The German Government has proposed legislation to create a national register to improve controls on medical implants such as pacemakers, breast implants and artificial hip joints.
The bill introduced in the German parliament on January 29, was published just two months after the November 2018 release of the International Consortium of Investigative Journalists’ Implant Files. The investigation involving 58 international media organizations revealed how governments around the world hold even the riskiest devices to lower safety standards than most drugs.
A Ministry of Health statement to German newspaper Süddeutsche Zeitung said the Implant Files had encouraged the Government “to consider how the existing system of approval and monitoring of medical devices can be improved.”
Süddeutsche Zeitung reporter and ICIJ member Frederik Obermaier, who collaborated with colleagues from German broadcasters NDR and WDR on the Implant Files, said it was no accident that after years of mooted legislation in Germany, the Implant Files appeared to be a catalyst for change.
“Currently there is hardly any available data on the safety and efficacy of implants in Germany: patients cannot even find out which defective products have led to the most deaths in recent years,” he said.
However, Obermaier cautioned that a comprehensive, public register would be required. He also emphasized that the legislation, which is expected to become law in 2020, is still in draft form.
“Only a public register that is mandatory for all products will really help patients and it is therefore too early to evaluate the proposal – the relevant law still has to be passed and the register built,” he said.
If the legislation is passed next year, it would still take a further three to five years to compile the register, according to Federal Health Minister Jens Spahn. Among other things, it would contain details on the deployment of various implants as well as on those that were surgically removed and the reasons for their removal.
Over time, this should allow researchers to determine which implants were more likely to cause injuries or even fatalities.
Under the present system, patients must rely on their doctors to inform them of any potential defects based on information provided by manufacturers. As the Implant Files showed, it often took weeks or months to inform patients that they had been fitted with a potentially lethal device.