Silicone scandal: nearly 500,000 women had dangerous breast implants

Breast implants scandalThe French government announced Tuesday it has initiated an administrative inquiry on faulty breast prosthesis of PIP company, and Health Minister Xavier Bertrand agreed to form a parliamentary commission on this scandal that has spread worldwide. According to the minister, such a commission, requested by a conservative senator, Chantal Jouanno, will allow “an overview of what happened”. Bertrand said he had “requested investigations” from General Directorate of Health and Sanitary Security Agency (AFSSAPS) to determine if lack of control systems have enabled PIP company to market breast implants that have become the source of a worldwide scandal.

“Today, the elements suggests that this gel (used for PIP breast implants) was indeed counterfeit”, the minister said, adding that what is “interesting is that, during the controls, it was not found that the gel is altered”. In France were reported 20 cases of cancer in carriers of these PIP implants, but there was not established a link between the cancer and PIP implants. The government has also recommended a number of 30,000 women in France to have these implants removed.

Czech Republic, following the example of other countries, recommended for women who have PIP implants to go to the doctor for advice, even if “on Czech territory there has been no case of adverse effects related to these implants”, according to a release of the National Agency of Health Security, Medicines and Medical Devices (SUKL).

An estimate shows that between 400,000 and 500,000 women (mostly in Latin America, Spain and UK) are carriers of prosthetic implant from the company Poly Implant Prothese (PIP) manufactured and exported until March 2010. Xavier Bertrand said that “in the coming days” “a telephone conference with the participation of his European counterparts”  will be held with the purpose to inform about developments in this case. In Italy an investigation was started against PIP founder, Jean-Claude Mas, who is already the object of two judicial inquiries in France for “deception” and “involuntary manslaughter”.

Analyses made by AFSSAPS on implants collected after a search at one of the PIP locations in March 2010 showed a gel that does not comply with the norms, being irritating, but without altering the DNA, and that there is a high risk of rupture of the membrane followed by infiltration of the gel in the body. Latest data released by the press about these prostheses have generated concerns about silicone gel composition used, which may contain a fuel additive, and the implant membrane presenting a significant rate of breaking.

Yves Haddad, lawyer for Jean-Claude Mas, , vehemently denied the presence of industrial compounds in silicone gel. Tuesday, a French provider for PIP testified that silicone delivered to this company was for a purely industrial usage. “Product specifications that was ordered from us was commissioned for an industrial product, data sheet available on the Internet reveals that this product is an industrial product and the customer has provided us no information about its destination”, said Pierre Gaches, President of Gaches Chemical Company, distributor of chemicals in the Toulouse region.