Silicone breast implants 311 R.
(photo credit:REUTERS/Eric Gaillard)
LONDON - Women with breast implants made by a now defunct French company have no reason to have them removed but should seek medical advice if they believe they have ruptured, British health officials said on Wednesday.
French officials have said they will decide soon whether to offer surgery to remove the Poly Implant Prothese (PIP) implants from up to 30,000 women in France if research finds that the silicone they are made of might cause cancer.
Up to 300,000 PIP implants, which are used in cosmetic surgery to enhance breast size or replace lost breast tissue, were sold worldwide before PIP went into administration last year and use of the implants was halted.
In France, eight cases of cancer have appeared in women with PIP breast implants, sparking a health scare and prompting an inquiry by the country's National Cancer Institute (NCI).
But Britain's drugs watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) said there was "insufficient evidence to indicate any association with cancer."
"There is currently no evidence to support routine removal of PIP or any other type of silicone gel breast implants," a spokeswoman said.
The MHRA, a government agency responsible for ensuring that medicines and medical devices work and are safe, said it was aware of reports in France that a woman who had PIP breast implants recently died from anaplastic large cell lymphoma, or ALCL - a rare form of cancer which affects cells from the immune system.
It said however that its own tests in 2010 on PIP silicone gel breast implants found no evidence of the potential to cause cancer or chemical toxicity of the filler material inside them.
"The MHRA's current advice continues to be that women who have questions about their breasts or think their implants may have ruptured, should seek clinical advice from their implanting surgeon," the agency said.
French health authorities suspended PIP's marketing and sales of silicone gel breast implants in 2010 after an inspection of the company's manufacturing plant found that most implants made since 2001 were filled with an unauthorized silicone gel and not the originally approved material. The company is no longer trading.
The British Association for Plastic, Reconstructive and Aesthetic
Surgeons (BAPRAS) said it too had not yet seen evidence demonstrating
health problems may have been caused by PIP breast implants, but would
"fully assess any that becomes available".
France's health minister Nora Berra said on Tuesday the ministry would
make a decision this Friday on what to do next, once it has the
conclusions of its NCI inquiry.
If a link is established, French social security will pay for all women with the implants to have them removed, she said.
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