A quarter of the PIP implants removed are defective. Since the discovery of the fraud in March 2010, nearly 15,000 women have had their breast implants removed.
A quarter of the PIP implants removed are defective. According to the latest report released by the Medicines and Health Products Agency (Ansm), the rate of “failure” observed is to date 25.9% with 6,644 defective implants out of the 25,644 removed. Since the discovery of the fraud in March 2010, nearly 15,000 women have had their breast implants removed.
In detail, the dysfunctions reported on all prostheses PIP of women who have removed their prostheses as a preventive measure, are 7,042, the same implant may have several defects. These were most frequently ruptures (59% of dysfunctions) and implant perspiration (25%).
In total, 5,048 women experienced at least one dysfunction of their implant (s) and 2,697 at least one adverse effect, the agency indicates, noting that the same woman can combine dysfunction and adverse effect. In addition, reports of adverse reactions have been reported, whether or not associated with a report of implant dysfunction. A total of 4,257 were reported in 2,697 women, mainly inflammatory reactions. The rate of adverse reactions with implants Pip is 16.6%.
In its report, the Ansm also takes stock of international toxicological and vigilance data from the United Kingdom and Australia. And the Agency specifies that these data “are consistent” with the French data, concluding with higher rates of prosthesis dysfunction for implants. Pip than for other implants. Suddenly, breast prostheses are under close surveillance. Ansm explains that it is pursuing “a specific action plan and reinforced monitoring of breast prostheses in France”. In this context, “the materiovigilance declarations relating to adverse events will continue to be monitored, the periodic report of which will henceforth be published three times a year”. Finally, the ANSM, beyond implants Pip, notes that “the monitoring of all other silicone breast implants is also reinforced”. This is why it is currently carrying out “an inspection and control program for all implants marketed in France”.
As for women who still have implants, the agency considers it necessary to continue to inform them of the importance of clinical and radiological follow-up and remind them that they can have preventive explantation. A message which will perhaps be heard by many of them since Thursday April 11, within the framework of another procedure under investigation for “involuntary injuries”, justice paved the way for the compensation of several thousand women who have had their breast prostheses removed as a preventive measure.
As a reminder, in the case, five former executives of the PIP company are summoned to appear on Wednesday April 17 for “aggravated deception” during a trial to be held in Marseille.
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