AMSTERDAM (Reuters) - Dutch health authorities said on Wednesday women who had breast implants made by a French company at the heart of a global health scare should have them removed because of the high risk of rupture, reversing an earlier recommendation.
The scandal erupted when the French government in December advised 30,000 women who had silicone implants made by the now-defunct firm Poly Implant Prothese (PIP) to have them removed. The advice followed the death from cancer in 2010 of a French woman who had PIP implants.
“Even if there is no rupture, it is advisable ... to have the prothesis removed,” the Dutch Health Inspectorate (IGZ) said in a statement.
As of the end of 2010, the statement said, an estimated 1,000 women in the Netherlands had PIP implants, which were also sold under the name M-implants. Another 400 had already had them removed by the end of 2010.
Three weeks ago, the inspectorate said women should have their implants checked by their doctor but did not recommend their removal. The new recommendation was based on advice from the Dutch plastic surgery association, the IGZ said.
“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.
It said symptoms and complaints from leaking or ruptured implants included “a changing breast shape, pain, and the visibility of the capsule around the prosthesis.”
The plastic surgeons said no relationship had been established between PIP implants and breast cancer.
PIP, once the third-largest maker of breast implants in the world, is accused of using industrial-grade instead of medical-grade silicone in some of its implants. They were sold in a number of European and Latin America countries.
Health authorities have said there is no evidence of an increased cancer risk due to the PIP implants, but have said they have higher rates of rupture that could cause inflammation and irritation.