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TÜV were apparently aware of health-threatening defects in the implants of the manufacturer PIP early on
As has now become known, TÜV Rheinland could have known about the faulty breast implants from the French manufacturer PIP early on. Nevertheless, the Cologne inspectors did not carry out any unannounced inspections and continued to certify the quality management of the implants until the 2010 scandal year. Hundreds of thousands of women were using PIP silicone breast implants that were harmful to their health.
In 2002, TÜV issued a warning about the biological safety of PIP implants against information from the daily newspaper "Handelsblatt", according to TÜV Rheinland long before the scandal surrounding the health-threatening breast implants of the manufacturer Poly Implant Prosthesis (PIP) came to light in 2010, a warning from the British health authority MDA before, according to which not the silicone pillow itself, but the biological safety of hydrogel implants from PIP was questioned. According to this, internal reports document that the TÜV scheduled a special inspection in February 2001 and no longer issued any certifications for the quality management of the hydrogel products from 2002. Nevertheless, the TÜV waived registered controls and certified the quality management of the silicone implants until 2010.
For hundreds of thousands of women who have had the faulty and unhealthy breast implants inserted, this message must feel like a slap in the face. In Germany alone, around 5,000 women received the PIP implants until the scandal became known. Far more women are affected in France.
At that time, the French agency for the safety of medical devices (Afssaps) had determined that PIP used a cheaper homemade gel for the breast implants instead of the silicone gel provided. The company acted out of pure profit interest. As it turned out, PIP had saved about a million euros annually at the expense of the health of several women by using the cheap gel, which was not suitable for medical purposes. The responsible public prosecutor Jacques Dallest in Marseille reported that the homemade gel only costs a tenth of the proper silicone gel. Immediately after the scandal was discovered, the French authorities banned the further use, marketing and export of PIP silicone gel breast implants throughout Europe. But tens of thousands of women still have to live with fear of long-term damage. Many of those affected decided to remove the implants due to the high health risk. In other cases, the health-endangering silicone pillow has not yet been removed. The PIP implants tear more easily than conventional breast implants and can cause severe inflammation. A possibly increased cancer risk is also currently being discussed. PIP boss Jean-Claude Mas is now on trial in Marseille for serious deception and fraud.
AOK may seek legal action against TÜV
As the daily newspaper reports, AOK Bayern, one of the largest German health insurance companies, could now file a lawsuit against TÜV Rheinland, because the fund demands a reimbursement of a total of 86,000 euros for the removal or replacement of the defective implants. According to European guidelines, only quality management is subject to an inspection, but inspection companies can also carry out unannounced inspections if there are suspicions. But that is exactly what TÜV Rheinland refrained from - tragically at the expense of the health of numerous women.
As the TÜV Rheinland informed the newspaper upon request, there is no connection between the quality management of the hydrogel products and that of the breast implants.
Breast implants are usually used after breast amputations or to enlarge the breasts. The implants used always consist of a silicone sleeve filled with a saline solution or with silicone gel. (ag)