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Europe Weighs Tougher Breast Implant Scrutiny

Police say France’s PIP put industrial gel in 400,000 devices
A demonstration at the PIP plant last April
A demonstration at the PIP plant last AprilPhotograph by Anne-Christine Poujoulat/AFP/Getty Images

Investigators say French medical device maker Poly Implant Prothèse in the 2000s developed a simple way to pass the required annual inspections of its manufacturing process for breast implants. To keep its outside auditors from discovering that PIP was filling implant casings with cheap, industrial-grade gel to shave costs, workers hid barrels of the unauthorized substitute for medical silicone in a separate warehouse and on a truck during the auditors’ visits, former employees told French police according to transcripts obtained by Bloomberg News. One employee told police he was asked to erase evidence of the unapproved substances from the computer system before the audits and to reintegrate the data afterwards. Each year after the auditors left, another former PIP employee told police, workers celebrated with a round of drinks toasting another successful deception.

To avoid a repeat of the breast implant scandal, European Union regulators are considering an overhaul of rules that leave medical-device makers such as PIP in charge of checking the safety of their own products. Currently, companies are required to hire outside contractors to certify quality controls and production systems before they can sell medical devices throughout the 27-nation bloc and in countries that recognize its standards. But PIP employees have told police they repeatedly deceived the German technical review company hired to certify its quality control, TÜV Rheinland Holding. French authorities pulled the devices, which also experienced rupturing after PIP moved to a thinner casing material, from the market in March 2010. PIP filed for bankruptcy the following day. Last year French health regulators recommended that all PIP implants be removed after a woman with ruptured implants died of cancer in November. About 400,000 PIP implants were sold in nations including Australia, Brazil, Germany, and the U.K.