Category Archives: Cholesterol

Children’s tsar savages NHS over ‘unacceptable’ mental health care

The children’s commissioner has launched a savage attack on the head of the NHS, accusing him of denigrating research that shows an “unacceptable” lack of children’s mental health provision.

In a highly unusual move, Anne Longfield has published an open letter to Simon Stevens, chief executive of NHS England, accusing him of ignoring young people’s experiences of the service and the frustrations of their parents. Laying out a list of grievances against him and his team, she also threatens to use the law to compel him to hand over data on waiting times for children’s mental health services.

Longfield made the decision to go public with her complaints – published on the commissioner’s website – after Stevens rubbished many of the claims in her recent report into children’s mental health, an issue she identified as her top priority after consulting with children.

“Many told me about their desperate attempts, sometimes lasting years, to access support, and even primary school children raised concerns about anxiety,” Longfield told Stevens in the letter. The report, published to coincide with World Mental Health Day last week, estimated that only between a quarter and a fifth of children with mental health conditions received help last year. It stated: “Progress in improving children’s mental health services has been unacceptably slow.”

Stevens is standing his ground. In a response to Longfield, obtained by the Observer, he suggests NHSE was “bounced” into giving a response to the report only after aspects of it were shared with journalists. He said that a key finding of the report, that “the government’s much-vaunted prioritisation of mental health has yet to translate into change at a local level”, was “demonstrably factually inaccurate”. Stevens writes: “I’m afraid we stand by our view that your report did indeed in places give a misleading view of NHS care.”

Longfield had warned that provision for young people was a postcode lottery and said that “children’s inability to access mental health support” was leading to a range of extra problems, “from school exclusions to care placements breaking down to children ending up in the youth justice system”.

It is highly unusual for the holders of two important public offices to be involved in such a public argument, particularly over an issue as sensitive as children’s mental health. Longfield, whose role is to promote and defend the rights of children, was appointed to the post by then education secretary Nicky Morgan in 2014. Stevens took his job at the head of NHS England (NHSE) in the same year.

Longfield’s report made difficult reading for the government at a time when concerns over the health service have reached a critical level. Theresa May identified improving mental health as a key issue but, before the busy winter period, there are concerns the NHS will struggle to cope with demand even for what are considered priority services, such as accident and emergency.

Stevens’s robust criticisms that the report contained “basic errors” were a powerful retort to Longfield’s claims. However, in a move that will ensure mental health provision for young people once again becomes a major political issue, Longfield has hit back, saying the report was published only after consultation with NHS England.

“The briefing was prepared using the NHS’s own data,” Longfield writes. “My conclusion on reading, checking and rechecking was that the service that exists at the moment is worryingly poor, a conclusion I stand by.”

In a highly personalised attack, Longfield tells Stevens: “I was very disappointed that NHS England’s response to our report, and your own personal response in front of the Commons health select committee, was to attempt to denigrate the research. Not once did you address the central issues raised. Instead, you and your team sought to undermine the important evidence that we are putting forward and strangely ignore the reality of children’s experiences of the service and the frustrations of their parents.”

Longfield suggested that Stevens’s claims that she and her team had not bothered to check the report were “untrue”. Similarly, claims that NHSE had not been given adequate time to review the report before commenting were also without foundation, according to Longfield. “I am under no duty or obligation to share my work in advance, yet we did so, out of courtesy.”

Stevens had indicated that NHSE was in possession of data that could be used to refute many of Longfield’s claims. However, the commissioner said: “If the NHS has data not in the public domain that disputes the picture we painted, then in the interests of transparency and accountability NHSE should publish it.”

She adds: “I hope you will feel able to share this data. As you will know, I am also able to demand such data under section 2f of the Children’s Act 2014.”

She concludes: “I hope in future we could all concentrate our efforts on tackling [health issues] rather than trying to undermine the work of those who make valid and constructive criticisms.”

Sarah Wollaston, chair of the health select committee, said the row would be discussed when the committee met on Tuesday.

“It’s very important that there is a constructive relationship between the Office of the Children’s Commissioner and NHS England,” she said.

Patients in England to be quizzed over their sexuality

Family doctors, nurses and other medical staff in England will be able to quiz patients on their sexual orientation under government plans.

People over the age of 16 visiting their local GP or hospital may be asked to confirm whether they are straight, gay, bisexual or other from 2019.

The NHS guidance apparently asks medical professionals to keep a record of the patient’s answer during face-to-face consultations.

The health service said the move was to keep in line with equality legislation to ensure those who do not identify as heterosexual are treated fairly.

Individual NHS trusts will decide whether to opt out of the move, and patients will not be forced to answer.

An NHS England spokesman said: “All health bodies and local authorities with responsibility for adult social care are required under the Equality Act to ensure that no patient is discriminated against.

“This information standard is designed to help NHS bodies be compliant with the law by consistently collecting, only where relevant, personal details of patients such as race, sex and sexual orientation.

“They do not have to do it in every area, people do not have to answer the questions and it will have no impact on the care they receive.”

‘Dr Huge’: the champion of dangerous weight-loss drug DNP

The two men behind Sacramento-based Enhanced Athlete – the company believed to be behind UK sales of the deadly weight-loss drug DNP – are a former lawyer and champion bodybuilder, known as Dr Tony Huge, and a convicted fraudster, Scott Cavell, who served time in Ireland and the US.

Dr Huge – whose real name is Charles Anthony Hughes – is the very visible face (and muscle) of Enhanced Athlete, promoting the fat-burning and bodybuilding supplements it allegedly sells in the US, Europe and Australia through numerous YouTube videos.

Among them is a video diary series entitled “DNP: World’s Most Dangerous Fat Loss Drug”, featuring Hughes swallowing the pills he sells and working out. “Will I die or will I arise shredded?” asks the caption. In another he shows off his Ferrari 430 Scuderia, at one point lifting a scantily clad woman above his head in front of the bonnet.

Hughes is not a medical doctor. His videos all feature warnings that he is experimenting with his own body and that DNP is a dangerous drug that is not for human consumption – before he consumes it or discusses its use with other people.

On another bodybuilding site, Hughes is filmed in England discussing the enthusiasm that people have for DNP. “It seems like everybody in England takes DNP. I’ve never been to a country or a place where so many people take DNP,” he says. “It’s incredibly more popular here in England than it is in the United States.”

The British bodybuilder he is talking to says says people are not afraid of it. “Only a couple of years ago, a teenage girl died of DNP overheating and her mum found her dead in a cold bath. DNP obviously isn’t for human consumption but having said that I think the only people that die from it are the people that abuse it.”

Cavell was involved in a $ 7.4m (£5.6m) mortgage fraud in the US. He and his accomplice, Christopher Warren, who managed a finance company in Sacramento, converted the loot into “travel friendly” gold and coins, according to the FBI and went on the run in 2009.

Both headed for Ireland, but Warren then paid $ 156,000 for a private charter plane to Lebanon. He was caught trying to re-enter the US with a fake passport and $ 70,000 hidden in his cowboy boots.

Cavell lay low in Ireland with a false Irish passport in the name of Marcus Dwyer. He opened two Irish bank accounts and lived in a comfortable apartment in Dublin on the $ 1.7m he had hidden in his luggage until the gold ran out. Then he took to drug dealing, growing cannabis in his apartment. In February 2011, the Irish drug squad turned up. Cavell was said to be out at the time but arrived during the raid and was arrested.

Nobody knew that Marcus Dwyer was not his real name until one of the detectives, curious about his American accent, sent his fingerprints to Interpol, who identified him as Cavell, a wanted man. However, at his trial, the judge allowed bail and he went on the run again, continuing to fund himself through drug peddling.

He was arrested in possession of 28 ecstasy tablets at the Electric Picnic festival in Ireland in September 2011, but released without charge. Eventually the gardai tracked him down in a modest rented house in Dublin, where they found equipment to make ecstasy tablets worth €20,000. He spent about eight months in Mountjoy prison before being deported.

Cavell was sentenced to five years for the mortgage fraud – considerably less than the 14 months that his accomplice Warren got, partly because it was claimed in court that he had suffered in the Irish prison.

“The conditions were deplorable, with buckets used as a latrine, rodent infestation, no running water, severe overcrowding, and no heat or air conditioning,” his attorney John Manning wrote in a memo to the court. “It is a place where Ireland houses the worst of the worst.”

Great Ormond Street hospital ‘failing’ intersex patients

Great Ormond Street hospital is failing to meet national standards and guidelines of care for intersex patients, it has been claimed.

NHS regulator, the Care Quality Commission, is investigating after the BBC said it found that some intersex patients and their families were not provided with any psychological care before irreversible surgery at the world famous hospital.

The broadcaster said it also found evidence that some operations were taking place on intersex babies and children without discussion by specialist teams.

The hospital is one of the leading authorities on care for people who are intersex, which means they are born with reproductive or sexual anatomy that does not seem to fit typical definitions of male or female.

Up to 1.7% of people have intersex traits, roughly the same proportion of the population who have red hair, according to the Office of the United Nations High Commissioner for Human Rights. The British charity DSD Families estimates that around 130 babies born in this country each year need investigations before their sex is assigned, although in many cases problems are only identified later in life.

The BBC says Gosh declined to say if it was meeting national standards.

Prof Ted Baker, chief inspector of hospitals at the Care Quality Commission, said: “We have asked Gosh to provide further information about the concerns, which were brought to our attention by the BBC.

“We are clear that NHS trusts and all providers of health and social care must have regard for nationally recognised guidance about delivering safe care and treatment. This could include guidance from NHS England and from the British Society for Paediatric Endocrinology and Diabetes around the need for multidisciplinary team involvement in decision making prior to performing surgery on children who are intersex or have variances in sex characteristics.

“We await the response from Gosh but in the meantime if anyone has any concerns about the care they or a loved one have received, they should get in contact with us.”

The BBC said it found that there was currently no face-to-face psychological support for children and families at Gosh who have been referred in the last six months but surgery continues to be carried out.

It also claimed that operations were taking place on intersex patients at Gosh without first discussing their cases with an expert panel at the hospital. The BBC further alleged that a lack of written information for parents to take home made it difficult for them to understand the treatments they were consenting to.

Ieuan Hughes, emeritus professor of paediatrics at Cambridge University, told the BBC the failure to provide this care was against national guidance. “No surgery should be undertaken without the whole team being involved with the decision,” he said.

“Making and signed up collectively to whatever that decision was to have surgery or not to have surgery, it’s the collective decision of the team.”

Gosh said in a statement that patients diagnosed at the hospital were discussed by multidisciplinary teams and that a new specialist psychologist would be joining in the coming weeks.

Obese people deserve surgical treatment, too | Richard Welbourn

One in four people in the UK suffer with obesity. Severe and complex obesity is a lifelong condition associated with many major medical problems, the costs of which threaten to bankrupt the NHS. The major ailment caused by obesity – type 2 diabetes – is linked to shorter life expectancy, decreased quality of life and increased socio-economic and psychosocial problems. A new report out this week suggests the global cost of treating obesity will rise to $ 1.2tn a year from 2025.

Yet in the UK, less than 1% of those who can benefit from it receive bariatric (sometimes called weight-loss) surgery, such as gastric bypass or gastric banding. So why is a safe, cost-effective therapy for a deadly disease so under-utilised?

For severely obese people, the hormonal effects of being obese mean that medical therapies, lifestyle changes and attempts at dieting rarely succeed in maintaining long-term, clinically beneficial weight loss. It isn’t just surgeons saying this – it is described in guidance by the British Obesity and Metabolic Surgery Society which is endorsed by 21 other professional organisations, including nine medical royal colleges.

The World Health Organisation identifies obesity as a chronic disease. But on the other side we have the popular perception – shared by some healthcare professionals – that it is purely a lifestyle choice. This totally disregards the fact that, driven by powerful food industry advertising, it is those who are poor who are most affected. Our tendency towards obesity is rooted in evolutionary biology: human beings have spent two million years developing a metabolic system which conserves energy in times of scarcity. It is only in the last 70 years that we no longer eat because of hunger alone.

The annual volume of bariatric surgery in the UK – about 5,000 operations a year – is five to 10 times lower compared with other European countries with similar population sizes and disease prevalence. In France, which has a similar population size to the UK, more than 37,000 surgeries are carried out each year. Belgium, with a population of 11.3 million, undertakes 12,000 surgeries while Sweden, with a population of 9.9 million, carries out more than 7,000 a year.

As a practising bariatric surgeon, I and my colleagues believe the social stigma of obesity is holding back the deployment of cost-effective treatments for vulnerable people. Health commissioners are aware of the figures, but remain slow to increase provision. Cost can’t be the issue. Getting a patient off insulin or other expensive anti-diabetes medications is cost-saving within two to three years of surgery: a win-win for the GP, the NHS and the taxpayer. Patients are also more likely to go back to work, and therefore pay more tax and claim fewer benefits.

I believe the problem is that commissioners and medical professionals, like the public, still see obesity as a lifestyle choice, and so blame patients. But there is a point of no return with obesity. There are parallels with other diseases. You may well suggest to someone who is a bit down in various ways for them to try and improve their mood, but once they become clinically depressed expert treatment is needed. We encourage our friends to stop smoking, but we don’t then begrudge them treatment for lung cancer.

Yet the reluctance to treat obesity lingers. Some argue that resources should be directed to prevention rather than treatment. Whenever possible, prevention is obviously better than cure. But this is no longer an option for people who have missed the boat of prevention and have gone on to develop severe, complex obesity with conditions such as diabetes.

Patients should be given quicker access to surgical assessment. If bariatric surgery is right for them, then the sooner the better. We already know that the UK is one of the most obese countries in Europe, and the patients we operate on are the sickest. The NHS should be performing 50,000 surgeries a year, closer to the European average.

To achieve this, health workers must be persuaded to put prejudice to one side and promote surgery where appropriate. GPs and commissioners alike must recognise both the health benefits and cost savings.

All the clinical evidence points to the fact that, as a country, we should be performing more weight-loss surgeries. It is the social stigma of obesity that is holding us back. Making fun of obese people is an endemic societal prejudice, and stigmatisation is allowed – and even encouraged – by the media. It’s time to stop judging and let the experts start treating the condition.

Richard Welbourn is a consultant bariatric surgeon at Musgrove Park Hospital, Taunton

MPs to debate use of controversial vaginal mesh implants

The use of controversial vaginal mesh implants will be debated by MPs next week, amid concerns over the traumatic complications suffered by some patients.

Parliament will discuss the risks associated with the implants, which are widely used to treat incontinence and pelvic organ prolapse, common conditions in women who have had children. During the past decade, more than 100,000 women in the UK have been fitted with the implants.

For many women, the operation is quick and successful but some have suffered debilitating complications including perforated organs and chronic pain. In July, the government released its three-year investigation into mesh implants, which concluded that the use of mesh to treat women with urinary incontinence and prolapse “is a safe option for women”.

However, since then further evidence has emerged about apparently high rates of complications, and the issue is gaining political momentum. Figures obtained by the Guardian suggested that around one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted and a recent US trial involving Johnson & Johnson, a leading manufacturer of the implants, heard of new products being used in patients without clinical trials.

The question of safety is complicated because a large variety of different vaginal mesh implants, made by different manufacturers, have been used without any systematic registry existing to collect data on long-term outcomes or safety. The success of the procedure also depends on surgical expertise, making it hard to know whether complications are wholly caused by problems with the device.

Emma Hardy, Labour MP for Hull West and Hessle, secured the debate on 18 October after hearing the experiences of several women in her constituency who she said had, until recently, been “suffering in silence”. “It’s a topic that people have felt ashamed and embarrassed about,” she told the Guardian. Hardy is calling for a public inquiry into the use of mesh, aimed at establishing the risks associated with the procedure and whether mesh removal helps resolve complications.

Kath Sansom, founder of the campaign group Sling the Mesh, welcomed the debate. “Women have been campaigning since 2007 but sadly it has taken until 2017 for us to be taken seriously,” she said. “So many have joined [the support group] describing their feeling of isolation having been told they were the only ones suffering and are shocked to see there are so many others.”

MPs to debate use of controversial vaginal mesh implants

The use of controversial vaginal mesh implants will be debated by MPs next week, amid concerns over the traumatic complications suffered by some patients.

Parliament will discuss the risks associated with the implants, which are widely used to treat incontinence and pelvic organ prolapse, common conditions in women who have had children. During the past decade, more than 100,000 women in the UK have been fitted with the implants.

For many women, the operation is quick and successful but some have suffered debilitating complications including perforated organs and chronic pain. In July, the government released its three-year investigation into mesh implants, which concluded that the use of mesh to treat women with urinary incontinence and prolapse “is a safe option for women”.

However, since then further evidence has emerged about apparently high rates of complications, and the issue is gaining political momentum. Figures obtained by the Guardian suggested that around one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted and a recent US trial involving Johnson & Johnson, a leading manufacturer of the implants, heard of new products being used in patients without clinical trials.

The question of safety is complicated because a large variety of different vaginal mesh implants, made by different manufacturers, have been used without any systematic registry existing to collect data on long-term outcomes or safety. The success of the procedure also depends on surgical expertise, making it hard to know whether complications are wholly caused by problems with the device.

Emma Hardy, Labour MP for Hull West and Hessle, secured the debate on 18 October after hearing the experiences of several women in her constituency who she said had, until recently, been “suffering in silence”. “It’s a topic that people have felt ashamed and embarrassed about,” she told the Guardian. Hardy is calling for a public inquiry into the use of mesh, aimed at establishing the risks associated with the procedure and whether mesh removal helps resolve complications.

Kath Sansom, founder of the campaign group Sling the Mesh, welcomed the debate. “Women have been campaigning since 2007 but sadly it has taken until 2017 for us to be taken seriously,” she said. “So many have joined [the support group] describing their feeling of isolation having been told they were the only ones suffering and are shocked to see there are so many others.”

MPs to debate use of controversial vaginal mesh implants

The use of controversial vaginal mesh implants will be debated by MPs next week, amid concerns over the traumatic complications suffered by some patients.

Parliament will discuss the risks associated with the implants, which are widely used to treat incontinence and pelvic organ prolapse, common conditions in women who have had children. During the past decade, more than 100,000 women in the UK have been fitted with the implants.

For many women, the operation is quick and successful but some have suffered debilitating complications including perforated organs and chronic pain. In July, the government released its three-year investigation into mesh implants, which concluded that the use of mesh to treat women with urinary incontinence and prolapse “is a safe option for women”.

However, since then further evidence has emerged about apparently high rates of complications, and the issue is gaining political momentum. Figures obtained by the Guardian suggested that around one in 15 women fitted with the most common type of mesh support later require surgery to have it extracted and a recent US trial involving Johnson & Johnson, a leading manufacturer of the implants, heard of new products being used in patients without clinical trials.

The question of safety is complicated because a large variety of different vaginal mesh implants, made by different manufacturers, have been used without any systematic registry existing to collect data on long-term outcomes or safety. The success of the procedure also depends on surgical expertise, making it hard to know whether complications are wholly caused by problems with the device.

Emma Hardy, Labour MP for Hull West and Hessle, secured the debate on 18 October after hearing the experiences of several women in her constituency who she said had, until recently, been “suffering in silence”. “It’s a topic that people have felt ashamed and embarrassed about,” she told the Guardian. Hardy is calling for a public inquiry into the use of mesh, aimed at establishing the risks associated with the procedure and whether mesh removal helps resolve complications.

Kath Sansom, founder of the campaign group Sling the Mesh, welcomed the debate. “Women have been campaigning since 2007 but sadly it has taken until 2017 for us to be taken seriously,” she said. “So many have joined [the support group] describing their feeling of isolation having been told they were the only ones suffering and are shocked to see there are so many others.”

Gambling remains a hidden addiction because ‘healthcare staff lack training’

Gambling is often described as a hidden addiction. Yet there are an estimated 400,000 problem gamblers in the UK. Dr Henrietta Bowden-Jones, consultant psychiatrist at the National Problem Gambling Clinic – the only one of its kind in the UK – says that a lack of training among healthcare professionals could partly be to blame for the problem flying under the radar.

“For many years while drug and alcohol addictions were being researched and funded in terms of treatment, the issue of gambling wasn’t taught at medical school,” Bowden-Jones says. “Even as an addictions psychiatrist, we weren’t taught about pathological gambling – I came across it by chance.”

Problem gambling can lead to arguments and emotional violence in the home, she says, often because one person wants to spend money that was saved up for retirement, for example, or the mortgage.

Gambling, Bowden-Jones adds, also moves any focus or passion away from a loved one: “It’s linked to the emotional disconnection you end up having with your partner or children because you’re just not there, either physically because you’re in the bookmakers or mentally because you’re disengaged, thinking about the gambling.”

And problems can go beyond mental or emotional issues: “Physically, we see people who are very underweight because they’re not eating – either because they’re gambling or because they haven’t the money to do so. Addicts aren’t healthy because they sit in front of a screen at home. You can imagine the consequences of not moving for months or years on end.”

One of the biggest issues is that problem gamblers are not accessing treatment or people do not know how to get help. Last year, support charity GambleAware saw 8,800 clients – a fraction of those with a problem.

Dr Jane Rigbye, director of commissioning at the charity, says more resources need to go into raising awareness of the addiction: “Although the impacts are as detrimental to family life, development and health, the kudos it’s given by other professionals isn’t as high as other addictions, partly because there’s no clear pathway for treating someone with a gambling problem.”

One solution is to empower healthcare professionals and have more conversations with them. “They have the skills to deal with this,” Rigbye says. “They just need to have some awareness of where to push people for help.”

I’d lose everything by 11am. It was hard for me to accept the loss

Owen Baily, 34, from Oxfordshire, has learned how to manage his gambling addiction after attending a cognitive behaviour therapy course run by the National Problem Gambling Clinic.

Owen Baily


‘I’ve used drugs – crack cocaine, amphetamines – but the high I experienced when I won big at gambling surpassed anything else.’ Photograph: Graeme Robertson for the Guardian

I was in receipt of benefits for a long time. In the lead up to the day I got my money, I tried to convince myself that I wouldn’t gamble. As soon as I woke up, my thinking changed – I’d become consumed by gambling. I couldn’t think about anything else. I became tense and anxious. It was like the money was burning a hole in my pocket. I tried to resist, but I couldn’t.

I didn’t have breakfast. I was filled with anticipation, tension and anxiety. I became convinced that I could win some money. I dismissed all my past experiences that proved gambling was not a good idea. My mind focused on positive possible outcomes. I was in the bookies as soon as the doors opened. I was oblivious to anyone and anything. It was just me and the terminal.

I’d often lose everything by 11am. It was very hard for me to accept the loss, bearing in mind that I had another 13 days until I got paid again. I’d curse myself and go into a period of depression for 10 or 11 days. It was like I had just assaulted myself. My brain hurt. I felt frustrated and annoyed with myself.

I would go home and wallow in self-pity and make plans for how I was going to survive. I’d check phone boxes for money, wait outside clubs on a weekend night because I knew that’s when people dropped things, and look for loose change on the streets, so I could buy baked beans and bread.

I’ve used drugs – crack cocaine, amphetamines – but the high I experienced when I won big at gambling surpassed anything else. It’s very potent, very toxic, very powerful.

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Revealed: Johnson & Johnson’s ‘irresponsible’ actions over vaginal mesh implant

A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices.

Internal company emails disclosed in a US court case, in which a 51-year-old woman was awarded a record $ 57m in damages this month, also show that senior executives even briefly considered suppressing unfavourable data that “could compromise the future” of the device.

J&J’s Ethicon unit was found by a US court to be liable for the serious injuries Ella Ebaugh suffered after receiving a mesh implant to treat urinary incontinence. The mother of five said she was left with a mangled urethra, bladder spasms and continual pelvic pain after an unsuccessful procedure that led to three revision surgeries to remove mesh that had cut into her urethra and migrated to her bladder.

But documents submitted to the court show J&J staff had raised concerns about the “spinning of data” in emails and male executives are seen bantering about a suggestion that sex with an earlier patient with mesh complications must be “like screwing a wire brush”.

Ella Ebaugh, who was awarded $  57m after a court ruled that Johnson & Johnson’s Ethicon unit were liable for the serious injuries she suffered.
Ella Ebaugh, who was awarded $ 57m after a court ruled that Johnson & Johnson’s Ethicon unit were liable for the serious injuries she suffered. Photograph: CBS

When it emerged from initial data that the success rates for a new device looked to be “way below” those seen for previous products, Ethicon’s director of sales, Xavier Buchon, suggested in an email “stop[ping] for a while such publications that could compromise the future”.

The J&J implant, used to treat urinary incontinence, was launched in 2006. Despite the early indications of a high failure rate, it was only withdrawn in 2012 after being used in thousands of operations in the US, the UK and Australia. The documents raise uncomfortable questions for the manufacturers of vaginal mesh products, which are the subject of growing controversy.

The implants, which reinforce tissue around the urethra, are widely used to treat incontinence, and for the majority of women the procedure is quick and successful. However, some women have suffered debilitating complications, including severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.

Class action law suits are underway in Australia and the US, where lawyers claim that patients have been exposed to unacceptable risks; in England, NHS data suggests as many as one in fifteen women later requires full or partial removal of the implant.

Vaginal mesh implant

Ebaugh, whose case was heard in Philadelphia, said that her complications have left her with constant pelvic pain, meaning for example, that although she attended her daughter’s recent wedding, she was unable to enjoy it. “I feel like I’m on fire down there,” she said in an interview with CBS.

The tranche of documents, revealed during the trial, places a spotlight on tensions between Ethicon’s commercial and clinical divisions at the time it launched its “miniature” mesh product, called the TVT-Secur, in 2006.

The company hoped that the new device, which was smaller and required fewer incisions, would reduce complications seen with its earlier devices. But getting to market ahead competitors, who had similar offerings in the pipeline, was described as “priceless” in company documents. It was approved for use without a trial under US and European equivalence rules, which allow this when a new device is similar to existing ones.

Carl Heneghan, professor of evidence-based medicine at the University of Oxford who has called for a public inquiry into the use of mesh, condemned the decision to launch a device before a trial, saying this had “led to direct patient harms”. “It has made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients,” he added.

Prof Bernard Jacquetin, an eminent French gynaecologist whose early study on TVT-Secur had led to misgivings among J&J management, told the Guardian the company had acted “irresponsibly” by launching the device without adaquate evidence.

Ahead of the device’s original launch, Jacquetin was invited to the US to give advice on the new design, but was taken aback when he was presented with a boxed-up product ready for release. Jacquetin and colleagues later carried out a study in 40 patients, which found success rates of 77% two months after surgery, compared to the roughly 85-90% success rate commonly reported for Ethicon’s original TVT mesh device.

On learning that Jacquetin’s results did not look promising (though not referring to the eventual 77% figure), marketing manager, Fabrice Degeneve emailed his superiors to ask: “How should we handle this without compromising the use of this new technique?”

Ethicon’s director of sales, Xavier Buchon, replied: “This is for sure a big concern,” before suggesting withholding results while the company reviewed the patients to be included in the analysis. “No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion,” he added.

In the event, the findings were presented at a major international conference and Jacquetin said he never felt pressure to bury unfavourable results. But he adds: “I was really disappointed. I told many people at Ethicon it was not [a good device].”

In 2012, TVT-Secur was withdrawn from the market, along with three other mesh products. J&J declined to provide exact figures on how many women had received the implants.

In other emails, J&J staff complain of colleagues “constantly spinning data” and of a dangerous blurring of the “lines between commercial and research” divisions. “I am continually amazed and surprised at our need to push back,” wrote Judi Gauld, Ethicon’s former clinical director in Scotland.

Other emails show a blasé attitude to distressing complications. In one, dated from 2003, a surgeon sought advice on treating a patient with a 2cm stretch of mesh poking through her vaginal wall. “Sex is like screwing a wire brush according to her spouse,” the doctor wrote. Martin Weisberg, Ethicon’s medical director, replied: “I’ve never tried the wire brush thing so I won’t comment.”

Following the trial, Ebaugh’s lawyer, Kila Baldwin, said in a statement: “I am pleased the jury recognised the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly.”

Johnson & Johnson said they plan to appeal the verdict. In a statement, the company said: “We believe the evidence in the Ebaugh trial showed Ethicon’s TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiff’s continuing medical problems.

“Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.”