IGJ response to Trouw and Radar reporting about medical implants

Attention for the safety of medical devices is increasing. Recent years have shown that serious problems can occur, particularly with implants. Issues with PIP breast implants and metal-on-metal hip implants have been illustrative. Since then, safe implants and their safe application have become even more of a priority in the market surveillance activities of the Inspectorate. Many improvements have already been implemented, and are still ongoing. On Monday, 26 November, Trouw and Radar reported on the international surveillance of medical devices.

Implants also save lives. We can no longer imagine a world without medical devices. We have to accept small risks in order to improve the quality of life of many people. Innovation is also needed and market surveillance must take this into account. However, we must be able to quickly identify any structural shortcomings. This requires collaboration between manufacturers, healthcare providers, patients and regulators.

New European legislation for medical devices has already been adopted, which is currently being phased in and will fully apply in 2020. This legislation imposes substantially stricter requirements on manufacturers of medical devices. Not only on the approval of new products before entering the market, but also on active post-market surveillance with regard to collecting experiences with the devices in daily clinical practice. All of these requirements have been put in place to further improve the safety of medical devices.

Furthermore, the new legislation pays special attention to increased transparency for both patients and health care professionals. Manufacturers are obliged to make more information publicly available, in a way that is understandable to patients. An extensive European information database will be established in which manufacturers and authorities will store all information (such as vigilance reports and safety warnings) about medical devices. Relevant information for patients will become publicly accessible in this database.

Risks need to be discussed

The Inspectorate reiterates that patients need to be well-informed. Although implant use involves risks, it can save lives. Therfore, physicians need to discuss the advantages and the risks of an implant with their patients. With this information, the patient can make a well-informed decision. The additional information that manufacturers need to make public will be able to help in this process. The Inspectorate will contribute to the transparency by publishing information on identified issues and safety warnings on its website. We are constantly working on making this information more accessible and will in particular take traceability of safety warnings into account.

The Netherlands has already implemented several specific improvements in anticipation of the European measures. For example, a national implant registry has been developed in which healthcare providers register data regarding implants. Such registration currently occurs on a voluntary basis, but as of January 1st, 2019 healthcare providers will be legally obliged to do so. From the same day forward, physicians must provide patients with written information about their implant.

In addition, a Notification Point for Complications of Implants has been established where patients and healthcare providers can easily report any unexpected events involving an implant. All patients and healthcare providers can report there. Potential problems with medical devices can also be reported to the National Healthcare Report Centre. To ensure comprehensive market surveillance, all possible user experience is needed.