Health officials in France have officially recommended that some 30,000 women with defective silicone breast implants made by Poly Implant Prothese SA (PIP) have them removed. According to a Reuters report, the French health ministry said new breast implants would be paid from public funds in cases where a PIP device was inserted for medical reasons.
As we reported previously, the PIP silicone breast implants were among the cheapest on the market, and are more fragile than other silicone breast implants. PIP Implants were pulled from the market last year, after it was learned cheaper industrial silicone, rather than medical-grade silicone, was used in the devices.
According to French health authorities, 1,000 women there have reported that their PIP breast implants have ruptured. The devices also sparked cancer fears after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. At least eight cases of ALCL have been reported among French women with the PIP implants.
Yesterday, the French health ministry said it was unable to find evidence showing the PIP silicone breast implants caused cancer. Nevertheless, it urged women with the implants to have them removed because of the risk of rupture, which can lead to inflammation and irritation, Reuters said.
PIP silicone breast implants were exported to Latin American countries such as Brazil and Argentina, and Western European markets such as Britain, Germany, Spain and Italy, according to Reuters. The company, which was founded by former butcher Jean-Claude Mas, produced about 100,000 implants a year before they were recalled last year. PIP has since gone out of business, but faces a French criminal probe for misreporting the type of silicone used in the implants.
More than 2,000 women in France have filed legal claims over the PIP breast implants, while 250 implant recipients in Britain have done the same, Reuters said.
In Britain, an estimated 30,000 to 40,000 women received the PIP silicone breast implants. But unlike their French counterparts, British regulators are not calling for their removal. However, a senior cosmetic surgeon told Reuters that there were concerns in the profession over a high rupture rate.
“We are worried about the rupture risk because it is the rupture that brings the contents into direct contact with the body’s tissues,” said Kevin Hancock, a consultant plastic surgeon at the Liverpool Women’s Hospital.
British officials said that reports indicated that only 1% of women there had experienced rupture of a PIP breast implant, versus about 5% in France. But according to a report from the Associated Press, standard mammograms and ultrasounds do not always indicate that an implant has ruptured, and many women may be walking around unknowingly with burst implants.
PIP never sought approval from the U.S. Food & Drug Administration (FDA) to sell the silicone breast implants in the U.S., so they were never available to women here. In March 2000, the FDA decided not to approve saline PIP implants for sale in the U.S.