TÜV knew about faulty PIP breast implants?

TÜV were apparently known to be health-threatening defects of the implants of the manufacturer PIP early

07/14/2013

As it now became known, TÜV Rheinland could have known early on the faulty breast implants of the French manufacturer PIP. Nevertheless, the Cologne auditors carried out no unannounced checks and certified the quality management of implants until the scandal year 2010 on. Hundreds of thousands of women were then used by PIP's health-damaging silicone breast implant.

In 2002, TÜV already issued a warning about the biological safety of the PIP implants
Information of the daily newspaper „Handelsblatt“ According to TÜV Rheinland, long before the scandal surrounding the health-threatening breast implants of the manufacturer Poly Implant Prothèse (PIP) became known in 2010, a warning from the British health authority MDA was submitted, after which not the silicone pads themselves, but the biological safety of hydrogel implants from the House of PIP was doubted. According to internal reports, TÜV issued a special audit in February 2001 and, from 2002, no longer awarded any certifications for the quality management of hydrogel products. Nevertheless, the TÜV waived registered checks and certified the quality management of the silicone implants until 2010.

Hundreds of thousands of women who have been exposed to the flawed and health-threatening breast implants have to feel like a slap in the face. In Germany alone, around 5,000 women received the PIP implants until the scandal became public knowledge. In France, far more women are affected.

At that time, the French agency for the safety of medical devices (Afssaps) had found that PIP instead of the intended silicone gel used a cheaper home-made gel for the breast implants. The company acted out of pure profit interest. As it turned out, at the expense of several women's health, PIP had saved around one million euros a year by using the non-medical cheap gel. Prosecutor Jacques Dallest in Marseille reported that the homemade gel costs only one-tenth of the proper silicone gel. Immediately after the discovery of the scandal, the French authorities prohibited the continued use, marketing and export of the PIP silicone gel breast implants across Europe. But tens of thousands of women still have to live with the fear of long-term damage. Many of those affected decided to remove the implants because of the high health risk. In other cases, however, the health-endangering silicone pads have not yet been removed. The PIP implants tear more easily and can cause severe inflammation compared to conventional breast implants. Also, a possibly increased cancer risk is currently being discussed. Meanwhile, PIP chief Jean-Claude Mas is in Marseille for serious deception and fraud in court.

AOK may seek legal action against TÜV
As the newspaper reports, could now AOK Bayern, one of the largest German health insurance, seek a lawsuit against the TÜV Rheinland, because the fund requires a refund of a total of 86,000 euros for the removal or replacement of defective implants. Although only quality management is subject to auditing in accordance with European directives, auditors may also carry out unannounced audits if there are reasonable grounds for suspicion. But that was exactly what TÜV Rheinland - tragically at the expense of the health of many women - did not want.

As TÜV Rheinland informed the newspaper on request, there was no connection between the quality management of the hydrogel products and that of the breast implants.

Breast implants are usually used after mastectomy or to enlarge the breasts. The implants used always consist of a silicone shell filled with saline solution or silicone gel. (Ag)