More than 17,000 women have had their PIP breast implants which contain fraudulent silicone gel removed. Among them, 74% did so without showing any warning signs.
Two months before the opening of the trial against Jean-Claude Mas, the French manufacturer of fraudulent PIP breast implants, women victims still prefer prevention than cure. In fact, according to the latest assessment drawn up at the end of September by the Medicines Safety Agency (ANSM), among the 17,135 women who had one of their prostheses explanted, 12,599 (74%) did so as preventive. Thus, since the Agency’s last report published at the end of May, 505 new women have had their PIP implants removed, without showing any warning signs. These figures include all the explantations carried out between 2001 (date of the placing on the French market of these implants) and the end of September 2013.
3 out of 4 explantations as a preventive measure
And this preventive measure sometimes turns out to be judicious, because, in 20% of cases, during preventive explantation, “a malfunction of the prosthesis (rupture, oozing, etc.) and / or an effect was discovered. undesirable undetected by the examinations preceding this intervention ”, indicates the Agency.
Regarding all the dysfunctions noted on these explanted women, the rate of failed PIP implants observed to date is 25.4%, with a total of 7,999 defective implants out of the 29,577 removed, specifies the Ansm. These include device ruptures, leaks, reversals or even changes in the color of the implant. As a result, with 7,186 defective implants removed at the end of May, nearly 1,000 new implant malfunctions were reported by the Ansm in this case of four months.
30,000 French women are affected
Finally, 74 cases of mammary adenocarcinoma (malignant tumor) were reported to the Agency in women with PIP silicone gel prostheses. A case of anaplastic large cell lymphoma was also recorded in November 2011. It is moreover his report which was at the origin of the recommendations for preventive explantation. “No other case of this type of cancer has been reported since,” says Ansm. However, “according to the opinions formulated by the National Cancer Institute (INCa) and experts from the European Commission, the tumors declared are not related to the particularities of PIP prostheses”, concludes the Ansm.
The number of women with PIP breast prostheses in France is estimated at around 30,000.
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