In December, reports that breast implants made by Poly Implants Protheses SA were leaking industrial silicone led French and German officials to recommend that thousands of women have the implants removed.
The hips the researchers studied included those made by New Jersey-based J&J; Zimmer Holdings of Indiana, and a London company, Smith & Nephew Plc (SN).
Because medical devices don't need the same type of clinical testing in Europe required of new drugs, the hips were implanted in patients without adequate safety studies, the researchers said. Potentially risky design changes made over the past 10 years weren't flagged by regulators and brought to the attention of doctors and patients.
Heneghan said procedures for medical device approval in Europe are less stringent than in the United States. In the United States, tests of medical devices are government-run under the Food and Drug Administration, and manufacturers must provide proof of safety and effectiveness. In the EU, however, manufacturers need only prove the devices are safe, and they can choose from about 70 private firms, called "notified bodies," to test their products, the Bloomberg report stated. Approval from one firms enables the manufacturer to market the device throughout the 27 EU nations.
Study co-author Nick Freemantle, professor of clinical epidemiology and biostatistics at University College London, said the current approval standards are dated. "The methods of device regulation seem to be more from the 1950s than the 21st century," he wrote in the study, Bloomberg reported.
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