The final word on PIP implants
Women have been reassured that ruptured Poly Implant Prothese breast implants pose no greater health risk than any other brand of breast implant.
Delivering its final verdict on the infamous PIP implants, which were the centre of a global health scare following revelations of sub-standard manufacture, the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks found that although the implants were more likely to rupture than those of other brands, there was no evidence they were more harmful.
The reassurance came as a group of law firms, led by Colombian outfit Lozano Blanco and Asociados, launched a worldwide appeal for women with PIP implants to join in claim being launched against a German firm that certified the implants, TUV Rheinland.
The class action is scheduled to be heard in the Court of Commerce in Toulon, France, next month, and the firm has called for any women who have not already claimed for compensation to register by 27 June. So far, it said, more than 2284 women worldwide have joined the action, including 12 from Australia.
Monitoring by the Therapeutic Goods Administration has found that, as at 16 May, there were 530 confirmed cases of PIP implant rupture in Australia, with a further 25 yet to be verified.
Around 300,000 women worldwide received PIP implants, including around 13,000 in Australia, and the company founder Jean-Claude Mas was last year convicted of fraud and sentenced to four years imprisonment by a French court, which also imposed a lifetime ban on working in medical services or running a company.
Much concern has centred on the presence of cyclic siloxanes in PIP implants in higher concentrations than in other brands, but the Committee said investigations had shown that such chemicals were common in the bodies of women even without breast implants, as a result of their widespread use in many household products. The chemicals were found to be non-toxic and not an irritant.
The Committee also investigated cases where the rupture of an implant had been associated with inflammation. It found that that neither the rupture, nor the inflammation, has been associated with breast cancer or anaplastic large cell lymphoma.
“While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer,” the Committee concluded.
It strongly advised that where rupture did occur, the implant be removed, and recommended that – because of concern ruptures might go undetected – that women with PIP implants seek regular clinical examinations.
But the Committee said there was no compelling medical reason for women with intact PIP implants to have them removed, except where they were experiencing significant anxiety, and advised that in these circumstances “the decision to remove an intact PIP implant…be based on an individual assessment of the woman’s condition by her surgeon or other treating physician”.
The TGA said the Committee’s findings and recommendations were consistent with its own position regarding PIP implants.
“The SCENIHR report is a comprehensive survey of investigations carried out around the globe on PIP breast implants,” the watchdog said. “[It’s] recommendations…agree with those made by the TGA, and the report does not identify any matter that requires further investigation by the TGA.”
Nonetheless, the regulator said, it would continue to monitor the situation and was ready to take further action if deemed necessary.