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Unauthorised replacement hips fitted to 650 in France

No reason, say health officials, to believe the non-certified prosthetics pose a health risk but surgeons will carry out checks on patients.

La rédaction de Mediapart

This article is freely available.

French surgeons have fitted 650 people with replacement hips that had not been certified as meeting European standards, it emerged in a case with echoes of a scandal over faulty breast implants, reports AFP.

Health officials said there was no reason to believe that the non-certified prosthetics posed any health risk but the surgeons involved have been asked to carry out checks, including scans, on the patients concerned.

Pending the outcome of those, an investigation has been launched into the manufacturer, Ceraver, and around 1,000 of its artificial hips have been confiscated, the national agency for medicine safety (ANSM) said on Thursday.

The safety agency is also studying claims that newly developed Ceraver metal pins that had not received official clearance were implanted into four patients without them knowing they were effectively taking part in an experiment.

Ceraver is France's second-biggest manufacturer of artificial joints with an output of around 3,000 prosthetic ankles, hips, knees and shoulders a year.

In an ongoing trial, several executives of French company PIP are accused of producing breast implants with unauthorised industrial-grade silicone gel and fraudulently passing them off as having met European Union health safety standards.

Read more of this report from AFP.