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.

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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.

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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. 

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