New figures show almost 1,000 women have already had faulty PIP implants removed by the NHS

The latest data from the Department of Health (DoH) shows that almost 1,000 patients who received faulty implants from French company Poly Implant Prothese (PIP) have been privately referred to the NHS to have them removed since January, with the NHS footing the bill.

 

607 women who had operations with private doctors have now decided to have their implants removed via the NHS, with 384 of these having already had the surgery. Another 378 women who had the implants put in by the NHS have also decided to have them removed, with 275 operations already taking place.

The cost to the NHS for appointments and scans that have already taken place is over £850,000. This will rise significantly when all 607 patients have had their surgery and could rise further as more women come forward.

In total over 7,000 individuals have approached the NHS with over 5,000 already having appointments and scans to establish if any rupture of the implants has taken place.

Who should foot the bill?

There have been arguments over who should pay for the removal or replacement of faulty implants. In January 2012 the Government announced that women given PIP breast implants on the NHS could have them removed for free, they expected private firms to offer the same.

Unfortunately it then emerged that many private clinics had disappeared and others refused. This led to the announcements that any women refused help would have access to NHS care but only for removal of implants, not replacement. In Wales the Welsh Government has gone further and agreed to replace as well as remove implants where the clinics will not assist.

Read the full release here.

Government’s final report on the safety of PIP implants released

The final Government report has concluded that the gel within PIP breast implants is not toxic or carcinogenic and is not a long term health risk to women despite the gel used being industrial based silicone.

The report has found that PIP breast implants have double the rupture rate of other implants. It is believed that around 47,000 women in the UK were fitted with PIP breast implants.

Mark Harvey of Hugh James Solicitors is representing nearly 1,000 women with PIP breast implants and has been appointed by the Court as the lead solicitor in the PIP Group Litigation. He has welcomed this new announcement, but warned that his clients will expect further tests to be undertaken on these implants:

“We welcome today’s announcements and it will be some relief to our clients that have been affected by this scandal. We also agree wholeheartedly with the recognition in the report that anxiety over possible health effects is in itself a form of health risk, something that we see on a daily basis in our own clients."

 

Read the full news release here.

PIP breast implants Medical Device Alert

On 15 March 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a new Medical Device Alert for PIP breast implants manufactured before January 2001.

The PIP breast implants manufactured after January 2001 by Poly Implant Prothèse are already the subject of a Medical Device Alert issued in October 2010, amidst concerns of increased rupture rates and the use of an unapproved, industrial grade silicone gel.

 

The French authorities have provided new information to the MHRA which suggests that no guarantees canbe made that PIP breast implants manufactured prior to January 2001 are filled with approved, medical grade silicone.

It is estimated that a further 7,000 women may have been fitted with PIP breast implants prior to January 2001, in addition to the 40,000 who are believed to have already been affected.

Mark Harvey of Hugh James represents more than 1,000 PIP patients and has been appointed as lead solicitor by the High Court. Mark says “This will be very disappointing for the women involved. We are not surprised given that PIP were facing compensation claims through much of the late 1990s but together with the recent scandal of the metal on metal hip prostheses it does of course simply reinforce our previously stated concerns of just how ineffective the regulation of these products has been.

We call for a public enquiry into the whole way in which medical devices and products are regulated in the UK and across Europe."

Read the full news release here.

Group Litigation Order (GLO) now in place for personal injury claims

On 9 March 2012, the High Court in Cardiff made a Group Litigation Order (GLO) in relation to personal injury claims being made by women who received PIP breast implants. Mark Harvey of Hugh James has been appointed as the lead solicitor. The GLO will allow those affected to have their cases heard by a Judge. Those who have not yet started their claim will need to do so to be included in any further action.

The purpose of the GLO is to ensure that all such cases are pursued and managed together. The GLO has been approved by the President of Queen's Bench Division and the GLO and has now been lodged in the High Court in London. It is anticipated that there will be a trial in the winter of 2013.

Read more about Hugh James PIP claims.

PIP breast implant scandal continues to be debated

The Royal College of Surgeons (RCS) recently issued a statement which calls for all women affected by the PIP breast implant scandal to have them removed upon request.

The advice contradicts guidance given by the UK Government, which states that the PIP implant poses no risk and should only be removed if a rupture is found. The RCS statement insists that all patients should have access to an assessment and be given the opportunity to have the implants removed upon requests. It also criticised private clinics by saying they “have an ethical and moral duty of care to offer patients treatment without charge”.

The statement follows a report issued in the Lancet medical journal which discusses how Brian Toft, Professor of patient safety at Coventry University had last year warned ministers of short comings in the regulatory process for approving medical products in the UK and Europe.

The PIP scandal has triggered the Health Secretary, Andrew Lansley to issue a review of the regulatory system in the UK.

Read our full news release

UK Government confirm that NHS will remove but not replace private PIP Breast Implants

In an announcement at the Commons yesterday, Health Secretary Andrew Lansely reiterated the statement released on Friday 6 January that the NHS will remove breast implants for women who had these implants on the NHS and will also remove breast implants for women treated privately where their clinic has ceased trading or will not help them, if there is a health risk to them. He again reiterated that he hoped the cosmetic clinics would step in to treat their patients so that this burden does not fall on the NHS.

A Review to examine the standards of private clinics was also announced by the Health Secretary.  This will be carried out by the Care Quality Commission and will report back by the end of March.

Mr Lansley was criticised in his handling of this matter by the Shadow Health Secretary, Andy Burnham, who stated that he has sent ‘mixed messages’ to women and has left them ‘fending for themselves.’

Mr Lansley did not take the same step as the Welsh Government who announced that the NHS would remove and replace PIP breast implants for all women affected who live in and are registered with a GP in Wales if they can show that they have sought assistance from their implanting clinic but that they failed to assist.

The Harley Medical Group, one of the British companies that implanted the most number of PIP breast implants have today confirmed that they will not replace these implants free of charge claiming that doing so would put them out of business.

Read our full release

Government reiterates that women with PIP breast implants do not need to have their implants removed

Head of Litigation at Hugh James, Mark Harvey condemns Government’s lack of control over ‘powerful cosmetic industry’

The Government announced on Friday 6 January that there is no need for routine removal of PIP breast implants. However, it continued to state that the NHS should pay for women who were fitted with these implants through the NHS and that it expected private clinics to follow suit. Renowned campaigning lawyer Mark Harvey, Partner and head of the top ranked personal injury team at Hugh James solicitors, is representing over 600 women with PIP implants of which over 300 have contacted Hugh James in the last two weeks. Reacting to the recent announcement Mark Harvey commented that:

“The announcement is indecisive and sends out mixed messages to women across the UK affected by the PIP implants; it will be a big disappointment to our clients who have again been shown a complete lack of support and care from the Government and I know they will feel let down. On the one hand, they have recommended that the NHS should remove implants for concerned women if they have had their implants on the NHS, which we of course support. However, by only making a suggestion that the cosmetic industry should follow the example of the NHS then the Government again leaves women vulnerable. The announcement also suggests that the Government has no power to enforce this on the clinics; leaving this powerful cosmetic industry to their own devices. From our client’s experiences with many of these clinics to date, they have shown affected women no sympathy or support and we are extremely concerned that this announcement will again allow cosmetic clinics to leave women to try to sort out this serious problem alone. The announcement has gone against recommendations already made by the professionals of the review group who must have the most relevant expertise and this will again, as has been caused  already by the MHRA and the Government’s dealing of this scandal, cause greater uncertainty and concern for our clients. Worst of all it goes against what Mr Lansley was telling the clinics early this week, that they should be removing the implants”.

The announcement was made following a Government review of the risks posed by faulty silicone breast implants after suggestions that more than 3,000 may be affected by these implants that were recalled in March 2010. Following contradictory data about the rupture rate of these implants, Andrew Lansley, the Health Secretary, announced last Saturday that there were fears that existing evidence about potential dangers was not reliable.

Mark Harvey will be continuing to pursue legal claims on behalf of his clients and will be making an application to the Court for a Group Litigation Order at the end of the month so that the legal issues may be dealt with by a Judge later this year. 

Read our full news release

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”.

Hugh James PIP Breast Implants History

Hugh James solicitors are representing over 225 women with implants manufactured by Poly Implant Prothese (PIP).

On the 31st March 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a Medical Device Alert in relation to all silicone gel filled breast implants manufactured by PIP, recalling all devices to the UK supplier.

It has been confirmed by the French medical device regulatory authority (AFSSAPS) that there may be a higher rate of rupture in PIP breast implants. The MHRA have however confirmed that the gel itself is not toxic, a health risk.
Hugh James Solicitors are advising all ladies with PIP implants to seek medical advice as soon as possible.

For information on joining the group represented by Hugh James please contact Mark Harvey on 029 2039 1174.

Frequently Asked Questions

What are PIP Implants? PIP Implants are silicone breast implants manufactured by French company, Poly Implants Prothese (PIP). It is reported that as many as 50,000 women, including thousands in the UK, could have received these implants.

Why are PIP Implants in the news? On the 31st March 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a Medical Device Alert in relation to all silicone gel filled breast implants manufactured by PIP, recalling all devices to the UK supplier. Recent testing by the French Authorities have confirmed that there are concerns that PIP Implants are more prone to rupture than other breast implants however the MHRA have confirmed that the implants are not a health risk.

PIP Implants are commonly referred to in the news as ‘cheap’ breast implants however from our experience, many women paid high prices from clinics for these breast implants or, were not give a choice as to which implants they were given.

Do I have PIP Implants? If you have had breast augmentation but are unsure as to whether or not you have PIP Implants, please firstly check the documentation you received from your implanting clinic. If there is no information in relation to the type of implant you received, please contact your implanting clinic directly who should be able to confirm whether or not you have PIP implants.

Are PIP Implants dangerous? The MHRA have announced that, from the testing they have carried out, the gel inside the implant is not toxic or cancerous and therefore not a health risk. The advice we are giving our clients is that they seek medical advice as soon as possible but please not to panic.

Will the MHRA want to hear from me? Yes, the MHRA will want to hear from all women with PIP breast implants. This will help the MHRA assess the safety of the implants and will guide them as to how many women have been affected by this faulty product. Please click here to be directed to the MHRA’s adverse reporting pages

What do I do next? Firstly, please seek medical advice. We advise our clients to firstly speak to their GP and to take all information that you have in relation to PIP Implants with you so that your GP can understand the concerns in relation to these implants.

Contact your clinic to discuss your possible next steps with them.

The French authorities and BAAPS have recommended that all women with PIP Implants have an ultrasound although this has not been advised by the MHRA. You may therefore want to discuss having an ultrasound with your GP and / or implanting clinic.  If you are interested in pursuing a claim, please contact Hugh James on 02920 224 871 to discuss in more details; we represent many ladies who will be in a very similar situation and we would be very happy to help.

Do I have a claim?  If you have had PIP implants for less than 10 years and are unhappy that you have these implants after what you have read about their quality, we believe you may have a claim. We believe that you may have a claim even if you have not suffered from any problems with your implants. Please contact Hugh James on 02920 224 871 to discuss your potential claim in more detail.

Hugh James Solicitors is representing over 225 women with PIP Implants and therefore your claim will be in safe hands with Hugh James.

How will I fund my claim with Hugh James?

All clients with PIP Implants are either represented through a legal cover that they already have as part of an existing insurance policy or through a Conditional Fee Agreement, a ‘No Win, No Fee’ Agreement. Please contact Hugh James on 02920 224 871 to discuss your funding options in more detail.

Should I tell my clinic about my claim with Hugh James?

As we are representing over 225 women with PIP Implants, we have already been in contact with most clinics that have been using PIP Implants therefore they will probably already be aware of our claims. Being instructed by us should not harm your relationship with the clinic.

PLEASE NOTE THAT YOUR SOLICITOR WILL NOT BE MEDICALLY QUALIFIED AND THEREFORE YOU SHOULD ALWAYS RELY ON YOUR GP / BREAST SURGEON FOR ADVICE ON WHAT MEDICAL STEPS TO TAKE IN RELATION TO YOUR PIP BREAST IMPLANTS AND ALL OTHER MEDICAL ISSUES.