Watchdog plays down breast implant scare

BRITISH women with silicone breast implants have been told there is no evidence to support claims from a French company that they should be removed.

And a watchdog said there was no proof of any link to cancer from the implants.

French authorities are expected to ask 30,000 women who received a specific type of implant to have them taken out in the next few days.

Alexandra Blachere, campaign organiser, who had breast augmentation after the birth of her third child, said “there has been a wave of panic” across France.

But the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said yesterday there was no evidence to support removal of the implants, manufactured by Poly Implant Prosthese (PIP).

Some 50,000 British women are thought to have had the implants, which have been linked to a French woman’s death from a rare form of cancer called anaplastic large cell lymphoma (ALCL).

The implants are filled with an unapproved gel and there have been reports the protective barriers are faulty.

PIP has since closed and more than 2,000 women have filed legal complaints.

Jean-Yves Grall, France’s chief health officer, told daily newspaper Libération that any woman with PIP implants should go back for surgery to have them removed. Eight cases of breast cancer, of which one was fatal, have been linked to the implants from the company’s laboratories in southern France.

The MHRA said it was aware of the death in France but its own testing last year revealed no evidence of a link with cancer.

It said it had received no reports of ALCL linked with breast implants in the UK.

It went on: “Discussions with the relevant UK professional bodies have not identified any cases.”

The MHRA said results from its own testing “confirmed that there was no evidence of genotoxicity [potential for cancer] or chemical toxicity of the filler material inside these implants”.

It said there was no evidence to support women having to have the implants removed.

“The MHRA has reviewed available evidence for association of cancers for women with breast implants in consultation with the relevant UK professional bodies for breast surgery and surgical oncology and has concluded that there is insufficient evidence to indicate any association with cancer.

“Additionally, the MHRA worked with the cancer registry and could find no evidence for any association.

“The MHRA continues to monitor for any associations of all types of breast implants, including PIP, with cancers and considers new evidence which comes to light. The MHRA’s current advice to women with any type of breast implant continues to be that women who are concerned about their breasts, or think that their implants may have ruptured, should seek clinical advice from their implanting surgeon.

“There is no evidence to support routine explantation of PIP or any other type silicone gel breast implants.”

In June, the US Food and Drug Administration said women with breast implants might have a very small but increased risk of developing ALCL, which is a rare type of non-Hodgkin’s lymphoma.

It said a literature review identified 34 cases of ALCL in women with breast implants worldwide.

In total, the agency said it was aware of about 60 cases of ALCL in women with breast implants, but this was “a very small fraction of the five to 10 million women who have received breast implants worldwide”.