THE MHRA REACT TO THE FRENCH AUTHORITIES’ ADVICE THAT ALL PIP IMPLANTS SHOULD BE REMOVED

Following the recent reports 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 Medicines and Healthcare products Regulatory Agency (the MHRA) have released a statement saying that they are aware of the recent report in France of the death of a woman implanted with Poly Implant Prosthese (PIP) breast implants from anaplastic large cell lymphoma (ALCL).

They have stated that they will:

“continue to monitor for any associations of all types of breast implants, including PIP, with cancers and any other health implications. We will continue to liaise with agence francais de securite sanitaire des produits de sante (AFSSAPS) and will consider any new evidence which comes to light as a priority.”

The MHRA have reiterated that their advice to women with any type of breast implant that have any questions or are concerned that their implants may have ruptured, is that they should seek clinical advice from their implanting surgeon.

Reports this week 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.

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 written again to 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.

I do not believe that MHRA’s reaction to date has been satisfactory; it is unbelievable that the MHRA have not ensured that they were involved with the consultations in France about a product that affects such a large amount of women in this country. I am and have been very critical of their role throughout the history of this product. This stems from allowing this company to sell these implants in the UK in the first place; their refusal to respond when I alerted them to the problems; their refusal to meet with any of my clients to discuss their concerns and now this latest health concern.”

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 (http://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.

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.