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.

AFSSAPS TEST RESULTS OF PIP BREAST IMPLANTS RELEASED

The long awaited results of testing undertaken by the French medical device regulatory authority, AFSSAPS on recalled PIP breast implants have today been released.  AFSSAPS have today confirmed that the results of the latest analysis have found that there is no link between PIP breast implants and genotoxicity (a potential to cause cancer). However, test results have confirmed that the gel inside can bleed through the pocket of the implant.  AFSSAPS have maintained their recommendation that women with PIP breast implants should consult their doctor every 6 months for a clinical examination and an ultrasound of the breast and lymph nodes located under the arm.

The French authorities have further recommended that if an implant rupture or leakage of silicone is suspected, both PIP breast implants should be removed. AFSSAPS advise that because of the complications associated with removing lymph nodes, these should not necessarily be removed due to the possible complications, but, removal should be considered in cases where women are suffering severe reactions as a result of silicone leakage into the lymph nodes. 

AFSSAPS have also recommended that when women have their PIP implants removed, they should attend a follow-up appointment within one year of replacement surgery.  Due to the possibility of the gel within the implant leaking outside of the shell, Afsaaps do not recommend that ladies with PIP implants breastfeed their children.

In September 2010 AFSSAPS confirmed that interim results of PIP breast implants testing had showed that the gel within the PIP implants was not the same as was described in the manufacturer’s design guide; that it did not reach the level of quality required before a silicone gel can be used in breast implants; that it could lead to an inflammatory reaction in some women and that PIP implants had a higher propensity to rupture. AFSSAPS recommended that all women with PIP implants should be referred for an ultrasound scan and all women with ruptures or suspected ruptures should have both their PIP implants removed.  One of the French genotoxicity tests in September was inconclusive and the results of their further testing was not known until today.

The MHRA have yet to release a statement on these latest results.  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. 

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.

Reacting to the announce, Hugh James Partner Mr Harvey commented that:  “Although our clients will be relieved to hear the results in relation to the gentoxicology results, the AFSSAPS results will still be extremely worrying for our clients. We are now eagerly awaiting a statement from the MHRA; our hope is that they will support the AFSSAPS finding that women with PIP implants should have regular ultrasounds however, we hope that they will go one step further to protect these vulnerable women by making it a requirement that clinics who implanted these faulty devices   provide adequate after care for these vulnerable patients.

We are now calling on the MHRA and all clinics who have implanted these faulty implants to support these women. Both women who have already suffered a rupture and women concerned that they may suffer a rupture in the future should be treated free of charge by their clinic and this should not be left as a burden for the NHS. AFSSAPS have confirmed that these implants are below the standard that is expected of breast implants and our clients should be compensated as soon as possible”.