BERLIN (AP) - Germany is recommending that women who have potentially faulty French-made breast implants get them removed as a precautionary measure.
Germany’s Federal Institute for Drugs and Medical Devices said Friday it was making the recommendation following information from doctors and other experts that silicon from the implants could leak and cause “possible health risks” even if the implants haven’t ruptured.
Its chairman, Walter Schwerdtfeger, said “how urgent a removal is in any given case depends essentially on how long the patient has had the implant.”
The institute had recommended last month that affected women have their implants checked for possible ruptures. It has no information on how many women received these breast implants in Germany.
THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP’s earlier story is below.
LONDON (AP) _ Britain said Friday that a review of the risk from potentially faulty French-made breast implants has found no link with cancer and no evidence to recommend their routine removal from 40,000 women in the U.K.
But Health Secretary Andrew Lansley said any U.K. patient with implants made by the now-defunct French company Poly Implant Prothese, or PIP, that were put in by the state-funded National Health Service would be offered an assessment and could have the implants removed for free if doctors believed it necessary. That would affect mostly former cancer patients, for the NHS does not do cosmetic surgery without a medical reason.
“There is not sufficient evidence to recommend routine removal,” Lansley said in a statement following a review by medical experts, who concluded there was no link between the implants and cancer.
Lansley also urged private medical centers to offer the same deal to those who had paid for cosmetic surgery.
“We believe that private health care providers have a moral duty to offer the same service to their patients that we will offer to NHS patients,” Lansley said.
However, his ministry said the non-medical grade silicone used by PIP “should not have been implanted in women in the first place,” and outlined its offer to provide examinations and possible removals for thousands of women.
Lansley said Britain and France were cooperating over the issue and planned to consult other European countries in the hope of preventing similar problems in the future.
PIP’s website says the company exported to more than 60 countries and was one of the world’s leading implant makers. The silicone-gel implants in question were not sold in the United States.
France has said it will pay for some 30,000 French women to have their implants removed, after more than 1,000 ruptures of the PIP implants, which were pulled from the market in several countries in Europe and beyond due to fears they could rupture and leak silicone into the body. Colombia and Venezuela have made similar offers.
France’s Health Safety Agency says the suspect PIP implants appear to be more rupture-prone than other types. Investigators also say PIP sought to save money by using industrial silicone instead of medical silicone.
In the Czech Republic _ where the implants were banned in 2010 _ the country’s health ministry on Friday recommended about 2,000 Czech women with potentially faulty implants should have them removed.
The Czech health ministry said it would negotiate with the country’s health insurers on how to cover the cost. Those women who refuse to have the implants removed should undergo regular health checks, it said. “No imminent risk of serious health problems has been proven,” the ministry said.
According to estimates by national authorities, over 42,000 women in Britain received the implants, more than 30,000 in France, 9,000 in Australia and 4,000 in Italy. Nearly 25,000 of the implants were sold in Brazil.
Australia’s medical watchdog, however, says health officials had found no evidence that the PIP implants had an increased risk of rupture in Australian women, and said lab testing of the silicone gel used indicated it was nontoxic to nearby tissue even if the implant did rupture.
Please read our comment policy before commenting.