One thing the medical community learned in the last few years is the value of artificial joint registries. The Australian National Joint Registry and the National Joint Registry of England and Wales both detected problems with DePuy Orthopaedics’ ASR hip replacements. They found that the ASR failed at higher-than-normal rates, and in early 2010 DePuy withdrew them from the market. In August 2010, DePuy and Johnson & Johnson (DePuy’s parent company) recalled the ASR entirely. Clearly, the registries helped prevent many people from receiving the implants, but at the time the United States lacked such a registry, which endangered more people. Although the U.S. is now phasing in its own artificial joint registries, it appears that the European Parliament has taken steps towards establishing a European Union medical device registry.
Faulty Breast Implants Lead to Hearings, Action
A European Parliament committee, the Environment, Public Health and Food Safety Committee, responded to a breast implant scandal involving 400,000 implants made by the French firm, Poly Implant Pothèse (PIP), by passing a resolution calling for a medical device registry. The “PIP scandal” began in early 2012 when a study appearing in the Journal of Plastic, Reconstructive and Aesthetic Surgery found that the implants’ rupture rate could exceed 33 percent even though it was originally predicted to be between two and five percent. PIP is now defunct.
The Committee’s resolution boldly states, “The case of PIP implants, as well as the case of hip implants have shown a failure of the current system of certification of compliance … as well as of the controls of the notified bodies and their surveillance by national competent authorities.” It then adds, “It is essential to learn from this fraud and to strengthen surveillance and safety controls and placing on the market requirements” for medical devices.
The resolution received unanimous approval by the Committee’s members.
RLG Represents People Injured by Metal-on-Metal Hips
An EU medical device registry has the potential for going a long way towards preventing another PIP scandal, and in the future it might even help those who receive artificial joints. Registries will not, however, help those who already suffered an injury. If you believe your ASR device caused you harm, it’s important to know that the amount of compensation from a DePuy hip lawsuit might be greater than what the company is willing to offer you via its recall reimbursement program. You might be eligible for full medical expenses, lost income, and damages for pain and suffering. For a free, confidential legal consultation with a lawyer from the Rottenstein Law Group, just click on this link or call 1-877-312-3274.
For more information click here to download this free DePuy ASR brochure.