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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Sunday, May 27, 2018

You, The UnProtected! Tailspin by Steven Brill




By STEVEN BRILL May 17, 2018. FiDA highlight

Brill, the author of Tailspin, is the founder of Court TV and the American Lawyer
ONE
Lately, most Americans, regardless of their political leanings, have been asking themselves some version of the same question: How did we get here? How did the world’s greatest democracy and economy become a land of crumbling roads, galloping income inequality, bitter polarization and dysfunctional government?
As I tried to find the answer over the past two years, I discovered a recurring irony. About five decades ago, the core values that make America great began to bring America down. The First Amendment became a tool for the wealthy to put a thumb on the scales of democracy. America’s rightly celebrated dedication to due process was used as an instrument to block government from enforcing job-safety rules, holding corporate criminals accountable and otherwise protecting the unprotected. Election reforms meant to enhance democracy wound up undercutting democracy. Ingenious financial and legal engineering turned our economy from an engine of long-term growth and shared prosperity into a casino with only a few big winners.

These distinctly American ideas became the often unintended instruments for splitting the country into two classes: the protected and the unprotected. The protected overmatched, overran and paralyzed the government. The unprotected were left even further behind. And in many cases, the work was done by a generation of smart, hungry strivers who benefited from one of the most American values of all: meritocracy.
This is not to say that all is rotten in the United States. There are more opportunities available today for women, nonwhites and other minorities than ever. There are miracles happening daily in the nation’s laboratories, on the campuses of its world-class colleges and universities, in the offices of companies creating software for robots and medical diagnostics, in concert halls and on Broadway stages, and at joyous ceremonies swearing in proud new citizens.


Yet key measures of the nation’s public engagement, satisfaction and confidence – voter turnout, knowledge of public-policy issues, faith that the next generation will fare better than the current one, and respect for basic institutions, especially the government – are far below what they were 50 years ago, and in many cases have reached near historic lows.
It is difficult to argue that the cynicism is misplaced. From matters small – there are an average of 657 water-main breaks a day, for example – to large, it is clear that the country has gone into a tailspin over the last half-century, when John F. Kennedy’s New Frontier was about seizing the future, not trying to survive the present.
For too many, the present is hard enough. Income inequality has soared: inflation-adjusted middle-class wages have been nearly frozen for the last four decades, while earnings of the top 1% have nearly tripled. The recovery from the crash of 2008 – which saw banks and bankers bailed out while millions lost their homes, savings and jobs – was reserved almost exclusively for the wealthiest. Their incomes in the three years following the crash went up by nearly a third, while the bottom 99% saw an uptick of less than half of 1%. Only a democracy and an economy that has discarded its basic mission of holding the community together, or failed at it, would produce those results.

Meanwhile, the celebrated American economic-mobility engine is sputtering. For adults in their 30s, the chance of earning more than their parents dropped to 50% from 90% just two generations earlier. The American middle class, once an aspirational model for the world, is no longer the world’s richest.
Most Americans with average incomes have been left to fend for themselves, often at jobs where automation, outsourcing, the decline of union protection and the boss’s obsession with squeezing out every penny of short-term profit have eroded any sense of security. In 2017, household debt had grown higher than the peak reached in 2008 before the crash, with student and automobile loans staking growing claims on family paychecks.

Although the U.S. remains the world’s richest country, it has the third-highest poverty rate among the 35 nations in the Organisation for Economic Co-operation and Development (OECD), behind only Turkey and Israel. Nearly 1 in 5 American children lives in a household that the government classifies as “food insecure,” meaning they are without “access to enough food for active, healthy living.”
Beyond that, too few basic services seem to work as they should. America’s airports are an embarrassment, and a modern air-traffic control system is more than 25 years behind its original schedule. The power grid, roads and rails are crumbling, pushing the U.S. far down international rankings for infrastructure quality. Despite spending more on health care and K-12 education per capita than most other developed countries, health care outcomes and student achievement also rank in the middle or worse globally. Among the 35 OECD countries, American children rank 30th in math proficiency and 19th in science.

American politicians talk about “American exceptionalism” so habitually that it should have its own key on their speechwriters’ laptops. Is this the exceptionalism they have in mind?
Perhaps they should look at their own performance, which is best described as pathetic. Congress has not passed a comprehensive budget on time without omnibus bills since 1994. There are more than 20 registered lobbyists for every member of Congress. Most are deployed to block anything that would tax, regulate or otherwise threaten a deep-pocketed client.
Indeed, money has come to dominate everything so completely that the people we send to D.C. to represent us have been reduced to begging on the phone for campaign cash up to five hours a day and spending their evenings taking checks at fundraisers organized by those swarming lobbyists. A gerrymandering process has rigged easy wins for most of them, as long as they fend off primary challengers–which ensures that they will gravitate toward the special-interest positions of their donors and their party’s base, while racking up mounting deficits to pay for goods and services that cost more than budgeted, rarely work as promised and are seldom delivered on time.

TWO
The story of how all this came to be is like a movie in which everything seems clear only if it is played back from the start in slow motion. Beginning about 50 years ago, each scene unfolded slowly, usually without any sign of its ultimate impact. The story of America’s tailspin is not about villains, though there are some. It is not about a conspiracy to bring the country down, nor did it spring from one single source.

But there is a theme that threads through and ties together all the strands: many of the most talented, driven Americans used what makes America great–the First Amendment, due process, financial and legal ingenuity, free markets and free trade, meritocracy, even democracy itself–to chase the American Dream. And they won it, for themselves. Then, in a way unprecedented in history, they were able to consolidate their winnings, outsmart and co-opt the forces that might have reined them in, and pull up the ladder so more could not share in their success or challenge their primacy.
By continuing to get better at what they do, by knocking away the guardrails limiting their winnings, aggressively engineering changes in the political landscape, and by dint of the often unanticipated consequences of their innovations, they created a nation of moats that protected them from accountability and from the damage their triumphs caused in the larger community. Most of the time, our elected and appointed representatives were no match for these overachievers. As a result of their savvy, their drive and their resources (and a certain degree of privilege, as these strivers may have come from humble circumstances but are mostly white men), America all but abandoned its most ambitious and proudest ideal: the never perfect, always debated and perpetually sought after balance between the energizing inequality of achievement in a competitive economy and the community-binding equality promised by democracy. In a battle that began a half-century ago, the achievers won.

The result is a new, divided America. On one side are the protected few – the winners – who don’t need government for much and even have a stake in sabotaging the government’s responsibility to all of its citizens. For them, the new, broken America works fine, at least in the short term. An understaffed IRS is a plus for people most likely to be the target of audits. Underfunded customer service at the Social Security Administration is irrelevant to those not living week to week, waiting for their checks. Except for the most civic-minded among them, corporate executives are not likely to worry that their government doesn’t produce a comprehensive budget. They don’t worry about the straitjacket their government faces in recruiting and rewarding talent or in training or dismissing the untalented because of a broken civil-service system. Civil service is another great American reform that in the last 50 years has become a great American moat, protecting incompetent or corrupt workers, like those who supervised the Veterans Affairs hospitals where patient waiting lists were found to have been falsified.

On the other side are the unprotected many. They may be independent and hardworking, but they look to their government to preserve their way of life and maybe even improve it. The unprotected need the government to provide good public schools so that their children have a chance to advance. They need a level competitive playing field for their small businesses, a fair shake in consumer disputes and a realistic shot at justice in the courts. They need the government to provide a safety net to ensure that their families have access to good health care, that no one goes hungry when shifts in the economy or temporary setbacks take away their jobs and that they get help to rebuild after a hurricane or other disaster. They need the government to ensure a safe workplace and a living minimum wage. They need mass-transit systems that work and call centers at Social Security offices that don’t produce busy signals. They need the government to keep the political system fair and protect it from domination by those who can give politicians the most money. They need the government to provide fair labor laws and to promote an economy and a tax code that tempers the extremes of income inequality and makes economic opportunity more than an empty cliché.

The protected need few of these common goods. They don’t have to worry about underperforming public schools, dilapidated mass-transit systems or jammed Social Security hotlines. They have accountants and lawyers who can negotiate their employment contracts or deal with consumer disputes, assuming they want to bother. They see labor or consumer-protection laws, and fair tax codes, as threats to their winnings–which they have spent the last 50 years consolidating by eroding these common goods and the government that would provide them.
That, rather than a split between Democrats and Republicans, is the real polarization that has broken America since the 1960s. It’s the protected vs. the unprotected, the common good vs. maximizing and protecting the elite winners’ winnings.

THREE

I was one of those elite winners. In 1964, I was a bookworm growing up in Far Rockaway, a working-class section of Queens. One day, I read in a biography of John F. Kennedy that he had gone to something called a prep school. None of my teachers at Junior High School 198 had a clue what that meant, but I soon figured out that prep school was like college. You got to go to classes and live on a campus, only you got to go four years earlier, which seemed like a fine idea. It seemed even better when I discovered that some prep schools offered financial aid. I ended up at Deerfield Academy, in Western Massachusetts, where the headmaster, Frank Boyden, told my worried parents, who ran a perpetually struggling liquor store, that his financial-aid policy was that they should send him a check every year for whatever they could afford.

Three years later, in 1967, I found myself sitting in the headmaster’s office one day in the fall of my senior year with a man named R. Inslee Clark Jr., the dean of admissions at Yale. Clark looked over my record and asked me a bunch of questions, most of which were about where I had grown up and how I had ended up at Deerfield. Then he paused, looked me in the eye and asked if I really wanted to go to Yale – if it was my first choice. When I said yes, Clark’s reply was instant: “Then I can promise you that you are in. I will tell Mr. Boyden that you don’t have to apply anywhere else. Just kind of keep it to yourself.”

What I didn’t know then was that I was part of a revolution being led by Clark, whose nickname was Inky. I was about to become one of what would come to be known as Inky’s boys and, later, girls. We were part of a meritocracy infusion that flourished at Yale and other elite education institutions, law firms and investment banks in the mid-1960s and ’70s. It produced great progress in equalizing opportunity. But it had the unintended consequence of entrenching a new aristocracy of rich knowledge workers who were much smarter and more driven than the old-boy network of heirs born on third base–and much more able to enrich and protect the clients who could afford them.
After college, I went on to Yale Law School and graduated in 1975, at a time when demand for lawyers in the flourishing knowledge-worker economy was exploding. By the mid-1980s, in terms of dollars generated, the legal industry was bigger than steel or textiles, and about the same size as the auto industry. The new lawyers were increasingly concentrated in fast-growing firms that served large corporations and were prepared to pay skyrocketing salaries to attract the best talent. Soon, the gap between pay in the private and public sectors was too large to attract enough talented young lawyers to government or public-interest law–a change described by Stanford law professor Robert Gordon in 1988 as “one of the most antisocial acts of the bar in recent history.”

I played a role in this “antisocial” movement. In 1979, I started a magazine called the American Lawyer, which focused on the business of law firms and the intriguing questions lurking behind their elegant reception areas. Which ones were best managed? Which offered the most opportunity to women or minorities? Which were more likely to promote associates to partnership? Which had the fairest or most generous bonus systems? And, yes, which provided the highest profits for partners?
That last question resulted in the American Lawyer launching a special issue every summer, beginning in 1985, in which we deployed reporters to pierce the secrecy of these private partnerships so that the magazine could rank the revenues and average profits taken home by partners at the largest firms. When the first survey was published, I received a call from a former classmate who practiced at a large Los Angeles firm. He was outraged because he–and his wife–had found out that another classmate who worked at a seemingly fungible L.A. firm made about 25% more than he did. Until then, they had been perfectly happy with his six-figure income.

The fallout from this report and those from similar trade publications was significant and double-edged. The new flow-of-market information about these businesses made those who ran them more accountable to their partners, their employees and their clients, but it also transformed the practice of law by the country’s most talented lawyers in ways that had significant drawbacks. The emphasis was now fully on serving those clients who could pay the most.

FOUR

The Meritocracy’s ascent was about more than personal profit. As my generation of achievers graduated from elite universities and moved into the professional world, their personal successes often had serious societal consequences. They upended corporate America and Wall Street with inventions in law and finance that created an economy built on deals that moved assets around instead of building new ones. They created exotic, and risky, financial instruments, including derivatives and credit default swaps, that produced sugar highs of immediate profits but separated those taking the risk from those who would bear the consequences. They organized hedge funds that turned owning stock into a minute-by-minute bet rather than a long-term investment. They invented proxy fights, leveraged buyouts and stock buybacks that gave lawyers and bankers a bonanza of new fees and maximized short-term profits for increasingly unsentimental shareholders, but deadened incentives for the long-term growth of the rest of the economy.

Regulatory agencies were overwhelmed by battalions of lawyers who brilliantly weaponized the bedrock American value of due process so that, for example, an Occupational Safety and Health Administration rule protecting workers from a deadly chemical could be challenged and delayed for more than a decade and end up being hundreds of pages long. Lawyers then contested the meaning of every clause while racking up fees of hundreds of dollars per hour from clients who were saving millions of dollars on every clause they could water down.
They deployed litigators to fend off private-sector unions in the South and to defend their firings of union supporters and other blatant violations of law, for which they happily paid fines equivalent to 1% to 2% of what they saved by underpaying their workers.

Deploying the First Amendment right to “petition the Government for a redress of grievances,” thousands of achievers began in the 1970s to turn Washington into a colony of lobbyists. Through the power of the campaign cash increasingly wielded by their clients, much of which they helped raise and distribute, the hordes of lobbyists were able to get riders or exemptions worth billions inserted into legislation governing trade, the tax code, job safety or industry subsidies. Although labor laws were routinely being violated by employers in highly publicized fights, and Democrats controlled both houses of Congress and the White House, they were able to block legislation introduced by President Jimmy Carter that would have toughened penalties for violations and helped level what had become a lopsided playing field when it came to organizing unions in the private sector. As private-sector unions continued to dwindle, the achievers made sure that no similar legislation even came up for a vote in the four decades that followed.

A landmark 1976 Supreme Court case brought by lawyers for consumer-rights activist Ralph Nader gave corporations that owned drugstores a First Amendment right to inform consumers by advertising their prices. In the years that followed, lawyers for the protected morphed that consumer-rights victory into a corporate free-speech movement. The result has been court decisions allowing unlimited corporate money to overwhelm democratic elections and other rulings allowing corporations to challenge regulations related to basic consumer-protection issues, like product labeling.
As government was disabled from delivering on vital issues, the protected were able to protect themselves still more. For them, it was all about building their own moats. Their money, their power, their lobbyists, their lawyers, their drive overwhelmed the institutions that were supposed to hold them accountable–government agencies, Congress, the courts.

There may be no more flagrant example of the achievers’ triumph than how they were able to avoid accountability when the banks they ran crashed the economy. The CEOs had been able to get the courts to treat their corporations like people when it came to protecting the corporation’s right to free speech. Yet after the crash, CEOs got prosecutors and judges to treat them like corporations when it came to personal responsibility. The corporate structures they had built were so massive and so complex that, the prosecutors decided, no senior executive could be proved to have known what was going on.
Meanwhile, the lobbyists for the big banks swarmed the often invisible process under which the thousands of pages of regulations were drafted to implement the Dodd-Frank financial-reform act, which was passed in 2010 to address the risks and regulatory gaps that precipitated the crash. As a result, about 30% of the 390 required regulations had not been promulgated as of mid-2016, according to the law firm Davis Polk. Under the Trump Administration and continued Republican control of Congress, efforts intensified to roll back the rules that were already in effect even as the big banks–which had argued that Dodd-Frank would kill their businesses–were enjoying record profits and market share.

It may be understandable for those on the losing side of this triumph of the achievers to condemn the winners as gluttons. That explanation, however, is too simple. Many of the protected class are people who have lived the kind of lives that all Americans celebrate. They worked hard. They innovated. They tried things that others wouldn’t attempt. They believed, often correctly, that they were writing new chapters in the long story of American progress.
When they created ways to package mortgages into securities that could be resold to investors, for example, it was initially celebrated as a way to get more money into the mortgage pool, thereby making more mortgages available to the middle class. But by 2007 it had become far too much of a good thing. As the financial engineers continued to push the envelope with ever-riskier versions of the original invention, they crashed the economy.

Thus, the breakdown came when their intelligence, daring, creativity and resources enabled them to push aside any effort to rein them in. They did what comes naturally – they kept winning. And they did it with the protection of an alluring, defensible narrative that shielded them from pushback, at least initially. They won not with the brazen corruption of the robber barons of old, but by drawing on the core values that have always defined American greatness.
They didn’t do it cynically, at least not at first. They simply got really, really good at taking advantage of what the American system gave them and doing the kinds of things that America treasures in the name of the values that America treasures.

And they have invested their winnings not only to preserve their bounty, but also to root themselves and their offspring in a new meritocracy-aristocracy that is more entrenched than the old-boy network. Forty-eight years after Inky Clark gave me my ticket on the meritocracy express in 1967, a professor at Yale Law School jarred the school’s graduation celebration. Daniel Markovits, who specializes in the intersection of law and behavioral economics, told the class of 2015 that their success getting accepted into, and getting a degree from, the country’s most selective law school actually marked their entry into a newly entrenched aristocracy that had been snuffing out the American Dream for almost everyone else. Elites, he explained, can spend what they need to in order to send their children to the best schools, provide tutors for standardized testing and otherwise ensure that their kids can outcompete their peers to secure the same spots at the top that their parents achieved.

“American meritocracy has thus become precisely what it was invented to combat,” Markovits concluded, “a mechanism for the dynastic transmission of wealth and privilege across generations. Meritocracy now constitutes a modern-day aristocracy.”
The frustrated, disillusioned Americans who voted for President Trump committed the ultimate act of rejecting the meritocrats – epitomized by the hardworking, always prepared, Yale Law – educated Hillary Clinton – in favor of an inexperienced, never-prepared, shoot-from-the-hip heir to a real estate fortune whose businesses had declared bankruptcy six times. He would “drain the swamp” in Washington, he promised. He would take the coal industry back to the greatness it had enjoyed 80 years before. He would rebuild the cities, block immigrants with a great wall, provide health care for all and make the country’s infrastructure the envy of the world, while cutting everyone’s taxes. Forty-six percent of those who voted figured that things were so bad, they might as well let him try.

FIVE
It seems like a grim story. Except that the story isn’t over. During the past two years, as I have discovered the people and forces behind the 50-year U.S. tailspin, I have also discovered that in every arena the meritocrats commandeered there are now equally talented, equally driven achievers who have grown so disgusted by what they see that they are pushing back.
From Baruch College in Manhattan to the University of California, Irvine, more colleges are working to break down the barriers of the newly entrenched meritocracy. Elite Eastern institutions such as Amherst, Vassar and Princeton are using aggressive outreach campaigns to attract applicants who might otherwise be unaware of the schools’ generous financial-aid packages.
Entrepreneurs like Jukay Hsu, a Harvard-educated Iraq War veteran who runs a nonprofit called C4Q out of a converted zipper factory in Queens, are making eye-opening progress with training programs aimed at lifting those displaced by automation or trade back into middle-class software-engineering jobs. “Some of the smartest, hardest-working people I’ve ever met were soldiers who didn’t graduate from college,” says Hsu. (Disclosure: I am an uncompensated board member of C4Q.)

Even Washington is poised to benefit from the new wave of achievers. Issue One, a nonprofit ensconced in an office on lobbyists’ row on K Street, is fighting for campaign-finance reforms and pushing legislation that would limit the influence of lobbyists by reining in their checkbooks. The group is supported by a growing band of disillusioned politicians from both parties. Better Markets, a well-funded lobbying organization that squares off against the usual lobbyists and is filled with people whose meritocracy credentials match those of their adversaries, is going after continuing abuses and lack of accountability on Wall Street. Two other organizations, the Bipartisan Policy Center and the Partnership for Public Service, are preparing blueprints for civil-service reform, tax reform, better budgeting and contracting, and infrastructure investment–all of which can attract bipartisan support if and when our elected officials finally get pushed to act.

Although their work is often frustrating, the worsening status quo seems to energize those who are pushing back. “My kid complained the other day that he still couldn’t play the violin, even though he’d been practicing for two days,” says Max Stier, president of the Partnership for Public Service. “Well, yeah, that’s true, but you have to keep at it. Persistence is an underrated virtue.”
Stier and the others believe that the country will overrun the lobbyists and cross over the moats when enough Americans see that we need leaders who are prepared and intelligent, who can channel our frustration rather than exploit it, and who can unite the middle class and the poor rather than divide them. They are certain that when the country’s breakdown touches enough people directly and causes enough damage, the officeholders who depend on those people for their jobs will be forced to act.

The new achievers are doing what they do not because they are gluttons for frustration, but because they believe that America can be put back on the right course. They are laying the groundwork for the feeling of disgust to be channeled into a restoration.

Steven Brill's Tailspin
Brill is the author of Tailspin, from which this article is adapted, out this month from Alfred A. Knopf, an imprint of The Knopf Doubleday Publishing Group, a division of Penguin Random House LLC
IDEAS
TIME Ideas hosts the world's leading voices, providing commentary on events in news, society, and culture. We welcome outside contributions. Opinions expressed do not necessarily reflect the views of TIME editors.

This appears in the May 28, 2018 issue of TIME.

Wednesday, May 16, 2018

60 Minutes, Boston Scientific, China and pelvic surgical mesh harm

https://www.cbsnews.com/news/boston-scientific-gynecological-mesh-the-medical-device-that-has-100000-women-suing/



Hernia Mesh JPML (Georgia,federal) and MCL (NJ, state)

Posted by Eric T. Chaffin
May 15, 2018 12:45 PM

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Eric T. Chaffin
Attorney • (888) 480-1123


In May 2016, Ethicon released an urgent field safety notice alerting hospitals, surgeons, and medical center personnel worldwide to stop using their “Physiomesh” mesh products because recurrence and revision rates after laparoscopic repair were “higher than the average rates of the comparator set of meshes among patients in these registries.”
In June 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally-filed Ethicon Physiomesh lawsuits into one court in the Northern District of Georgia. Currently, about 750 cases are pending there, filed by plaintiffs who claim that their Ethicon Physiomesh implants caused them to suffer from serious injuries.
U.S. District Judge Richard Story is overseeing the MDL, and, currently, the parties are working toward preparing a small number of cases for early “bellwether” trials. The plaintiffs and the defendants are actively identifying potential cases for early trial, from which a final 10 cases will be chosen.
The first bellwether trial is expected to begin in September 2019. Meanwhile, many additional cases involving plaintiffs who claim that they were injured by multi-layered hernia mesh products have been filed in New Jersey state court. In a recent Notice to the Bar, acting administrative director of New Jersey state courts Glenn A. Grant noted that the state Supreme Court had received an application to consolidate all Ethicon multi-layered hernia mesh lawsuits into a Multicounty Litigation (MCL).
Plaintiffs Advocate for Consolidated Hernia Mesh Litigation
On behalf of 62 plaintiffs who have filed cases in Bergen County, the application was filed advocating for an MCL designation for cases involving personal injuries allegedly caused by multi-layered hernia mesh products designed and manufactured by Ethicon, Inc. and its parent company Johnson & Johnson.
Plaintiffs’ attorneys noted in the letter that they expect many more multi-layered hernia mesh cases to be filed in the future. They added that consolidation will “conserve resources, reduce costs, eliminate delay, and reduce the likelihood of inconsistent results.” Comments either for or against the proposed MCL are due to Acting Administrative Director Grant by May 14th, 2018.
The MCL, if approved, would consolidate cases concerning a number of different polypropylene-based mesh prosthetics intended for the repair of hernias. These include the Proceed Surgical Mesh, Proceed Ventral Patch, Physiomesh Flexible Composite, Prolene 3D Polypropylene Patch, and Prolene Hernia System. Plaintiffs allege that the products were defectively designed and/or manufactured and were unsafe for their intended use.

All of these mesh products are composed of several layers of materials that the plaintiffs say substantially increase the risk of serious side effects and complications, including pain, mesh migration, mesh erosion, and mesh contraction.

Wednesday, January 24, 2018

Australia withdraws J&J pelvic mesh

Regulator says the mid-urethral vaginal sling, subject of a class action, is no longer being imported
Mon 22 Jan 2018 23.14 EST
On Tuesday a spokeswoman for Australia’s medical devices regulator, the Therapeutic Goods Administration, confirmed to Guardian Australia that the mid-urethral vaginal sling devices, used to treat stress urinary incontinence in women, were no longer being imported.

The devices are produced by the Johnson & Johnson company Ethicon and no longer appear on the Australian Therapeutic Goods Register, which is a list of products that can be lawfully supplied in Australia. The TGA has not responded to questions about whether the removal of the products from the register also means that products already on hospital shelves cannot be used by surgeons.
The TGA asked all manufacturers of transvaginal sling and mesh devices to update the “instructions for use” on transvaginal mesh and tape products before 17 January to include information about possible adverse events such as severe chronic pain, groin pain and bladder perforation.
According to the TGA, Johnson & Johnson did not meet this deadline and withdrew the supply of their mid-urethral sling devices to enable them to consider their options. A list of pharmaceutical companies that have met the new requirements has been made public.
The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson, told Guardian Australia he had written to all members to alert them to the development. It was his understanding that Johnson & Johnson slings already on hospital shelves could still be used but new supplies could not be imported.
Robson said he did not have “exact figures”, but the Johnson & Johnson devices were probably the most widely used by surgeons to treat incontinence.
“What I have heard is once the stock on the shelf is gone that’s it, and many hospitals, if not most, are looking at other options including other brands of urethral tape, which are still available,” Robson said.
“The feedback is some places are exploring transition arrangements so women can be offered other similar products. What I also wrote to our members yesterday was that it is clear mid-urethral tapes are the most appropriate response to incontinence which has not responded to other clinical treatment. We recirculated a Cochrane review that shows that mid-urethral tapes are the most appropriate treatment when used appropriately, and are very safe.
Visit us at WE MOCKINGBIRD STATION D
“In fact, I think it’s regrettable it won’t be available for a while, but there are other similar products.” 
The Johnson & Johnson/Ethicon implant became the subject of a class action run by Shine Lawyers in 2017, with 700 Australian women alleging that faulty pelvic mesh implants caused them debilitating pain.
Similar class actions involving thousands of women are also under way in the UK and US. More than 100,000 transvaginal mesh lawsuits have been filed in the US, the largest number against Johnson & Johnson, the manufacturer of the most commonly used meshes. Shine Lawyers alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients.
A Senate inquiry has examined whether any financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants; the lack of data available on how many procedures were performed; and the type and incidence of health problems woman have experienced.
The class action is due to return to the federal court in Sydney on Monday.

Johnson & Johnson has been contacted for comment.

https://www.theguardian.com/society/2018/jan/23/johnson-johnson-withdraws-pelvic-vaginal-mesh-device-from-australian-market

Friday, January 12, 2018

A Ban on Hernia Mesh? NICE !


10 January 2018  FiDA highlight


Experts are currently looking at the use of vaginal mesh implants in Wales, but the impact on hernia patients is not being considered in the study.
Last month the National Institute for Health and Care Excellence (NICE) recommended mesh operations should be banned from treating organ prolapse.
The Welsh Government said it was outside the scope of its review.

Richard, 67, from Penarth, said the exclusion of hernia patients has been "pretty upsetting".
He has had to give up work as an actor because of the pain, and can no longer stand for too long after several mesh implants for hernias.
"It feels at times like a knife sticking into the wound," he said. "I had hoped to be doing an awful lot more with my time.
What is a hernia?
A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall.
In many cases, it causes no or very few symptoms, although people may notice a swelling or lump in their abdomen or groin.
The Royal College of Surgeons said mesh can be the "most effective" way to treat a hernia.
"There's always a small risk with any type of surgery but hernia mesh implants have a lower risk of infection than those used to treat prolapse," it added.
But one former surgeon based in Kent said there needed to be more awareness about any potential complications.
Peter Jones said patients were becoming more aware but "in the main, no they are not warned about the risks".
Plastic mesh implants were also used to ease incontinence and to support organs which have prolapsed after childbirth, but some have caused painful and debilitating complications for patients.
Last month, NICE recommended vaginal mesh operations should be banned for treating organ prolapse in England.
The Welsh Government said the review group has focused on the "use of vaginal mesh and tape for pelvic stress urinary incontinence and vaginal pelvic organ prolapse".

It added all NHS Wales organisations were expected to follow the NICE guidelines. It said the group's work will be completed by the end of the month.
http://www.bbc.com/news/uk-wales-42641633#

Monday, January 1, 2018

Evidence for Device Safety is Inadequate: Transvaginal Mesh



  • Carl J Heneghan1, Ben Goldacre1, Igho Onakpoya1, Jeffrey K Aronson1, Tom Jefferson1,2, Annette Pluddemann1, Kamal R Mahtani1

FiDA highlight
Abstract
Introduction Transvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms.
Methods We used FDA databases to determine the evidence for approval of transvaginal mesh. To create a ‘family tree’ of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies.
Results We found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1–14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes).
Conclusions Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.



Strengths and limitations of this study
  • We searched a variety of Food and Drug Administration (FDA) summary database providing listings of all FDA 510(k) device clearances since 1976.
  • We identified all FDA-522 postmarketing surveillance orders for mesh products issued in 2012.
  • Searching the latest Cochrane review on Mesh allowed data to be extracted from all of the published randomised controlled trials comparing transvaginal grafts versus traditional native tissue repair in women with vaginal prolapse.
  • Although we searched extensively for mesh-approved devices, we will have failed to identify some products, especially those that may have been withdrawn from the market.
  • The lack of a publicly accessible registry of licensed invasive devices with details of marketing status and linked evidence prevents accurate assessment of current status for many implantable devices.
  • We were unable to scrutinise the European approval system due to its lack of accessibility. The lack of European approval evidence prevents meaningful comparison between the European and US regulatory systems.
Introduction
Implantable devices, such as non-absorbable polypropylene mesh (‘mesh’), are used for surgical treatment of pelvic prolapse and stress urinary incontinence. While evidence suggests that mid-urethral slings are safe and effective,1 2 there have been concerns about the safety of transvaginal mesh used for managing pelvic organ prolapse.3 4 A Cochrane review concluded that although permanent transvaginal mesh may reduce the rates of recurrent prolapse, its use is associated with higher rates of reoperation and bladder damage.5 In 2011, the Food and Drug Administration (FDA) raised concerns about the safety of some transvaginal mesh products.6 Serious adverse events attributed to the use of such products were not rare and included serious complications, such as vaginal erosions, infections and organ perforation.
Implantable devices are approved by the FDA, depending on the class of device. Class II devices are generally approved under the 510(k) process while Class III devices are subject to a Premarket Approval Application (PMA) process. Transvaginal mesh devices were originally included in Class II and required the 510(k) process, but they were reclassified in January 2016. In the 510(k) process, anyone who intends to market a new medical device has to submit a premarketing notification to the FDA at least 90 days before the date scheduled for marketing to begin.7 The regulatory system for medical devices has a low threshold for approval and the limited requirement for clinical data, for which it has been criticised.8 9 The PMA process10 imposes a higher standard of evidence for new devices, including clinical trials. However, Section 510(k) of the Food, Drug and Cosmetic Act allows manufacturers to bypass this requirement by seeking approval for new devices because they are ‘substantially equivalent’ to other devices (referred to as predicates) that are already available.11
Section 522 of the Food, Drug and Cosmetic Act gives the FDA the authority to mandate manufacturers to undertake postmarket surveillance studies of Class II or III devices, among other criteria, when ‘failure would be reasonably likely to have serious adverse health consequences … or the device is to be implanted in the body for more than one year’.12 However, when the FDA asked manufacturers of surgical mesh products to conduct new safety studies in January 2012,13 some manufacturers removed their products from the market, thus preventing the proper assessment of the benefit to harm balance of their devices.14
We set out to systematically assess the nature and quality of the evidence that was available for transvaginal mesh products at the time of their approval by the FDA, and the rate of compliance with orders requiring manufacturers to generate better evidence in response to concerns about harms after approval. We also set out to characterise how assumptions of device equivalence have been used during approvals by mapping the network of devices approved on the basis of equivalence to earlier devices, back to one pivotal device withdrawn from the market two decades ago.
Methods
Approvals and device equivalence
To assess the extent to which device equivalence underpins approval of modern mesh products, we used the 510(k) regulatory approval (K851086) of the 1985 Mersilene Mesh (Ethicon) and the (K963226) 1996 ProteGen Sling (Boston Scientific) to search for related device approvals. We used the FDA summary database for 510(k) Premarket Notification,15 the 510 k.directory/search directory16 and fdazilla.com to search for approvals.17 In combination, these searchable databases provided complete listings of all FDA 510(k) device clearances since 1976, with image PDFs converted into searchable documents using Optical Character Recognition. They also facilitated forward and backward navigation of cross-referenced device applications. Once we found a device in the tree, we then searched for further approvals of that device using the 510(k) number. We developed a ‘family tree of equivalence’ for devices that included the 510(k) number, the year of approval and the current status of the device. We also searched the 510(k) applications using 510kdecisions.com,18 which contains >132000 FDA 510(k) applications submitted since May 1976 for relevant clinical trial evidence for that application.
Randomised trials evidence in the year of approval
We extracted the year of publication from the first published randomised trials for a vaginal mesh product that was included in the Cochrane review published on February 2016.5 This review evaluated 37 randomised controlled trials (RCTs) comparing transvaginal grafts versus traditional native tissue repair in women with vaginal prolapse. We then located the relevant trial device 510(k) application and extracted its year of approval to establish the time from approval to trial publication.
Postmarketing surveillance studies: 522 orders analysis
We identified all FDA-522 postmarketing surveillance orders for mesh products issued in 2012.12 These were obtained from the FDA’s searchable resource19 containing current information on the status of all 522 postmarket surveillance studies. All 522 orders issued in 2012 were obtained, and from these, we extracted all mesh devices named the 510(k) orders, and the current status of the orders, whether active or inactive. We further extracted the reasons underlying the inactive orders and the amount of evidence about the active orders and their reporting status (on the fifth of every month the FDA website posts revised data on interim or final reports).12
Patient involvement
The ideas and design of this study have been formed through long-standing discussions with members of the public, those involved in litigation and members of the media.
Results
Approvals and device equivalence
We found 61 devices related to the 1996 approval of the ProteGen Sling (Boston Scientific; K963226, 1996) and Ethicon’s Mersilene Mesh, which has been used for treating hernias since 1954 (Ethicon K851086, 1985). Figure 1 shows the chain of approvals for these two devices. Searching for the ProteGen ID number K963226k retrieved 22 associated clearances. As examples, these included the 1997 Influence IN-SLING (K972651)20 and the 1998 Tension Free Transvaginal tape (K974098),21 which generated the forward chain.

Figure 1
Food and Drug Administration device chain approval for transvaginal mesh.

Figure 1 also shows that the chain of device approvals using ‘substantial equivalence’ can be traced back through more than one predicate, providing a confusing picture. Newer devices are compared with various older devices, and devices with similar names are compared with each other. For example, the 2008: Avaulta Solo Support System K08257122 has been compared with the 2009: Avaulta Solo Support System K083839, part of the same system.23 Some devices have been removed from the market (eg, 2008: IVS. Tunneller device, Covidien UK; K073164),24 and some have had changes to their indications over time (eg, 2002: Surgical Mesh, Boston Scientific; K020110).25 26
Randomised trials evidence in the year of approval
We found no clinical trial evidence for any of the devices shown in figure 1 in the 510(k) submissions at the time of approval. Table 1 shows that we were able to trace the year of approval and the relevant approval documentation for 29 of 33 different mesh products. In no case was the trial published before approval, and publication occurred at a median of 5 years after approval, range 1 (Gynecare Prolift Ethicon)27 to 14 years (Sofradim, Parieten).28
Table 1
Comparison of randomised controlled trial publication date of transvaginal mesh and date of US FDA approval

Postmarketing surveillance studies: 522 orders analysis
From the FDA’s website,19 we retrieved 119 orders in 2012 relating to the manufacturers of 126 different vaginal mesh devices, marketed by 34 different companies, 23 of which marketed at least two devices (Search date March 2017). Four companies covered 43% of the orders (American Medical Systems, Boston Scientific, Coloplast Corporation and Synovis Surgical Innovations/Baxter) (see online supplementary web table).
Supplementary file 1

Analysis of the 119 orders showed that in 79 (66%) the manufacturer ceased market distribution of the device subject to the postmarketing surveillance order (if the manufacturer resumes device distribution, they will be required to address the postmarketing surveillance order); in 26 (22%) the 522 orders no longer applied (the indication for use had been revised and no longer included the indication subject of the 522 orders); for 2 (1.7%) orders the manufacturer (Shellhigh) reported that it was no longer in business; and 1 order reported that the device was not a vaginal mesh product. Only 11 orders (9.4%) reported that they were undertaking postmarketing studies. In four orders. the manufacturer requested that their multiple orders should be consolidated into one, leaving a total of seven studies (six cohorts and one RCT) including 2756 participants recruiting (none had reported outcomes).
Discussion
Summary
Our analysis shows a consistent pattern of device approval through the use of ‘substantial equivalence’, with chains of equivalence that ultimately lead back to the Mersilene Mesh. Clinical trials evidence did not form part of the approval process, and when trials were conducted, they occurred a considerable time later (up to 14 years). After the FDA 522 orders requiring postmarketing studies were issued, many manufacturers removed their devices from the market without performing the required research; only seven studies were performed at that stage, and none reported outcomes. Thus, in most cases, there was no opportunity to determine whether the marketed devices had a favourable benefit to harm balance.
Limitations
Though we searched extensively for meshes approved through the FDA 510(k) process, we have failed to identify some of the products, especially those that may have been withdrawn from the market. The withdrawal of some mesh products from the market prevents us from precisely assessing the quality of the evidence for the clinical effectiveness of such products. The failure to identify any clinical trials before regulatory approval of transvaginal meshes casts some doubts on the criteria used by the FDA to grant marketing authorisations for the products; this is further compounded by the lack of postmarketing surveillance for most of the approved products. It is therefore highly likely that more devices could be found in the chain of equivalence shown in figure 1.
Over 100 devices manufactured by at least 40 different companies have at some point been in circulation. A real-time database is needed to allow patients, clinicians and regulators the opportunity to view, and understand, the regulatory chain of any device alongside the evidence used at the time of its approval. We have focused on the USA, which is the only regulatory system that provides transparent access to approvals (called ‘clearances’). In the European Union, approval is overseen by Notified Bodies and is a closed access system29; therefore, it is impossible to scrutinise the European approval system, given its lack of accessibility. The lack of evidence to assess devices approved in Europe prevents meaningful comparison between the European Medicines Agency and FDA regulatory systems.
Findings in context
A US study of devices cleared through the 510(k) process in 2008 found 1105 predicates for 43 new implantable devices. Only eight devices demonstrated evidence to support substantial equivalence of previously cleared devices: most studies provided no data, highlighting the lack of publicly available evidence.9 30 A 2011 analysis of 113 devices recalled because of life-threatening harms showed that recalled Class III devices were often approved using the less burdensome 510(k) process.31 In February 2012, partly in response to problems with transvaginal mesh devices and to address the risk of harms, the US Congress introduced a bill that aimed to alter the 510(k) approval process, and in January 2016 the FDA changed the approval requirements for surgical mesh from Class II to the higher risk Class III. Some mesh devices have been documented as having been marketed in the USA without approval: for example, Johnson & Johnson brought the Gynecare Prolift (K071512) to market in 2005, 3 years before it received regulatory approval, as reported by Bloomberg.32 A previous family tree of the type we present included 16 products.33
Implications
In the USA, the Medical Device Amendment of 1976 decreed that the FDA would review all existing medical devices and put them into one of three classes (Class I, lowest risk; Class II, moderate risk; and Class III, highest risk).34 Once existing devices were classified, all new devices for use in humans were to be labelled as Class III, requiring PMA, which can require evidence from well-controlled investigations (but can also be granted on the basis of lower-quality evidence).35 As the classification of existing devices took >14 years to complete, legislation allowed mesh devices that were developed after 1976 to be approved without the need for clinical data. Consequently, the higher standards required by the PreMarket Approval process for Class III devices were in fact not applied, and mesh devices have consistently used the ‘substantially equivalent’ claim to ensure market access through the less burdensome 510(k) route.
While the PMA route requires clinical data, 510(k) focuses primarily on mechanical performance and material safety; requiring bench and/or animal testing to confirm that certain technical specifications are met, and evidence that mesh is biocompatible. However, the 510(k) regulation allows approval to be obtained by comparison with a chain of equivalent devices, rather than through well-designed clinical trials, which would be preferable.
In response to FDA 522 orders, manufacturers have withdrawn from the market a substantial number of lifelong implantable devices that had not been subjected to clinical trials, leaving uncertainties about their relative benefits and harms. Devices are not subjected to the well-tested methods that have for many years been applied to medicinal products, and this has important implications. For example, a device, the Exhale Drug-Eluting Stent, which appeared to be effective in a phase II study, was found to be ineffective and harmful in phase III.36 37 Furthermore, the FDA has recently reported 22 case studies of drugs, vaccines and medical devices for which promising phase II clinical trial results were not confirmed in phase III studies.38 Better designed and adequately powered trials are required to allow for better assessment of the benefit to harm balance of transvaginal meshes in those most likely to gain some benefit for the repair of pelvic organ prolapse.
Transvaginal mesh for pelvic organ prolapse has not even generally been subjected to adequate clinical studies at any phase of its development. The available trials have been poorly designed and poorly conducted and have failed to account for variable lengths of patient follow-up, underlining the importance of properly designed clinical trials during the development of devices and careful postmarketing surveillance. The IDEAL collaboration has proposed a framework for life-cycle product evaluation whereby devices could be tested before and after marketing.38 39 One such study trialling the benefits and harms of transvaginal mesh for pelvic organ prolapse based on the IDEAL framework was recently published.40
In 2016, device manufacturers, the FDA and professional organisations established the Pelvic Floor Disorders Registry.41 Postmarketing studies and registries of patients treated with such devices should be mandatory at the time of approval.
Conclusions
Our findings highlight the lack of evidence used for licensing transvaginal mesh products. When evidence has been forthcoming, it has often emerged too late to inform clinical practice. The current systems for ensuring patient safety are inadequate for medical devices. We think that clinical trials evidence should be mandatory for marketing authorisation of implantable devices and that there should be incentives for the development of high-quality evidence-based devices. A publicly accessible registry of licensed invasive devices with details of marketing status and linked evidence should be created and maintained.
References

Footnotes
  • Contributors CJH designed the study, collected the data and drafted the first version for the manuscript. IO, BG, AP, JKA, TJ and KRM contributed to the data interpretation and development of the manuscript and approved the final draft. CJH is the guarantor.
  • Disclaimer The views expressed are those of the authors.
  • Competing interests CJH is an expert witness in a current medical device legal case and has received financial remuneration from an asbestos legal case. He has received expenses in the past from the US FDA to attend a working group on device regulation. CJH and BG receive funding from the National Institute of Health Research (NIHR) School of Primary Care. BG receives funding from the Laura and John Arnold Foundation and reports personal fees from intermittent additional personal income from speaking and writing for lay audiences on problems in science and medicine including regulatory shortcomings. TJ and CJH were recipients of a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for preventing and treating influenza. Also, TJ receives royalties from his books published by Il Pensiero Scientifico Editore, Rome and Blackwells. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-2013, TJ acted as an expert witness in a litigation case related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage, and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-1999), GSK (2001-2002), Sanofi-Synthelabo (2003) and IMS Health (2013), and in 2014 was retained as a scientific adviser to a legal team acting on oseltamivir. In 2014-2016 TJ was a member of three advisory boards for Boehringer Ingelheim and is the holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. In 2016-2017 TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. JKA has published papers and edited textbooks on adverse drug reactions; he has also acted as an expert witness in cases related to adverse drug reactions.
  • Provenance and peer review Not commissioned; externally peer reviewed.
  • Data sharing statement A spreadsheet recording the individual 522 orders is available on request from the corresponding author.

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