French police have arrested Jean-Claude Mas, whose breast implant firm Poly Implant Prothese (PIP) sparked an international health scandal by using substandard silicon.
Mr Mas was arrested at around 7am (6am Irish time) at his home in southern France and police searched the premises.
He will be held for 48 hours while investigators decide whether to charge him with involuntary manslaughter and causing injury.
A second PIP executive, Claude Couty, was also arrested under an investigation opened in the southern port city of Marseille, close to PIP's former premises, on 8 December.
Mr Mas, who sold some 300,000 implants around the world, recently acknowledged that he had used unapproved silicon but dismissing the idea that it constituted a health risk.
PIP closed down in March 2010 after regulators discovered it was using a non-medical grade silicon.
In December 2011, the French government advised women with PIP implants to have them removed, sparking alarm around the world.
Several PIP managers were already expected to appear in court in Marseille in October this year following a prior investigation into fraud and deceptive business practices by the company, once the world's third-largest global seller of breast implants.
Around 2,700 women in France have filed complaints against Mr Mas.