It has been reported by Clinica that recalled PIP Breast Implants have been ‘rebranded’ and sold under the name M-Implants by Dutch firm Rofil Medical. Alerts were issued by Dutch regulator IGZ to cosmetic clinics using the implants that Rofil had bought PIP’s fraudulent implants and resold them internationally under the name “M-implant”. These implants were used in some of the most popular cosmetic surgery tourism destinations around Europe, regularly visited by British patients.
PIP breast implants were the subject of a Medical Device Alert (MDA) by the MHRA on 31 March 2010, ordering a recall on all stocks of the PIP implant. This followed an earlier issue with PIP implants using recalled hydrogel solution in 2006. 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.
The MHRA has 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. The results of these tests are expected early this year.
It has been reported that thousands of women will be affected by this rebranding and as PIP warnings do not mention the Rofil rebranding, these women have not been informed of the dangers of their implants.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have told Clinica that “The MHRA has no evidence to suggest that any Rofil-branded silicone breast implants were implanted in the UK”, “The MHRA’s remit is to ensure the safety of devices implanted in the UK. We do not therefore consider it necessary to alter our advice”.
The British Association of Aesthetic Plastic Surgeons (BAAPS) have also issued a warning to women who have gone abroad for breast augmentation. BAAPS have estimated that around 50,000 women in the UK have PIP breast implants, but the discovery that the fraudulent devices were also sold in countries such as Belgium, Poland and the Czech Republic under re-branded name ‘M-Implant’ by Dutch firm Rofil Medical means that the number of women who should be on the alert is much higher.
BAAPS President Fazel Fatah advised women who may have gone abroad for their surgery to contact their clinic to find out what type of implant was used. If, as has occurred in some cases, they no longer can be contacted, women should visit their GP for advice. Mr Fatah advises that it may be necessary for women with these implants to have a breast scan, and if there is a rupture both implants should be removed. He concludes that this yet again demonstrates the difficulties patients who travel abroad for cheaper cosmetic surgery may have when something goes wrong with the treatment.
Mark Harvey, Partner at Hugh James has successfully obtained free breast replacement surgery for some clients with PIP breast implants and is continuing to fight to get compensation for over 350 women for the pain and suffering his clients have suffered as a result of these breast implants. In response to the news that PIP breast implants had been renamed and sold Mr Harvey commented that:
‘It is extremely worrying that so many more women are at risk of these faulty implants. I urge the MHRA to amend its warning in relation to PIP breast implants to include the Rofil-branded silicone breast implants in the hope that this would alert women who may have had breast augmentation abroad to seek medical advice’.
The Sun Newspaper has also reported on the scandal and is launching a campaign to highlight the risks of cosmetic surgery abroad.