International #MeshAwarenessDay #LiveLifeMeshFree May 1, 2017

Caz Chisholm recognised for campaign supporting women pelvic mesh victims

Joanne McCarthy

1 May 2017, 10:23 a.m.

A WOMAN who launched a campaign to support women victims of pelvic mesh and hold Australian health regulators to account has won two awards for consumer health advocacy.

Australian Pelvic Mesh Support Group founder Caz Chisholm received the Western Australian Health Consumers Council health consumers award and the Rosemary Caithness Award for outstanding service to health consumers after a campaign, supported by the Newcastle Herald, for a Senate inquiry into pelvic mesh.

Winner: Australian Pelvic Mesh Support Group founder Caz Chisholm with two health consumer awards received for her work since 2014 campaigning for victims of pelvic mesh.

Ms Chisholm’s group jumped from 39 members in early 2015 to more than 600 by Thursday when she received the awards, only days before International Mesh Awareness Day on Monday, May 1. The day was initiated by mesh support groups in countries including Australia, America, New Zealand, Great Britain and European countries including the Netherlands. In America alone more than 125,000 women have initiated legal action against mesh manufacturers after they were implanted with transvaginal mesh (surgery through the vagina rather than the abdomen) after post-childbirth complications.

An American woman on Friday was awarded $20 million compensation for complications after mesh surgery in 2007 using a Johnson & Johnson transvaginal mesh. In Australia 450 women have joined a class action against Johnson & Johnson, another 350 women have joined a class action against a second American device manufacturer, and more than 1000 women in total have complained of serious injuries after mesh surgery.

Ms Chisholm said she was “thrilled and honored to receive these awards as this represents the acknowledgement of all women suffering from the devastating effects of mesh”.

“What we seek first and foremost is recognition of our pain and suffering because most of us have been ignored by doctors, and when we do present with complications we are told they are caused by anything other than mesh,” Ms Chisholm said.

“Yet when women join the support group and they read about the same complications as others, they breathe a sign of relief and often cry because finally they have the recognition that they are not imagining their pain and they are not going crazy.

“They realise their pain is real and their pain is from mesh.”

Western Australian Health Consumers Council executive director Pip Brennan said Ms Chisholm’s double win of the two most prestigious consumer health awards recognised her tireless advocacy for mesh victims and outstanding work on giving them a voice.

“The use of mesh is now the subject of a federal Senate inquiry, which is taking submissions until May 31, and the inquiry’s title is ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. This highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications,” Ms Brennan said.

“Caz Chisholm has spent significant time and energy raising awareness for women about the issue and providing essential peer support. She was also directly responsible for ensuring that the Senate inquiry was successfully advocated by Senator Derryn Hinch.”

In 2016 Australia’s peak health regulator for medical devices, the Therapeutic Goods Administration, quietly placed on its website a list of at least 30 known complications following pelvic mesh surgery, after TGA executives met with Ms Chisholm and other support group members.

The complications include punctures of vessels, nerves, structures or organs including the bladder, urethra or bowel; foreign body response including erosion of mesh into the vagina, bladder or bowel; chronic infections; acute or chronic pain; pain during intercourse; temporary or permanent inability to void via the lower urinary tract; bleeding; chronic pain in the groin, thigh, leg or abdomen; atypical vaginal discharge; exposed mesh may cause pain to the patient’s partner during intercourse and abscess.   

Johnson & Johnson shareholders: are you listening? Divest or be complicit!

Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case

POSTED:APR 28 2017 03:07PM EDT

UPDATED:APR 28 2017 03:09PM EDT  FiDA Highlight

PHILADELPHIA, PA (WTXF) - On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.

The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.

Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.

She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.

As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."

The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.

"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.

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“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”

Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”

The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.

The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.

Survey: 95% of Chronic Pain Patients Report Harm by New CDC Opioid Guidelines

Harmed by CDC’s Opioid Guidelines

April 18, 2017

FiDA highlight

This large survey of pain patients and healthcare providers found that most patients had an unfavorable impression of CDC Opioid Prescribing Guidelines, which were released in March 2016.

By Elizabeth Michaelson Monaghan

Interview with Paul Christo, MD, MBA, and Pat Anson, National Pain Report editor

An online survey by Pain News Network (PNN) and the International Pain Foundation1 found that both patients and healthcare providers have an overwhelmingly unfavorable impression of the Centers for Disease Control and Prevention (CDC)’s voluntary opioid prescribing guidelines, first released in March 2016.2

More than 3,100 chronic pain patients and 278 doctors, pharmacy employees, and other healthcare professionals took the survey in early 2017; results suggest that about 95% of patients believe that the CDC's guidelines hurt pain patients. About 40% of healthcare providers thought the new guidelines were hurting patients, and another 30% didn’t know.

Almost half of patients reported having a harder time finding doctors to treat their chronic pain, and close to 85% are in more pain, likely due to the fact that about 70% of them are now being prescribed lower doses of opioids—or none at all. (Editor's Note: About two-thirds of PNN readers use opioids to manage their pain.3)

Some patients are hoarding opioids (22%) and/or getting hold of then illegally (11%). More than 42% of respondents have considered suicide. At the same time, 85% of patients and more than 65% of healthcare providers think the guidelines have not reduced opioid abuse or overdose.

About the Survey

The survey was created by PNN President and Editor in Chief Pat Anson, in consultation with several pain experts. Respondents were recruited via PNN’s email newsletter, website, social media, and through affiliates.

While it was not a scientific study, “I do think it's a fairly good indication that the guidelines have resulted in harm to many patients, and created a fair amount of uncertainty and even fear among prescribers,” Anson said.

Are Attempts to Curb Abuse Misguided?

The survey also found that “relatively few patients were referred to addiction treatment (4%) or were discharged for failing a drug test (4%)” Anson pointed out. “That would indicate to me that the misuse and abuse of opioid medication is rare among pain patients—yet they are often blamed for fueling the nation's opioid epidemic.”  

“Most patients with chronic pain using opioids therapeutically do so responsibly,” agreed pain specialist Paul J. Christo, MD, MBA, a Practical Pain Management Editorial Board Member who also hosts a radio show “Aches and Gains.”4

He cited a recent study showing that less than 13% of patients “presenting to the emergency room for opioid overdoses carried a diagnosis of chronic pain.5 Unfortunately, the war on opioids is hurting certain patients who need them the most.” Dr. Christo is Associate Professor in the Department of Anesthesiology and Critical Care Medicine at Johns Hopkins University School of Medicine in Baltimore.

Interpreting the Guidelines

Among other recommendations, the CDC urges primary care physicians to exercise caution in prescribing 50 or more morphine milligram equivalents (MME) a day, and avoid prescribing 90 MME or more a day. Note: the CDC guidelines are designed for primary care physicians, and are not meant for specialists. In fact, the American Pain Society and the American Academy of Pain Medicine, which represent pain specialists, consider 200 or more MME a high dose.6

Furthermore, while the guidelines are voluntary, “Too many providers [30%, according to the survey] either don't know [that], or believe the guidelines are mandatory,” Anson noted, adding that the guidelines are prompting insurers to decline to cover long-term opioid treatment. Indeed, 57% of healthcare providers reported that insurance companies have refused to cover pain treatment they thought patients should receive.

Anson added that federal agencies are also making some guidelines mandatory: A new law in Maine, for instance, prevents doctors from prescribing chronic pain patients (not including those receiving cancer treatment or palliative care) more than 100 MME a day, and patients currently taking more than that should taper down by July 2017.7,8 In North Carolina, the state’s medical board, which adopted and endorsed the CDC’s guidelines,9 may now investigate some opioid prescribers.10 These kinds of laws help illustrate why more than 35% of health care providers worry about being prosecuted or sanctioned for prescribing opioids, according to the survey.

“The survey indicates that we need to strongly support patients … and highlights the chilling effect the CDC guidelines are having on the lives of chronic pain patients,” Dr. Christo said.

“Doctors and patients also agreed overwhelmingly that the guidelines have worsened the quality of pain care, not improved it,” Anson concluded. “Insurers may think they are reducing costs and reducing liability by making it harder for doctors to prescribe pain medication, but in the long run they are creating millions of chronically ill patients that are bedridden, unable to work, or disabled because their pain is untreated or under-treated. The long-term costs to society will be immense, and we're just starting to see the fallout.”

https://www.practicalpainmanagement.com/resources/news-and-research/survey-finds-patients-are-harmed-cdc-opioid-guidelines

Regulatory Watchdogs Complicit With Medical Device Industry: A Case In Mesh

NHS and medical devices regulator tried to limit scandal over vaginal mesh implants

Minutes show NHS England and MHRA worked together to try to ‘avoid media attention’ of problems faced by women

Denis Campbell and Carmen Fishwick

Friday 21 April 2017 11.19 EDT

Last modified on Friday 21 April 2017 12.43 EDT

NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.

Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency (MHRA) agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.

More than 800 women sue NHS and manufacturers over vaginal mesh implants

The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be incorporated into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.

The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by the health secretary, Jeremy Hunt – to be open and transparent over patient safety failings.

NHS England and the Department of Health both refused to comment on the minutes of the meeting.

MHRA officials said the minutes were more than six months old and the conversation noted in them was one of many conversations held during one of many oversight meetings about the issue.

The campaign, when it begins, will aim to ensure that both women and healthcare professionals know that there is no time limit on reporting complications with mesh devices. It will include engagement with the media, officials stressed. 

An MHRA spokeswoman said: “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients. MHRA strongly encourages the reporting of issues related to all medical devices. When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.”

One possible reason for the NHS to want to limit exposure of the issue could be to reduce the number of potential lawsuits faced by the health service.

More than 800 women are suing the NHS and the manufacturers of the implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.

Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.

About 11% to 12% of users have reported problems, while lawsuits in the US have already seen about $2bn (£1.5bn) paid to affected women.

Campaigners say that hundreds more women have come forward after learning of the group planning to sue.

What's your experience of vaginal mesh implants?

Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.

“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”

Data from the MHRA, which has been looking at the issue since 2011 after complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years. 

Despite the problems that have emerged the MHRA insists the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.

A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.

https://www.theguardian.com/society/2017/apr/21/nhs-vaginal-mesh-implants-scandal-suppress-media

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Hernia Mesh Harm: Canada Health

Growing concerns in Canada over surgical mesh usage, recalls

Published Monday, April 17, 2017 10:00PM EDT CTV News.ca Staff  FiDA highlight

Warning: Some of the content may be disturbing to some viewers

There is growing concern over the number of recalls of hernia mesh in Canada, as patients speak out about complications they believe are linked to the surgical device.

Patients across the country contacted CTV News after a story on health problems linked to hernia mesh aired last month.

Patient Ivan Richardson said his hernia mesh has caused him ongoing, unexplained pain.

"You couldn't even touch me, I would cry, I mean literally cry and I went to the doctor and they kept saying they couldn't find nothing," Richardson said in an interview with CTV News.

That is until one doctor cut open his abdomen. There, what was supposed to be flat plastic mesh was rolled up inside Richardson's torso.

Even with part of it removed, Richardson said he still suffers.

"It will feel like a bunch of little needles," he said. "I assume that is the edge of the plastic mesh. I'm scared to do anything anymore, really."

Figures from Health Canada show that some 12 brands of hernia mesh have been recalled or removed from the Canadian market since 2000.

Some were linked to infections and perforations. There were 185 reports of serious injury and other complications, including three deaths.

Still, studies indicate the majority of hernia mesh patients have no problems, and its use is on the rise.

Data shows mesh helps improve recovery and lowers hernia recurrence.

But Dr. John Morrison, president of the Canadian Hernia Society, warns it may be used too often given the growing questions of the harm being done to some patients. In some cases, he said, mesh may not be required.

As part of his practice, Dr. Morrison often removes mesh that's shifted and punctured organs.

"I've seen pictures of it in the bladder, I've seen mesh in the stomach," Morrison told CTV News. "The mesh can erode into other organs over a period of time."

Morrison said studies show 10-20 per cent of people are left with chronic pain.

"It is a very serious phenomenon that's happened," Morrison said.

The physician said if the pain persists longer than three months, a hernia patient should find another physician or a hernia surgeon.

Morrison called the complications an "epidemic, and unfortunately, there's no end in sight, it's going to get worse because almost all hernias are now repaired with mesh."

Dr. Morrison advises patients who are scheduled for hernia surgery to "ask their surgeon if they're going to be using mesh, ask them exactly what type of hernia they have, why the mesh is being used.

He said prior to the operation, a patient should read on the internet the effects of the mesh being used on the hernia they're having repaired.

"An educated patient is the number one thing that will solve this problem," Morrison said.

There is research underway to try to better understand these emerging complications. The research will be of vital importance to the thousands of Canadians who have hernia surgery every year.

With a report by CTV medical specialist Avis Favaro and producer Elizabeth St. Philip

Akathisia: GSK knew Paxil could cause adult suicide?

Doctors: Ignorance of the Law Harms Patients (& Destroys Your Future, Too)

‘Life destroyed’: A doctor warns about accepting money from drug and device manufacturers

by Joanne Finnegan | Apr 13, 2017 12:37pm  FiDA highlight

A doctor convicted of accepting a bribe now warns future physicians to never accept anything from drug and device manufacturer reps.

A New York doctor, who is now a convicted felon, is warning other doctors about the dangers of accepting bribes from drug and device representatives.

Michele Martinho, who faces the possibility of jail time and the loss of her medical license when she is sentenced, pleaded guilty in 2014 to one count of accepting a bribe. This week she spoke to a small audience at the Georgetown University School of Medicine, telling her story as a warning to future doctors, according to The Washington Post.

While she learned about medicine, Martinho said her training did not prepare her for the business of medicine.

Martinho was one of more than two dozen doctors who have pleaded guilty in a $200 million health fraud scheme operated by the now-defunct blood-testing company Biodiagnostic Laboratory Services in New Jersey. She accepted monthly payments of $5,000 to refer patients to the lab for blood tests and other screenings, the newspaper said.

She told students her life has been “destroyed,” and she advised them to never accept anything from drug, device and other representatives who parade through doctors’ offices and to consult an attorney who specializes in medical practice with any questions.

RELATED: New Jersey doctor, 79, faces jail after conviction in $200M fraud case

Martinho accepted $155,000, always in monthly envelopes full of cash, and acknowledged she knew she was evading tax laws when she took the money, the newspaper said. However, she says she did not understand that the referral itself was considered a kickback.

Now she speaks at healthcare and ethics institutions, but doesn’t know if her efforts at "restorative justice" will help at sentencing.