PIP scandal rages amid mixed information

Jean-Claude Mas is facing charges of aggravated fraud and manslaughter

It has been revealed that up to 20 cancer cases have been linked with the PIP (Poly Implant Prosthèse) breast implants. Two women have died – 53-year-old Edwige Ligoneche and, according to health union Afsaaps, a woman from Le Gers.

Around 300,000 women are believed to be have received the implants, which were filled with industrial grade rather than medical grade silicon and, reportedly, have a higher than normal rupture rate. But the public is receiving mixed messages about the product’s safety.

Two British surgeons carried out an audit of 453 patients and found between 16 and 34 per cent of the PIP brand ruptured. The failure rate among new implants that surgeons are using is 0.9 per cent. Meanwhile, a report by Australia’s regulatory body the Therapeutic Goods Administration, suggests that the rate of rupture is actually less than for other types of implants – only 0.4 per cent. While this figure has been criticised as improbably low, it is clear that there is no reliable data available on breast implants.

Hence why France and Germany have advised that women have the implants removed while Britain and Australia say they have found no evidence to warrant the routine removal of the implants.

The fact that many women received the implants for cosmetic reasons has sparked debate about who should foot the bill for removal. France will cover the cost of removal, estimated at around 2,000 euros per surgery, but only those who received them for medical reasons will have their reconstructive surgery covered. Monaco, on the other hand, is funding both removal and reconstruction. Admittedly, only 90 women have had the procedure at the Princess Grace Hospital since 2001, compare to around 30,000 women in France.

And anger has been fuelled by a police document that was leaked to the French media last week, in which the company’s boss admits to investigators that he made the gel because it was cheaper, and he knowingly covered it up.

The PIP gel manufactured in-house cost five euros per litre while the medical grade gel could be bought at 35 euros per litre. Jean-Claude Mas was making one million euros a year profit from his deceit.

He managed to conceal his illegal activity by covering up the evidence before routine inspections – appointments that were made with plenty of notice.

But warning signs about the implant’s potential for rupture came as early as 2000 when the US refused to grant approval for PIP’s saline-filled implants. The relevant authorities wrote to the Var-based company highlighting their concerns. Then, in 2006, Mr Mas was accused of intentionally concealing complaints by regulators from its insurers. In fact many people were concerned about the PIP implants, including Mr Mas. The company created a ‘new and improved’ version called PIP2, but that was actually worse, and between 2009 and 2010 he paid up to 70,000 euros in compensation.

Former staff of PIP are slowly coming out of the wood works, revealing that they were also concerned about the product’s safety. Some told French media Le Parisian that they used the same materials to make implants for men, including testicle, chest and buttock implants. Regulators in France say they are only aware of the breast implants.

Most importantly, this fiasco has ignited concern over the safety of cosmetic surgery products and the obvious lack of regulation. The new head of Europe's drugs watchdog told Reuters on Friday there was an acute need to tighten controls on medical devices. Guido Rasi, executive director of the European Medicines Agency (EMA), said there needs to be the same level of regulation on medical devices as medicines.

The PIP scandal is really just beginning. Mr Mas is now facing charges of aggravated fraud and manslaughter, and 2,400 cases have been registered with the courts in Marseille so far. More information will emerge when these cases are heard. Meanwhile, the Director of Health in France will present a report for the country’s Health Minister by the end of this month.

Cassandra Tanti