| Parliamentary questions | ||
| 3 October 2013 |
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| Question for written answer to the Commission Rule 117 Marc Tarabella (S&D) | ||
| Subject: PIP implants: Medicines Agency called into question | |
| On Tuesday 1 October 2013, Mediapart revealed an internal report that is highly critical of the French National Agency for the Safety of Medicines and Health Products (ANSM, formerly the French Agency for the Health Safety of Health Products — Afssaps) over its failure to issue an alert regarding PIP implants, which was concealed at the time by the Minister for Health. The document dates back to the first quarter of 2012, and was seized during a search of the ANSM’s headquarters. According to Mediapart, the agency’s management did not disclose this internal document, which they were aware of, but circulated an official report, sent to Xavier Bertrand in February 2012, with the most embarrassing information for Afssaps redacted. Moreover, the increase in the number of ruptured PIP implants started as early as 2006 and Afssaps should have reacted in 2007, or 2008 at the latest, whereas the French health authorities announced their recommendation that all women should have their implants removed as a precaution in late 2011. Over 16 000 women have had their PIP breast implants, which contained illegal silicone gel, removed, according to the latest count by the ANSM at the end of May. The ‘failure’ rate for implants taken out now stands at 25.4%, 7 186 defective implants of the 28 276 removed from 16 426 women. 1. What is the Commission’s response? 2. Does it plan officially to call on the French authorities or the former authorities to explain themselves? | |
