Recently, a Dutch television broadcast alerted to the ease with which implantable medical devices can be applied in patients. Radar TV is one of the most influential consumer platform on Dutch television and it is to be hoped that this will have a broader effect on the use of medical devices, with an emphasis on patient outcomes.

Radar submitted an orange packing mesh as a surgical mesh for pelvic organ prolapse. Although it was not made clear that the approval from the notified body was actually received, the notified body indicated that a CE approval would not be much of a problem. This is a known problem; new devices can be put to the market with only a CE approval from a notified body. There is a serious conflict of interest problem here as a denial from the notified body could cost them future costumers. Further, the requirements for new implantable devices are limited. New devices can be approved if they show conformity to existing devices. This has resulted in many copycats in the medical device industry. Of course patents prevent the copies from being comparable, so why should the effectiveness and safety also be comparable? The notified body should be forced to increase their quality of assessment. This should include patient outcomes and safety of the specific product. One step to the solution would be make the notified bodies more independent, for example forcing open access to the information that led to the approval.

This is of course only a part of the problem. Medical devices are not drugs. Use of health care interventions should be based on their safety and clinical effects. In medical devices, clinical effects are more difficult to assess than with pharmaceutical interventions, where the placebo-controlled, double-blinded study design is required. Medical devices can have many variations in shape, size and mechanical properties. Effects can only be assessed in the very long periods. For example the Meta-Metal hip implant only showed its detrimental effect on wear particles after many years. By then many patients had been implanted the new and innovative device. These effects are difficult to assess with clinical trials and these are thus quite scarce.

We have to acknowledge that a clinical trial on every medical device is unfeasible, except for the very large-quantity implants. This means we have to assess the effect with other means. New devices should be gradually introduced with limited amount of patients who are followed for clinical effectiveness compared to known effects of the golden standard. Safety issues should be actively monitored looking at a wide array of possible problems that may arise with the specific device.

Medical specialists are left with a limited amount of evidence and a large offer of devices when deciding on a treatment for a patient. The patient should be made aware of this. Medical specialists should thus inform themselves and their patients on the clinical effectiveness and safety of the implants that are used in their hospital. Hospitals should seek help from clinical expert and epidemiologists in getting this information and safeguarding their patients from possible harms.

The solution to the problem is in the hands of all parties. The industry should assess clinical effects and safety of new and innovative devices in a limited, well-informed, amount of real patients. Doctors and their institutes need to acquire knowledge on the safety and effectiveness of these interventions and inform the patient before a shared decision for treatment is made. Governments should impose stricter rules for these devices, demanding clinical results before a new device is fully allowed to the market. It is to be hoped that the EU will implement stricter regulations for the use of medical devices in patients. The attention, also from EU parliament members like Glenis Willmott is promising, but I truly hope it will be in time before a new dramatic case puts our patients at risk for a healthcare intervention with unknown clinical effects and safety.