Ethicon Media Monitoring 11/28/2018

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Ethicon Cites Its Atty's Dying Dad In Pa. Mesh Mistrial Bid

   Nov 28, 2018 | Law 360

   By Ryan Boysen
   
   
   Johnson & Johnson unit Ethicon moved for a mistrial in Pennsylvania state court on Tuesday after the first day of a trial on defective pelvic mesh claims, saying the judge’s refusal to delay the case to allow the company's key attorney to be with his dying father “manifestly prejudiced Ethicon.”
2. Pharma firm sold mesh implant despite pain warnings

   Nov 28, 2018 | The Guardian

   By Hannah Devlin
   
   
   A vaginal mesh implant made by one of the world’s biggest pharmaceutical firms was launched despite the company being warned it could shrink and harden inside the body, company documents reveal.
3. Pharma company 'KNEW vaginal mesh implant would leave women in pain': Emails reveal executives were warned it could twist patients' nerves before it hit the market, report claims

   Nov 28, 2018 | The Daily Mail

   By Mia De Graaf
   
   
   Johnson & Johnson sold a faulty vaginal mesh implant that left tens of thousands of women in agony despite knowing the risks before it hit the market, a new report claims.
4. Johnson & Johnson Sold a Vaginal Mesh Implant Despite Health Warnings, Without FDA Approval

   Nov 27, 2018 | Jezebel

   By Maria Sherman
   
   
   In 2017, New Zealand introduced restrictions on vaginal mesh last year citing safety concerns; in 2011 the FDA announced it would investigate claims into the danger of vaginal mesh after multiple women complained of untenable, childbirth-like, persistent pain
5. At FDA, a New Goal, Then a Push for Speedy Device Reviews

   Nov 28, 2018 | The Associated Press (In The New York Times)

   Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices.
6. FDA overhauls approval process as medical devices come under fire

   Nov 27, 2018 | CNN

   By Susan Scutti
   
   
   As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit newsroom is reporting more than 80,000 deaths potentially linked to medical implants since 2008.
7. FDA's 'Flawed' Device Pathway Persists With Industry Backing

   Nov 27, 2018 | The Associated Press (In The New York Times)

   Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness.
8. US FDA plans overhaul of decades-old medical device system

   Nov 28, 2018 | The Hill Top Monitor

   After presentation of the Institute was due in the past, in about 40 percent of the cases, the reported Problem on a medical product and, therefore, not reportable.
9. FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program

   Nov 28, 2018 | The National Law Review

   By Aaron L. Josephson
   
   
   FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety.
10. 'NEVER STOP' Carlow mum left in excruciating pain after getting vaginal mesh implant vows to keep fighting for ban on controversial devices

    Nov 28, 2018 | The Irish Sun

    By Aoife Finneran
    
    
    Lesley-Anne Stephens has been left with irreversible injuries caused by the implant and will join dozens of other women outside the Dail as they bid to prevent it happening to others
11. Campaigners insist mesh implant report doesn't go far enough

    Nov 27, 2018 | Belfast Telegraph

    By Lisa Smyth
    
    
    Just over 1% of people who had a mesh implant to treat a prolapse had them removed over a nine year period, official figures have revealed.
12. Nine patients in Northern Ireland readmitted for complications after use of controversial vaginal mesh implants

    Nov 28, 2018 | Belfast Telegraph

    By Belfast Telegraph
    
    
    Nine patients in Northern Ireland who under went surgery using controversial vaginal mesh implants had to be readmitted to hospital to have them removed, a new reported has found.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Ethicon Cites Its Atty's Dying Dad In Pa. Mesh Mistrial Bid

   Nov 28, 2018 | Law 360

   By Ryan Boysen

   Law360 (November 27, 2018, 8:48 PM EST) -- Johnson & Johnson unit Ethicon moved for a mistrial in Pennsylvania state court on Tuesday after the first day of a trial on defective pelvic mesh claims, saying the judge’s refusal to delay the case to allow the company's key attorney to be with his dying father “manifestly prejudiced Ethicon.”
   
   Ethicon said Joseph E. O’Neil of Lavin O’Neil Cedrone & DiSipio LLP, one of four firms representing it in the case, had repeatedly asked both opposing counsel and Judge Kenneth Powell of the Philadelphia County Court of Common Pleas to reschedule the trial after his father’s condition took a turn for the worse on Black Friday, but  both parties ultimately refused.
   
   Given the “Hobson’s choice” of whether to return to Rhode Island to be with his dying father and grieving family or to prejudice his client, O’Neil ultimately chose the former, Ethicon said, and the trial began on Monday in his absence.
   
   O’Neil was by far the most experienced trial lawyer of the team in the Philadelphia courts, Ethicon said.
   
   “There is a code of civility imposed on all lawyers,” Ethicon said. “It is regrettable that code was not honored in this case.”
   
   “The court’s ruling penalizes a respected member of the trial bar for choosing to be with his dying father and irreparably prejudices Ethicon from fully and fairly defending itself before a jury,” Ethicon added.
   
   The mistrial motion came just a day after Judge Powell brushed aside a request from Ethicon that he step aside because his mother is pursuing a similar suit against the pelvic mesh maker.
   
   Ethicon had previously asked Judge Powell to recuse from another mesh-related case he was scheduled to preside over earlier this year, and the judge denied that motion as well.
   
   In the trial that began Monday, Suzanne Emmet and her husband are suing Ethicon over a pelvis mesh implant that she says left her in chronic pain after it malfunctioned and sawed into the soft tissue of her vagina.
   
   Ethicon said O’Neil told the Emmets' counsel and Judge Arnold New, who oversees all of the Pelvic Mesh Mass Tort, of which the Emmets' suit is a part, as early as Nov. 14 that his father was ill and that he may have to travel to be with him if his condition worsened.
   
   Ethicon said O’Neil was assured that “the court understood and would accommodate his need to be with his father, if conditions changed.”
   
   When conditions did change on Friday, however, Ethicon said the plaintiffs' counsel refused to consent to delaying the trial. In a conference on Monday morning before jury selection was slated to begin, Ethicon said Judge Powell said he “had no authority to grant a continuance and that the lawyers for both sides should try to work it out.”
   
   “The court then informed Mr. O’Neil that he was free to leave to be with his family but that the trial would proceed in his absence,” Ethicon said.
   
   Ethicon said suggestions from the Emmets’ counsel and Judge Powell that O’Neil simply rejoin the trial when he was done seeing his father and grieving with his family were totally unrealistic for a number of reasons.
   
   For starters, Ethicon said, it’s cruel to even expect O’Neil to be vigilantly following the proceedings in the trial while literally at his father’s deathbed.
   
   Even if he did, Ethicon said, “the suggestion that Mr. O’Neil can suddenly reappear at some indeterminable time later in the trial and resume his planned prominent role in this trial completely ignores how jarring that will be for the jury.”
   
   Besides, Ethicon said, “Mr. O’Neil is no potted plant. He has more than 35 years of courtroom experience as a trial lawyer.”
   
   “The court’s suggestion that Mr. O’Neil might participate in jury selection by phone and opposing counsel’s suggestion that Mr. O’Neil can read testimony instead of observing it in court are not suggestions that recognize Mr. O’Neil’s contributions to a fair and balanced trial,” Ethicon added.
   
   None of the parties involved responded Tuesday to requests for comment.
   
   Ethicon is represented by Kenneth Murphy, D. Alicia Hickok, Melissa Merk and Molly Flynn of Drinker Biddle & Reath LLP, Joseph O’Neil of Lavin O’Neil Cedrone & DiSipio LLP, Anita Modak-Truran of Butler Snow LLP and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
   
   The Emmets are represented by Thomas Kline, Kila Baldwin, Elia Robertson and Thomas Bosworth of Kline & Specter PC.
   
   The case is Suzanne Emmet et al. v. Ethicon Inc. et al., case number 130701495, before the Court of Common Pleas of Philadelphia County, Pennsylvania.
   
   --Additional reporting by Matt Fair. Editing by Janice Carter Brown.

   https://www.law360.com/health/articles/1105472/ethicon-cites-its-atty-s-dying-dad-in-pa-mesh-mistrial-bid
   

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2. Pharma firm sold mesh implant despite pain warnings

   Nov 28, 2018 | The Guardian

   By Hannah Devlin

   Exclusive: staff at Johnson & Johnson had concerns it could harden in body, emails show

   • Revealed: how faulty implants harm patients worldwide
   • Why we’re examining the implants industry

   A vaginal mesh implant made by one of the world’s biggest pharmaceutical firms was launched despite the company being warned it could shrink and harden inside the body, company documents reveal.

   Internal emails between executives, shared with the Guardian, show staff at Johnson & Johnson (J&J) were concerned that the plastic material the mesh was made from had the potential to turn “hard as a rock” and roll up like a “folded potato chip” inside patients.

   Despite this risk, the Prolift implant was made available in 2005 and marketed for seven years. In one exchange, staff discussed how “shrinkage of the mesh may lead to pain”.

   The documents are among hundreds submitted to a US court as part of a civil case brought by Suzanne Emmett, 60, from Pennsylvania. She is one of many women who allege they suffered traumatic complications after receiving the implant.

   The revelations follow a global investigation into the harm caused to patients by faulty medical implants, some of which had not been tested in patients before being marketed.

   The Guardian and organisations including the BBC, Le Monde and Süddeutsche Zeitung, coordinated by the International Consortium of Investigative Journalists (ICIJ), uncovered stories of faulty pacemakers, spinal implants that disintegrated and breast implants linked to a rare form of cancer.

   Emmett is suing J&J for damages, and a Philadelphia court will hear this week that she needed nine revision surgeries and has been left struggling to cope with her pain after the implant perforated her vagina. J&J is contesting the claims.

   Emmett’s legal team alleges the mesh device was defective and the company was negligent in its manufacture and failed to warn doctors of all the potential dangers.

   The Prolift was designed to treat pelvic organ prolapse, in which the muscles supporting the pelvic organs weaken and one or more of them press into the vagina, sometimes causing discomfort.

   It was launched in the US in 2005 without approval from the Food and Drug Administration (FDA) and only obtained clearance three years later after the US regulator was alerted it was on the market.

   At the time, J&J argued the implants were sufficiently similar to existing products that it believed approval was not required. The company said it could not confirm whether the implant had CE mark safety approval in Europe “due to ongoing litigation”.

   Emmett was given the implant in 2007. She says that, several months later, the mesh had cut through into her vagina and since then has resurfaced more than a dozen times, with surgeons removing it piece by piece.

   Her husband’s penis was scratched by the mesh during sex, which he likened to “barbed wire”. Emmett says she suffers painful bladder contractions, urge incontinence and that her sex life has been affected.

   Tens of thousands of women in the UK have received mesh implants to treat prolapse, although there is no available breakdown by manufacturer. NHS data suggests as many as one in 15 women who has a vaginal mesh later requires full or partial removal of the implant.

   Company documents provided to the court as part of the case show J&J was keen to position Prolift as a more effective alternative to traditional surgery, which has a recurrence rate of about 30%.

   However, ahead of its launch, J&J staff also discussed the implant’s potential downsides. In a message dated May 2004, a product director at J&J’s Ethicon unit, which sold the implants, warned of the potential for the mesh to harden and fold.

   The company received correspondence from surgeons raising concerns. In a 2005 message, months after the device was launched, Prof Linda Cardozo, from King’s College hospital in London, told a senior J&J manager that she found Prolift’s safety profile “quite worrying” and doctors had been given “no efficacy data to review”.

   “I still have major concerns regarding the erosion rate and possible problems with [sex becoming painful],” she wrote. Cardozo said she subsequently remained unconvinced by Prolift and had not used it.

   The paperwork provided to the court also included details of a study of 90 women who were given the implants between 2004 and 2006 and followed up for a year. Doctors reported an 18% failure rate, the mesh had eroded into the vagina in 9% of women and 13% had “moderate or severe vaginal retraction”, where the tissue hardens and contracts due to scarring around the implant.

   The mesh implants, which are designed to be permanent, become embedded in the pelvic tissue. If the material shrinks, nerves in the tissue can be compressed, causing pain.

   The court documents suggest that J&J executives liaised with US doctors behind the scenes about lobbying. One email chain discussed how to mount an offensive after the American College of Obstetricians and Gynecologists (ACOG) warned its 55,000 members in February 2007 that mesh implants should be viewed as “experimental”.

   Dr Vincent Lucente, a US doctor who was paid $1.7m by the company over 12 years in travel expenses, consulting and training fees, advised J&J executives to launch a “great offence” to get the guidance changed. “I suggest a physician leader with whom you can work with be a female, well respected, with no strong industry ties,” he wrote in a 2007 email.

   By September 2007, ACOG had replaced the bulletin with an updated version, without the word “experimental”, which Lucente said was down to his efforts. A J&J marketing director responded: “I am doing the happy dance! I love you man!”

   ACOG said the change had been made after it received emails, letters and phone calls from members who objected to the use of the word “experimental, which these members felt did not “accurately reflect the expanding use of these surgical approaches”. Lucente did not play any role in the revision, it said.

   Lucente told the Guardian he had made a single phone call to ACOG because he believed the bulletin was “factually incorrect”. “There was no lobbying; it definitely wasn’t done on behalf of Ethicon or any other industry,” he said.

   The largest comparative trial of mesh and traditional surgery for prolapse, published in the Lancet in 2016, showed that for both procedures, about 30% of women still had prolapse symptoms a year later. But the trial found higher complication rates for mesh surgery, with more than one in 10 patients experiencing complications linked to the mesh implants. In 2017, the UK’s National Institute for Health and Care Excellence (Nice) guidelinesrecommended that mesh should no longer be used to treat prolapse.

   In June 2012, Johnson & Johnson voluntarily withdrew Prolift from the market, after being ordered by the FDA to carry out further testing.

   Asked about the issues raised by the documents, Johnson & Johnson declined to comment. In a statement, the company said: “We think it is inappropriate to litigate these issues in the media or for conclusions to be drawn based on references to selectively chosen documents taken 

   https://www.theguardian.com/society/2018/nov/27/vaginal-mesh-implant-sold-despite-warnings-could-cause-pain-johnson-johnson
   

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3. Pharma company 'KNEW vaginal mesh implant would leave women in pain': Emails reveal executives were warned it could twist patients' nerves before it hit the market, report claims

   Nov 28, 2018 | The Daily Mail

   By Mia De Graaf

   ·         Scores of women are suing Johnson & Johnson over an incontinence implant

   ·         The product is no longer in the market anywhere in the world; thousands of women reported life-changing side effects

   ·         The mesh binds to pelvic tissue, pulling on a woman's nerves as it shrinks

   ·         The Guardian has seen emails from executives at the pharmaceutical company 

   ·         The emails allegedly show they had been briefed on the flaws - that it could turn rigid, inflict serious pain, and could be near impossible to remove

    

   Johnson & Johnson sold a faulty vaginal mesh implant that left tens of thousands of women in agony despite knowing the risks before it hit the market, a new report claims. 

   Internal emails seen by the Guardian show executives at the pharmaceutical company had been briefed on the product's flaws - namely that it could turn extremely rigid, inflict serious pain, and could be near impossible to remove. 

   In May 2004, before the product was launched, a member of staff warned others that the mesh could turn 'hard as a rock' and could bend like a 'folded potato chip' after implantation, while another said its capacity to shrink 'may lead to pain'.

   And yet, months later, the device was launched and promoted, and over the next seven years tens of thousands of women unwittingly followed their doctors' advice to undergo the operation which would change their lives. 

   Now, Johnson & Johnson's internal dealings are coming to light amid a series of lawsuits, the latest of which comes from Suzanne Emmett, 60, from Pennsylvania, who says she now suffers incontinence, chronic pain, and sexual dysfunction. 

   Vaginal meshes, designed to treat urinary incontinence, cannot be easily removed.

   'Mesh', the noun, refers to netted wire material that the device is made of.

   It was a cruelly ironic accident that the verb applies too: it meshes with a woman's pelvic tissue, which grows around and binds to the wiry structure. If the mesh solidifies, twists, or shrinks, it tugs on the woman's nerves. 

   Surgeons risk damaging the organs if they try to remove it, and even then, they will likely only remove parts of it.

   Johnson & Johnson has protested ignorance to warnings of these particularly crippling side effects. 

   The company continued to promote the devices even as reports of severe outcomes emerged. 

   The Guardian reports that in 2007 executives debated over email how to put a positive spin on the product in light of injury reports that sparked alarm in the American College of Obstetricians and Gynecologists (ACOG). 

   It seems their plan worked. 

   ACOG had warned their members that the device should be treated as 'experimental' due to the high rate of injuries. 

   A doctor - who received almost $2 million in kick-backs from J&J over 12 years - allegedly advised the firm to find a female physician 'with no strong industry ties' to vouch for the product. 

   Seven months later, ACOG removed the phrase 'experimental' from their advisory. 

   The doctor claimed credit for the turn-around in subsequent emails, the Guardian reported (meriting an effusive response from 'a J&J marketing director' who allegedly replied: 'I am doing the happy dance! I love you man!')

   Responding to the Guardian's allegations, the doctor said he did not lobby to twist ACOG's phrasing, he contacted them to change an inaccuracy. 

   Johnson & Johnson refused DailyMail.com's request for a comment.  

   https://www.dailymail.co.uk/health/article-6435317/Pharma-company-KNEW-vaginal-mesh-implant-leave-women-pain.html

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4. Johnson & Johnson Sold a Vaginal Mesh Implant Despite Health Warnings, Without FDA Approval

   Nov 27, 2018 | Jezebel

   By Maria Sherman

   In 2017, New Zealand introduced restrictions on vaginal mesh last year citing safety concerns; in 2011 the FDA announced it would investigate claims into the danger of vaginal mesh after multiple women complained of untenable, childbirth-like, persistent pain. Now, in emails acquired bythe Guardian, it has become apparent that Johnson & Johnson launched its own vaginal mesh, the Prolift implant, in 2005, despite knowing the mesh could harden inside the vagina, causing the patient pain—and did so without FDA approval.

   From the Guardian:

   Internal emails between executives, shared with the Guardian, show staff at Johnson & Johnson (J&J)were concerned that the plastic material the mesh was made from had the potential to turn “hard as a rock” and roll up like a “folded potato chip” inside patients....In one exchange, staff discussed how “shrinkage of the mesh may lead to pain.”

   All of this is coming to the forefront now because of a civil case filed by 60-year-old Pennsylvania resident Suzanne Emmett. She’s suing the pharmeceutical company on the grounds that the the Profit implant she received in 2007 perforated her vagina, resulting in 10 mesh erosions that required nine revision surgeries, several Botox injections, and multiple silver nitrate applications, Mesh Medical Device News Desk reports.

   Johnson & Johnson declined to comment on the Guardian story, but shared the following statement:

   “We think it is inappropriate to litigate these issues in the media or for conclusions to be drawn based on references to selectively chosen documents taken out of context.”

   https://jezebel.com/johnson-johnson-sold-a-vaginal-mesh-implant-despite-h-1830692526
   

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5. At FDA, a New Goal, Then a Push for Speedy Device Reviews

   Nov 28, 2018 | The Associated Press (In The New York Times)

   WASHINGTON — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices.

   "We don't use our people as guinea pigs in the U.S.," Shuren said, holding firm as the new director of the U.S. Food and Drug Administration's medical devices division.

   Again and again in 2011 — four times in all — Shuren was summoned before Congress. Lawmakers accused the agency of being too slow and too demanding in reviewing new devices like heart valves and spinal implants, driving U.S. manufacturers overseas where products faced less rigorous review. Each time, he pushed back.

   And yet the next year, Shuren and his team adopted an approach that surprised even some of his closest colleagues: The FDA would strive to be "first in the world" to approve devices it considered important to public health.

   The agency's shift mirrored the talking points of the $400 billion medical device industry — a lobbying behemoth on Capitol Hill — and ushered in a series of changes that critics say have allowed manufacturers to seek regulatory approval for high-risk devices using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.

   Under Shuren, annual new device approvals have more than tripled, while warnings letters to device manufacturers about product safety and quality issues have fallen roughly 80 percent, an Associated Press investigation found.

   The assortment of medical devices now on the market includes spinal rods that can leave metal shards in children and a nerve-zapping obesity implant that may not work for many patients.

   The cheaper and faster medical device approvals began despite multiple, high-profile safety problems involving pelvic mesh, hip replacements and other implants.

   An AP analysis of FDA data shows that since 2012, tens of thousands of injury and death reports have been filed in connection with devices that were cleared through a streamlined pathway that minimizes clinical trial testing. The FDA's database for reporting device problems often includes incomplete, unverified information submitted by manufacturers, physicians, lawyers and patients. Because of these limitations, it's often unclear whether a device played any role in an injury or death.

   In response to questions from the AP, the FDA said its "first in the world" goal was not about a competition with other countries but rather was adopted as part of a strategy that also focused on quickly identifying defective products to ensure U.S. devices "remain safe, effective and of high quality."

   The agency said it has focused on taking steps to reduce the time and cost of device development "that do not compromise our standard of reasonable assurance of safety and effectiveness."

   Warning letters have declined, the FDA said, because the agency is using a new approach that involves fewer warnings but more inspections to oversee companies that violate its rules.

   Last week, the FDA announced a new goal to be "consistently first" among the world's regulatory agencies to identify and address medical device safety issues.

   The agency also rejected the idea that Shuren's approach to regulation has changed over time, saying he has worked for years to improve patient safety.

   Still, some current and former FDA officials are worried about the ambition to be first on approvals. They include Dr. Peter Lurie, who calls the agency's new direction "an invitation to a race to the bottom for scientific standards" seemingly prompted by industry pressure. Lurie held senior posts at FDA from 2009 to 2017 and now heads the nonprofit Center for Science in the Public Interest.

   The FDA's medical device standards are still considered among the highest in the world, requiring "reasonable assurance" of both safety and effectiveness. But by trying to outpace countries with less stringent requirements, Lurie said, the FDA has opened the door to lowering its own standards to achieve its goal.Sign Up for On Politics With Lisa Lerer

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   The FDA's struggle to find the right mix of regulation and innovation in overseeing more than 190,000 medical devices — from pacemakers to contact lenses to surgical robots — has been chronicled for decades by government inspectors and outside researchers.

   For almost as long, the agency has had a symbiotic relationship with industry.

   Fees paid by medical device manufacturers for the review of their products now cover about 35 percent of the annual budget of the agency's Center for Devices and Radiological Health. The last four officials in Shuren's position have gone on to higher-paid positions in industry.

   In addition, Shuren's wife, Allison, is a former lobbyist who now leads her law firm's health-care practice group and advises medical device clients, among others, on regulatory and legislative issues. The FDA said Shuren passed a "rigorous ethics review process" before assuming his position that addressed potential conflicts of interest. He also recuses himself from FDA matters involving clients represented by his wife or her firm, the agency said.

   Joshua Sharfstein, a former FDA deputy commissioner now teaching at Johns Hopkins University, praised Shuren for balancing the competing demands of protecting the public while promptly approving beneficial new devices.

   "I don't think there's a viable way to be the head of devices and be in open warfare with industry all the time," he said.

   But some who spent years working under Shuren say speeding up product reviews became the clear priority after 2012.

   "Basically, it was 'We need to find ways to get products on the market quicker, faster and we need to figure out how to reduce the premarket data requirements,'" said Christy Foreman, an industry consultant who spent 22 years at the FDA, including four years leading its device review office.

   The FDA notes that laws passed by Congress require the agency to emphasize the "least burdensome approach" to reviewing new devices. But the agency itself helped fashion those laws, working with industry lobbyists and lawmakers on provisions that effectively limit its ability to request additional evidence from manufacturers.

   The philosophy of "acceptable uncertainty" is sometimes the price of making life-saving devices quickly available, according to the FDA. At the same time, it acknowledges its main system for tracking problems is riddled with "incomplete, inaccurate, untimely, unverified or biased data."

   "So instead, you have devices of unknown benefit on the market that still harm patients," said Dr. Rita Redberg, a prominent medical researcher and cardiologist at the University of California San Francisco. "I do feel that the FDA sees their role as making industry happy and not as much protecting the public health."

   ___

   Every day, patients in the U.S. and around the world benefit from medical technology. The inventions of this global industry include implants that help the deaf hear, implantable lenses that restore sight to the elderly and cardiac pumps that keep failing hearts beating.

   For most of the last century, medical devices were not regulated in the U.S. But a series of high-profile safety problems in the 1970s — including deaths, miscarriages and injuries caused by a contraceptive implant — pushed Congress to intervene.

   The laws that resulted are both more complex and less demanding than those governing drugs.

   To win FDA approval, for example, most new prescription drugs undergo two large, rigorous clinical studies proving they benefit patients. But most new medical devices enter the market with no clinical trial testing.

   Historically, more than 95 percent of FDA-reviewed devices on the market went through a streamlined process in which they need only show that they are "substantially equivalent" to a product already on the market. Typically, only devices considered high-risk, like heart pumps, must demonstrate safety and effectiveness in humans, but even those can sometimes rely on existing scientific data as opposed to new studies.

   On Monday, the FDA proposed changes to the streamlined system that would push manufacturers to incorporate more up-to-date technology into their devices. But some of the major reforms could take years to implement.

   Some experts have long argued that this fast-track pathway was never intended to be permanent. As framed by Congress in 1976, the system was originally meant to be a temporary way to grandfather in thousands of devices already on the market that weren't considered high-enough risk to require immediate review. But instead of being phased out, it became mainstream.

   The industry contends that flexibility is critical to innovation, allowing manufacturers to quickly and cheaply experiment and improve. An FDA review under that process costs about $11,000, compared to $320,000, under the more rigorous standard.

   The result, though, is that some medical products barely resemble the decades-old "predicates" they reference in applying for FDA clearance. And even when old devices have been linked to injuries or death, future products are allowed to reference them for approval because the FDA lacks explicit legal authority to swiftly intervene.

   In more than four decades, the FDA has banned only two products — powdered surgical gloves, which caused allergic reactions in patients, and fake hair implants, which caused infections and didn't work. The agency says its ability to ban products is "bound by federal law" and is essentially limited to devices that are either deceptively marketed or unreasonably dangerous.

   The U.S. device system is "basically set up to get things on the market, not to get things off the market," said Larry Kessler, a University of Washington professor and consultant who worked more than a decade in the FDA's device center.

   ___

   A device used to treat childhood scoliosis illustrates how quickly manufacturers can win FDA approval with minimal clinical trial testing.

   The MAGEC rod uses remote-controlled magnets to gradually extend titanium columns implanted in children's backs to correct debilitating spinal curvature. It is marketed as an alternative to traditional implants, which require frequent surgeries to manually extend the rods as a child grows.

   Prior to clearing it for use in the United States, the FDA allowed the MAGEC rod's California-based manufacturer, Ellipse, to begin exporting its product overseas.

   The company enlisted a Hong Kong surgeon to conduct its first human trials after winning European approval in 2009 following experiments in pigs. In a company-funded study published three years later — based on the results of just two patients — the surgeon concluded the MAGEC rod "improves quality of life and is more cost-effective." The rods were later implanted in patients in Australia, Israel, Korea and elsewhere.

   The company had assumed it would need to conduct a large clinical study including American children to win FDA approval for use in the United States, Dr. Behrooz Akbarnia, a San Diego-based surgeon and company consultant, said in an interview.

   But in early 2014, the FDA informed the company it could seek approval via the streamlined process, Akbarnia said. Ellipse claimed its device was "substantially equivalent" to a mechanical implant developed in the 1950s. It was cleared for use in the U.S. by the FDA in just 35 days.

   "That was one of the things that surprised me," Akbarnia said, "because it was so fast."

   The approval also "shocked the spine industry," according to an article by Ellipse's former vice president of engineering Tiger Buford, who did not respond to repeated requests for an interview.

   More than 2,000 children have been implanted with MAGEC rods worldwide, according to company filings by Ellipse, which was purchased by Nuvasive in 2016 for roughly $400 million.

   Anthony Wainess was 9 when he became the first U.S. child to have MAGEC rods implanted in 2013 under a "compassionate use" exemption by the FDA. The rods temporarily helped the boy's spine grow correctly, but began breaking within a year and were removed in 2016.

   Anthony's doctors theorized his body might be having an allergic reaction to the metal rods, according to his father, Steven Wainess.

   The FDA told the AP that the MAGEC rod was cleared based on laboratory testing, animal studies and a clinical study "to demonstrate the device is safe and effective."

   The agency said it requires makers of all spinal implants to include warnings about potential risks, noting that the MAGEC rod's labeling warns that it can break, move, corrode, cause pain and should not be used by patients with metal allergies.

   Researchers in Europe have identified cases of metallosis in children with the rods, the tissue around their spines stained black by titanium shards and debris.

   The long-term effects of titanium metallosis are not yet known, but metal debris in patients with chrome and cobalt hip implants can cause bone and tissue damage. The all-metal hip implants, also cleared through the FDA's streamlined path to market, were implanted in an estimated 500,000 Americans before the FDA reclassified them as high-risk in 2016. Today, they have largely been recalled or phased out.

   In a paper published in January in the medical journal, Spine, British orthopedic engineer Thomas Joyce said all 34 MAGEC rods examined by his lab at Newcastle University showed signs of metal wear, which could lead to debris spreading throughout children's bodies.

   The level of metal debris from MAGEC rods is about 100 times the levels he'd previously seen with hip implants, "a shocking amount," he reported. Joyce has worked as an expert witness for lawyers suing metal hip makers. He donates his payment to his employer, per university rules.

   Nuvasive said in a statement that its device has been shown to be effective in helping avoid the "pain, elevated complication rates, and psychological distress" of traditional spinal rods.

   "While no technology in these patients is without risk, we have also seen MAGEC rebuild patient and family lives," the company said.

   Joyce said Nuvasive initially cooperated with his research, providing materials to help with his tests. But after his research was published, he said the company sent a letter to spine doctors worldwide questioning its validity.

   Joyce said he's simply trying to answer basic safety questions that haven't been addressed by the company or regulators: Why does the MAGEC rod cause metallosis, and what are the long-term effects on children?

   A device that claims to treat depression by beaming rapid-fire bursts of magnetic energy into the brain's prefrontal cortex had a similarly smooth path to market, even though its benefits were unclear.

   Between 2012 and 2016, former U.S. military members participated in a Department of Veterans Affairs study of the transcranial magnetic stimulation device, or TMS. As of 2018, the VA has spent more than $3.4 million acquiring dozens of the machines and related supplies, based on the FDA's approval.

   The FDA cleared TMS technology for the U.S. market in 2008 even though the agency's own advisers said data submitted by the original manufacturer failed to establish its effectiveness. In fact, the advisers called its effect "marginal," ''borderline" and "questionable."

   The experts did note that TMS therapy appeared "reasonably safe," producing only minor complications such as headaches and scalp pain. That compared favorably to older devices used for hard-to-treat depression, including electro-shock therapy.

   The FDA eventually approved the device through a pathway reserved for "low to moderate" risk devices that are not equivalent to previously approved devices.

   Under Shuren's tenure, six more TMS manufacturers have come on the market, mainly by piggy-backing off the original FDA clearance.

   This June, when the VA published the findings of its study , they echoed the results of a decade earlier: TMS made almost no difference in patients' depression. The authors offered several explanations, including that veterans often have multiple psychiatric problems that complicate treatment.

   The American Psychiatric Association's guidelines describe TMS as offering "relatively small to moderate benefits." And even when TMS treatment is successful, its long-term durability has not been established in rigorous patient studies.

   Still, with persistent marketing from manufacturers, TMS has gradually won acceptance as an alternative to antidepressants. Some clinics also advertise unapproved uses of the device, including for autism, Alzheimer's and post-traumatic stress disorder.

   More than 800 U.S. clinics have the devices, according to a filing from the original TMS manufacturer, Neuronetics Inc. The firm tells doctors they can recoup the cost of a machine by treating just 12 patients, with a typical course of treatment costing up to $10,000 for 30 or more sessions over four to six weeks.

   "The clinics are proliferating, the insurance is reimbursing, but we still don't exactly know what kind of patients should be receiving this intervention," said Dr. Dost Ongur, a Harvard Medical School psychiatrist and editor of the journal that published the VA study.

   TMS can be effective for certain patients, Ongur and other psychiatrists say, but identifying them can be challenging.

   The FDA said it approved TMS after determining that its benefits outweighed its risks. The device's approval is limited to patients who have failed to respond to drug therapy with at least one antidepressant, the agency said.

   Neuronetics said in a statement that its device has been proven effective in studies of more than 900 patients and is covered by more than 65 private insurers and the government's Medicare plan. And Magventure, which makes the device used in the VA study, said TMS' impact on the brain is "a well-established fact," though researchers are still exploring the "optimal way" to treat different patient types.

   But skeptics remain. The Blue Cross Blue Shield network's unit for reviewing medical devices has assessed TMS three times, most recently concluding in 2014 that the studies "do not provide convincing evidence." The group is considered a pioneer in evaluating medical technology.

   Foreman, the former FDA review chief, said the "least burdensome" requirements that bind FDA reviewers make it difficult to demand better evidence for devices like TMS. In such cases, the agency's position is generally "the device isn't going to hurt anybody so let's put it out there and let the consumer use it," she said.

   But even ineffective treatments for depression can be harmful, according to Diana Zuckerman, a depression researcher and president of the nonprofit National Center for Health Research, which assesses the quality of outside research and conducts its own.

   "If you are going five days a week for a month, spending all this money and you feel you're no better than when you started, you could end up more depressed," Zuckerman says.

   A new analysis of the TMS literature by Zuckerman's group concludes that the treatment "is not shown to be beneficial compared to typical placebo effects."

   ___

   One of the rationales FDA cites for accepting uncertainty in new device safety and effectiveness is "patient preference," which holds that the agency should consider patient opinions in its approval decisions.

   Former FDA regulators say Shuren has repurposed that idea to justify putting even more devices on the market.

   "Jeff tells wonderful stories in terms of 'We're doing this to make sure patients have this greatly improved technology,'" Foreman said. "But there's another side to it, too."

   In recent years, patient preference information has been used to push approvals through the FDA's pathway for high-risk devices, even in a case where the manufacturer failed to meet its own study goal.

   In early 2015, the FDA approved a first-of-a-kind obesity device — an implantable stimulator that shoots electricity through the nerves connecting the stomach and brain. But less than a year earlier, the Maestro Rechargeable System had received a mixed review from the agency's scientists and outside advisers.

   To demonstrate effectiveness, the FDA and the manufacturer agreed Maestro patients would need to lose at least 10 percent more excess body weight than patients who received a sham treatment. But one-year data showed patients with the device lost only 8.5 percent more of their weight.

   FDA scientists cautioned that long-term complications from removing and adjusting the device were not known. And some agency advisers said the demographic of study participants was unacceptable, since 93 percent were white and U.S. obesity rates are highest in African-Americans and Hispanics.

   Still, the agency approved the device, citing a survey that showed patients were willing to accept the risks.

   The patient survey, for which the FDA paid $280,000, is being used by regulators to "define minimum clinical effectiveness to evaluate new weight-loss devices," the agency said, adding, "The FDA recognized obesity as an area of unmet patient need."

   The device manufacturer, ReShape Lifesciences, did not respond to requests for comment.

   Earlier this year, Shuren addressed a conference of medical device industry executives, each of whom paid about $1,000 to attend.

   Armed with dozens of PowerPoint slides, he explained how the FDA was approving more new devices in less time and credited his "north star" — the FDA's goal to be "first in the world" to approve new devices.

   He highlighted the agency's new focus on "customer service," including removing "unnecessary burdens" for companies and streamlining clinical trials.

   "We all know that premarket clinical trials can be very costly, very time-consuming and, in some respects, of limited value," Shuren said.

   He explained that the FDA was now using easier-to-produce data to approve a variety of devices, including artery-opening stents, spinal implants and diagnostic tests.

   Meanwhile, warning letters to device makers over safety, marketing and other issues have fallen to their lowest level in over a decade. The FDA says it has offset warnings with increased inspections and that companies continue to fix their violations at the same rate.

   The stepped-up approvals and modified enforcement have the endorsement of President Donald Trump and his appointee, FDA Commissioner Dr. Scott Gottlieb, who has highlighted "acceptable uncertainty" as a key concept to "modernize" device regulation.

   In September, the FDA began codifying that concept in draft guidelines for manufacturers, which would ease pre-market testing standards for certain devices, in exchange for companies conducting larger follow-up studies, even though the FDA's own data show that many studies are not completed until five or more years after approval.

   The FDA said in a statement that all devices carry a level of uncertainty, even after extensive testing. It said its guidance focuses on "breakthrough" devices, where "it may be appropriate to accept a little more uncertainty," while still meeting FDA standards.

   Lurie and other former regulators worry that the FDA is laying the groundwork for a "sliding scale" of medical evidence that will leave patients even more uncertain about the safety and effectiveness of devices.

   "This guidance is basically a 'come hither' to industry, inviting them to ask FDA for the lower standards of evidence," he said.

   https://www.nytimes.com/aponline/2018/11/27/us/politics/ap-us-implant-files-fda.html
   

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6. FDA overhauls approval process as medical devices come under fire

   Nov 27, 2018 | CNN

   By Susan Scutti

   As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit newsroom is reporting more than 80,000 deaths potentially linked to medical implants since 2008.

   Despite the timing, the FDA denies any connection between its communications and the report from the International Consortium of Investigative Journalists.

   "We didn't even know about what the ICIJ was doing until early October," FDA spokeswoman Deborah Kotz said Tuesday. She added that the agency issued its Medical Device Safety Action Plan in April, laying out what it has done and what new steps it plans to take to enhance device safety.

   "These actions are things that we've been working on for quite a while," Kotz said.

   Still, the concurrent release of information from the government regulator and the investigative team highlights the many challenges and missteps related to patient safety.Thousands of devices

   "The FDA regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide," FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the agency's Center for Devices and Radiological Health, said in a statement last week announcing the agency's plans. "On average, we approve, clear or grant marketing authorization to approximately 12 new or modified devices every business day after carefully determining -- based on valid scientific evidence -- that the devices are safe and effective."

    

   Meanwhile, the journalism collaboration, which included more than 250 journalists based in 36 countries, examined more than 8 million device-related health records, including death and injury reports. Called the "Implant Files," the extensive analysis of pacemakers, insulin pumps, breast implants, spinal cord stimulators and other surgically embedded appliances and materials found nearly 83,000 deaths and more than 1.7 million injuries possibly linked to medical devices and reported in the United States alone since 2008.

   Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its analysis Sunday.

   "Patients around the world have become unwitting test subjects for new medical technology," the consortium said. "Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants."

   Nathan Cortez, a professor and associate dean for research at Southern Methodist University Law School, explained that "the process for FDA to review medical devices was established by Congress in 1976." He noted that in the 42 years since, "a lot of new medical devices" have been introduced into the US market.

   "What the general public probably doesn't understand is that many medical devices allowed on the market haven't received much in-depth scrutiny from the FDA," Cortez, who was not involved in the consortium's work or the FDA's plans, wrote in an email. "Some have; but most haven't.

   "For well over a decade, the FDA has had to listen to critiques from the Institute of Medicine (now the National Academy of Medicine), as well as academics, members of Congress, and manufacturers," he wrote.

   What is the FDA, tasked only with protecting American patients, doing to improve its own performance?

   A big element of its plan is "trying to implement a more active surveillance system to learn more about medical device problems," Kotz said. This system is known as NEST, the National Evaluation System for health Technology.FDA wants an active not passive surveillance capability

   Frequently, the FDA learns about device risk through the existing passive reporting system, by which doctors, hospitals, manufacturers and patients can post problems to an agency database, according to Kotz. "We analyze those, and if we see a signal, we can take action: We can ask the company to do a recall; we can issue a change of labeling, a safety communication."

    

   But there are limits to this "passive reporting" system, she said. "A lot of the time, there's under-reporting, and we don't necessarily get a real-time look at what's happening. So we're trying to switch to this active system that we call NEST."

   NEST relies on real-world evidence, including anonymized information from insurance claims, patient registries, and electronic health records, Kotz said. Combing through this data, the FDA would be able to see, in real time, which devices might be causing problems.

   Another important component of NEST is the Unique Device Identification system, in which devices are marked with a specific code and if a particular device, model or batch of medical devices malfunction or become contaminated, the FDA can pull it from the market.

   NEST, if funded by Congress, will help the FDA in its efforts to monitor the general medical device industry, yet device therapies unique to women's health require additional surveillance systems, Gottlieb and Shuren said. They noted that "the President's budget for fiscal year 2019 includes a request for an additional $46 million" to support NEST.

   Women's health in the spotlight

   Therapies unique to women, including treatments for uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception, will become the focus of the FDA, Gottlieb and Shuren said. To evaluate real-world data on the safety and performance of medical products, the FDA will strengthen its Coordinated Registry Networks and, separately, its National Breast Implant Registry.

   "We've heard from patients who are concerned that their implants may be linked to other health conditions, like chronic fatigue, cognitive issues and muscle pain," Gottlieb and Shuren said.

    

   Another FDA concern is the "growing number" of manufacturers marketing "vaginal rejuvenation" devices to treat conditions and symptoms related to menopause, urinary incontinence or sexual function.

   Finally, the FDA will convene an advisory committee in February to discuss the safety and effectiveness of surgical mesh for transvaginal pelvic organ prolapse repair. The meeting will provide an opportunity for the agency to hear from the public about their experiences.

    

   Kotz said the FDA is committed to modernizing its 510(k) approval process, the regulatory pathway undertaken by manufacturers submitting new devices to the agency.

   "We're planning to finalize this guidance early next year and will rename this new approach the 'Safety and Performance-Based Pathway' to reflect its focus on advancing improved safety and performance of new products," Kotz said.

   The FDA's overhaul of its approval process may be too late for many patients, according to the International Consortium of Investigative Journalists.

   "If a drug goes wrong, patients can stop taking it. Many implanted devices are installed adjacent to vital organs or pressed against sensitive nerves, meaning removal may carry risks of serious injury or death," the consortium notes. "Nearly 500,000 reports over the last decade describe explant surgeries in connection with a medical device."

   Cortez said the FDA's modernization program "looks like the agency is trying to turn 510(k) reviews into a more rigorous process. Although we've seen hints of this coming for a few years, the new programs are important."

   https://edition.cnn.com/2018/11/27/health/fda-medical-devices/index.html

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7. FDA's 'Flawed' Device Pathway Persists With Industry Backing

   Nov 27, 2018 | The Associated Press (In The New York Times)

    Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness.

   Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing.

   The agency's streamlined review system has been blamed for a string of defective devices coming to market, including hip replacements that can leach metal debris into patients' joints and pelvic mesh that can puncture internal organs. Still, the 42-year-old system persists, in part because of the power of the medical device lobby, which floods Washington with hundreds of lobbyists and millions of dollars.

   On Monday, the FDA proposed changes to the system that would push manufacturers to incorporate more up-to-date safety features into their devices. FDA Commissioner Dr. Scott Gottlieb described it as "the most significant modernization" of the agency's review pathway in a generation, though some of the reforms could take years to implement. The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press.

   Nearly a decade ago, the FDA had responded to criticism of the system by asking the Institute of Medicine to study whether the process was helping the FDA fulfill its dual goals of protecting patients and promoting medical innovation. The nonpartisan group — now part of the National Academies of Sciences, Engineering and Medicine — advises the federal government on medical matters.

   Industry observers assumed the institute would seek to bolster safety standards by suggesting reforms to the streamlined process, which clears more than 95 percent of medical devices now on the market. But the group concluded the process offered little assurance that devices were actually safe and effective and said there was no evidence to support industry's claim that the system supported "innovation."

   Instead of trying to improve a "fundamentally flawed" system, the experts recommended the FDA develop a new framework for medical device review.

   Dr. David Challoner, a former university administrator who led the study, said his group came under fire from industry long before its findings were released.

   He had assembled a 12-member panel of medical experts, including several device industry consultants. But the industry thought it should have more representation, said Challoner, who himself had previously served as a board director for a device manufacturer.

   As the committee was finalizing its report, a University of Minnesota professor co-authored a paper in May 2011 arguing that the FDA could be "legally prohibited" from using any of the committee's recommendations because industry was not adequately represented. The paper did not disclose that the co-author, Ralph Hall, had previously been an executive for the device maker Guidant and had also worked for an industry lobbying group. Hall did not respond to multiple requests for comment.

   In June, another industry ally weighed in. The conservative Washington Legal Foundation filed a petition to the FDA, saying the agency would be breaking the law if it took advice from a panel that was not "fairly balanced."

   Richard Samp, the group's chief counsel, says his group intervenes when appropriate to urge agencies to follow the law.

   By July 2011, the FDA rejected the findings of the report it had commissioned, saying its longstanding review process should stand.

   The FDA said in a statement to the AP that it can — and sometimes does — require "exhaustive testing" for devices reviewed through the streamlined pathway, but that patient testing and clinical trials are not appropriate or needed for most lower-risk devices, such as syringes.

   Lawmakers later introduced a flurry of industry-backed proposals that would have loosened FDA oversight. One failed measure would have even rewritten the FDA's mission to include "job creation."

   Since then, the relationship between regulators and the regulated has grown closer.

   Federal lobbying records analyzed by the nonprofit Center for Responsive Politics show that the 50 largest device manufacturers and trade groups have spent more than $140 million to deploy 450 lobbyists in Washington since 2013.Sign Up for On Politics With Lisa Lerer

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   The industry's chief lobbyist — the Advanced Medical Technology Association, or AdvaMed — said there's no evidence that requiring additional patient studies would improve safety. Regarding Challoner, AdvaMed said the device industry "was nothing but supportive" and that his committee "failed to provide any meaningful recommendations" to improve the FDA's review system.

   In August 2015, AdvaMed lobbyists met with the FDA to discuss the group's "priorities for the year," according to an FDA memo of the meeting, first published by Inside Health Policy. At the meeting, AdvaMed and the FDA discussed how they had "worked together" on provisions of a bill then moving through Congress, the 21st Century Cures Act.

   The measure, later signed into law, required the FDA to emphasize the "least burdensome means" for reviewing medical devices and to train staff in the concept. That effectively gave manufacturers a legally binding tool to challenge FDA requests for more information during the review process.

   The FDA said in a statement that the "least burdensome" requirement is misunderstood and is intended to eliminate "outdated, unnecessary burdens." It does not change the agency's approval standards, the FDA said, adding that streamlined reviews are generally reserved for lower-risk devices that are not truly "new products." When appropriate, the FDA said, it requires patient testing.

   In recent years, the FDA said, it has been "raising the bar" for certain devices, including insulin pumps used to treat diabetes. As a result, the average page count for a device application submitted for streamlined review has doubled since 2009 to more than 1,100 pages.

   The closed-door meetings that helped produce the Cures bill, which included FDA and device lobbyists, were convened by staffers for Rep. Fred Upton, R-Michigan, who then chaired the House Energy and Commerce Committee. Upton has received more than $118,300 in campaign contributions from the device industry since 2013, federal records show.

   Tom Wilbur, a spokesman for Upton, said the Cures bill was the result of "unprecedented" collaboration between various parties, adding, "We're proud of this bipartisan work, which is helping patients across the country."

   AdvaMed said it does not write laws but is "routinely asked to comment on various concepts and policies that lawmakers and regulators are considering."

   Meetings between the FDA's device division and industry are now routine.

   The agency's public calendars show that since January 2017, the FDA's medical device chief has met with industry representatives more than 60 times, including at FDA headquarters and industry conferences. That's nearly six times the number of industry meetings attended by the FDA's drugs director in the same time frame.

   Looking back, Challoner said he was "pretty naive" about the industry's influence.

   Initially, he thought the device lobby was similar to the pharmaceutical industry, a handful of multibillion-dollar companies concentrated in a few states. But the device industry's geographic layout — and political clout — is much broader, including thousands of smaller firms in congressional districts across the country, he said.

   "We really ran up against a political stonewall," Challoner said. "I don't think anything has changed since."

   Reacting to Monday's announcement by the FDA, he said: "If the device industry comes back at this full bore with their lobbying efforts, this could all die a slow and painful death."

   https://www.nytimes.com/aponline/2018/11/27/us/politics/ap-us-implant-files-industry-influence.html
   

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8. US FDA plans overhaul of decades-old medical device system

   Nov 28, 2018 | The Hill Top Monitor

   After presentation of the Institute was due in the past, in about 40 percent of the cases, the reported Problem on a medical product and, therefore, not reportable. "With devices, that rigour is not there". "Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants".

   It said: "The need to protect public health, whilst not stifling innovation, must be carefully balanced".

   The House of Lords peer was appointed head of a review into the mesh implants which was ordered by Prime Minister Theresa May in February.

   The Conservative MP Sarah Wollaston, a former GP and chair of the health select committee, described the findings of the investigation as "very concerning".

   Because no such global resource exists, ICIJ created the International Medical Devices Database, a publicly available research tool which gathers more than 70,000 recalls and safety notices from 11 countries.

   'This requires government funding and support, and potentially national guidelines on the introduction of new procedures and technologies'.

   This included journalists from The Guardian, the British Medical Journal, BBC, French paper Le Monde, and Germany's Suddeutsche Zeitung.

   Jameis Winston Settles With Woman He Groped in an Uber
   Two years later, the woman - who goes by "Kate P." in legal docs - filed suit against the Tampa Bay Bucs quarterback. While the details of the settlement are not included in the documents, the woman sued Winston in September.

   Its president Derek Alderson said: "All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long term".

   Pacemakers, artificial hips, contraceptives and breast implants are among the devices that have caused injuries or in some cases death.

   Something similar came to light earlier this year in India, when Johnson and Johnson, a medical device manufacturer, was accused on implanting 1000s of patients with poorly designed hip implants that led to metal poisoning, loss of hearing, pain for some, death for others.

   As a result of the revelations, the Royal College of Surgeons has called for changes to regulation.

   The regulations in Europe are so lenient that medical companies that sell these implants keep sending their products to safety organisations, until one them approves.

   Previous year the Government suspended the use of vaginal mesh, which has been given to an estimated 100,000 women for incontinence in the past decade. Another was a hip resurfacing system - where the ball of a patient's hip joint was retained, but a metal cap was put over it surface which then sat on another metal cap on the pelvis.

   The issue is worsened by the fact that such medical products are hard to recall, even if the manufacture and regulators learn of the problem. Regulators are also said to have approved spinal disc replacements that disintegrated.

   http://hilltopmonitor.com/2018/11/us-fda-plans-overhaul-of-decades-old-medical-device-system/
   

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9. FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program

   Nov 28, 2018 | The National Law Review

   By Aaron L. Josephson

   On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable. Most devices come to market through the 510(k) pathway.

   FDA’s announcement contains three key points.

   FDA wants device manufacturers to use more modern predicate devices or objective performance criteria when they seek clearance of their 510(k).

   According to FDA, nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. FDA suggests that means some devices are not continually improving, but is it the role of FDA to encourage such improvement and are more modern predicates needed in every situation? The agency is taking a forward-leaning approach rather than playing the part of a passive regulator, which should be understood alongside recent news that portrays FDA as too slow to respond to safety issues. But there may be reasons to use an older predicate that have nothing to do with safety, such as when a type of device does not evolve quickly.

   FDA is considering publicizing devices that were cleared based on comparison to a predicate that is more than 10 years old.

   FDA would seek public comment on this approach, including if other criteria should be considered and if there are other ways to promote the use of more modern predicates. Despite FDA’s repeated statement that relying on an old predicate does not mean a device is unsafe, this seems like an obvious attempt to publicly shame companies into using more modern predicates by creating an impression that there is something wrong with devices that were cleared based on older predicates (otherwise, a layperson may reasonably ask, why publish a list of them?). This is an interesting approach for two FDA leaders—Drs. Gottlieb and Shuren—who, based on my experience working with them, favor market-based approaches rather than government intervention. That is, if patients and doctors prefer devices based on more modern predicates, the market for devices based on old predicates will dwindle. Drs. Gottlieb and Shuren would likely respond by saying this is a small nudge to the market to improve conditions, necessary especially because of the potential benefits for patient safety.

   FDA plans to finalize in early 2019 its Expanded Abbreviated 510(k) draft guidance, issued in April 2018, and rename the approach the “Safety and Performance Based Pathway”.

   In its April 2018 Medical Device Safety Action Plan, FDA said that allowing device manufacturers to use objective performance criteria to demonstrate substantial equivalence (rather than comparison to a predicate) may drive greater market competition to develop safer devices. The draft Expanded Abbreviated 510(k) guidance issued that same month was further evidence of the agency’s plans to encourage use of objective performance criteria rather than predicate devices. The November 26, 2018 announcement removes any uncertainty about FDA’s vision: the new pathway is envisioned to “supplant the practice of manufacturers comparing their device technologically to a specific, and sometimes old, predicate device.” The word “technologically” is important because, without a change to the law, new devices must still have the same intended use as a predicate device, but the technological characteristics of the new device can be compared to safety and performance criteria rather than the technological characteristics of the predicate. This is similar to the existing Abbreviated 510(k) pathway.Why is FDA doing this?

   Coupled with April 2018’s Medical Device Safety Action Plan, the November 26, 2018 statement should be understood as a subsequent chapter in FDA’s story to refute public perception that it cannot or does not appropriately respond to unsafe devices. Such perception has not been helped by recent high-profile exposés involving the female contraceptive device Essure, hip implants, vaginal mesh, and other devices. The November 26, 2018 statement was published the same day AP published a story about safety issues with spinal-cord stimulators.

   FDA is typically a reactive agency largely because it must act within the statutory limits set by Congress; when an issue arises for which FDA is not legally equipped to handle, it must find alternative solutions (such as asking companies to make changes to devices and/or labeling and making public statements) until Congress acts. The November 26, 2018 statement is a proactive approach to improving the safety of devices generally. Dr. Shuren has said that safety and innovation are not opposites; in fact, many new, innovative devices are inherently safer because they incorporate mitigations to address known safety issues. FDA states that patient and consumer safety is its first priority—this is an example of the agency proactively crafting policy to advance that priority.Anticipated Reaction

   I have heard mixed reviews on this approach from the device industry. Some medical device manufacturers have complained that it is difficult to show substantial equivalence (the 510(k) clearance standard) between a new device and a decades-old predicate and welcome an alternative approach. Others have said that FDA should not mandate use of the new pathway or otherwise suggest that devices that go through the traditional approach are somehow less safe.

   The device community may be wondering how this is different from the existing Abbreviated 510(k) pathway. Based on my experience at the agency, I think this refresh of the abbreviated model is paving the way for getting rid of predicates. While FDA is currently approaching this policy change via guidance, the agency’s statements suggest they are looking to work with Congress to codify the new pathway in statute, which could, over time, allow the agency to require a manufacturer use the new pathway and could open to the door to eventually eliminating predicates.

   The biggest question mark in Congress is House Democrats, who will have the majority starting in January. They should view this as a win for device safety but may be skeptical about a proposal that comes from the same agency pushing for overhauls of lab test and digital health oversight that have not exactly aligned with their priorities. Republicans in both chambers will probably be supportive as long as the new approach remains an option in addition to the current 510(k) review model. Even though FDA wants this new model to supplant the current model, that could be seen as a step in the direction FDA wants to move, and therefore a win.

   We’ll continue to follow this proposal and take advantage of opportunities to share comments with FDA and Congress.

   https://www.natlawreview.com/article/fda-s-refreshed-approach-to-device-safety-would-require-major-changes-to-510k
   

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10. 'NEVER STOP' Carlow mum left in excruciating pain after getting vaginal mesh implant vows to keep fighting for ban on controversial devices

    Nov 28, 2018 | The Irish Sun

    By Aoife Finneran

    Lesley-Anne Stephens has been left with irreversible injuries caused by the implant and will join dozens of other women outside the Dail as they bid to prevent it happening to others

    A VICTIM of the vaginal mesh scandal has vowed to keep fighting for a ban on the controversial devices.

    Lesley-Anne Stephens has been left with irreversible injuries caused by the implant, which is used to treat stress incontinence and pelvic organ prolapse.

    Today, she and dozens of other women will take their case to the gates of the Dail in a bid to prevent other women suffering the same fate.

    Lesley-Anne, who had the implant inserted following the births of her two children, suffers excruciating pain and bleeding and struggles to walk.

    The procedure took just 20 minutes, but she says she would never have considered it if she had been aware of the risks.

    Women have reported stabbing pain, difficulty standing or sitting and an inability to be intimate with their partners due to the mesh eroding into internal tissues and cutting through the vaginal wall.

    Lesley-Anne has undergone surgeries to remove parts of the mesh but like thousands of women worldwide, she is dealing with an irreversible injury.

    The Carlow woman said: “I am in constant, debilitating pain and this has destroyed any idea of a healthy exciting future for me and our family.

    "This is why I will never stop fighting to ban this mesh so no other family have ever to go through what we are.”

    The group received a boost last week when a Department of Health review concluded that the devices weren’t suitable as a first-line treatment for pelvic organ prolapse.

    It also said they should only be offered to women as a last resort after a detailed discussion about the possible risks and alternative options.

    They’re among 19 recommendations by chief medical officer Dr Tony Holohan, who lauded the women’s bravery in making their “private suffering” public.

    However, while the report has been welcomed by those affected, they say nothing less than an outright ban will do.

    Lesley-Anne said: “Whether the consultants decide that one or 100 of their patients need this mesh as a last resort, they are still going to destroy lives and families up and down this country.

    "I want this banned for the future of women’s health in this country.”

    https://www.thesun.ie/news/3444780/lesley-anne-stephens-vaginal-mesh-ban/
    

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11. Campaigners insist mesh implant report doesn't go far enough

    Nov 27, 2018 | Belfast Telegraph

    By Lisa Smyth

    Just over 1% of people who had a mesh implant to treat a prolapse had them removed over a nine year period, official figures have revealed.

    The Department of Health has released new statistics on the use of the controversial mesh implants and subsequent removals.

    They show that, between 2008 and 2017, some 694 patients had a mesh insertion procedure for prolapse.

    Nine patients were readmitted to hospital for a removal procedure, according to the report.

    However, a campaign group has said the figures do not reflect the agony being endured by hundreds of people across Northern Ireland.

    Jackie Harvey from Sling the Mesh NI said: "These statistics only show the number of people who have been in hospital to have their mesh removed.

    "They don't reveal the countless people in our group who have been suffering for years and have been told that it was all in their mind, that there was nothing wrong with them.

    "For far too long, women have been suffering, they have been robbed of their mobility, robbed of their jobs, their relationships.

    "Some patients have even been referred to psychology as though they are mad. These figures don't reflect the people who are being referred to pain clinics, who are going back and forward to their GP for years or being fobbed off by consultants."

    Ms Harvey said it is essential that as many women as possible attend an upcoming fact finding mission to Belfast by the Independent Medicines and Medical Devices Safety Review.

    Chaired by Baroness Julia Cumberlege, the review was announced in February by the Health Secretary at the time, Jeremy Hunt. It is investigating how the health system responds to reports from patients about harmful side effects from medicines and medical devices.

    It is looking at the hormone pregnancy test, Primodos, anti-epileptic drug, sodium valproate, and surgical mesh.

    The review team will be at the Hilton Hotel at Lanyon Place in Belfast on December 6 to hear from affected patients.

    Ms Harvey continued: "For so long, we were told there was nothing wrong with mesh but officials are finally acknowledging that isn't the case. Only recently we have had two women from our support group go to England to have the mesh removed.

    "They came back and for the first time since I met them they were able to come to one of our meetings without using crutches. It was so emotional.

    "It's absolutely vital that as many people as possible who have been affected, or think they may have been affected by mesh, to come along to the Cumberlege review next week.

    "The figures released by the Department of Health really mean nothing, but this review is actually listening to patients and trying to find out the complications that mesh can cause."

    Sinn Fein MLA Órlaithí Flynn has welcomed the publication of the statistics but said more work needs to be done to establish the harm that has been caused by mesh implants.

    "The analysis doesn't include variables such as the type of mesh used, the surgical technique used or patient profiles as these are not collected as part of the hospital inpatient system," she said. "The data also doesn't record the severity of the condition before surgery or any subsequent complications."

    In July, health officials in Northern Ireland issued a directive suspending the use of vaginal mesh implants for the treatment of stress urinary incontinence.

    Women have long complained about vaginal mesh implants causing agony by cutting into tissue. A number have even taken their lives as they were unable to live with the complications.

    https://www.belfasttelegraph.co.uk/news/northern-ireland/campaigners-insist-mesh-implant-report-doesnt-go-far-enough-37572633.html
    

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12. Nine patients in Northern Ireland readmitted for complications after use of controversial vaginal mesh implants

    Nov 28, 2018 | Belfast Telegraph

    By Belfast Telegraph

    Nine patients in Northern Ireland who under went surgery using controversial vaginal mesh implants had to be readmitted to hospital to have them removed, a new reported has found.

    The Department of Health undertook a review of urogynaecological surgery for the treatment of pelvic organ prolapse and stress urinary incontinence using vaginal mesh or tape, in comparison with non-mesh/tape procedures for the same conditions.

    The data was based on procedures undertaken between 2008 and 2017.

    In Northern Ireland between 2008/09 and 2016/17, 694 patients had a reported mesh insertion procedure in Northern Ireland, reducing by 69% from 121 patients in 2008/09 to 38 in 2016/17.

    According to the Department of Health, nine patients had to be readmitted within this time period for removal procedures more than 30 days after the initial surgery.

    Between 2008/09 and 2016/17, 3,131 patients had a non-mesh procedure, reducing by 43% from 441 in 2008/09 to 251 in 2016/17. During this period, there were no readmissions within 30 days for removal, and only three readmissions for removal more than 30 days after the surgery.

    The vaginal mesh implants are intended to repair damaged or weakened tissue in the vaginal wall. However, some women reported severe and constant abdominal and vaginal pain after surgery. Infections, bleeding and even organ erosion have also been reported.

    In July surgeons in Northern Ireland were told to stop using vaginal mesh- one day after health officials suspended use of the implants in England. 

    https://www.belfasttelegraph.co.uk/news/northern-ireland/nine-patients-in-northern-ireland-readmitted-for-complications-after-use-of-controversial-vaginal-mesh-implants-37569882.html
    

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