European Lobbying Impeded on Safety of Medical Devices
Article Link: https://www.icij.org/investigations/implant-files/how-lobbying-blocked-european-safety-checks-for-dangerous-medical-implants/
Article Title: How lobbying blocked European safety checks for dangerous medical implants
By Simon Bowers
In recent years, there have been two major attempts to increase safety regulations for medical implants in the European Union. However, lobbyists have shot down both of these reform attempts by misleading policymakers about their products.
Public health spokespeople criticize the European Union for its lax regulations and speedy approvals of medical implant devices. As proof of this, they point to the fact that “the EU has borne the brunt of many of the world’s worst implant scandals,” which have caused patients to suffer and even die because of their implants.
The Implant Files is a year-long investigation that involved over 250 journalists around the world. Their extensive investigation found that medical technology has advanced very quickly, but the laws surrounding them have not kept up. As a result, patients with medical implants have suffered from faulty devices entering the market too quickly.
Experts have found that the time it takes to approve medical products in the US has gotten shorter and shorter, which has created massive profits for medical device companies.
It’s even easier and quicker to get products approved in Europe, which has “some of the lightest regulations in the developed world.” Medical device lobbyists based out of Europe have encouraged other countries, including the United States, to adopt Europe’s relaxed policies.
These trends apply to all sorts of medical devices, including metal-on-metal hip implants, which have been some of the most controversial medical products to hit the market in recent decades.
Jurgen’s hip
Because the laws are so relaxed in Europe, medical device manufacturers like to introduce their products in Europe first. Once their products have been approved in Europe — which acts as a stamp of approval for the rest of the world — it is much easier to get them marked as safe for consumption in other countries.
The article tells the story of Jurgen Thoma, who was 48 when he received a metal-on-metal hip implant in Germany. His implant, manufactured by Zimmer Biomet, had not been approved by the FDA when he received it in 2005.
Europe legally classified Zimmer Biomet’s product as “safe for use” two years before Jurgen’s surgery, in 2003, despite not having a single human study testing its product. European laws did not require Biomet to test their implant on humans before marking it safe for consumption.
Thoma said that the hip implant quickly became painful. In 2009, just four years after getting his implant, Thoma had to get a revision surgery to replace his device. The surgeons found that the implant was shedding metal debris. As a result, his bone became spongey, soft, and grey. Thoma said his bone looked like Swiss cheese.
Thoma said that, because of Europe’s poor safety standards, he felt he had become the “guinea pig” for the product.
He decided to sue Zimmer Biomet in 2010. In 2018, a judge in Germany declared that the Zimmer implant “should not have been put on the market,” and Thoma received only $28,600 for his injuries at the end of the eight-year legal battle. Zimmer has since denied any problems with their product and appealed the court’s decision.
That being said, the article states that Thoma is relatively lucky because European laws tend to protect manufacturers over consumers.
Scandals and Loopholes
The article goes on to talk about a 2010 scandal involving metal-on-metal implants. Many metal-on-metal implants were pulled from the market as people began to realize that they were failing at extremely high rates.
As the scandal unraveled, a group of journalists went undercover, posing as metal-on-metal hip device manufacturers, and visited EVPU. EVPU is a Slovakian firm that the government has put in charge of testing whether products are safe for use in the European Union.
The journalists presented the EVPU with a mock-up drawing for a fake metal-on-metal hip implant, which was designed to be identical to a hip implant that had already been recalled. The EVPU approved the fake hip design. The exchange exposed blatant corruption and carelessness in medical device regulation.
