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Dutch Health Authorities Advise Removal Of Defective French Breast Implants

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Dutch health authorities are advising women to have certain French-manufactured silicone breast implants removed following a worldwide health scare involving device rupture and cancer.

Recently health authorities in France advised about 30,000 women who received Poly Implant Prothese (PIP) silicone breast implants to have them removed over rupture risks. The debacle began following the death of a French woman who received PIP implants and developed rare aplastic large cell lymphoma (ALCL), said Reuters. The devices have not yet been definitively linked to cancer; however, no less than eight other cases of the rare ALCL have been reported among French women who received PIP implants. PIP is now defunct and is the focus of a French criminal investigation.

“Even if there is no rupture, it is advisable … to have the prosthesis removed,” the Dutch Health Inspectorate said in a statement, wrote Reuters. By year-end 2010, some 1,000 women in the Netherlands had received PIP implants, which were sold under the “M-implants” name, the statement noted; another 400 women had the implants removed at that time, as well, wrote Reuters.

The Dutch announcement is a reversal of the inspectorate’s original recommendation three weeks ago in which it urged women to have their implants checked by a physician, but did not call for removal of the devices, said Reuters. The changed recommendation followed advice from the Dutch plastic surgery association.

“The implants have an increased risk of rupturing or leaking and it is not clear whether there are physical reactions to the silicone in the long term,” the plastic surgery association said on its website. The association noted that this could include “a changing breast shape, pain, and the visibility of the capsule around the prosthesis,” according to Reuters.

PIP silicone breast implants, already one of the cheapest and most fragile available, were recalled last year after it was discovered that the devices contained industrial, not medical grade, silicone. Prior to the recall, PIP produced about 100,000 silicone implants annually. Now, fears about ruptures and cancer have other countries on high alert, including Brazil, Argentina, Britain, Germany, Spain, Italy, and Israel, said NewsInferno. About 2,000 French women have filed legal claims over the PIP breast implants as well as another 250 implant recipients in Britain.

In the United States, the PIP silicone breast implants were never approved for sale; however, PIP sold about 35,000 saline implants between 1996 and 2000. Those implants were the subject of a 2000 U.S. Food & Drug Administration (FDA) warning letter, and are also subject of product liability lawsuits in the U.S., filed by women alleging the devices deflated after several years.

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