Regulatory Focus™ > News Articles > Executives of Company Accused of Pulling Wool Over Eyes of EU Regulators Sentenced to Prison

Executives of Company Accused of Pulling Wool Over Eyes of EU Regulators Sentenced to Prison

Posted 10 December 2013 | By

The former CEO of a now-disgraced manufacturer of breast implants that was accused of willfully misleading regulatory officials for years has been found guilty by a French court and sentenced to four years in Jail.

Background

Jean-Claude Mas, former CEO of the now-defunct manufacturer Poly Implant Prothese (PIP), was accused in 2010 of distributing hundreds of thousands of breast implant products made with deficient, industrial-grade silicone without the approval of regulators.

In the midst of the crisis, regulators around the globe scrambled to determine what, if any, risks patients implanted with the devices might face. Some were concerned about higher-than-expected reports of the devices rupturing and requiring surgical revision, while others were concerned that the silicone within the devices could result in toxicities in the body.

Ultimately, most of those concerns seemed to be unwarranted. Australia's Therapeutic Goods Administration (TGA), for example, said there was "no evidence of an increased rupture rate for PIP Poly Implant Prothese silicone gel breast implants used in Australia." The UK's Medicines and Healthcare product Regulatory Agency (MHRA) said it would not-unlike Sweden-recommend getting the implants removed as a precautionary measure. And the UK's Department of Health (DOH) subsequently cleared the implants of most serious concerns, saying it found no indications that they would adversely affect long-term human health.

In October 2013, those concerns were further put to rest by the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), which issued a report indicating that the chemicals within the products were safe. The committee did, however, note a higher-than-anticipated rupture rate for the implants.

Prison Time

According to Reutersand CNN, Mas has now been sentenced to four years and jail and ordered to pay €75,000 in penalties. Four other former executives of PIP, including the director of quality, were also sentenced to prison time ranging between 18 and 36 months.

Reuters reports that Mas will appeal the decision.


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