Leading surgeons reassure UK patients not to worry
Reports by the French publication Libération state that the French medical authorities will ask all women in France who received breast implants supplied by the Poly Implant Prothese (PIP) company to have them removed.
The faulty implants, manufactured by Poly Implant Prothese, 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.
The recent development in the approach by the French Government has been made in reaction to reports this month of an association between the death of a French woman with PIP implants. The British Association of Aesthetic Plastic Surgeons (www.baaps.org.uk) has, however, reiterated previous recommendations by urging UK patients not to worry.
According to consultant plastic surgeon and BAAPS President Fazel Fatah:
It is important to remember that the number of breast implant patients globally is considered to be higher than 10 million, yet these tumours are extremely rare. The risk of death is just 1 in 2 million from it and cure available for 94% of sufferers, so women should continue to feel that their implants are safe. The cause is still unknown and is probably the result of a number of rare different factors, partly genetic, coming together in the afflicted women. In relation to PIPs we continue to reiterate our advice to UK patients in line with the French authorities: if you have, or suspect you have these implants, you should have a scan every six months. If there is any rupture or weakening, have both implants removed.
BAAPS further reported that although a possible association in women with breast implants and Anaplastic Large Cell Lymphoma (ALCL) has been observed in a small number of reported cases worldwide, a direct link with the implants has not been established.
Since the recall of the faulty implants, PIP has gone into liquidation, leaving victims with no clear route for legal recovery. Renowned campaigning lawyer Mark Harvey, Partner and head of the top ranked Personal Injury Team at Hugh James solicitors, is acting for over 250 women with PIP implants. Reacting to today’s French coverage, Mark Harvey says:
The recent reports have, of course, been very worrying to our clients, many of whom have already suffered terrible problems as a result of their implants. I have today written again to the Medicines and Healthcare products Regulatory Agency (the MHRA), to urge them to react to the developments in France and, similarly to France, to set up a suitable protocol for women affected in this country.
Earlier this month, The French Health Products Safety Agency (AFSSAPS) published new recommendations for patients with PIP breast implants, advising that they should contact their doctor or surgeon to arrange a clinical, and or radiological examination to determine the condition of their PIP implants. If any rupture or leakage is detected, AFSSAPS recommend that women have both PIP implants removed. Mark Harvey calls on affected women to take heed of these recommendations and to seek medical advice if they are worried about their implants.
The Medicines and Healthcare products Regulatory Agency have not yet reacted to the recent updated release by AFSSAPS.
