by ARALENA MALONE-LEROY
PIP plant back door. La Seyne sur Mer, Var, France. PHOTO/Flickr user marcovdz and used under a Creative Commons license
In late December 2011, while most Europeans were doing last-minute holiday shopping and preparing for gargantuan meals and family festivities, hundreds of thousands of women spent achingly sleepless nights, worried that their breast implants might be giving them cancer. The French Ministry of Health had just released a statement recommending that women with breast implants manufactured by the French company Poly Implant Prothèse (PIP) have them removed, even in the absence of signs of rupture or other complications. All medical fees for the “preventive” process would be covered by national health resources.
This announcement, which concerns more than 450,000 women worldwide – approximately 30,000 in France and 40,000 in the United Kingdom alone, with thousands more in Spain and Italy, as well as Brazil, Bolivia, Colombia, Argentina, Ecuador, and Venezuela – came nearly 12 years after the first alarm sounded on the substandard quality of the PIP breast implants.
In early 2000, the U.S. Food and Drug Administration sent a damning report to the PIP factory. The “low-cost” implants contained industrial-grade silicone (including such chemicals as Baysilone, a fuel additive, and Silopren and Rhodorsil, used in rubber manufacturing) instead of the required medical-grade silicone. The rupture rate of the PIP implants was dangerously high, over 1 in 10. PIP stopped selling the unsafe implants to the United States, but they remained impervious to the health risk of their faulty products and continued to market the low-cost implants elsewhere. It was not until April 2010 that PIP was shut down by the French government and the implants definitively removed from the French and international markets.
Why it took nearly 10 years for French authorities to finally remove PIP silicone implants from the market is one that the government will attempt to answer over the next few months. Xavier Bertrand, Minister of Labour, Employment, and Health, has ordered France’s two main regulatory agencies for drugs and medical products to disclose the tests and controls that allowed toxic silicone implants to be sold.
Twenty cases of cancer have been reported in French women with the PIP implants. One woman passed away due to lymphoma. While official statements continue to deny any direct link with the implants and cancer, the dangerous rates of rupture and inflammation caused by leakage of the industrial-grade silicone is proven and condemned by the government.
Italy, the Czech Republic, and Germany have all released official recommendations that women with PIP implants have them removed. But not all health officials are recommending removal. While suggesting that patients schedule appointments with their surgeons to have the implants checked for leaks or ruptures, health department statements from Britain, Israel, and Venezuela deny any urgency for removal. Other governments suggest that clinics have a “moral duty” to remove the implants for free, if necessary.
Women’s International Perspective for more