German firm to pay damages to women given defective PIP implants

PIP implants are no strangers to health scandals, as over the course of 2010 and 2011, the French medical safety agency recalled all stock, having found that they contained unapproved, potentially carcinogenic substances.

The PIP company (Poly Implant Prothèse) was itself liquidated in March 2010. Now the implants have been back in the news as a French court ordered TÜV Rheinland, the German company that awarded EU safety certificates to the French implant manufacturer, to compensate the thousands of women who have been fitted with these faulty products.

Silicone implants are elastomer silicone shells filled with a viscous silicone gel and have historically been associated with rupture and leakage, causing pain and immune system diseases. Indeed it has been proven than PIP covertly used sub-standard silicone gel inside up to 75% of their shells, resulting in the rupture of thousands of implants.

In the case, TÜV Rheinland was sued for £42m by 1,672 women (including around 100 Brits), alongside six implant distributors. In the landmark ruling on 14 November 2013, the court degreed that TÜV Rheinland had “neglected its duties of checking and vigilance” in granting PIP the CE certification for safety, relied on by thousands of surgeons. As a result, the plaintiffs in the civil case have been awarded an initial compensation of €3,000 each, to cover the costs of the necessary surgery to remove the highly dangerous implants.

And the scandal doesn’t stop within Europe. A large portion of PIP’s business lay in Latin America, with implants shipped to Brazil, Columbia and Venezuela. With more than 300,000 women affected in 65 countries, 42,000 of the total estimated patients at risk are British. There have been some 4,000 reported ruptures to date and the tally is only set to increase. In France, the government has already overseen the removal of 15,000 French women’s implants.

Jan Spivey, a spokeswoman for the British plaintiffs who herself received PIP implants as part of reconstructive surgery following breast cancer, declared she was “delighted” with the court’s ruling so far. “It is a first important victory for PIP victims worldwide and especially those British victims who have received no help from the health service or the Government,” she said.

Cologne-based TÜV Rheinland – up until recently deemed a market leader in safety standards – Is set to appeal the court’s ruling, claiming that the company has been the victim of a cover-up and fraud by PIP. Should this appeal fail, there will be a second hearing in 2014 to examine the full compensation claim by the 1,672 civil plaintives, who are demanding €16,000 each. The same case will also cover a claim for €28m in compensation brought by implant distributers hailing from Bulgaria, Brazil, Italy, Syria, Mexico and Romania; potentially leaving the German company open to damages of over €6bn in total.