French authorities are to issue an expert report on Friday saying whether the implants, produced by the now-bankrupt Poly Implant Prothese (PIP) company, should be removed after several suspicious cancer cases.
Documents obtained by AFP on Wednesday showed that tens of thousands of women in more than 65 countries, mainly in South America and western Europe, received implants produced by the company.
According to PIP’s 2010 bankruptcy filing in the French city of Toulon, it exported 84 percent of its annual production of 100,000 implants.
Between 2007 and 2009, 50 to 58 percent of its exports went to South American countries including Venezuela, Brazil, Colombia and Argentina, the filing showed.
In the same period, 27 to 28 percent of exports went to western European nations including Britain, Spain, Italy and Germany.
French health officials have already said the government plans to recommend to the 30,000 French women with PIP implants that they be removed, after eight cases of cancer, mainly breast cancer, were reported.
France’s health ministry however has said there was no “urgent health risk” from the implants and no “causal link” with cancer has yet been proved.
PIP was shut down and its product 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, where up to 50,000 women have been given PIP implants, 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 incidence 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 that 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 commercial filing also showed eastern European countries including Bulgaria, Russia and Poland accounted for 10 percent of PIP’s exports in 2009.
Middle Eastern and Asian countries accounted for only about eight percent of its exports that year.
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.
A lawyer for PIP founder Jean-Claude Mas, 72, told AFP his client was prepared to face prosecution and denied the implants could be linked with health problems.
“For the moment there is no evidence that the product can cause illness,” the lawyer, Yves Haddad, said.