A French court has ordered the certification body TUV Rheinland to pay $2,082,000 in damages to women who were injured by defective breast implants sold by Poly Implant Prothèse (PIP), an organization that TUV had certified under the European “CE Mark” medical device directive.
PIP intentionally used lower-cost industrial-grade silicone in its breast implants, rather than medical grade, causing leaks, internal bleeding, cancers, and at least one patient death. It’s estimated the implants have been used in nearly half a million women worldwide, with many in Latin America. The French ruling only addressed about 400 women in that country, ordering TUV to pay about $5,206 to each woman as compensation.
TUV was previously found culpable and ordered to pay $65.5 million to another 20,000 victims.
The founder of PIP, Jean-Claude Mas, was arrested in the scandal and sentenced to four years in jail. The company’s Quality Director, Hannelore Font, was also arrested and sentenced to prison, but has now reappeared in the medical implant industry working as a quality consultant for the French company Nexialist, under a different name, having changed her hair color. Nexialist has hired others involved in the PIP scandal, but regulators appear to have their hands tied in taking action against the company for now.
To date no one at TUV has been arrested.
The PIP scandal marks the first time a registrar has been publicly held accountable for the failings of products covered by its certifications. The British certification body BSI now faces a similar scandal, as reports of spinal implant failures have resulted in arrests of the company Ranier Technologies, which BSI granted a CE Mark to previously. investigators found the implants are dissolving inside patients, and that Ranier may have conducted insufficient human and animal trials before rushing the products to market, using the BSI certification to do so.
In 2017 the US Food and Drug Administration issued a warning letter to the company DRG Instruments for releasing “adulterated medical devices” into the market; that company holds ISO 13485 and CE Mark certifications issued by TUV Rheinland. Those certifications have not been revoked despite the FDA’s warning letter.
TUV Rheinland is accredited by the German accreditation body DAkkS, which has so far refused to take any action against the company despite being responsible for ensuring TUV adheres to international accreditation rules. Likewise, the International Accreditation Forum (IAF), which oversees the entire accreditation scheme and holds authority over DAkkS, has refused to act.
Increasingly the various certification and accreditation bodies involved in the ISO and CE Mark schemes are under scrutiny for their roles in patient deaths, product recalls, scandals and crimes conducted by their certified companies. In nearly all cases, such companies would never have been granted access to produce products under contracts had the certification bodies not granted ISO or CE Mark in the first place. Routinely, however, it is found that such certificates are issued with poor oversight and under a system rife with conflicts of interest, and then allowed to be retained even after the scandals are reported.