Product News and Recalls

EU agencies would have approved ‘toxic’ hip implant

A joint investigation by the Telegraph, a U.K. newspaper, and the British Medical Journal exposed flaws in the European Union’s regulatory approval process for medical devices.

The two publications essentially set up a sting operation by submitting approval applications to European regulatory agencies for an all-metal artificial hip implant similar to a model that’s already been recalled over safety concerns. According to the Telegraph, EU regulatory agencies were prepared to approve it anyway.

The report describes the model as a “toxic” hip replacement suspected of poisoning thousands of European patients.

That hip replacement, manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics, was also recalled in the United States in 2010 because of its tendency to break down after only a few years and shed toxic metal debris in patients’ bodies.

Reporters claiming to represent a Chinese company approached regulatory agencies within the EU. They submitted a technical dossier detailing a chromium and cobalt hip replacement explicitly based on the DePuy model.

The report quotes British Health Secretary Jeremy Hunt as saying: “The safety of patients is paramount so it is completely unacceptable that patients could be subject to substandard implants.”

You should consult with a doctor if you have any ongoing symptoms or health concerns from a DePuy hip implant. If you have significant injuries, you should also consult with a DePuy hip lawyer to discuss your legal rights.

See the story here:

http://www.telegraph.co.uk/health/9626756/Faulty-medical-implants-investigation-Patients-health-put-at-risk-by-unscrupulous-EU-regulators.html