Recalled PIP Breast implants ‘rebranded’ and sold as M-Implants
Hugh James now represents over
350 women with PIP breast implants
25 I 02 I 11
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
Solicitors 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.