More Countries Issue Advisories for Defective French Breast Implants

Health authorities in two more countries are calling for the removal of defective silicone breast implants made by the now-defunct French company, Poly Implant Prothese (PIP). According to various media reports, regulators in the Netherlands have advised women to have the PIP silicone breast implants removed. Meanwhile, the Icelandic government has decided to bear the cost of patient monitoring for women with the implants, as well as implant removal for patients whose devices are damaged.

PIP silicone breast implants were recalled in 2010 after it was learned that they contained industrial, rather than medical grade, silicone. Late last year, the same breast implants sparked cancer fears in France after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. French health authorities have advised some 30,000 women there who had received the PIP silicone breast implants to have them removed because of their risk of rupture, but have been unable to definitively link them to cancer. The government there has also decided to pay for removal procedures for women who had received the implants as part of breast reconstruction surgery.

Fears about ruptures and cancer have spread to many of the other countries where the PIP devices were sold, including Brazil, Argentina, Britain, Germany, Spain, Italy, and Israel. Germany has also advised women to have the devices removed, and women in several countries, including France, Iceland, Britain and Argentina, have filed or are planning to file lawsuits over the implants.

In the Netherlands, where around 1,000 women are believed to have the devices, Dutch health regulators have called for the removal of PIP silicone breast implants, the Associated Press has reported.

“If it is torn, the implant must be removed. Even if there is no tear shown… it is recommended that the implant be removed,” the countries health regulator and the Dutch Association of Plastic Surgeons said in a joint statement.

In Iceland, ICENEWS is reporting that all women with PIP implants will be called in for a medical examination in the near future and any implants which appear damaged will be safely removed at the cost of the state. However, Iceland will not pay to have implants removed if they are not damaged, but they will be monitored. About 440 women in that country have received the PIP silicone breast implants.

The PIP silicone breast implants were never approved for sale in the U.S. However, PIP did sell roughly 35,000 saline filled implants in the U.S. between 1996 and 2000, and those devices are the subject of U.S. product liability lawsuits alleging they deflated after several years. The saline implants were also cited by a U.S. Food & Drug Administration (FDA) warning letter in 2000.

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