Faulty implants re-branded and sold

THE CONTROVERSIAL French PIP breast implants were allegedly re-branded and sold by a Dutch company registered in Cyprus, Health Minister Stavros Malas revealed yesterday.

Malas said he could not rule out filing a criminal case against Rofil Medical, which has registered offices in Cyprus.

Alerts were issued by Dutch regulators to cosmetic clinics using the implants that Rofil had allegedly bought PIP’s fraudulent implants and resold them internationally under the name ‘M-implant.

Malas said the PIP and M-implants “are one and the same” and that authorities here were investigating how far they had been used by Cypriot women, calling on those who may have them to contact their personal plastic surgeons and the Nicosia General Hospital on the helpline 22604288.

From information gathered so far, Malas said, at least 10 women here have used the ‘M-implant’, while 30 more women had used implants of an unknown brand.

The implants in question have never been used by public hospitals here, but appear to have been used by private clinics and abroad.

French newspaper Liberation recently cited concerns that the implants supplied by French manufacturers Poly Implant Prothese (PIP) carry potential health risks.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced that its independent UK tests found no evidence of chemical toxicity or the implants potentially causing cancer to victims.

However, French results have confirmed that the implants are more prone to rupture and that more extensive testing on genotoxicity (potential for cancer) was required.

Many women who were supplied with PIP implants during breast augmentation have experienced agonising problems including ruptures and leakages.  Studies last year also found that the manufacturers of PIP breast implants not only dispensed with a protective shell but used an untested gel, said to have been intended for use in mattresses.

As PIP warnings do not mention the Rofil rebranding, these women have not been informed of the dangers of their implants.

Women who had breast augmentation surgery abroad, particularly in Syria, are also advised to contact authorities.

Asked about Rofil Medical, Malas said the company was under investigation abroad concerning its ‘commercial practices’, but added he had not contacted the company yet.

He went on to urge women who may have used the two brands of implants not to panic, as at the moment no direct link has been established between use of the implants and the emergence of cancer.

Responding to questions, Malas did not rule out initiating criminal proceedings against Rofil Medical in Cyprus, but said such a decision rested with the Attorney-general.