Portuguese doctors have been warned against using breast implants marketed by Dutch firm Rofil Medical Nederland, marking a further twist in the crisis involving the fraudulent implants made by Poly Implant Prothèse (PIP) of France.
This is a serious development, as it appears to be the first official indication that the fraudulent filler used by PIP poses more than a theoretical risk of being present on the international market in other guises.
The news comes four months after the Dutch regulatory authority (IGZ) warned that PIP implants had previously entered the market, rebranded by Rofil. A device alert issued by IGZ on 19 April stated that the Breda-based firm had been marketing the now defunct French maker’s implants until early 2009, under the brand name M-implant.
The Portuguese health ministry’s circular, dated 9 August, was issued in response to a warning by regulatory agency Infarmed that Rofil’s M-implants have now appeared on the Portuguese market. It recommends heightened vigilance and requires doctors to not implant the devices and to report their existence to Infarmed. The warning emphasises that Portuguese wholesalers have not distributed M-implants on the domestic market.
“Unlikely in UK, but vigilance needed”
Pending confirmation from the Medicines and Healthcare products Regulatory Agency (MHRA), the British Association of Aesthetic and Plastic Mechanics (BAAPS) considers it unlikely that Rofil implants are on theUKmarket.
“Despite the unlikelihood that PIPs will have been sold under a different brand name in the UK, this development further emphasises the need to choose the right surgeon, who is using quality products with a proven track-record,” Dr Douglas McGeorge, consultant plastic surgeon and former BAAPS president, told Clinica.
PIP filler tests – “results expected shortly”
Meanwhile, the MHRA told Clinica today that the “final results” of its tests on the fraudulent PIP silicone filler were not yet available. The agency had hoped to complete the testing by mid-August. “We are expecting them shortly,” a spokesperson said.
The MHRA announced last month that it would conduct its own biocompatibility tests, after French regulatory agency Afssaps said its testing of the filler had been delayed by the ongoing criminal investigations into PIP (www.clinica.co.uk, 12 July 2010). Since the end of March, theLa Seyne-sur-Merfirm has been the subject of a global recall of non-implanted devices produced since 2001.
Bernard Murphy, Clinica Medtech Intelligence, 18 August 2011