French authorities act over breast implants

The French authorities have recommended that thousands of women with implants made by the French company Poly Implant Prostheses (PIP) should have them them taken out at the state’s expense, “as a preventive measure not of an urgent nature”.

There have been concerns that they could be linked to cancer, but France’s health minister said there was no evidence of an increased incidence of the disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) said there was no case for need for “routine removal of PIP breast implants” in Britain.

It was supported by Health Secretary Andrew Lansley, who told the BBC: “At the moment we are in a position where we have no evidence of a link to cancer. We have no evidence of toxicity, we have no evidence of substantial difference in terms of ruptures of these implants compared to others. So we don’t have a safety concern that would be the basis for the routine removal of these implants.”

Cancer

The implants have been linked to the death of a French woman from a rare form of cancer called anaplastic large cell lymphoma (ALCL), and are implicated in another seven or eight cancer cases.

The implants are filled with an unapproved non-medical grade silicone believed to be made for mattresses and there have been reports that the protective barriers are faulty.

But the MHRA said in a statement on its website: “Our current advice to women with PIP breast implants continues to be that should they have any questions about their breasts or implants, that they should seek clinical advice from their implanting surgeon. There is currently no evidence to support routine removal of PIP breast implants.”

More than 270 women in the UK intend to sue clinics where they underwent surgery to be fitted with the implants. Lawyers say the number of complainants is growing rapidly and they have lodged class action cases.

It is unbelievable that the MHRA have not ensured that they were involved with the consultations in France about a product that affects such a large amount of women in this country. Mark Harvey

Figures from the MHRA suggest 84,300 PIP implants have been sold in the UK since 2001. At least 42,000 women in the UK could be affected, but the figure could be higher.

Criticism from lawyers

Mark Harvey, a partner at Hugh James solicitors, which is representing more than 250 women, said: “I have written again to the MHRA to urge them to react to the developments in France and, similarly to France, to set up a suitable protocol for women affected in this country.

“I do not believe that MHRA’s reaction to date has been satisfactory; it is unbelievable that the MHRA have not ensured that they were involved with the consultations in France about a product that affects such a large amount of women in this country.”

MHRA said in a statement: “Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.

“We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.

“We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.

“We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France. This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.

“In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants.

“In the meantime we would recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon.”