Replace Faulty French-Made Breast Implants for Free, Says Venezuela Court

June 13, 2012 10:36 AM

VENEZUELA - Venezuela's Supreme Court has sided with women who have defective French-made breast implants, saying in a preliminary injunction that the cost of removing and replacing the implants should be paid by surgeons, hospitals and a company that imported them.

The court announced in a statement Thursday that it was taking up a suit brought by the country's public ombudswoman. While the suit progresses, the court ordered the company Galaxia Medica as well as surgeons and private hospitals to remove and replace leaking implants for free.

Thousands of women in Venezuela have the breast implants, which were made with industrial-grade silicone by the now-defunct French company Poly Implant Prothese, or PIP.

Gilberto Andrea, a lawyer representing more than 2,000 women who received the implants, praised the measure and said a lawsuit is still pending seeking additional damages. He said an estimated 33,000 women have the implants in Venezuela and that the court's initial decision "is a measure for all of those affected."

The cost of replacing PIP implants with those made by other brands ranges from about $5,000 to about $9,000, which is beyond the budgets of many women, said Sandy Contreras, who heads an association of women who have received the implants.

She said both she and her 24-year-old daughter have the implants, but so far they haven't ruptured as they have in the cases of other women.

Contreras said about the court decision, "We're extremely happy."

Breast enlargement surgery is common in Venezuela, and the PIP brand was used frequently until the implants were pulled from the market in 2010.

The company Galaxia Medica did not immediately respond to the court's decision.

Poly Implant Prothèse (PIP) was a French company started in 1991 that produced breast implants. It was founded by the Frenchman Jean-Claude Mas. PIP went into liquidation in 2011. The company and its founder are at the heart of a public-health care scandal.
  
PIP was the 3rd largest maker of breast implants in the world. The company produced circa 100 000 implants per year, during circa 20 years. Approximately 400 000 women worldwide may have PIP gel implant products implanted to enhance breast size or correct for tissue loss. The implants have been exported to Latin American countries such as Brazil, Venezuela and Argentina, Western European markets including Britain (25 000), Germany, Spain and Italy, as well as Australia (8900).

The lawyer Yves Haddad is representing Mas. Legal complaints have been filed by 2500 women in France and 250 women in Britain. Mas is wanted in Costa Rica for "life and health" offenses, a warrant issued by Interpol.  Frédéric Van Roekeghem, general director for La Caisse Nationale d'Assurance Maladie (French state social insurance agency, CNAM) has filed criminal charges, in consultation with the minister of health, Xavier Bertrand.

Latin and South America:

 •Costa Rica - breast implants banned and taken off the market in March 2010
 •Brazil - banned the breast implants on 30 dec 2011, taken off the market in 2010
 •Bolivia - implants replaced free of charge for some women on 29 dec 2011
 •Venezuela - promised to remove them free of charge
 •Ecuador - sales banned on 29 dec 2011
 •Argentina - ban
 •Chile - ban
 •Colombia - ban

The bad breast implants were sold to about 1000 Dutch women under the name "M-implants" by a Dutch company. It is not exactly know how many women in the Dutch Caribbean have PIP implants.