Vale Senator Brian Harradine 1935-2014

Richard William BRIAN HARRADINE 1935-2014

Australia’s longest-serving independent Senator Brian HARRADINE has died in Hobart, Tasmania, aged 79 after a long illness.

Senator HARRADINE was the one and only politician who would listen to us, and we mean listen to the tragedy that was the tainted blood scandal.  He was instrumental in having the Australian Senate Inquiry into Hepatitis C and Blood Supply in Australia in 2004.

Senator HARRADINE read out some things in the Senate which led to the first waves of truth about CSL and the Australian Red Cross Blood Service (ARCBS) becoming public.

Senator HARRADINE was only interested in hearing from us direct, not people who purported to be representing us.  We had the facts and not the poly waffle. A great man.  He was incorruptible;  that was the feeling he gave off.  How many people, particularly politicians, are like that?

Here’s a tribute in itself:  Blood inquiry witness faces court action | 3 April 2003

Medical Error Action Group, incorporating The Tainted Blood Product Action Group, salutes Senator HARRADINE.

Failed PIP breast implant replaced with now recalled brand CEREFORM

Faulty PIP breast implants replaced with now recalled brand CEREFORM, hundreds of Australians may be affected
ABC News Online
By medical reporter Sophie Scott and Alison Branley
1 April 2014  18:00 hours

Authorities do not know how many Australian women had faulty French breast implants replaced with a second, now recalled brand.

Last month the Therapeutic Goods Administration (TGA) announced the Australian distributor of PIP breast implants, Medical Vision Australia, had pulled its CEREFORM implants from shelves following a recall in France.

Despite the recall, Medical Vision are still spruiking the product on their website.

The recall occurred after the French regulator found the paperwork around sterilisation did not meet international standards.

In Australia, the TGA said there had been no increase in infection rates with the implants and there was no health risk.

About 4,800 CEREFORM implants have been sold in Australia since 2009 and while only some would have been replacement implants, hundreds of women could be affected.

Among them is Cairns woman Christine STEPHEN, who was never told her CEREFORM implants came from the same distributor as PIP.

Ms STEPHEN had her PIP implants removed after one ruptured.

She developed a severe infection around her replacement CEREFORM implants and had to be rushed to hospital.

“It had to be all scraped out. I didn’t know whether I was going to wake up with or without a breast,” she said.

While she was understanding about the PIP recall, she is angry the CEREFORM implants have also been recalled.

She has spent $25,000 on surgeries so far and needs another operation to remove scar tissue.

“I cannot understand why a product from the same company [sic] and same distributors was allowed into the country and knowingly put into somebody who had been through PIP,” she said.

CEREFORM was distributed by the same company in Australia as PIP but is made by a different company in France.

Ms STEPHEN refutes the TGA’s assertions there has been no increased rate of infections with CEREFORM.  She says she had an infection and it was not recorded.

“It just feels like there’s been a lot of lies. And a lot of people passing on blame where it’s black and white,” she said.

Medical Vision Australia did not respond to the ABC’s inquiries.

No figures available on CEREFORM replacements.

Authorities say they do not know how many women in Australia had PIP implants replaced with CEREFORM implants.

The TGA says it does not monitor the sale of approved products and relies on information from surgeons and suppliers.

The Australia Society of Plastic Surgeons says it does not have figures on CEREFORM replacements.

Its president, Dr Geoff LYONS, says the latest recall underlined the need for a breast device registry.

“A world-class registry has been developed in Australia and is ready for national roll-out pending government funding,” he said.

PIP removal process ‘traumatic’ for many women

Lawyer Tim WHITE represents women who had faulty French breast implants, and says the CEREFORM recall was following the same pattern as PIP.

“I expect this is a first step they are using so that if there is a problem it’s not further multiplied by continuing to use the product,” he said.

Mr WHITE has clients who had the PIP implants replaced with CEREFORM.  He says the PIP removal process was traumatic for many.

“A lot of the women ended up consulting psychologists because they were that concerned,” he said.

“Some were put on anti-depressant medication.  A lot of women took time off work because they weren’t coping emotionally.

“It was a significant impact on many of them.”

Mr WHITE is concerned regulators have not learned lessons from the PIP saga, with no requirement for distributors to have product liability insurance.

“Here you’re dealing with a class three medical device which is a high-risk device according to the TGA,” Mr WHITE said.

“If these implants have to be removed because there is a fault then… it falls to the individual lady to cover the cost out of her own pocket.  This is the great concern for consumers in Australia.”

TGA says no identified health risk from CEREFORM implants

The TGA says CEREFORM was recalled overseas because its makers did not comply with regulations.

A spokesman says there is no identified health risk but as a precaution surgeons in Australia were notified and surgeries with the implants were cancelled.

“The TGA is not aware of any increased infection rates among Australian patients receiving CEREFORM breast implants and there is no evidence that any of the implants already supplied in Australia have not been sterilised properly,” he said.

Dr Daniel FLEMING from the Australasian College of Cosmetic Surgery advises the TGA on the implants, and says there is no risk to patients with CEREFORM implants.

“This is a failure of documentation, not a failure of the sterilisation,” he said.

“The TGA is not aware of any increased infection rates among Australian patients receiving CEREFORM breast implants and there is no evidence that any of the implants already supplied in Australia have not been sterilised properly.”  A TGA spokesman.

“The importer, the distributor in Australia, has been duped in the same way everybody else has in these matters.”

Dr FLEMING says patients with CEREFORM are at no greater risk of infection.

He does not use CEREFORM implants.

“All patients who have an implant have a chance of infection, about 1 per cent, so of course there are patients who are going to have an infection with CEREFORM implants,” he said.

“But the risk is no greater with CEREFORM.”

The TGA says if there was to be an infection associated with the implant it would follow the initial operation.

Mr WHITE says it also underlines the need for an opt-out breast implant register.

“There’s no process to be able to alert individuals to inform them of this potential problem,” he said.

“There’s certainly been other cases of breast implants failing and so no this is not the second example of it, there’s certainly been others.”

VIDEO:  Faulty PIP breast implants replaced with now-recalled brand (ABC News)
PHOTO:  Despite the recall, Cereform breast implants are still advertised on Medical Vision’s website (ABC News)
RELATED STORY:  Australian investigation into breast implants after French recall
RELATED STORY:  Founder of French breast implant scandal firm jailed
RELATED STORY:  German company ordered to pay over faulty breast implants

http://www.abc.net.au/news/2014-04-01/faulty-pip-breast-implants-replaced-with-now-recalled-cereform/5359086

UK hospital poisonings: Nurse charged with three murders

A 47-year-old registered nurse Victorino CHUA has been charged with murdering three hospital patients.  He also faces 31 charges involving 25 other patients at the Stepping Hill Hospital in Stockport, Greater Manchester, United Kingdom.

They include eight attempted poisonings, one of grievous bodily harm and 22 of attempted grievous bodily harm (GBH).  CHUA is due to appear at Manchester magistrates’ court tomorrow morning. 

The medic had spent two years and three months on bail after first being quizzed by detectives in January 2012.  the probe followed the death of patients whose drips were allegedly contaminated in the summer of 2011.

CHUA was originally held on suspicion of killing three patients – Tracey ARDEN, 44, Arnold LANCASTER, 71, and Derek WEAVER, 83 – by poisoning.

The latest charges came after he was dramatically re-arrested in a dawn raid on Thursday, 27 March 2014.

CHUA, a registered nurse since 2003, was pictured wearing a camouflage hooded top and black hat as he was led from his home in Heaton Chapel and bundled into the back of a police van.  Several officers were involved in the arrest of CHUA, who had been due to answer police bail on Monday.

In a statement, a Greater Manchester Police spokesman said: “A man has been arrested in connection with the investigation into the deliberate contamination of products and tampering of medical records at Stepping Hill Hospital.”

Detectives believe a worker at the hospital injected insulin into saline solution, poisoning 22 patients in June and July 2011.

Former journalist, Bill DICKSON, 82, Linda McDONAGH, 60, John “Jack” BEELEY, 73, Beryl HOPE, 70, and Mary CARTWRIGHT, 89, died several months after it was suspected they were poisoned.

They are among the number of cases being treated as grievous bodily harm.

Police are understood to have obtained new evidence after an investigation which lasted almost three years.

CHUA was barred from approaching any witnesses or attending any medical sites during the probe.

Before his arrest, another Stepping Hill nurse, Rebecca LEIGHTON, spent six months in prison accused of poisoning patients.

All criminal charges against her were later dropped but she was sacked after admitting stealing drugs.  She was suspended for three months by the Nursing and Midwifery Council.

Adelaide: Ex-midwife banned, fined after homebirth baby deaths

Former Adelaide midwife Lisa BARRETT has been found guilty of professional misconduct and fined $20,000 after being involved in a number of home births where babies died.

The Health Practitioners Tribunal of South Australia also banned Ms BARRETT from working as a midwife, including the provision of almost any services to pregnant women and their babies.  It found that while she had relinquished her midwifery registration in 2011, she had continued to provide services akin to midwifery.  The findings follow a coronial inquest in South Australia into the deaths of three infants between 2007 and 2011 where Ms BARRETT was involved in supervising high-risk home births.  The Coroner found that all three babies would have lived had they been born in hospital by caesarean section.  He had also been made aware of another death in Western Australia where Ms BARRETT had been involved with the birth.

In its judgment the Tribunal found that Ms BARRETT’s conduct was substantially below the standard reasonably expected of registered midwives of her level of training and experience and amounted to professional misconduct.  It said the protection of the public was its paramount consideration and for that reason only health practitioners suitably trained and qualified to practice in a competent and ethical manner were entitled to be registered.

“The respondent is reprimanded in the strongest terms,” the judgment said.
AAP

Sydney: Former nurse banned after cosmetic injections lead to necrosis

Former nurse, Ms Jenny TRAN, aka Marie WILLIAM and aka Thi Cuc TRAN, performed a series of injections into a 27-year-old male patient’s face after leading him to believe she was a registered nurse.  She injected an unregistered hyaluronic acid filler into the forehead of the man who came to see her because he wanted a lip enhancement.  TRAN has been permanently banned from providing any injectable cosmetic treatments.  The man suffered necrosis as a result of the procedure.

The male patient visited TRAN for a lip enhancement procedure on the recommendation of a friend.  However, she advised him that he did not need to have his lips enhanced and should have hyaluronic acid injected around his eyes and in his forehead instead.  The man alleged that during the treatment — which involved the application of a unregistered ‘numbing cream’ imported from Korea — he told TRAN that he was experiencing intense pain.

He said Ms TRAN advised him that the pain, along with some discolouration and significant swelling of his skin around the injection sites, was normal and gave him antihistamine tablets to take home.  The NSW HCCC found the antihistamine was likely diphenhydramine under the brand name Paxidorm, which is not available in Australia, and that her supply of the tablets contravened the Poisons and Therapeutic Goods Act.

The patient became increasingly unwell over the next few days, suffering swelling and redness of his forehead as well as nausea, drowsiness, headaches, diarrhoea and depression after taking the tablets.  He returned to the clinic and was told by Ms TRAN’s husband that the product injected was not Restylane obtained in Australia but a product that had been imported by the couple from Korea or Vietnam.  At a third consultation TRAN returned the $1,000 the man paid her.  TRAN subsequently visited the patient and supplied him with the antibiotic ciprofloxacin 500mg (Cifran) without authorisation.  The HCCC found that TRAN had personally obtained the antibiotic by telling a medical practitioner it was for her own use.

“The evidence also indicates that the procedure performed by Ms TRAN on the male patient was unsafe, incompetent and outside her expertise and training.  The procedure involved the medically unsupervised injection of an unregistered, unprescribed substance into the man’s forehead and glabella region,” the HCCC said.  “This had the potential to cause vascular compromise, or compression or embolisation of the filler material into the man’s vasculature.  The procedure performed by TRAN in fact caused necrosis of the skin, infection and scarring on the man’s forehead, necessitating ongoing treatment to restore the skin’s condition.”

Ms TRAN was found to have committed multiple breaches of the Code of Conduct for Unregistered Health Practitioners.  These included providing treatments and medications she was not competent, qualified or authorised to provide and using previous and embellished training qualifications to mislead.  The HCCC also found that Ms TRAN has breached the code by failing to provide treatments in a safe and ethical manner, failing to take safety precautions to reduce the chance of infection and administering inappropriate and potentially dangerous treatments.  TRAN was found to pose an ongoing risk to the health and safety of the public and along with the ban on her providing injectable treatments was also barred from administering or supplying any unregistered or scheduled medicines.

Sydney: Nurses conduct ‘giggle-fest’ at Coroner’s Court

BODINGTON Nursing Home at Wentworth Falls, in the Blue Mountains of New South Wales, became the subject of a Coroner’s Inquest this week after a resident died following an alleged overdose of morphine by a registered nurse.  The resident, 84 year old Mrs Sybil Zimmerman, died on 15 May 2011 after being transferred by ambulance in a comatose state to the Blue Mountains District Hospital in Katoomba.

Current and past nurses in the employ of BODINGTON aged care facility conducted themselves in an unprofessional and contemptible manner.  They appeared to be flippant and unconcerned that the inquest related to the circumstances of a person’s death.

Not only were the nurses and their companions discussing the evidence in loud whispers disrupting the public gallery, they, after the Coroner had ordered nurses who had not given evidence to leave the courtroom, went on to feed evidence being heard to their companion nurses outside the courtroom at regular intervals.  The conduct of the nurses and their intimidatory tactics were reported to the Registrar of the Coroner’s Court.

On the 4th day of Inquest, a number of nurses deliberately and intentionally engaged in intimidatory behaviour by spreading themselves around the public gallery including sitting with and surrounding the deceased’s family while one family member was waiting to complete giving evidence.

The Coroner interrupted proceedings to address the Court about the conduct and reactions of nurses and that their ‘ripples of laughter’ throughout the courtroom were unacceptable.  They were reminded that their presence in the courtroom be mute.

The disruptive conduct by RN Rosemary CHAPLIN, RN Elizabeth HANDLEY, RN Charlotte TILY and RN Linda VERITY, carer Mary PINKERTON, three of their counterparts from BODINGTON Nursing Home, plus several companions, was ordered to cease.

The nurses’ scant regard for court protocols and their unprofessional conduct illustrated that they conduct themselves in their day-to-day nursing jobs in the same manner.

NSW Attorney-General insults police and victims of criminal doctor

Sunday, 29 December 2013

SYDNEY:  NSW Attorney-General and Minister for Justice, the Hon Greg Smith, SC MP, today insulted the NSW Police Force investigation by saying ‘there’s insufficient evidence to pursue additional charges against former obstetrician and gynaecologist Graeme REEVES who was convicted of assaulting his patients’.

“He would say that, wouldn’t he?” said Lorraine Long spokeswoman for Medical Error Action Group.

“How come Attorney Greg Smith is spruiking this line that it’s a lack of evidence that’s the problem?”

“It is all about State government budget cuts in the DPP and nothing to do with weakness in the brief of evidence.  It’s an insult to the victims alive and dead”, Miss Long said.

“This is not just one or two offences; it’s a multitude relating to just one doctor.  Police clearly believe there’s a solid case against Reeves on these outstanding charges of aggravated sexual assault, aggravated indecent assault, maliciously inflicting grievous bodily harm, common assault, and grievous bodily harm many times over.”

Evidence Medical Error Action Group had gathered for years and presented to police was examined and investigated by them and it was the NSW Police Force “Sex Crimes Squad” that compiled the brief that was given to the DPP.

“It must be pretty galling that an action group, with extremely limited resources, can expose the facts and people involved, yet the NSW Government, with all the power, resources and expertise at its disposal, seemingly cannot.”  “It is to them we look for the administration of justice”, Miss Long said.

Graeme Stephen Reeves wasn’t dubbed “the Butcher of Baulkham Hills and Bega” for no reason.  The depth of his crimes and depravities has not been before the courts to be aired.

The Attorney’s comments confirm that the Reeves scandal has been unimportant to the NSW Government since it came to office in 2011.  The Minister for Health Jillian Skinner, and the Minister for Disabilities Services and Member for Bega, Andrew Constance, have been ‘missing in action’.

Minister Skinner, and Minister Constance have ignored correspondence Medical Error Action Group has sent to them over the past 2½ years pertaining to Reeves matters and compensation for Reeves’ victims.  “None of those letters have been acknowledged, or responded to”, said Miss Long.

“Whilst in Opposition, Jillian Skinner misled Parliament on 5 March 2008 [see Hansard: ‘Skinner Wed 5 Mar 2008 at 15:10 hours’] by denying she knew about Reeves earlier and did nothing, which explains why she hasn’t wanted to “revisit” any matters Reeves since”, Miss Long said.  “But that’s not good enough as the majority of Reeves’ victims ended up with zilch, i.e. no compensation whatsoever”, Long further added.  “The sums some received were insultingly paltry.”

Both Skinner and Andrew Constance knew about Reeves’ malpractice in April 2006 and allegedly July 2007 respectively, yet neither went to police nor raised Reeves’ malpractice with any Minister for Health.  Now Constance wants the DPP to ‘review its decision’.

“Look what happened in the UK when regulatory authorities failed to take action against Dr Harold Shipman.  He was allowed to harm and kill hundreds of patients at least before he was dealt with”, Miss Long said.

“Members of Parliament contact Medical Error Action Group with curious frequency when they’re off to hospital to make sure they don’t encounter a rogue surgeon”, Miss Long said, “but may this latest inaction serve as a warning to all MPs and the DPP that by allowing doctors to get away with their misdeeds gives them licence to not change their medical practising habits.” 

“Reeves’ patients have already been let down by the government and the medical regulatory authorities, now by the DPP.  Where do trusting patients ending up harmed by a rogue doctor turn to now?” Miss Long said.

Butcher of Bega “released” from his crimes

Former doctor Graeme Reeves “released” from his crimes

Friday, 27 December 2013

SYDNEY:  Victims of the disgraced ‘Butcher of Bega’, Graeme Stephen REEVES, have angrily attacked the decision by the NSW Director of Public Prosecutions to abandon 61 pending criminal charges against the former obstetrician and gynaecologist, who was found guilty of maliciously inflicting grievous bodily harm and financial deception in 2011.  Medical Error Action Group spokeswoman Lorraine Long said that because of the DPP’s outrageous decision it is very likely that the “Butcher of Baulkham Hills and Bega” will walk free from his NSW jail in coming days.

Miss Long said a massive NSW Police Force “Strike Force Tarella”, costing taxpayers millions of dollars, put a brief containing 17 criminal charges to the DPP in September 2008 and a further 52 charges in December 2009.  Sixty-nine charges were formally laid against Reeves but 61 have lain dormant in the court system for years without any action from the DPP.   Miss Long said that shortly before Christmas she learned that not only would all the pending criminal charges laid against Reeves be dropped but that Reeves would soon be released from prison after having served his sentence for the only four offences on which he has stood trial and been convicted.

“What are the victims of criminally incompetent doctors in our medical system meant to conclude from this decision?  That there’s one law for doctors and another for any other type of criminal?  I challenge the DPP to publicly explain why they have made this decision to abandon all outstanding charges.   Nothing has changed in the evidence since brave women and bereaved families came forward to help police investigate one of the most appalling criminals in New South Wales medical history”, Miss Long said.

Today Miss Long accused the NSW Government of slashing the DPP’s budget so severely that prosecutors had been forced to abandon one of the most high-profile prosecutions of a doctor in recent decades.  Interested journalists had approached police and the DPP in the past year to try to get answers on why the remaining charges had not been proceeded with; no answer was ever given.

“There is now a price on justice because of budget cuts to the Prosecution service in New South Wales.  The DPP clearly believed there was sufficient evidence when police laid the original 17 charges that Reeves stood a reasonable chance of conviction if and when the cases came to trial.”

“There is no valid evidential reason why these charges are being abandoned – just a cold, cynical, decision by the DPP.  Nothing has changed with this evidence of clear criminal conduct.  The women who were raped, who were physically abused and damaged, rendered infertile, genitally mutilated, and who lost their babies to this man will never have the opportunity to see justice done in the New South Wales courts.   I ask why?” 

Miss Long was especially critical of what she described as the cynical decision by the DPP to quietly drop all charges against Reeves during the holiday season – clearly in the hope that the bad news story would be missed by the media and the public.

“My organisation has spent the past 19½ years fighting the cosy relationship between the legal profession and the medical profession.  Too often doctors have been treated excessively leniently by the Health Department, the oversight bodies such as health complaints commissions, Medical Boards and professional registration bodies such as the Royal Australasian College of Surgeons.   The Reeves case was an enormously symbolic step forward for New South Wales.  Evidence Medical Error Action Group provided to police was of a shocking pattern of criminal assaults, cover-ups and failures inside the health system”, Lorraine Long said.

Miss Long said there was still a question mark over the case of the late Mrs Kerry McAllister, whom a NSW Coroner found in February 2013 had died in 1996 because of Reeves’ gross negligence.  The Coroner’s Court heard that Reeves failed completely to respond adequately to Mrs McAllister’s post-natal infection after she gave birth to her third son in The Hills Private Hospital, Baulkham Hills.  The evidence in the case raised the strong possibility that Reeves should be charged with manslaughter because of his refusal to assist Mrs McAllister despite the multiple concerns of hospital staff.

The victims Reeves harmed and the bereaved families of victims he killed suffer for the rest of their lives with inexplicable injustice by the perpetrator getting off so lightly and getting away with his long-running pattern of depravities and criminal behaviour.

“I hope that someone the NSW Government or the DPP loves never has to suffer in a New South Wales hospital because of the decision that the DPP has made today”, Lorraine Long said.  “This decision to abandon charges against a notorious recidivist offender in the health system sends a terrible message to the medical professionals out there who take similar licence with their patients.”

 

Canberra: Butcher of Bega Reeves can appeal against mutilation sentence

Former obstetrician and gynaecologist Graeme Stephen REEVES, who was convicted for maliciously inflicting grievous bodily harm on one of his patients by removing her clitoris, has an appeal against his sentence upheld.

REEVES, 63, was sentenced to three and a half years jail after being found guilty of removing a woman’s vulva, labia and clitoris without her consent during an operation in Bega, southern country town of New South Wales, in August 2002.

He was also found guilty of indecently assaulting two others and sentenced to two and a half years in prison.

On appeal by the NSW Director of Public Prosecutions, his sentence was increased by 18 months.

REEVES appealed against the conviction and sentence to the High Court of Australia, Canberra.

Today the court unanimously dismissed his appeal against his conviction but upheld his appeal against his sentence and referred it to the Criminal Court of Appeal.

In the judgment it says the appeal court did not consider REEVES’ deteriorating health and that his non-parole period was about to expire.

MEAG COMMENT:  Who cares about HIS health!  What about the victims he butchered for years?  Take note all his legal defences and applications to appeal have been funded by Legal Aid, i.e. the taxpayer.  Outrageous considering his victims could not obtain Legal Aid to sue him for malpractice.

Marseille: PIP breast implants founder Jean-Claude Mas jailed

It was one of the biggest trials in French legal history.  The boss of a French company which distributed defective breast implants around the world has been sentenced to four years in prison for fraud.

Jean-Claude MAS, the founder of the PIP company, was also fined 75,000 euros (£63,000) by a court in Marseille.

The company’s sale of faulty implants caused a global health scare with an estimated 300,000 women in 65 countries affected.

The company used sub-standard silicone gel, causing many implants to rupture.

Four other former PIP executives were also convicted and given lesser sentences.

About 300,000 women in 65 countries are believed to have received PIP implants.  Europe was a major market but more than half went to Latin America.  They were not sold in the United States.  42,000 British, 30,000 French, 25,000 Brazilian, 15,000 Colombian and 16,000 Venezuelan women received PIP implants.

With more than 5,000 women registered as plaintiffs in the case, the trial was considered one of the biggest in French legal history.

The health scare came to public attention in 2011 when the French government recommended that women have PIP implants removed due to an abnormally high rupture rate.

There was confusion as British health authorities said there was no need for routine removal – though they later agreed to replace the implants to put women’s minds at rest.

The issue of whether the sub-standard silicone used in the implants posed any danger was not resolved by the trial, AFP news agency notes.

MAS, 74, showed no sign of emotion as sentence was passed. His defence lawyer, Yves Haddad, said he planned to appeal.

He and the others had all admitted to fraud.

PIP’s director-general was sentenced to three years in prison, two of which were suspended.

The company’s head of quality control received two years, one of them suspended, and the head of research and development was sentenced to 18 months, suspended.

Throughout the trial, MAS had denied the silicone used was harmful while all but one of the other defendants said they had not been aware of the risks.

When an implant ruptures, the silicone gel filling can leak into the body. Some women will not notice anything at all, and there is no evidence of an increased cancer risk.

However, it can result in the formation of scar tissue that can change the shape and feel of the breast. The gel can be an irritant, causing pain and inflammation. It can also be more difficult to remove an implant once it has ruptured.

France’s Health Products Agency (ANSM) has to date registered more than 7,500 implant ruptures and 3,000 cases of undesirable effects, mainly inflammations, among the 30,000 women using PIP products in France.

In a report released in June, the ANSM noted: “Taking into account the known under-reporting of medical device incidents, the number of women actually explanted may be greater than the number of cases reported to the agency.”

Isabelle Traeger, who received a PIP implant and attended the trial, said earlier that four years would be too little for what Mas had done.

“They explained what was in them [the implants],” she told Reuters news agency.

“Inflammable substances, substances to make your car work, and that at a certain point they said to the engineer who made them, ‘How did you make them?  How did you mix together these substances?’  And he said, ‘You use your best guess’.

“And then they asked him, ‘Could you repeat what you just said?’.  ‘You use your best guess’.  Which explains why there were women in the room who had been much more seriously affected, as well as others who actually are coping quite well.

“Can you imagine? It’s a matter of chance.  A dollop more, a bit more, a bit less.  And he’ll get four years for that?  For what is put in your body using one’s best guess.  We don’t even give horses their food according to a ‘best guess’.”

BBC