying it.
„The regulator is also a strong voice in the process. They are defining to which standards the device needs to comply to,“ Bart V. explained. Determining the project specification which are translated into requirements are steps that come together to form the project definition phase that focuses primarily on the specifications and requirements of the final product. Once this phase 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,” commented Bart V. Compromises are made with focus on the most important requirements of the implant. „Verification, that’s testing in the lab and validation is testing on patients,“ he clarified. Testing can be done in the lab and on humans. 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. 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.“ It was relieving to hear, that the priorities here lie again in the safety and performance of the device. 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,“ were the words that stuck with me most, truly showing the importance of the patient and their safety to the people involved in the development process.
Hearing this process from someone dedicated to developing a safe and life improving device reassures my doubts about implants. They’re complex devices, able to severely improve or lower our quality of life. Although statistics like depicted above show frightening data, there are still people like me, whose implants have led to an improved and healthy life with no complications, as they are meant to.