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SURGERY

France hit by new scandal over prosthetics

France was hit by yet another medical scandal on Thursday when it emerged that surgeons have fitted around 650 people with prosthetic hip and knee replacements that had not been certified as being up to European standards.

France hit by new scandal over prosthetics
Another French medical scandal, this time over artificial joints Photo: DPStyles/flickr

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

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has been launched into the manufacturer, a company called Ceraver, and around 1,000 artificial hips have been withdrawn from circulation, the national agency for medicine safety (ANSM) said.

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.

The implants, which were fitted to an estimated 300,000 women worldwide, were subsequently discovered to rupture twice as often as those made with medically approved gels.

The non-certified artificial hips were sold to around 60 French hospitals. None were exported and, to date, there have been no reports of problems with them, the ANSM's deputy director-general, Francois Hebert said.

The company's failure to abide by correct procedures was discovered during unannounced inspections of Ceraver's two production centres near Paris in early April following a tip-off from a whistle-blower.

The company's CEO-Chairman, Daniel Blanquaert, admitted in an interview with newspaper Le Parisien, which broke the story, that there had been irregularities in the labelling of the artificial joints.

"We are in the wrong," he told the paper. "But for us the modifications we made to the joints were minor and did not justify going through the whole certification process again, which would have taken one to two years."

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HOSPITAL

Furious Frenchwoman forced to fly to US to get new hands

A French amputee has hit out at her country's health system claiming she was forced to get a double hand transplant on the other side of the Atlantic - even though France was the first country in the world to do a hand transplant.

Furious Frenchwoman forced to fly to US to get new hands
Photo: AFP
A Frenchwoman called Laura was 19 years old when a sepsis infection left her with no choice but to have her hands amputated below the elbow. 
 
Now aged 28, the woman has told how this summer she decided to get two new hands in an operation in the US rather than wait around for France to help, reported Le Figaro newspaper
 
“In France we have the medical means to do this kind of surgery. It's heartbreaking, it's maddening, it's outrageous,” she told the paper. 
 
And she's right. France is a pioneer in the field of hand transplants, and was actually the first country in the world to carry out a successful hand transplant, which took place at a Lyon hospital in 1998.
 
But the operation today is a costly one filled with administrative hurdles. 
 
Laura reportedly spent two years on the waiting list in France after going through all the administrative mazes, only to hear nothing from the hospitals. 
 
Her doctor in France said that to make matters worse, nurses hadn't even been told that they should be asking the families of the deceased whether they'd give the green light to donate the hands of their dead relatives. 
 
Eventually, the Frenchwoman was told that she had been removed from the waiting list. 
 
Deterred but still determined, she contacted a leading doctor in Philadelphia to ask for his help. 
 
By late June this year she was on the waiting list, and she got a call in late August to say there was a set of hands waiting for her. 
 
Within a matter of days she was undergoing a mammoth surgery effort – that involved 40 medical workers and took eight hours – and the Frenchwoman was able to leave the hospital last week with two new hands.  
 
By the end of this month, she will return to Paris to carry out the rest of her rehabilitation on home soil. 
 
The story has proved inspirational for at least one other amputee in France, who has added herself to the same waiting list in the United States. 
 
“It's a shame to be massacred in a French hospital and then have to head to the US to get put back together,” the second amputee told Le Figaro. 
 
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