More than 250 British women are taking court action after more than half experienced ruptures in breast implants made by a French company at the centre of a cancer  scare, a lawyer said yesterday.

France’s Health Ministry has said there is no urgent health risk from the implants and no causal link with cancer has yet been proved

The women are among up to 50,000 in Britain who have had implants that were manufactured by the now-bankrupt Poly Implant Prothese (PIP).

Health officials in France have said the government plans to recommend to 30,000 French women with PIP implants that they have them removed, after eight cases of cancer, mainly breast cancer, were reported.

A lawyer representing more than 250 women in Britain said legal proceedings would start next year, with the complainants making claims against the clinics which carried out the operations to insert the implants.

“Over half of these women have suffered ruptured implants and we are also representing other women who are worried by the reports of problems and worried that their implants could rupture eventually,” lawyer Esyllt Hughes said.

“We have issued some court proceedings and we expect them to begin in Cardiff next year.”

Documents yesterday showed that tens of thousands of women in more than 65 countries, mainly in South America and Western Europe, received implants produced by PIP, which ceased trading last year.

European authorities yesterday sought to head off panic over the scare, saying there was no proof of a link to cancer.

France’s health ministry however has said there is no “urgent health risk” from the implants and no “causal link” with cancer has yet been proved.

An expert report will be released in France tomorrow saying whether the implants should be removed.

PIP was shut down and its products banned last year after it was revealed to have been using non-authorised silicone gel that caused abnormally-high rupture rates of its implants.

Facing financial difficulties, the company, once the world’s third-largest producer of silicone implants, replaced the medical-grade silicone in its implants with industrial-strength material.

The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain urged patients not to panic, although it said they may want to consult their surgeons.

“We did extensive genotoxic and chemical tests and we could find no evidence of any safety aspect associated with this filler,” MHRA medical director Suzanne Ludgate told BBC radio.

“We have been working very closely with the professional bodies to look at the incid-ence of cancer associated with these breast implants and we’ve worked with the cancer registry and we can find no evidence for any association.”

In Germany, authorities said it was not known how many German women had received the implants and no recall was planned for the moment.

“We are waiting for the decision from French authorities, with whom we are in close contact,” a health ministry spokesman told AFP.

German authorities “had already in April warned women and doctors who used these products”, he said.In Spain the health ministry said it was not recommending the implants be removed but was urging women who had received the implants to have them checked for ruptures.

It also could not say how many Spanish women had received the implants.

The documents also showed Eastern European countries including Bulgaria, Russia and Poland accounted for 10 per cent of PIP’s exports in 2009.

Prosecutors in Marseille, near the firm’s home base of Seyne-sur-Mer, have received more than 2,000 complaints from French women who received the implants and have opened a criminal investigation into the firm.

Timeline

• At the end of March last year, the French medical regulatory authority – AFSSAPS – informed the company Medicines and Healthcare products Regulatory Agency that it had suspended the marketing, distribution, export and use of the silicone gel-filled breast implants manufactured by PIP.

• PIP was ordered to close by the French government for allegedly making the implants fraudulently using unsanctioned silicone gel.

• The French authority recalled all of these devices at that point.

• On inspecting the PIP manufacturing facility, the AFSSAPS found that breast implants made by the company since 2001 had been filled with a silicone gel with a composition different from the original European CE Mark approval, making it illegal.

Malta consulted

A UK Department of Health spokesman said MHRA officials spoke to health or regulatory experts from France, the Netherlands, ­Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta

A spokesman said: “They all agreed that there was no evidence of any increase in incid-ents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates. This is in line with UK findings.

“MHRA is currently advising that women with any concerns should make an appointment with their implanting surgeon and have a full discussion. MHRA and its experts will be looking carefully at the French safety statement when it comes out as a matter of priority and issue further advice as necessary.”

 

 

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