According to French daily Libération, a report delivered this morning to the French Ministry of Labor and Health confirms that P.I.P. implants were tested by independent physicians in 1996 who reported that they found leakage issues.
Moreover, the report cites 41 reported P.I.P. implant malfunctions that year (note that these were saline implants since silicone was banned at the time in France). French inspectors sent to P.I.P. HQ in 1996 noted in their file that “further investigations by qualified physicians would be needed” but the case was then dropped. No explanation as to why.
For those who are not aware, in 2000, the F.D.A. sent a letter to P.I.P. refusing to permit the marketing and sales of its implants in the U.S.
As noted in an earlier post on this subject, a change in device regulations is not the problem here. This is an issue of application of existing rules and better communication between health authorities, physicians and device manufacturers.