Health Committee to take evidence on PIP breast implants

PIP Implant Claims

On 7 February the Health Committee will hold an oral evidence session on PIP breast implants and regulation of cosmetic interventions.

Tuesday 7 February 2012

Witnesses:

At 10.30 am

Professor Sir Bruce Keogh KBE, NHS Medical Director

Professor Sir Kent Woods, Chief Executive of MHRA

Dr Anne-Marie Slowther, Associate Professor of Clinical Ethics at Warwick Medical School and Consultant Clinical Ethicist at University Hospitals, Coventry and Warwickshire NHS Trust

Mr Simon Withey, Consultant Plastic Surgeon, Member of the Council of the British Association of Aesthetic Plastic Surgeons, Member of the Steering Committee looking at Standards in Aesthetic Plastic Surgery

Location: To be confirmed by noon on Thursday 2 February

Visitors are advised to allow about 20 minutes to pass through security.

Please wait outside the meeting room until invited by Committee staff to enter the room.

You might find this link to maps and directions useful.

You may wish to bookmark the following link to the Health Committee website. Any previously bookmarked Health Committee pages should be deleted as they could take you through to obsolete material. Please remember to refresh your screen each time you visit this website or the Parliamentary website in order to obtain the most up-to-date information.

source: parliament.uk

PIP breast implant boss Jean-Claude Mas faces charges

PIP Implant Claims

The owner of a French breast implant maker that sparked a safety scare faces charges of "involuntary injury", his lawyer says.

He said Poly Implant Prothese (PIP) founder Jean-Claude Mas, 72, had been freed on bail of 100,000 euro ($130,000).

In 2010, France banned PIP implants made with the low-grade silicone, amid fears they could rupture and leak.

Up to 400,000 women in 65 countries are believed to have been given implants.

Mr Mas remained at his home in Six-Fours-les-Plages, in the South of France, while police searched it - as required by French law. He was later taken to the national police station in Marseilles.

'Nothing to say'

His lawyer, Yves Haddad, told AFP news agency: "He is not well, he is tired and he is waiting for his doctor."

Mr Mas has been under investigation since he revealed in a police interview last year that PIP ordered employees to hide the unauthorised silicone when inspectors visited its factory.

It was thought that he would be investigated for manslaughter but although Mr Mas is still considered a suspect, his lawyer told Reuters news agency that "on the charge of involuntary homicide [manslaughter], the judge decided that for now there is no link".

A lawyer representing women who had been fitted with PIP implants said he welcomed the arrest of Mr Mas.

"This is a relief. It's come late, but at least it's happened," Philippe Courtois said.

"He's been placed in preventive detention. Let's see in the coming hours what his interrogation by the investigating magistrate brings. But what we're really hoping for is his formal investigation, under remand in custody, just to make sure that he doesn't leave French soil during the investigation."

Mr Mas told police in an interview last year that PIP had deceived European safety inspectors for 13 years.

But he has insisted they posed no threat to health and attacked the French authorities for offering to pay for their removal because it put women through a "surgery risk".

He also said he had "nothing" to say to women facing surgery for their removal and that victims had only filed complaints "to make money".

Excerpts from Mr Mas's interview have been re-examined by a French magistrate.

In France, 30,000 women have been advised to remove the implants and 2,700 have filed complaints against Mr Mas.

'Medically necessary'

Women in 65 countries - mainly in Latin America and elsewhere in Europe - have received implants made by the company, which closed down in March 2010.

Health officials in Germany, the Czech Republic and Venezuela have advised women to have them removed.

But the medical advice in the UK, where 40,000 are affected, is that there is no need for all the implants to be removed, only those causing problems such as pain or tenderness.

In England, patients fitted with PIP implants by the NHS will have them replaced by the health service, while it will remove implants from private patients if their clinics refuse. The NHS in Wales said it would replace implants only when it was deemed medically necessary.

Women in Northern Ireland who received PIP implants for health reasons will have them replaced, but the NHS will only remove, not replace, those inserted for cosmetic reasons.

Scotland's Health Secretary Nicola Sturgeon said concerned women who had them fitted privately would be offered advice and the option of removal if necessary. There are no records of PIP implants being used by the NHS.

On Thursday, two more private firms in the UK said they would remove PIP implants free of charge.

Transform, which has just over 4,000 UK patients with the implants, had originally said patients would have to pay for removal. It now says those who have had the implants fitted since 2001 can have free removal - but will have to pay around £2,500 for replacements.

Those who had replacements since 2006 may still be within their warranty period and would therefore get both removal and replacement for free.

The Hospital Group also announced it would offer free removal for patients who had PIP implants fitted between 2001 and 2009 - but would charge between £1,500 and £3,500 for replacements.

The international police agency Interpol has said Mr Mas is wanted in Costa Rica over a drunk driving charge.

It said the "red notice" over an alleged incident in June 2010 was "totally unconnected" to PIP.

source: bbc.co.uk

Sink taps source of infection that killed three babies

Birth Injury Claims

Sink taps were the source of an infection which killed three babies at a Belfast hospital, the Northern Ireland health minister has confirmed.

Edwin Poots told the NI Assembly that the Pseudomonas bacteria had been traced to taps at a neo-natal unit in the Royal Jubilee Maternity Hospital.

The unit was deep cleaned at the weekend after six babies were found to be infected.

A seventh case which emerged on Tuesday has now been confirmed as Pseudomonas.

That child remains very ill.

Sterile water is now to be used for nappy changing in the neo-natal unit.

"I can report that investigations so far have shown that pseudomonas bacteria have been found in a number of taps in the intensive care area of the neonatal unit in the Royal Jubilee Maternity Hospital," Mr Poots told the assembly on Tuesday.

"The Trust Health Estates team are in the process of removing and replacing all taps and related pipe work in the affected area."

The health minister stressed that there was no evidence that the bacterium was in the water system.

He said the trust had taken specialist advice from England and work would be carried out over the next few weeks to ensure the environment was safe.

He said new ultraviolet light taps which kill bacteria at source would be introduced in the neo-natal unit as a result of the infection.

"The unit will only be opened once all remedial work is completed and tests show that it is safe to nurse babies in this environment," he added.

So far seven babies have been infected; three died, two recovered, one recovered but later died from unrelated causes and one has pneumonia and is potentially infected.

Eight other babies are carrying the bacteria on their skin, but are not infected.

"The circumstances surrounding this are complex and there is considerable detective work involved," Mr Poots said.

"Our neo-natal network is managing well and well-established arrangements are in place.

"My priority is to manage the outbreak which is a complex and dynamic situation."

Earlier on Tuesday, the BBC learned that the Western Health Trust dealt with three cases of the pseudomonas infection before last Christmas.

One baby being treated in Altnagelvin's neo-natal unit died, while another made a full recovery.

A third was transferred to the Royal Victoria hospital in Belfast.

All three infants had a different strain of the infection that is currently being investigated at the Royal Maternity's neo-natal unit.

It has been confirmed that sink taps were the source of the infection at Altnagelvin.

Pseudomonas aeruginosa is found widely in soil and stagnant water. It does not usually cause illness in healthy people but can pose a serious threat to people with weak immune systems.

source: bbc.co.uk

Peers warn against medical negligence legal aid cuts

Irish Woman Receives Euros2.5M in Birth Injury Claim

Birth Injury Claims

23 years after being born during a poorly performed birth delivery, an Irish woman confined to her wheel chair was awarded 2.5M euros.

Lauren Tinney was born in 1988 at the Letterkenny General Hospital. During the birth it was claimed that Lauren suffered from fetal distress and asphyxiation, and was not properly monitored during labour, which caused her cerebral palsy.

source: jdsupra.com

Louth packaging firm admits safety breach after worker's arm was crushed

Personal Injury Lincolnshire
Machinery Claims

AN EMPLOYEE of a Louth packaging firm has been left disfigured and suffering “constant pain” after his arm was crushed as he was thrown over a machine while at work.

Through a solicitor, DS Smith Packaging Ltd, the UK’s leading supplier of corrugated packaging products which has two sites in Louth, pleaded guilty to breaching the Health And Safety At Work act at Skegness Magistrates Court.

The company also has a previous health and safety at work conviction following a fatal accident at its Northfields factory in Louth in 2005.

Emma Madeley, prosecuting for the Health And Safety Executive, said that on June 9, 2010, Daryl Bushnell was working at the Abbey Converters site on Fairfield Industrial Estate.

He had been with the company two weeks and was being trained by another colleague, Mr Telleson, who had been with the company for just over three weeks, to work on a semi-automatic re-winder as part of the process for making corrugated packaging.

The material, known as web, is fed into a machine and is then rotated on a spindle making corrugated card.

On the day of the accident, Mr Bushnell was operating the spindle while Mr Telleson operated the control panel.

They had been working this way for about two hours when Mr Bushnell got his hand stuck between the webbing and the spindle.

Mrs Madeley said: “Although Mr Telleson had not pressed the button, Mr Bushnell could not alert him. Both men were wearing ear plugs and Mr Telleson was facing the control panel.

“He could not see or hear there was a problem. He pressed the button and the spindle rotated on full speed.”

Mr Bushnell was thrown over the top of the machine and only came free when the webbing tore, falling on to the floor.

Mrs Madeley said: “Despite the force, he was able to walk away.

“The bottom part of his arm had snapped and was pointing inwards to his body.”

He had also suffered cracked ribs and spent three nights in hospital.

Mrs Madeley told the court that no guards were in place and that sensory equipment could have been installed to detect when someone was in the danger area.

She also told the court that it had become common practice for two operators to use the machine at the same time when, if only one person operated it, they would walk to the control panel, taking away the danger.

She also said the machinery was faulty and it had become common practice for operators to keep their hand on the spindle to hold the web in place until full rotation had started.

In a victim impact statement read to the court, Mr Bushnell, who was previously a joiner, said: “I think about this accident every day and keep reliving the shock of being thrown over the bar and how serious it could have been. The worse thing is I cannot lift my baby son without pain or weakness in my arm.”

He said he suffers constant pain and has been left self-conscious about the appearance of his arm.

Mr Bushnell was off work for a year and is now back with the company.

Since the accident, DS Smith has installed sensory guards on all the machines and has employed a member of staff specifically for training.

Paul Verrico, in mitigation, said: “The company believed they had adequate procedures in place. The management in Louth believed only one person was operating the machine as a general course. The issues around the mandrel (spindle) may have been known by the employees but not by the management in Louth. They had a spare for the machine in the warehouse – no one realised there was a problem with the grip.”

He said the company immediately put measures in place with modifications to the whole area and have reconfigured their approach to training.

He added the previous fatal accident happened at a different site and since then, the company nationally has reduced the number of accidents reported to the Health And Safety Executive by 60 per cent.

He said at the time of the incident, the Abbey Converters site had gone 1,406 days without any accidents.

The company will be sentenced at Lincoln Crown Court on a future date after magistrates felt they did not have the jurisdiction for sentencing.

source: thisislincolnshire.co.uk

PIP breast implants: Women march on private clinics

PIP Implant Claims

Around 60 women have marched on private cosmetic clinics that fitted now-banned PIP breast implants, as an NHS media campaign set out government advice.

Marchers in London called on clinics to replace PIP implants free of charge.

Some clinics blame poor regulation for the use of the substandard implants and say they cannot afford to remove them.

NHS adverts in national papers repeated the message there was no evidence they were riskier than others but said the NHS would replace any it had implanted.

The now-closed French company Poly Implant Prostheses (PIP) filled its implants with industrial grade - rather than medical grade - silicone. It was originally manufactured for use in the mattress industry.

Around 300,000 of the PIP implants were sold around the world, mainly in Europe, with 40,000 fitted in the UK.

French, German and Dutch health authorities have all recommended that women fitted with PIP implants should have them removed as a precaution.

However, the UK government advertisement published in English newspapers on Saturday repeated its position that there was no need for routine removal.

In cases where implants were fitted privately, ministers have said only that the NHS will remove them. Replacements will only be funded if a patient's GP deems it "clinically necessary".

The chief medical officer, Prof Dame Sally Davies, said the government had already been issuing the advice through a number of sources.

"What we're doing... this weekend is making sure the clarity of the information, with the advice from an expert group involving plastic surgeons, is out there for the whole population to see."

BBC correspondent Richard Lister says Saturday's protest in London was small but passionate. He says the women all believed they had been let down by the private clinics and by a government that would pay to remove the implants but not to replace them.

He says the women were not reassured by the NHS newspaper advertisements.

The marchers began their protest at the headquarters of the Harley Medical Group, which installed some 13,900 PIP implants between September 2001 and March 2010.

The company has blamed the government's regulatory authority for approving the PIP implants. It accused the Medicines and Healthcare products Regulatory Agency (MHRA) of not carrying out proper checks.

Protester Mia Wood, 32, from Doncaster, South Yorkshire, told the Press Association: "I'm angry, I'm frustrated, I'm crying every day.

"They are so happy to take our money but not prepared to help support us."

Ms Wood said the women wanted their implants to be replaced by the private clinics that fitted them rather than the NHS because "we've paid for a service".

Stacey Williams, 25, from Portsmouth, said that some clinics had gone into liquidation and reopened under a different name since fitting the implants.

"They say because they are a different company we aren't covered any more," she said.

Before participating in the protest, Gemma Pepper told the BBC she felt that the government's advertisement showed that it was "still pretty much sitting on the fence".

"And as long as they say they're not dangerous, the clinics are gripping hold of that and sticking to it like glue basically, because they are refusing... to do anything at all as long as the government continues to say this."

Europe-wide regulation

The European Commission says the implant scandal "reinforces" the need to reform Europe-wide regulation.

Breast implants in Europe are regulated by the 2007 directive on medical devices. The commission has been reviewing the rules for the past three years and is due to give its recommendations this year.

Cosmetic surgeons have called for more spot checks and a register of all devices implanted into the body, and the commission is expected to recommend tougher rules.

There are more than 10,000 medical devices ranging from class I devices such as plasters, class IIa and IIb which include X-ray machines and class III, such as breast implants, pacemakers and hip replacements.

Frederic Vincent, health and consumer policy spokesperson for the European Commission, told the BBC: "It [PIP] reinforces our opinion that we have to be tougher on medical devices, particularly class III."

However, he added: "We are dealing with a case of fraud. It means that what happened in France could have happened even with a more stringent pre-market assessment of the products."

The formal proposals will be sent to the EU Parliament and the Council of Ministers for approval. However, it could take up to three years before they are adopted by member states.

source: bbc.co.uk

PIP breast implants – latest from the NHS

PIP Implant Claims

Women concerned about French-made PIP breast implants can find all the latest NHS information about the issue on this page.

Worries about the implants have emerged since news of a major investigation into them in France was widely covered in the media in December 2011.

It is thought that around 40,000 women in the UK have the implants, with about 95% of them having been provided privately for purely cosmetic reasons.

What’s the problem?

The French implants caused global concern after it was revealed they contained industrial silicone rather than medical-grade fillers and that they may be more prone to rupture and leakage. Initially reports also linked the implants to a rare form of cancer known as ALCL. This cancer link has been now been firmly discounted by medical experts here and in Europe.

What type of implants are involved?

The implants involved are called Poly Implant Prosthèse (PIP) and were made, starting in 2001, by a French company of the same name.

The marketing, distribution and use of the PIP implants was suspended in March 2010 after regulators found that the manufacturers were using silicone intended for industrial use, and not medical-grade silicone fillers. It is reported that the company used a cheap type of silicone gel intended for making mattresses.

Do the implants have to be removed early?

Most breast implants need to be removed or replaced after 10-15 years.

An expert committee was set up recently to examine the specific risks associated with PIP implants. It concluded that as yet there was not enough evidence to recommend their early removal.

However, the committee said the NHS would remove and replace the implants without charge if patients that the NHS had operated on remained concerned. The government expects the private sector to follow suit.

NHS medical director Professor Sir Bruce Keogh, who led the expert review group, said: “On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants.

“But we understand that some women will be very concerned so we support the government’s position that the NHS will support removal of PIP implants if the patient has concerns and, with her doctor, she decides that it is right to do so.”

Andrew Lansley, the health secretary, said he was putting patients' interests first. "We believe that private healthcare providers have a moral duty to offer the same service to their patients that we will offer to NHS patients - free information, consultations, scans, and removal if necessary."

How many people are affected?

More than 300,000 PIP implants have been sold globally in 65 countries over the past 12 years. Europe was a major market but more than half of the implants went to South America.

In the UK, 40,000 women are thought to have the implants. Private clinics fitted 95% of these for women seeking cosmetic breast augmentation. The remaining 5% were fitted on the NHS.

The NHS provides breast implants only where there is clinical need. For example, women who have a mastectomy (breast removal surgery) as part of treatment for breast cancer are often offered implants as part of reconstructive surgery.
 

What happens if I got a PIP implant through the NHS?

Women who received a PIP implant from the NHS will be contacted to let them know they have one.

If you are worried, you should book a consultation with your specialist or GP. They will offer clinical advice on the best way forward. This could include an examination using scans, such as MRI, to look for any signs that the implant may have ruptured.

The NHS will support removal and replacement of PIP implants if a woman and her doctor decide that it is the right thing to do. The secretary of state has made clear that patients' concerns must be put first.

What if I got a PIP implant privately?

The following private clinics have said they will replace PIP implants free if clinically necessary: Holly House, Highgate Hospitals, Make Yourself Amazing, Ramsay Health Care, Spire Healthcare, BMI Healthcare, Nuffield Healthcare and HCA International.

If a private clinic that provided PIP implants no longer exists or refuses to help, then, so long as you are entitled to NHS services, the NHS will cover the cost of the removal of PIP implants if your doctor agrees. However, the NHS will not replace implants unless it is clinically necessary.

What’s the evidence around the saftety of PIP implants?

During December 2011 UK media had originally focused on a possible link between PIP implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL). This arose after a French woman with PIP implants developed the cancer and died. However, after reviewing the evidence, the expert group conducting the review agreed that there was no link with cancer.

More recently, attention has focused on the rupture rate of the implants, and whether the unapproved gel filling of PIP implants could have a toxic affect.

The review has specifically looked at these issues, and found:

• From the “patchy” data available, the review panel was not able to tell whether the rupture rate for PIPs is higher than for other types of implant
• From the implants that have been tested there appears to be no risk of dangerous toxic effects in the event of a rupture
• The review group said it could not be certain that the manufacturer did not change the content of the implants, so could not completely rule out the possibility that some might contain toxic substances.  

What is a rupture and what are the signs?

A rupture is a split that occurs in the implant’s casing. A rupture can be caused if:

• the implant’s shell gets weaker over time
• the implant is damaged during the operation
• there is a flaw in the implant
• the breast is injured 

When implants were first developed, they had very thin walls and rupturing was a common problem. However, modern implants that have been used in the UK since the 1990s rupture much less frequently.

If an implant ruptures, it is recommended that it be removed and replaced with a new one. If it is a saline implant, any leakage from the implant is not expected to cause problems as saline is a sterile, saltwater solution that the body is able to safely absorb. However, with silicone implants, silicone that leaks out of a ruptured implant may cause problems, such as siliconomas or a gel bleed.
SiliconomaA siliconoma is a small lump formed of silicone that has spread outside of the scar capsule and into the breast. Siliconomas can be tender to touch and if they are causing significant pain they may need to be removed. In rare cases, the silicone can spread to the muscles under the breast, armpit or around the nerves to the arm. 
Gel bleeds
Gel bleeds are where tiny particles of silicone are released from the surface of a silicone breast implant. This can occur when the breast implant ruptures, or sometimes it can happen when there is no rupture. If silicone particles get into the lymphatic system (the network of vessels that help the body to fight infection) they can be transported to nearby lymph nodes (glands), such as those in the armpit. This may cause the lymph nodes to become slightly swollen. This is usually a minor problem, although in some cases the enlarged lymph nodes may become uncomfortable.

MRI scanning is considered to be the most effective method of detecting “silent rupture” of silicone gel-filled breast implants. In the US the Food and Drug Administration recommends that women with silicone gel-filled breast implants receive MRI screening for silent rupture three years after receiving their implant, and then every two years. In the UK women can get specific advice from their implanting surgeon.

source: nhs.uk

PIP implant claims - We have the solution

PIP Implants


Every day there seems to be another press update concerning PIP breast implants causing further confusion to the women who need answers.


We started our PIP claims service in January last year (2011) as part of our gocompensate.com range of personal injury and medical negligence specialist claims services.


After the news release in December 2011 we have received a huge number of enquiries and have assisted by connecting potential claimants with specialist solicitors on a regional basis. 


Our commitment is to keep claims local where possible to enable potential claimants access to regional specialist compensation solicitors.


We also provide this at no cost to the potential claimant and do not charge referral fees to the solicitor either.


If you are concerned about PIP implants and where you stand access our dedicated website to enable you to claim online.

The English have weaker necks and the North West have the weakest of them all!

http://www.lawcouncil.org.uk/#/blog/4559438054/The-English-have-weaker-necks-and-the-North-West-have-the-weakest-of-them-all/812198

'Stunning variation' in whiplash claims

Whiplash Claims

The Commons transport select committee is calling for urgent action to cut the amount of compensation paid to people who claim they suffered whiplash in car accidents.

Former justice secretary Jack Straw told the Today Programme's Sarah Montague that there are "huge profits to be made" in the chain of parties involved in claims for compensation.

There were "stunning variations" in whiplash claims across the country, he said, with the large number of claims indicating people in the UK had "weaker necks" than international counterparts.

Nick Starling from the Association of British Insurers said that in a country where there is "one whiplash claim every minute", there needs to be a complete reform of the "dysfunctional" personal injury system.

Insurers, too, play their part in the problems, he acknowledged, saying that "everyone is to blame in a system that is dysfunctional".

source: bbc.co.uk

LISTEN TO RADIO INTERVIEW

Circuit Judge - Death in Service

The Lord Chancellor, the Right Honourable Kenneth Clarke QC MP, was saddened to learn of the death today of His Honour Judge John Ashley Taylor.

His Honour Judge John Taylor (65) was admitted as a Solicitor in 1980. He was appointed as a Deputy District Judge in 1992, as an Assistant Recorder in 1997, as a District Judge in 1998, as a Recorder in 2000, and as a Circuit Judge on the North Eastern Circuit in 2006.

source: justice.gov.uk

Record number of enquiries for PIP Implant claims website

PIP Implants

The PIP Implant Claims website that has been online since January 2011 has seen a record number of enquiries in recent weeks from ladies throughout the UK who have PIP breast implants.

On Saturday the government confirmed that the NHS would fund the cost of removal and replacement surgery for those who had PIP breast implants inserted on medical grounds but expected the private cosmetic surgery sector to offer the same deal for their clients.

A number of private medical companies are yet to confirm acceptance of the government's expectation leaving their clients with further unexpected bills. 

Speaking on behalf of gocompensate.com, the owners of the pipimplantclaims.co.uk website said "We identified that there was potential to provide support and assistance for the thousands of women who had breast augmentation with these defective implants and that we could connect them to specialist regional solicitors to assist them in their claim. We launched our website in January 2011".

"Recently we have seen a significant increase in online and telephone enquiries and have connected each and every enquiry with a specialist solicitor able to help them".

gocompensate.com connects potential claimants with specialist personal injury and medical negligence lawyers throughout the UK and does not take a fee for referring the claim. It is the original referral fee free online claims service.