Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, April 21, 2017

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

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.”

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

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.

Since you’re here …
… we’ve got a small favour to ask. More people are reading the Guardian than ever, but far fewer are paying for it. Advertising revenues across the media are falling fast. And unlike many news organisations, we haven’t put up a paywall – we want to keep our journalism as open as we can. So you can see why we need to ask for your help. The Guardian’s independent, investigative journalism takes a lot of time, money and hard work to produce. But we do it because we believe our perspective matters – because it might well be your perspective, too.
If everyone who reads our reporting, who likes it, helps to support it, our future would be much more secure.

Tuesday, April 18, 2017

Hernia Mesh Harm: Canada Health

Published Monday, April 17, 2017 10:00PM EDT CTV 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

Friday, April 14, 2017

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

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.
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.

Wednesday, April 12, 2017

Johnson & Johnson toxic metal-on-metal hips: trial 'discovery' exposes secrets of scandal

11 APRIL 2017 • 10:00PM  The Telegraph
British patients were fitted with controversial hip implants despite the company behind them being warned by experts that the type of device was unsafe, secret documents reveal.
A senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted in Britons.
More than 20,000 patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear. Thousands  were left in agony and had to have costly operations to have them replaced with safer alternatives.

Andrew Selous, a Conservative MP on the Commons health committee,  described the disclosure as “appalling”, saying: “If the company was aware of problems, they should have acted on the precautionary principle.”
A Daily Telegraph investigation today exposes a series of previously unseen memos, reports and emails, obtained from DePuy, that raised questions about the safety of metal-on-metal devices.
Dr Graham Isaac, a senior engineer based in DePuy’s Yorkshire factory, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris.
In the same year, a surgeon advising DePuy told the firm that “we need to be cautious of the legal/litigation issues, lawyers etc ... perception of metal debris and metal ion release.” 

More than two decades later, the firm faces thousands of legal claims by patients who say they have suffered as a result of the metal-on-metal joint subsequently produced by DePuy wearing away in their bodies.

The Telegraph’s investigation also reveals how: 
  • Senior company figures were told in 2003 that one surgeon had already collected “a lot of bad data about metal-on-metal debris” in patients who had received DePuy implants; 
  •  A 2005 report warned that risks to patients of metal-on-metal were “as yet undetermined” but “the risk to DePuy may be major in terms of product liability or business impact”; 
  • An internal email in September 2008 acknowledged there were “growing concerns over metal-on-metal hips”. Surgeons needed “a high stability non-metal option”; 
  • Tony Nargol, a surgeon based in North Tees, repeatedly told DePuy from around 2008 about problems with its implants but was labelled an “outlier” and told his patients may simply have high volumes of metal in their blood because of a local “water supply problem”; 
  • A report commissioned by the company in 2008 about the use of one of DePuy’s first metal-on-metal implants found that tiny particles released from the devices “have killed the bone” and soft tissues around the hip and “resulted in the tendons ripping away”. 
The papers, filed in a US court, include an email from John Irving, a US orthopaedic surgeon, in 2010, forwarded internally to the company’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. 
The metal ions released have killed the bone and soft tissues around the hip replacement resulting in:
a. Fluid retention often under high pressure causing pain
b. Tendon rupture causing hip dislocation
c. Bone death resulting in fractures around the implant

Excerpt from Investigation into the Performance of the Ultima Metal-on Metal Hip Replacement, East Norfolk and Waveney Research Consortium, 2008
He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued.

DePuy’s Pinnacle implant was first used in the UK in 2002, with the ASR, another metal-on-metal device, released two years later. They were promoted as offering better mobility than devices that used a metal ball and plastic socket.
In his 1995 memo, Dr Isaac, now “distinguished engineering fellow” at the firm, examined data on metal-on-metal hips produced by rival companies. He wrote: “It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory.
Paul Peters MD: We need to be cautious of the legal/litigation issues and lawyers etc… perception of metal debris and metal-ion release.

Minutes from the first Alternate Bearing Project designing surgeon meeting, May 1995
“Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”
He quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.
I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease. I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients. DePuy needs to contact physicians that have used the product and encourage them to contact their patients for an urgent follow-up. Many of our hips have asymptomatic osteolysis!

Excerpt of letter to DePuy head of US marketing, Paul Berman, from John F Irving MD
The document was part of papers read out in a Texas court, where patients are suing DePuy over the Pinnacle implant. They were passed to the Telegraph by their lawyers. 
Mark Lanier, a lawyer,  said: “These documents show that DePuy knew this hip would fail.”
DePuy’s lawyers have said in court that the company had “always warned about the potential for a tissue reaction in a metal-on-metal device”.
A spokesman said patient safety was its “first priority” and it “acted appropriately and responsibly in the design and testing” of the Pinnacle.

The implant was cleared for sale by national regulators and “is backed by a strong track record of clinical data showing reduced pain and restored mobility for patients suffering from chronic hip pain”.
The spokesman added that the plastic and ceramic alternatives also “wear and produce debris”, and “the body reacts to any foreign material”.
Boz Michalowska Howells, representing more than 300 UK claims, said  it “appeared to be commonly known in the 90s that metal-on-metal hips cause could adverse reactions and it should have rung alarm bells”. 
Metal implants put under scrutiny

  • 2002

    Pinnacle hip implants, including metal-on-metal type, sold in UK by DePuy

  • March 2004

    DePuy sells its ASR metal-on-metal implants in Britain

  • 2008

    DePuy aware some metal-on-metal parts for Pinnacle Ultamet “were slightly outside our manufacturing specifications”. Internal investigation finds it would not cause “safety issues”

  • August 2010

    DePuy recalls its ASR Hip System “after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data”

  • June 2011

    US Food and Drug Administration report states that “production capabilities for the Pinnacle metal-on-metal liners and femoral heads at the Leeds facility should be reviewed”

  • June 2012

    Medicines and Healthcare Products Regulatory Agency guidelines say larger metal-on-metal hip implants should be checked for “life”, not just five years, with tests for metal particles in patients’ blood

  • March 2013

    DePuy announces “discontinuation” of Pinnacle Ultamet device “because of low clinician use”

J&J Lawsuits on Recalled Elbow Replacement: Deja vu all over again . . .


Johnson & Johnson (NYSE:JNJ) is recalling its DePuy Synthes radial head prosthesis because of the risk of loosening in the component that anchors the implant in the arm’s radius bone.
The entire prosthesis is designed for primary and revision replacement of the radial head, but only the radial stem surgeons insert into the radius is involved in the loosening issue, according to a letter the J&J unit sent to physicians Dec. 30, 2016.
“Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors. Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market,” the company wrote.
If the radial stem loosens, the risks include osteolysis, poor joint mechanics, pain, post-operative fracture and soft tissue damage, J&J said.
Patients already implanted with the device should be followed as normal and the device will still be available on request for revision surgeries “in which only the head would be replaced using the evaluation or loaner set programs only,” according to the letter.

DePuy Elbow Implant Lawsuit Evaluations Offered By Bernstein Liebhard LLP Following Class II Recall for Synthes Radial Head Prosthesis System

NEW YORK, April 11, 2017 /PRNewswire/ -- The nationwide law firm of Bernstein Liebhard LLP is now investigating potential product liability lawsuits involving the recall of more than 50,000 DePuy Synthes Radial Head Prosthesis Systems The DePuy elbow implant components were removed from the global market in December out of concern that the radial stem could loosen at the stem-bone interface following implantation. The U.S. Food & Drug Administration (FDA) has declared this action a Class II medical device recall, which indicates that recipients of the DePuy Synthes Radial Head Prosthesis System may be at risk for temporary or medically reversible health consequences.
"Individuals who allegedly suffered complications related to this DePuy elbow implant recall could be entitled to compensation for medical bills, lost wages and other injury-related damages. However, it is important that those affected act quickly to ensure that their legal rights are protected," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now offering free, no-obligation case reviews to individuals who may be eligible to file a DePuy elbow implant lawsuit.

 DePuy Synthes Radial Head Prosthesis System
The DePuy Synthes Radial Head Prosthesis System was cleared via the FDA's 510(K) protocols in June 2011, which do not require human clinical trials when a device is shown to be "substantially equivalent" to a product that was previously approved by the agency. The DePuy elbow implant system is indicated for primary and revision replacement of the radial head.
DePuy Synthes announced that it was removing the Radial Head Prosthesis System from the worldwide market in December 2016, due to the potential for the radial stem to loosen at the stem-bone interface. Complications associated with radial-stem loosening include:
  • Osteolysis
  • Poor joint mechanics
  • Pain
  • Post-operative fracture
  • Soft tissue damage
DePuy Synthes noted that multifactorial issues (including possible product characteristics, as well as operative and patient factors) could be to blame for radial-stem loosening. Because it was unable to determine the exact cause, the company could not issue further instructions to surgeons that might mitigate the problem.
The FDA granted the DePuy elbow implant recall a Class II designation in February 2017.
 Patients who experienced complications related to radial-stem loosening of the DePuy Synthes Radial Head Prosthesis System may be entitled to compensation. To learn more about filing a DePuy elbow implant lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP 
10 East 40th Street 
New York, New York 10016 
ATTORNEY ADVERTISING. © 2017 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
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