Preview Newsletter
Ethicon Media Monitoring 11/27/2018
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Pa. Mesh Judge Won't Recuse Over Mom's Case Against J&J
Nov 26, 2018 | Law 360
By Matt Fair
A Pennsylvania state judge is refusing to step aside from presiding over an upcoming trial over a Johnson & Johnson unit’s allegedly defective pelvic mesh despite concerns that his mother is pursuing her own product liability case against the company. -
International investigation links 1.7M injuries to medical devices, as FDA moves to reform its 510(k) process
Nov 26, 2018 | Fierce Biotech
By Conor Hale
A yearlong global investigation into the safety of medical devices—involving more than 250 reporters from more than 50 media organizations, led by the International Consortium of Investigative Journalists (ICIJ)—analyzed 10 years' worth of FDA data and found more than 1.7 million injuries and 83,000 deaths linked to approved and cleared devices. -
FDA’s New Safety Action Plan May Overturn Old Predicate Devices
Nov 26, 2018 | Mesh Medical Device News Desk
By Jane Akre
The FDA realizes that 42-year-old rules that regulate medical devices need updating. -
FDA Looks to Revamp Medical Device Approval Pathway
Nov 26, 2018 | Modern Healthcare
By Virgil Dickson
The Food and Drug Administration wants to overhaul the regulatory pathway that most medical devices follow to enter the market. -
Why has it taken so long to wake up to the danger implants that caused 1,000 deaths?
Nov 27, 2018 | Mail Online
By Carl Heneghan
Would you want to swallow a pill that hadn’t been subjected to rigorous tests? Or use a prescription cream that hadn’t undergone strict trials? -
The Guardian view on medical implants: patients need protecting
Nov 26, 2018 | The Guardian - Editorial
t will surely have startled most readers of our joint investigation of medical implants to learn that devices such as surgical mesh, pacemakers, replacement hip joints and contraceptive coils are not subjected to the same stringent tests as medicines. -
The Irish Times view on medical implants: The regulatory gap must be fixed
Nov 27, 2018 | The Irish Times
Medical implants are a €352bn global industry. Products have revolutionised medical care and changed hundreds of thousands of people’s lives for the better. -
Campaign group responds to AdvaMed over Implant Files
Nov 27, 2018 | Medical Plastics News
By Reece Armstrong
The global investigation, led by the International Consortium of Investigative Journalists (ICIJ), looks into the lax regulations surrounding medical devices. -
Under the skin of ICIJ’s Implant Files
Nov 26, 2018 | Columbia Journalism Review
By Jon Allsop
In 2014, Jet Schouten and her colleagues at AVROTROS, a public broadcaster in the Netherlands, embarked on an intricate undercover operation. -
Concerns raised following media probe into medical implants
Nov 26, 2018 | Medical Plastics News
An investigation from 58 media organisations including BBC Panorama, International Consortium of Investigative Journalists, The Guardian and the British Medical Journal has led to calls in changes of the rules regarding implants. -
Investigative Report Casts a Troubling Light on the Medical Device Industry
Nov 26, 2018 | Medical Device and Diagnostics Industry
By Amanda Pedersen
The consumer media has not been kind to the medical device industry this year. A consortium of journalists released an investigative report on the industry over the weekend that blames poorly regulated medical devices for millions of patient injuries and thousands of deaths. -
Faulty medical implants: who is at risk?
Nov 26, 2018 | The Week
Faulty medical implants have caused the deaths of more than 1,000 people in just three years, a global investigation has found. -
'People crying in the ward alone': Patients describe their experiences in Irish hospitals
Nov 26, 2018 | Thejournal.ie
By Michelle Hennessy
The majority of patients treated in Irish hospitals report good overall experiences, but a new survey has identified deficiencies in how healthcare staff communicate with people about their care.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Pa. Mesh Judge Won't Recuse Over Mom's Case Against J&J
Nov 26, 2018 | Law 360
By Matt Fair
A Pennsylvania state judge is refusing to step aside from presiding over an upcoming trial over a Johnson & Johnson unit’s allegedly defective pelvic mesh despite concerns that his mother is pursuing her own product liability case against the company.
Judge Kenneth Powell in the Philadelphia County Court of Common Pleas inked a one-page order on Wednesday brushing aside arguments from J&J unit Ethicon Inc. that hearing the case while his mother pursues a lawsuit involving what the company called “similar subject matter” would create an appearance of impropriety warranting his recusal.
The judge did not issue an opinion outlining his reasoning, and a spokeswoman for Ethicon declined to comment on the decision on Monday.
Judge Powell is getting set to preside over a jury trial this week over claims that Lancaster County resident Suzanne Emmet was left to suffer chronic pain after a mesh implant that she received in the mid-2000s to treat her urinary stress incontinence sawed into the soft tissue of her vagina.
As the case moved toward its trial date last week, however, Ethicon filed a motion on Nov. 19 seeking Judge Powell’s recusal based on what it said was its understanding that the judge’s mother was pursuing a similar case against a J&J entity in Philadelphia.
“Here, because Your Honor’s mother has a pending lawsuit against certain Johnson & Johnson companies on a similar subject matter, and which may implicate similar issues, there is a perception of an appearance of impropriety that warrants recusal,” the company argued.
The company did not identify the case it said it believed Judge Powell’s mother was pursuing or what specific allegations it involved.
While court records show that a woman by the name of Helen Powell is currently pursuing a mesh case against Ethicon in Philadelphia, an attorney for the woman told Law360 on Monday that she was not the judge’s mother.
Ethicon had previously asked Judge Powell to recuse from another mesh-related case he was scheduled to preside over earlier this year.
The judge denied that motion as well, although the case ultimately settled before trial.
In responding to Ethicon’s motion to recuse in the first case earlier this year, plaintiffs accused the company of “judge shopping.”
Judge Powell had previously overseen a mesh case that ended in a $13.7 million verdict against Ethicon.
In fighting last week’s recusal bid, the plaintiffs simply pointed to Judge Powell’s decision to deny the first motion as precedent for the move.
“Plaintiffs respectfully request that your honor enter the same order here,” Emmet and her husband said in a filing.
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, 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.https://www.law360.com/articles/1104878/pa-mesh-judge-won-t-recuse-over-mom-s-case-against-j-j
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Nov 26, 2018 | Fierce Biotech
By Conor Hale
A yearlong global investigation into the safety of medical devices—involving more than 250 reporters from more than 50 media organizations, led by the International Consortium of Investigative Journalists (ICIJ)—analyzed 10 years' worth of FDA data and found more than 1.7 million injuries and 83,000 deaths linked to approved and cleared devices.
The series of stories published this weekend across several outlets details the patchwork of international regulatory regimes overseeing the medical device industry, finding products being marketed with little to no human testing, or devices pulled from sale due to safety concerns in some countries while still being sold in others.
For example, the U.S. issued over 26,700 device recalls during that 10-year period, while India issued only 14 from 2013 to 2017. To centralize that information, the ICIJ built the first international public database of more than 70,000 device recalls, safety alerts and field safety notices gathered from 11 countries.
Of the more than 4,000 types of devices listed in the FDA’s data, six accounted for about 25% of the injury reports: hip prostheses, insulin pumps with sensors, implanted insulin pumps, spinal stimulators, surgical mesh and defibrillators, according to the Associated Press, which participated in the investigation. Other high-profile devices have included contraceptive coils and breast implants.
The day after the reports were published, the FDA outlined plans to modernize its 510(k) clearance program, which covers the large majority of the agency’s device reviews—including plans for additional safety and performance criteria, as well as a push to urge manufacturers to use more recent predicate devices as the basis for their submissions.
“We believe firmly in the merits of the 510(k) process” first established in 1976, FDA Commissioner Scott Gottlieb, M.D., and CDRH Director Jeff Shuren, M.D., said in an agency statement. “But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices.”
Under the 510(k) pathway, manufacturers compare their products against previously cleared predicate devices to demonstrate that they are just as safe and effective. However, older predicates may not reflect the modern tech in new devices and other advancements.
The FDA said its data showed that nearly 20% of current 510(k) clearances are based on predicates over 10 years old. In 2017, CDRH cleared 3,173 devices through the pathway, totaling 82% of all devices cleared or approved.
“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market,” Gottlieb and Shuren said. “However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.”
As a result, the agency believes more manufacturers will opt for the de novo review pathway. In the coming weeks, the FDA plans to propose a rule clarifying the requirements and procedures for de novo submissions. In addition, the agency plans to finalize its guidance early next year on an alternative 510(k) pathway allowing the use of objective safety and performance criteria to show equivalence in well understood device types.
Last week, before the ICIJ’s investigation was published, the FDA committed to being “consistently first” among international regulatory agencies in responding to medical device safety signals. The agency said it has begun transitioning to an active surveillance system using real-world evidence and plans to seek new authority to take faster postmarket regulatory actions. In addition, the FDA pointed to increased inspections of medical device manufacturers over the past decade, especially overseas.
“Our increased oversight has led to tangible results with improved compliance,” Shuren said in a statement. Since 2007, annual numbers of device inspections have increased 46%, while inspections of foreign firms have increased 243%.
In a statement responding to the agency’s 510(k) changes, the U.S. medical device lobby the Advanced Medical Technology Association, also known as AdvaMed, said that while the pathway has proven to be effective over the years, it’s a process that can be improved.
"FDA acknowledges that its concern with older predicates only applies to a minority of devices and that those devices have no demonstrated safety concerns,” said AdvaMed CEO Scott Whitaker. “It is our hope that through the regulatory review, the agency will recognize that in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense. The proposed 10-year cut off criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices.”
AdvaMed’s response to the ICIJ investigation, however, stressed that medical devices form the foundation of modern medicine.
“Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and lifesaving solutions delivered to billions of people worldwide,” Whitaker said. “We should never discount any patient's experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others.”
MedTech Europe, which represents the industry in the EU and Brussels, pointed to the strict regulatory environment the industry operates under.
“The ICIJ investigation shares the same fundamental belief that it is important to provide products that work and are safe,” it said in a statement. “Its perspective, however, on how the industry works does not align with ours.”
https://www.fiercebiotech.com/medtech/international-investigation-links-1-7m-injuries-to-medical-devices-as-fda-moves-to-reform
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FDA’s New Safety Action Plan May Overturn Old Predicate Devices
Nov 26, 2018 | Mesh Medical Device News Desk
By Jane Akre
The FDA realizes that 42-year-old rules that regulate medical devices need updating.
Patients of failed devices already understand that all too well.
1976.
Many of you weren’t even alive then, but those who were might remember that is the year that Steve Jobs and Steve Wozniak founded Apple Computers and created the first prototype for what would become the personal computer.
The film, Rocky was first released, 14-year-old Nadia Comaneci scored a perfect “10” on her uneven bar routine in the Montreal Olympics, and Georgia peanut farmer Jimmy Carter won the presidency.
That is also the year that the Food and Drug Administration (FDA) started regulating medical devices, creating the largely hands off 510(K) clearance pathway that allows a device to make it to market with an exchange of paperwork and identifying a “predicate” device that the new one resembles, already on the market.
No clinical trials were needed.
Industry liked 510(k). Instead of years to the marketplace,the premarket approval that drugs must undergo, for a few thousand dollars and 90 days a new device could be cleared and ready to sell.
For decades, more than 90% of devices made it to the market through 510(k).
That is also how at least sixty new pelvic meshes made it to market – polypropylene mesh to shore up falling pelvic floor or organs, to support a sagging urethra or bladder.
But with no clinical trials, the fallout of that experiment can be seen today in the hundreds of thousands of defective product lawsuits filed around the globe and the claims of thousands of women who say their lives will never be the same.
So today the FDA announced plans to modernize the 510(k) clearance pathway, (here) taking into account rapidly evolving technology, novel materials and electronic devices. Much has changed in 42 years and the FDA wants to meet those changes relying on “modern safety and performance criteria.”
Currently the FDA’s, Center for Devices and Regulatory Health (CDRH) oversees more than 190,000 medical devices and thousands more enter the market every year.
Today’s announcement says the FDA wants to retire “outdated” predicates, that is a named predicate device older than ten years.
Currently the FDA’s, Center for Devices and Regulatory Health (CDRH) oversees more than 190,000 medical devices. Twenty percent of the current 510(K) clearances are based on a predicate that is ten years old or older.
In the next few months the FDA will “consider” naming those older predicates and name the devices that followed using it as a model. *Note* the words “consider following” is how the FDA frames that move.
ProteGen incontinence mesh, was made by Boston Scientific and marketed in 1996.
MND researcher, Suzanne McClain found more than 60 pelvic mesh devices were approved naming ProteGen as their predicate. That work was echoed by a British Medical Journal review of the 1985 Mersilene Mesh (Ethicon hernia mesh) and the ProteGen sling, also finding 61 devices that named them as a predicate.
There were no clinical trials evidence for the 61 devices at the time of approval.
Unfortunately, ProteGen was recalled from the market March 17, 1999.
“The use of the ProteGen in the treatment of female urinary incontinence is associated with a higher rate than expected of vaginal erosion and dehiscence and does not appear to function as intended.”
Dehiscence is a wound rupture at a surgical incision.
In short, the mesh was recalled after proving to be defective in ways that were harmful to patients, however, there is no regulation within the FDA to spark a review of those meshes that followed the lead of ProteGen.
In other words, a defective medical device can serve as a predicate.
In the next few months the FDA will “consider” naming those older predicates and name the devices that followed using it as a model. *Note* the words “consider following” is how the FDA frames that move.
“To be clear, we don’t believe devices that rely [sic] on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.. It would help the overall product environment continue to evolve in the direction toward more modern performance standards.”
Translation – the FDA may rely on more modern predicate devices which should meet “modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles.”
Other changes – a 510(K) submission is now 1,185 pages rather than 475 pages as it was a decade ago.
A few other changes are underway. Fewer 510(K) clearances occurred in 2017.
Generally more than 95% of devices make it to market easily through 510(k), but in 2017 that number was 3,173 devices, which was 82% of the total devices cleared to market. Presumably, the rest, 18% had to undergo a more vigorous review that involved some assurances of safety and efficacy.
https://www.meshmedicaldevicenewsdesk.com/fdas-new-safety-action-plan-may-overturn-old-predicate-devices/
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FDA Looks to Revamp Medical Device Approval Pathway
Nov 26, 2018 | Modern Healthcare
By Virgil Dickson
The Food and Drug Administration wants to overhaul the regulatory pathway that most medical devices follow to enter the market.
Currently, the FDA clears medical devices under the 510(k) process if they're substantially similar to another product already on the market. But some of those devices are decades old and may not be the best comparison to justify regulatory approval.
"Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks," FDA Commissioner Dr. Scott Gottlieb and FDA device chief Jeff Shuren said in a joint statement.
The agency wants to steer companies to use newer devices for their comparable devices in 510(k) applications and is considering prohibiting medical device companies from citing products that are more than a decade old.
The FDA will ask devicemakers whether it should post a list of products or manufacturers that have scored market clearance based on predicates that came to market more than 10 years before.
"We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes," Gottlieb and Shuren said.
But devicemakers say it still makes sense to cite these older products if the technology hasn't substantially changed over time.
"The proposed 10-year cutoff criteria could prove arbitrary as older predicates can offer extensive data about their performance, which helps sponsors introduce newer, safer devices," Scott Whitaker, CEO of the Advanced Medical Technology Association, said in a statement.
The agency also wants to launch a new pathway next year that would allow new iterations of commonly used medical devices to receive regulatory clearance based on how well they meet safety and efficacy objectives, instead of comparing them with other devices.
The 510(k) process has been under fire in Washington circles for years, as some allege the quick process has allowed some unsafe products to reach consumers.
A notable example is vaginal surgical meshes, which have been linked to numerous cases of chronic pain, infection and pelvic organ prolapse. Most of the mesh brands associated with the adverse events were cleared through the 510(k) process.
In 2011, the National Academy of Medicine, a health advisory group to the federal government, urged the FDA to replace the pathway with a new one.
The FDA asked the group whether the 510(k) process protected patients and promoted innovation in support of public health. The group said it was difficult to answer those questions since the pathway was not intended to determine whether a device was safe or effective. Instead, Congress created it to determine whether a new device is substantially equivalent to one already on the market, it said.
Around 80% of the devices coming on the market each year go through the 510(k) process. Nearly 20% of those products now in use were cleared based on a predicate that's more than 10 years old, according to the agency.https://www.modernhealthcare.com/article/20181126/TRANSFORMATION02/181129964
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Why has it taken so long to wake up to the danger implants that caused 1,000 deaths?
Nov 27, 2018 | Mail Online
By Carl Heneghan
Would you want to swallow a pill that hadn’t been subjected to rigorous tests? Or use a prescription cream that hadn’t undergone strict trials?
Of course not. And yet for years patients have been undergoing surgery with implants — everything from hip joints to mesh for incontinence — some of which have had only the most basic testing, and in some cases, haven’t been subject to tests on humans.
It’s a scandal, and one that’s had an enormous impact, because as with all experiments — and this is a mass experiment — things can go wrong. And they have.
Implantable devices can cause immune reactions, often leading to pain and other adverse effects.
I’ve heard of women who’ve had the Essure contraceptive device — which is placed in the fallopian tubes, where it stays and helps form scar tissue as a form of sterilisation — who’ve needed hysterectomies because of what the device has done to them.
And as the Mail has highlighted, some women given vaginal mesh to treat incontinence have been left crippled by pain, needing a number of operations to remove fragments of the mesh that had splintered into their tissues.
Often the damage can’t be undone simply by removing the device. The patient may need another operation, and in some cases these faulty devices have led to deaths.
As the BBC’s Panorama reported last night, new freedom of information requests have found that the UK regulators — the Medicine and Healthcare Products Regulatory Agency (MHRA) — received more than 62,000 adverse incident reports relating to implants between 2015 and 2018 — yet the number of these cases the MHRA referred on for investigation has actually slumped.
Tragically, more than 1,000 people died, according to the MHRA. I think that’s an underestimate.
But even if you think about that MHRA figure — some of these people will have been having routine operations to fix health conditions that in no way could be considered life-threatening.
PIP breast implants are a particular example. They were withdrawn from the UK market in 2010 after they were found to contain industrial-grade silicone.
So what is going wrong? It’s largely a commercial problem. The implant industry is big business, worth £300 billion globally.
Obviously, when companies come up with a new device, they want it to be better than what is already out there. Vaginal mesh was supposed to be a quicker, less intrusive surgical method of fixing incontinence. Metal-on-metal hip implants — where both the ball and socket were made of metal — were going to last longer than the ceramic ones used before.
However, after they were introduced here in the Nineties with little data, it transpired they had a far higher failure rate than the ceramic implants they replaced.
The problem is that the device manufacturer isn’t paid for the work that goes into getting the device to market — it is paid for the number of implants it sells. So the system encourages them to get their device on sale as quickly as possible.
As I discovered when I started investigating implants ten years ago, getting a device to market requires none of the rigorous testing we expect from medicine.
I became interested in how implants were regulated when I was asked what I knew about their regulation, and specifically the metal-on-metal hip joints.
It was the first time I had looked at the regulation of medical devices and I was genuinely shocked.
As a GP, I was used to the approval system for drugs, which involves years of clinical data showing there is a clear benefit above and beyond a placebo. Patient safety is our highest priority. No effective medical intervention is completely free of risk. As a regulator, our work is underpinned by robust and fact-based judgments to make sure that the benefits justify any risks. Before any implant is put into a patient, the clinician responsible should consider why that implant is appropriate, and discuss the potential risks. In the case of a new implantable device, part of this discussion should highlight what is known about the long-term safety and performance in the body. An MHRA spokesperson
With implants, there is no such demand for test data. Some were approved under what’s called the ‘equivalent’ rule. This means the manufacturer of a new product can claim it’s so similar to existing devices that it does not need to provide clinical evidence of its effectiveness in humans.
As a result, devices that will be left inside a patient for life are waved through without any long-term human data: but this is vital, as many of these do very well in the short term, but it is the longer term, by which I mean more than a year, that is so important.
About 18 months ago, we here at Oxford University looked at 61 mesh devices — a mixture of vaginal and other surgical meshes — and found all had been subject to only basic tests: they might have been tested in a rabbit or a mouse for about five days.
The data on the products’ efficiency is effectively provided courtesy of the unwitting patients these devices are put into.
And to whom do these companies have to submit the evidence that their devices work? Well, this is to what are known as notified bodies, of which there are four in the UK.
But who funds these bodies? The industry itself. So although the MHRA is supposed to audit its decisions, in theory implants can come to the market without the MHRA knowing about it.
It’s a ridiculous situation. Furthermore, as private companies, these notified bodies can work without any commitment to transparency — and can bat away queries such as freedom of information requests that might question any of their decisions.
The fact is, no one can tell you what evidence was used to get a device onto the market, because in Europe it is judged to be commercially sensitive information.
The U.S. has a more transparent system, with more published data about what’s going on.
New regulations were put in place in April last year, which should put more burden on manufacturers to provide more technical data, among other things. There will be a three-year transition period before this is enforced. But I think the language used is so vague it will have little impact. I would like to see a national registry that keeps lifelong data about patients with implants. That way we can identify patterns and safeguard patients.
It is also time that we have safeguards with the MHRA — so that an outside agency decides when an investigation into a device is warranted. At the moment the MHRA in effect decides when to investigate its own decisions.
I would also like to see more people — and it is mainly women who’ve been affected by these devices — who are suffering terribly as a result of harm brought by a device, to have a full apology.
They were meant to revolutionise medicine. And thousands of NHS patients have, unquestionably, benefited from man-made implants.
But some devices have caused problems for thousands of patients . . .
CONTRACEPTIVE IMPLANT
Essure, a small spring-like implant made from tough titanium, was developed 15 years ago and was meant to be a drug-free alternative form of contraception for women.
It works by blocking eggs from moving out of the fallopian tubes and into the womb. The device, inserted via the vagina, works by triggering the formation of scar tissue in the fallopian tubes.
The big attraction was it didn’t involve surgery; the whole procedure took just 15 minutes.
But Essure was withdrawn by the manufacturer last year after claims some women suffered problems such as chronic pelvic pain and ectopic pregnancies.
A U.S. study, published in the British Medical Journal in 2015, found women with the implant were ten times more likely to need follow-up surgery to correct problems than if they had conventional sterilisation.
However, the numbers were still small — just over two per cent needed surgery, compared with 0.2 per cent in the other group.
HIGH-TECH PACEMAKERS
around 35,000 people a year in the UK have a pacemaker fitted.
In 2015, a device called Nanostim was withdrawn because nearly one in 20 patients suffered a build-up of fluid that, untreated, can cause a life-threatening drop in blood flow to vital organs. A study in the latest Journal of Interventional Cardiology and Electrophysiology found more than one in 20 out of 1,439 patients fitted with a Nanostim suffered serious adverse effects within the first 30 days.
The implant was turned down by safety bodies in Germany due to lack of evidence but given the green light by the British Standards Institution in the UK.
INCONTINENCE MESH
Arguably the scandal that brought implant concerns to a peak, vaginal mesh, is thought to have maimed thousands of women in the UK.
The material was widely used to tackle stress urinary incontinence. But while successful in many women, in some the plastic mesh started to disintegrate, causing extreme pain.
The Medicines and Healthcare Products Regulatory Agency (the MHRA) says between 1 and 3 per cent of women suffer adverse effects. But a study by Case Western Reserve University in the U.S. suggested the figure was actually over 40 per cent.
In July, officials in the UK announced it could no longer be used unless a list of strict conditions have been met.
BREAST IMPLANTS
One of the biggest implant scandals was the use of industrial-grade silicone for human breast implants. So-called PIP implants were made from silicone gel which ruptured, causing pain and swelling. They were withdrawn in the UK in 2010, but an estimated 47,000 women had them implanted.
The MHRA advises women not to have them removed unless they are causing problems.
HIP REPLACEMENTS
In 2004, a new type of man-made replacement hip joint was introduced in the UK. The joints were made from bare metal and were meant to have lower failure rates than other joints available.
Around 12,000 people had the metal-on-metal joints implanted. But in some, the joints began to wear out quickly — causing damage in the bone around the hip.
Research revealed that the number of patients who needed repeat surgery because their artificial hips had failed were higher in metal-on-metal joints.
In 2013, U.S. manufacturer DePuy (part of Johnson & Johnson) pulled the Pinnacle Ultamet from the market, blaming poor uptake by surgeons.
https://www.dailymail.co.uk/health/article-6431939/Why-taken-long-wake-danger-implants-caused-1-000-deaths.html
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The Guardian view on medical implants: patients need protecting
Nov 26, 2018 | The Guardian - Editorial
t will surely have startled most readers of our joint investigation of medical implants to learn that devices such as surgical mesh, pacemakers, replacement hip joints and contraceptive coils are not subjected to the same stringent tests as medicines. It can take pharmaceutical companies more than a decade to get a new drug through the three phases of clinical trials that are standard practice before it is approved for use in humans. By contrast, the regulation of medical items classed as devices, a category that includes some diet pills, has evolved in such a way that some new products undergo no formal testing at all – because they resemble another item already on sale.
Earlier this year we reported that about one in 15 women fitted with vaginal mesh implants in the UK went on to have it removed as a result of complications including chronic pain. This week’s investigation, carried out in partnership with media organisations around the world, reveals that vaginal mesh is far from the only implant to have caused harm as well as good. Examples of what appears to be a global regulatory failure include thousands of serious incidents linked to breast implants, which have also been linked to a rare form of cancer; the voluntary recall of metal-on-metal hips due to high levels of follow-up surgery; and the withdrawal of the permanent contraceptive Essure (used to block fallopian tubes) in the US and Europe.
In the UK, regulators received 62,000 “adverse incident” reports linked to medical devices between 2015 and 2018; 1,004 of these resulted in death. But worryingly, the proportion of reports leading to an investigation overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA) has fallen sharply, while freedom of information requests, including one relating to the contraceptive Essure, were turned down on grounds of commercial confidentiality. New rules are due to come into force across the EU in 2020, but these fall short of the mandatory national registers called for by senior doctors we spoke to. They point to the influence of lobbyists in a European industry worth €110bn (£98bn) a year. Due to Brexit, there can in any case be no guarantee that the UK will remain part of the European system.
Around 160,000 hip and knee replacements are carried out in England and Wales each year. Most are successful, and the role played by companies that manufacture and market items such as artificial joints is key. But they must also be regulated, which is another way of saying that patients must be protected. The former secretary of state for health, Jeremy Hunt, made patient safety one of the themes of his tenure. His successor, Matt Hancock, should now set out how the government plans to increase transparency around medical devices, and ensure that mistakes such as those made with vaginal mesh can never happen again. The current regime gives manufacturers too much control over information – such as the number of devices in use – that should be in the public domain.Advertisement
These are technical matters to which most people would not give much thought unless they or someone they knew was directly affected. In this, they have something in common with buildings regulation. Only when such a system fails catastrophically, as construction rules appear to have done at Grenfell Tower, is there a demand for action. There are obvious differences between healthcare and building. But both examples illustrate the folly of denigrating regulation. Used wisely, red tape saves lives.
https://www.theguardian.com/commentisfree/2018/nov/26/the-guardian-view-on-medical-implants-patients-need-protecting
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The Irish Times view on medical implants: The regulatory gap must be fixed
Nov 27, 2018 | The Irish Times
Medical implants are a €352bn global industry. Products have revolutionised medical care and changed hundreds of thousands of people’s lives for the better. But research by more than 250 journalists from 59 media organisations, including The Irish Times, through the International Consortium of Investigative Journalists, has uncovered a range of problems in the implant industry.
Failures include replacement hip joints and vaginal mesh products being used without adequate clinical trials; the continued use of faulty pacemakers when manufacturers were aware of problems; and a lack of central regulatory registers which means surgeons are unable to quantify the risk of implants when advising patients.
People in the Republic were especially exposed to a problem with a particular replacement hip: on a per capita basis, more innovative hips manufactured by DePuy were implanted in Ireland than in any other country. Such is the scale of the problem that in excess of 1,000 Irish patients have issued proceedings against DePuy.
In contrast with new drugs, medical devices are often not screened by way of clinical trials before market approval. This is partly to do with how they work, but also to a regulatory framework that is, arguably, still unfit for purpose. Unlike for medication, regulation is a national competence rather than a European one which has been a factor in allowing an uneven and sometimes lax approval regime across the EU.
The regulator in the Republic is the Health Products Regulatory Agency(HPRA) and more than 800 adverse incidents involving medical devices are reported to it each year. But no deaths have been definitively found to be directly attributable to a medical device over recent years, the HPRA says.
Innovative implantable medical devices have transformed the lives of patients, especially those with chronic disease. Stents have revolutionised cardiac care, while insulin pumps and pain-management devices have brought relief to many. And the pace of innovation is accelerating.
Medical devices are a major industry in Ireland. Medical devices account for almost 10 per cent of all Irish exports and Ireland comes second to Germanyas the largest European exporter of such devices. The industry employs some 38,000 people, mainly in the west of Ireland.
This pre-eminent position should be used by Ireland to drive regulatory reform. Doctors and patients require access to up-to-date databases on individual devices so that they can form a reliable opinion as to the risks and benefits of choosing a particular implant.
An equivalent regulatory body to the European Medicines Agency must be set up. And the practice of approving devices for human implantation without adequate risk assessment must end.
https://www.irishtimes.com/opinion/editorial/the-irish-times-view-on-medical-implants-the-regulatory-gap-must-be-fixed-1.3711093
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Campaign group responds to AdvaMed over Implant Files
Nov 27, 2018 | Medical Plastics News
By Reece Armstrong
The global investigation, led by the International Consortium of Investigative Journalists (ICIJ), looks into the lax regulations surrounding medical devices. In particular, it states that over a 10-year period medical devices in the US have been related to 83,000 deaths and more than 1.7 million injuries.
The investigation also revealed that medical device company Johnson & Johnson has alone paid out $4.3 billion to US patients who claim they were injured by defective hip implants, mesh and surgical staplers.
Now AdvaMed, a trade association group with members including Johnson & Johnson and Medtronic has responded to the investigation.
"One of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care.
“Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide.
"We should never discount any patient's experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.
“As we do that work, we recognise why we developed these technologies in the first place: to address the critical, debilitating, and often life-threatening needs of patients who are desperate for solutions—who need a miracle,” the company said in a statement.
Medical Plastics News contacted campaign group Sling the Mesh for a response to AdvaMed’s statement. Sling the Mesh has been a staunch advocate for better regulations surrounding medical devices, campaigning for improved guidelines for vaginal mesh implants. The group includes over 7,000 global members suffering from both pelvic and hernia mesh complications.
In a response to AdvaMed’s statement, the group said: “The Implant Files have not magnified stories of a few individuals, they have merely dipped a toe in an ocean of people suffering from medical devices that were allowed on to the market with barely any clinical trials and no long-term independent data bases to track problems. Complications only come to light following media campaigns and the tireless work of patient safety campaigners.”
https://www.medicalplasticsnews.com/news/campaign-group-responds-to-advamed-s-implant-files-statement/
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Under the skin of ICIJ’s Implant Files
Nov 26, 2018 | Columbia Journalism Review
By Jon Allsop
In 2014, Jet Schouten and her colleagues at AVROTROS, a public broadcaster in the Netherlands, embarked on an intricate undercover operation. Their aim was to show how easy it can be to get medical devices onto the market in Europe, and, consequently, inside patients’ bodies. Schouten came up with a fake product, made from the netting used to hold mandarin oranges at the grocery store. She claimed it was a vaginal mesh used to enforce weakened tissue in the pelvic area.
Working with a professor from the University of Oxford, Schouten and her team compiled a bogus dossier on their “mesh,” copied, in large part, from information they found on the internet. They argued, as many manufacturers have done in real life, that their device should be approved by regulators because of its similarity to existing, approved devices. Even if their mandarin net had been a real vaginal mesh, this claim would have been disingenuous—the “similar” devices they referenced had all been publicly flagged as having safety issues, and one of them was not a vaginal mesh at all. Schouten and her team booby trapped their dossier with massive (and made-up) safety risks: attesting, for example, that one in three women using the device would sustain serious, permanent injuries.
Schouten then submitted the application to regulators. In Europe, devices are not approved by government agencies but by private “notified bodies.” Rather than being regulated like drugs, they qualify for the same, looser safety certifications as commercial products like teddy bears and toasters. The notified bodies draw revenue from manufacturers, including medical device-makers, who typically want their products approved at the lowest cost to them and with as little delay as possible. “I started negotiating with them. I told them, ‘I want this price and I want it tomorrow,’” Schouten remembers telling the notified bodies she approached, all of which, she says, were reputable. When they haggled back, she would reply, “I have a different notified body and they gave me a better price. Why should I choose you?”
In the end, not one of the notified bodies Schouten approached questioned her product’s alarming safety data. “They didn’t ask us one question about the product, they didn’t even want to see the product,” she says. The regulators only pointed out a few fixable “non-conformities” in their dossier; for example, that they hadn’t translated information into the required number of languages. The only major stumbling block the team met was that it had not, as is legally required, submitted to a factory inspection. “We’re journalists, we didn’t have a real factory,” Schouten says.
The story, not surprisingly, attracted widespread attention. After it won an award for investigative journalism in the Netherlands and Belgium in 2015, Schouten received a congratulatory email from Joop Bouma, a veteran Dutch newspaper reporter. (“When I started in journalism, I always used to clip out articles,” Schouten says. “I kept them in a binder, and then at some moment in time, I was like, these are all from Joop Bouma!”) Bouma is a member of the International Consortium of Investigative Journalists, or ICIJ, the global network of reporters and news organizations that burst into the limelight with its work, in 2016, on the Panama Papers.
“We’re journalists, we didn’t have a real factory.”
After getting in touch over email, Bouma and Schouten went hiking and talked about the potential for a global look at the medical devices industry. Bouma said he would take the idea to Gerard Ryle, ICIJ’s director. Ryle was interested. Schouten submitted a written proposal, then drudged through months of research to prove the story had enough merit to proceed. Finally, in November 2017, ICIJ gave the green light, and began to marshal more than 250 reporters across 59 news organizations and 36 countries for the biggest-ever investigation into an industry responsible for the life or death of millions of people around the world. Yesterday, its partners began a coordinated, worldwide drop of their findings.
Medical devices—like vaginal meshes, pacemakers, and breast implants—make up a $400 billion worldwide industry. Devices often don’t undergo rigorous clinical testing: sometimes they’re tested on animals like sheep or baboons, other times patients themselves are the guinea pigs without ever knowing it. Device makers, too, have long evaded serious scrutiny, even as many of their products have been found to be faulty. ICIJ found manufacturers have paid out at least $1.6 billion to settle charges of corruption, fraud, and other regulatory violations over the past decade. Johnson & Johnson alone spent even more than that compensating patients. And Medtronic, the biggest company in the world that makes devices only, has faced serious allegations on four continents, including fraud and price gouging (it denies wrongdoing).
The dangers with these products often aren’t reported to regulators; even when they are, there’s no coherent international system to alert doctors and patients to potential problems. A globalized medical industry works in their favor. Faulty devices often stay inside patients—and on the market—in one country long after another has seen fit to withdraw them. While the US has better safeguards, and makes more data available, than other countries, its system is still severely flawed. A Food and Drug Administration (FDA) database that tracks suspected problems with devices—including, prominently, insulin pumps, hip implants, and spinal cord stimulators—is clunky for patients to use and far from comprehensive, effectively allowing industry players to mark their own homework.
ICIJ found more than 1.7 million injuries and 83,000 deaths potentially linked to devices since 2008. “I started this project because I wanted to create an awareness that medical devices are not only a problem in this country or in that country. Devices go global,” Schouten says. “What journalists do is they check, what are the stories in my country?” In mid-October, Schouten watched on in a darkened black-box studio in Hilversum, a media hub southeast of Amsterdam, as her colleague, Antoinette Hertsenberg, filmed segments for a documentary that will air tonight as part of the Dutch contribution to the ICIJ effort (Bouma’s newspaper, Trouw, is also involved). Hertsenberg was explaining grim statistics as they flashed, in the bright font of a spy movie, across a gossamer screen in front of her.
Schouten sat the other side of the screen, checking data on her laptop. She was dressed in neat leather shoes, dark jeans, and a knitted sweater worn under a baggy black blazer, her cropped hair curling just above the collar. Before getting into TV, Schouten worked in radio. Before that, she was an academic, co-writing a book about the theological underpinnings of the work ethic.
While ICIJ brass pulled the strings of the global project from Washington, Schouten remained its beating heart. She took frequent calls from partners around the world, talking them through problems that frequently had nothing to do with her own slice of the project. “I find it very impressive that at the origin of this investigation, this enormous machine, was one extremely determined journalist who wanted to inform patients,” says Stéphane Horel, a journalist with Le Monde who worked on the project’s French chapter.
For the past five months, CJR embedded inside ICIJ’s investigation: listening in on conference calls, spending time with Schouten in the Netherlands, and talking regularly with ICIJ staffers and partners in 10 other countries, from Canada to Lebanon. The result is a picture of a massive journalistic collaboration—a critical new muscle for journalists everywhere. CJR heard repeatedly that the project ran amazingly smoothly given its size and international scale, which added reportorial and data-crunching muscle, then lent a megaphone to the findings.
When ICIJ published the Panama Papers in 2016, its collaborative model seemed like a bold departure from the old logic of fierce competition. Two years later, pooling resources across organizations no longer feels so novel. News organizations the world over are struggling financially; many have folded, those that survive often have such slender resources that ambitious investigative work is beyond their means. In the Trump era, meanwhile, some outlets, especially in the US, have started to see each other less as rivals and more as allies in the face of vicious rhetoric attacking the media as a whole. ICIJ’s success with the Panama Papers—not to mention its Pulitzer Prize for the work—no doubt fueled this trend, too.
The devices project nevertheless was a departure, and a risk, for the group. ICIJ gained global renown and increased the scale of its operations through its work on leaks. This was its first large-scale project since then based on public records and shoe-leather reporting. (The project was also, possibly, the biggest ever journalistic collaboration of this type, period.) The group will now have to watch to see if a consumer affairs story, albeit one highlighting the deaths of patients, can land with the same impact as the scandalous secret dealings of the world’s super-rich, a particularly tough ask in a hyper-charged news cycle dominated by US politics.
When ICIJ published the Panama Papers in 2016, its collaborative model seemed like a bold departure from the old logic of fierce competition.
“The draw that the leak cachet has can be enormous. This time, we’re in a world without that automatic entitlement to the reader’s attention—because we’re bringing them something that had been kept secret from them,” says Simon Bowers, who coordinates ICIJ’s European partners from London. “We’ll see how that goes. It’s obviously a harder thing to say, Well why exactly are you doing this now? It’s a leap of faith.”
The offshore leaks did not fall into ICIJ’s lap in finished form: it took immense effort to make them searchable for partners in an easy, and secure, way. But those projects did, in a sense, have a headstart compared to the devices story—not only did the leaks have inherent news value, but reporters knew the data they needed was inside waiting to be unlocked. The devices story, by contrast, had to be stitched together from what one ICIJ staffer called a “patchwork quilt” of inconsistent public records. “We had 13 million documents for the Paradise Papers,” says Ryle, ICIJ’s director, of the organization’s second big offshore investigation. “It’s much easier to convince media partners to do a story like that than to say, We have a working theory here, but we need documents, we’ll try and find them.”
It took more than six months of preliminary digging before ICIJ approved the devices project. The task for Schouten was to show that the story was truly global—with problems in different countries linked by a single failing system. Once ICIJ decided to go ahead, the project picked outlets from more than 30 countries.
Some of the same organizations that worked on the offshore leaks bought in again, including The Guardian in the UK, Le Monde in France, and Süddeutsche Zeitung in Germany. The Associated Press expressed interest at the instigation of Michael Hudson, its new investigative editor who had, until recently, worked for ICIJ; ICIJ reciprocated, in part, because of the AP’s strong record of reporting on the FDA. NBC News, too, was invited to join after approaching ICIJ. The New York Times, which did not participate in the Panama Papers but did participate in the Paradise Papers, was not involved this time. (While ICIJ has a collaborative model, once it invites a major partner into a project it often avoids inviting a direct competitor from the same country.)
In April, ICIJ hosted partners from around the world in Washington, DC, to workshop story ideas and set a timetable for the project. The summit was an overwhelming moment for Schouten. “I saw this whole group finally all in one room,” she says. “I understood that it’s going to really happen, that now there are over 200 journalists.”
On a conference call in mid-September, Fergus Shiel, project manager at ICIJ, scratched into a notepad on the table in front of him. Behind him, someone had scribbled a list of countries on a whiteboard: the UK, France, the Netherlands, Sweden, Denmark, Andorra, China, Croatia, Latvia, Malaysia, Singapore, and the UAE (and those were just the legible ones). Slightly higher up, tacked to a wall, was a postcard depicting a cartoon cat and a message: “Keep calm and be cool.”
After starting his career in Ireland working for local newspapers, Shiel moved to Sydney, Australia, where he balanced journalism work with side hustles, ushering at a movie theater and working in construction. He spent more than 20 years with The Age, a daily in Melbourne, editing its tablet edition before joining ICIJ last year and relocating to DC in March.
The devices project was Shiel’s first with ICIJ. He acted, in part, as its institutional memory, flagging trends and links in the global story and connecting reporters around them. He was also chief troubleshooter. “We have meetings where it’s 5am in one place and 10pm in another, neither of which is conducive to clarity of thought, really,” Shiel says. “That’s one thing. The second thing is language. There’s also cultural differences… Then there’s libel law. So, for instance, you can say things in America which you can’t say in Europe, and certainly can’t say in Australia or Ireland, without being sued.” (Shiel was not the project’s lawyer, but he did help ensure that stories could float both in Europe, where powerful people and companies can injunct reporting they don’t like, and the US, where they cannot.)
ICIJ communicated with partners on the project on regular conference calls, which partners used to share findings and joint reporting opportunities, and pep colleagues up at moments of low morale. A lot of reporting action, meanwhile, happened on the iHub—a byzantine, encrypted portal where partners could ask each other questions and upload new findings. Some participants were overwhelmed by the sheer density of information on the iHub; they compared it, variously, to a bazaar, a runaway New Yorker subscription, and a train you chase as it’s leaving the station. “It’s all there—anytime, anyone can log on and read up on Finland or Germany,” said Matthew Perrone, the AP’s FDA reporter, in June, plucking two random countries out of the air. “You see the great work other people are doing and you’re like, I gotta go find something. It’s like a fire under you.”
Rather than enforce frequent deadlines, ICIJ insisted that just two dates be set in stone: October 12, when reporters could start to seek comment from industry and regulators (preferably through ICIJ), and November 25, when findings would start to roll out simultaneously to heighten the project’s impact. These dates were set at the April project meeting in Washington; since then, partners in several other countries have joined the project, while a few have fallen by the wayside.
“You see the great work other people are doing. It’s like a fire under you.”
While partners worked on their own stories independently, ICIJ, in the words of one staffer, acted like a “wire service”—preparing its own package, including an overview story, for distribution to, and republication by, partners. Every word was checked, every stat verified. At any news organization, that can be a tense process. At ICIJ, keeping stories alive and interesting amid a thicket of technicalities provoked especially lively debate. “To try and wrangle the overview, the global perspective on the device industry, into a shape that is digestible, that is evocative, readable, that is entirely accurate, that does justice to the complexity of the issue… has been extremely, extremely hard,” Shiel says.
For the project to work, reporters in as many countries as possible needed to show how manufacturers get their devices to the market, how they handle reported device flaws (or don’t) once they get there, and how devices get recalled and/or withdrawn from the market. Throughout the project, reporters in Europe found it difficult to get their hands on data related to every part of this process. And if the Europeans had a hard time getting data, partners in Latin America, Asia, and the Middle East often found it all-but impossible.
Europe is a regulatory hub for the devices industry, and the continent exports much of the lax oversight that Schouten exposed in her mandarin net story: manufacturers in other parts of the world, seeing Europe as a soft touch, have been known to test out high-risk products, in particular, on the continent, then seek approval there. If they’re successful, they can return to their home regulators with a European safety certification, which can make local approval easier.
The European Commission, which is the policy arm of the European Union, is notoriously opaque and bureaucratic; “It’s like Fort Knox,” Schouten says. European partners thus had to ask national-level governments for data on a continent-wide system. Some countries (Norway, for example) were more forthcoming than others. Schouten says Dutch authorities denied one of her requests, citing European privacy rules, only for the French government to hand the same data over to her colleagues. Since notified bodies are private, meanwhile, a lot of information about the device approval process lies beyond the scope of freedom of information laws.
“We did FOI the world, basically.”
In the US, reports of suspected problems with devices, known as adverse event reports, are made publicly available through the FDA’s MAUDE database (MAUDE stands for Manufacturer and User Facility Device Experience). Since MAUDE’s public interface only allows users to view 500 reports at a time, ICIJ needed access to a more complete set of data. A team led by Emilia Diaz-Struck, ICIJ’s data editor, found a backdoor on the FDA’s website with over 5 million records stuffed behind it.
Each record consists of a checklist, which manufacturers are supposed to use to report basic information, as well as space for a more detailed description of the suspected problem. To complicate matters, the checklist and description sometimes contradict each other; the latter, for example, might detail a death that the manufacturer neglected to flag on the checklist. Sometimes, descriptions contain awkward synonyms—“expired” instead of “died,” for example—that make them hard to scan for keywords. Common variations in device and company names, as well as routine spelling mistakes, are a hazard, too: Diaz-Struck found more than 180 differing references to one type of heart device in the data, for example. In addition to cleaning up the reports, ICIJ’s data team wrote a computer program to crawl through the prose descriptions for hidden nuggets.
They also created two user-friendly interfaces to help partners search the FDA database (which mostly contains US records but also has some international data) for information relevant to their reporting. (“We like to work with great journalists, but we don’t require them to be data journalists,” Diaz-Struck says.) Diaz-Struck and her team also built an ambitious database for the public, showing which devices have been recalled in a given country, and, crucially, which have not been, despite being withdrawn elsewhere.
To build the public database, Diaz-Struck and her team stitched together patchy and disparate recall data from many different countries, all of which store the information differently and make differing amounts of it public. “We did FOI the world, basically,” Diaz-Struck jokes. In Mexico alone, reporters submitted more than 900 freedom of information requests. In response, authorities yielded information on only two recalls. When data was forthcoming, it was often vague—sometimes lacking key information like a manufacturer or device name, or even the level of risk associated with a product. And because devices currently lack unique identifier numbers that stay the same across borders, matching one country’s recalls to another’s was tough.
Though they got there in the end, work on the database continues: it currently contains data from 11 countries, a number ICIJ hopes will eventually be closer to 40. Even then, the database won’t be anywhere near comprehensive. Over 80 percent of the world’s countries will not be in it at all. And the device industry is plagued by the problem of under-reporting, meaning that some red flags simply never come to the public’s attention. “No one can say precisely how many people are injured, maimed or killed by these devices around the world,” says Shiel in an email. “Not regulators. Not manufacturers. No one.”
ICIJ was founded in 1997 by Charles Lewis, an American investigative journalist who previously founded the Center for Public Integrity in the late 1980s. ICIJ was initially a project of the Center, but disentangled itself last year after outgrowing it. At the time, Poynterreported that pressure on ICIJ to lay off staffers, despite its recent success and rapidly rising profile, was a key impetus for the split, with ICIJ keen to solicit and set its own funding. (Both the Center and ICIJ are non-profits.)
In its 21 years of existence, ICIJ has always sought to tackle problems that cross borders, especially those exacerbated by globalization, like tobacco smuggling and climate change. In recent years, the group has become synonymous with investigations into global tax evasion and avoidance. In April 2016, it dropped the Panama Papers, which drew on a massive leak from inside Mossack Fonseca, a secretive Panamanian law firm, to expose the tax affairs of a posse of world leaders and their associates. Tax authorities the world over pledged to clean house, and the Icelandic prime minister, who appeared in them, stepped aside amid a public outcry. In 2017, ICIJ won a Pulitzer Prize for the story. This year, Netflix optioned a movie about it, with Steven Soderbergh in the director’s chair and Meryl Streep, Gary Oldman, and Antonio Banderas lined up to star.
Just over a year ago, ICIJ followed up the Panama Papers with the Paradise Papers, a second offshore leak, this time mostly from inside a different firm, Appleby. While the Paradise Papers implicated further high-profile individuals—from US Commerce Secretary Wilbur Ross to members of the British royal family—the stories landed with less immediate impact. As CJR wrote at the time, however, the project nevertheless was important. By proving the Panama Papers were not a one-off, ICIJ showed users of offshore tax structures that they can no longer take secrecy for granted, and would-be whistleblowers that they can leak masses of sensitive data without getting caught.
ICIJ has not abandoned the offshore beat. “If we had had another Panama Papers that was going to be as good or possibly even better than the previous one, of course we’d have done that. The reality is, we don’t,” Ryle, its director, says. Nonetheless, its pivot to medical devices was a conscious departure. As senior reporter Chavkin puts it, “We wanted to show that we are a leading global investigative newsroom and we can do great stories whether or not someone gives us documents. One reason that we’re sustainable at ICIJ is because we can do different kinds of stories… in terms of subject matter and… in terms of reporting process.”
Chavkin says a previous ICIJ investigation he worked on, examining how projects funded by the World Bank displaced millions of the world’s poorest people, was a template of sorts for the devices project (the World Bank story was published in 2015, but Chavkin still sometimes posts updates). The devices story, however, has involved many more partners than its antecedent—making it a test of ICIJ’s ability to scale up a project based on shoe-leather reporting and public records.
The devices project has a different texture from much of ICIJ’s past work in more ways than just its sourcing. As Shiel puts it, “There’s an appreciation that, broadly speaking, the offshore industry is, if not illegal, at least unethical. But with the medical device industry it’s quite different because the truth is the medical device industry saves a lot of people’s lives, it makes a lot of people’s lives better.”
“One reason that we’re sustainable at ICIJ is because we can do different kinds of stories.”
According to Shiel, a reporter working on the project in the US now needs a medical device himself after he was knocked off his bike at an intersection a few weeks ago; two partners in Europe, meanwhile, suffered heart problems and may also require them. “This is one of the things about the medical device industry: even the reporters who are reporting on the industry as we speak are, in some instances, actively requiring a medical device,” Shiel says. “The universality of the devices and their importance to people has been…” He pauses. “We’ve lived it. It’s an odd thing. When you start focusing on devices you see how ubiquitous they are and how important they are.”
Even before ICIJ began to seek comment on its story, regulators and industry figures got wind that an impending bombshell was about to hit. Some have acted in advance of publication to soften the landing. Last week, DC lobbyists with the trade association AdvaMed hit back, accusing ICIJ of distorting the facts around medical devices—many of which are perfectly safe—and of using its model of coordinated worldwide publication to stoke panic among patients. (In a statement yesterday, AdvaMed said ICIJ’s stories “counterfeit” implants’ life-changing potential.)
ICIJ is clear it won’t disburse medical advice to patients who come to them with worries: before readers can access its public database, they have to read a disclaimer advising them to contact their doctors with questions. Nonetheless, “there’s just a real lack of information and knowledge about medical implants and their safety out there… People don’t know how their devices are tested, they don’t know how they’re approved,” says Ben Hallman, ICIJ’s lead reporter. “If the takeaway from this, from a patient perspective, is they simply know to ask more questions than they would otherwise, I think that’s a pretty good result.”
The leaked databases behind the Panama and Paradise Papers projects were, in a sense, democratic; any reporter anywhere in the world could search them for prominent local figures they suspected might be squirreling cash offshore. The devices project, by contrast, centered more on Europe and North America: By one estimate, between a third and a half of the reporters working on the project were in Europe.
The devices project exposes how decisions made in the developed world have a knock-on effect in poorer countries. In particular, while devices move around the world, no similarly global system has emerged for reporting problems with, or recalling, faulty devices, then communicating adequate safety information to doctors and patients. “The developing country aspect of this story is interesting because Europe and the US have a bigger responsibility, not just that the system has to be fixed for their own people, but for the rest of the world that is relying on them,” says Scilla Alecci, who oversaw the project’s Asian partners out of Washington.
While past reporting, by Schouten and many others, has raised awareness in Europe and the US, ICIJ’s investigation has broken fresh ground in parts of the world where the industry had, until now, escaped scrutiny. “In India, this is virginal territory,” says Ritu Sarin, investigations editor at The Indian Express.
“Even the reporters who are reporting on the industry are, in some instances, actively requiring a medical device.”
Working with reporters and news organizations in less economically developed countries—and countries that lack a free media—leads to unavoidable disparities in the output different partners can produce. Andras Petho, one of the last crusading reporters left in Viktor Orbán’s Hungary, told CJR in August that he was struggling to contribute to the project as his access to official information was so poor. “I was hoping that this was going to be different,” he said. “But the relationship between the government, the state agencies, and the remaining independent media has deteriorated to such a low level that even pursuing a story like this—which is not about oligarchs, it’s not about politics—we cannot really get help or cooperation.”
Rather than lean on challenged outlets, ICIJ seeks to lift all boats, lending them reporting resources and investigative capacity beyond their usual means. While Petho did finally get hold of some Hungarian data in October, he says his story was considerably strengthened by his ability to tap into partners’ research.
Alia Ibrahim, a co-founder of Lebanese news website Daraj, had a similar experience. “We have access to the international information and then add local reporting, looking for cases, looking for human stories. But the big chunk of the work—when it comes to validating the argument, the hypothesis, all that—is already done,” she says.
Daraj’s site launched on November 3, 2017; two days later, it was part of the global drop of the Paradise Papers. Ibrahim says Daraj was the only Arabic-language publisher on that project (this time it’s working with organizations in Tunisia and Jordan). When the son-in-law of the speaker of Lebanon’s Parliament sued Daraj in the wake of the Paradise Papers, Ibrahim felt ICIJ had her back (in any case, a judge threw the suit out). “Being part of an international investigation, we can kind of just—quote, unquote—‘blame’ it on the bigger organization. It gives us a unity we really need,” she says. “This is not a minor detail for us.”
“In India, this is virginal territory.”
Differing accountability climates worldwide mean partners have different expectations about what impact their work might have. While Ibrahim says many partners around the world were “waiting for the earthquakes that are going to happen once they publish,” in Lebanon, by contrast, “I could give you 100 examples of how investigations proving corruption, proving malpractice, didn’t lead to anybody being held accountable.”
In the US and Europe, the project has already started to have impact: FDA Commissioner Scott Gottlieb instantly promised a substantial overhaul of the device approval process, while doctors’ groups and government agencies in France, Spain, and the Netherlands issued new recommendations, for example around breast implant safety. Wherever in the world partners are based, however, they are all reporting on a giant global system with giant global flaws. It is, obviously, unrealistic to expect that system to disintegrate, or to right itself, at all—let alone overnight.
With that in mind, partners all over the world do not see this week as the end—or even the beginning of the end—of the devices project, but rather as a milestone on a longer journey. While some partners extracted whistleblower testimony, the project was built mostly from publicly available information. Now that the story is out in the world, Ryle hopes it will catch the eye of well-intentioned industry insiders with secrets to share, thus propelling further reporting. Besides, he says “we’ve educated a whole bunch of journalists on a new topic.”
Back in the black-box studio in Hilversum in mid-October, Schouten watched on as Hertsenberg, her colleague, interviewed Madris Tomes, an American expert on the medical devices industry. Tomes worked as an analyst at the FDA before leaving to found a company, Device Events, that scrapes the FDA’s database and repackages it into a more robust and user-friendly interface. While ICIJ’s French and German partners filmed interviews with Tomes at her home in Pennsylvania and in Washington, DC, respectively, Schouten’s team flew her to Europe so she could use its high-tech projection screen. “I think she is the only one outside the FDA who really understands the data, who really understands how to connect the dots,” Schouten says. “There are only a few worldwide who are really aware of it.”
As Tomes and Hertsenberg filmed a series of segments on a wide variety of topics related to the global devices landscape, graphics—from bar charts to human avatars, implants throbbing red under their skin—appeared on the projection screen in front of them. Tomes explained how weird synonyms for death, such as “expired,” make FDA data harder to analyze. She then talked through summary reporting, or an old process whereby US regulators would only count each individual report of potential problems with a device, even though each report might contain many separate incidents.
Hertsenberg kept interrogating Tomes’s US-specific knowledge for her Dutch viewers, asking, for example, whether certain US rules should be replicated in the Netherlands. At one point, off camera, Hertsenberg and Schouten asked Tomes to contextualize a local finding about vagus nerve stimulators, which are commonly used to regulate seizures in epileptic patients. Tomes could not, off-hand, so she logged into her Device Events system to search for stats on the devices. Tomes came back with a 40 percent rate of reported potential problems in FDA data.
Taking the devices project global hasn’t just enabled Schouten to inform patients beyond Dutch shores of the unknown risks they run when they put implants in their bodies. It’s given her—and hundreds of reporters who previously knew little to nothing about the devices industry—an in-depth understanding of a global system that lurks in the shadows while compromising public safety; an understanding that most doctors lack.
Working with ICIJ has also exposed Schouten to a worldwide community of investigative reporters who make routine work of exceptional journalistic collaborations. “You have all these people who are completely obsessed,” she says. “They’re completely driven, they’re very, very talented. They’re maniacs. I love that. You never have to explain why you don’t watch Netflix.”
https://www.cjr.org/special_report/behind_the_scenes_icij_implant_files.php/
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Concerns raised following media probe into medical implants
Nov 26, 2018 | Medical Plastics News
An investigation from 58 media organisations including BBC Panorama, International Consortium of Investigative Journalists, The Guardian and the British Medical Journal has led to calls in changes of the rules regarding implants.
The investigation was prompted by a Dutch investigative journalist and broadcaster, Jet Schouten, who led a sting operation by convincing notified bodies that mesh netting from a bag of mandarin oranges was in fact surgical mesh. Schouten said that the results made her want an investigation into device approval around the world.
Some of the key findings of the investigation include governments allowing products on the market with little or no human testing that went on to cause great harm; devices that have been pulled off the market over safety concerns in some countries, but which remain on sale in others. Other findings include the device industry and regulators’ struggle to quickly identify hazardous implants after they are released; while manufacturers, doctors and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade; and some of the highest profile controversies involve products marketed to women including: contraceptive coils, vaginal mesh, and breast implants.
“The Implant Files” have revealed that one company alone, Johnson & Johnson, has paid out $4.3 billion to people in the U.S. who claim they were injured by defective hips, mesh and surgical staplers.
The Guardian’s report on hip-on-hip replacements revealed that faulty implants caused tissue damage for patients as a result of two different procedures. One was a total hip replacement, where a metal ball and stem were attached to the thigh bone, and a metal cup attached to the pelvis. 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.
As a result of the revelations, the Royal College of Surgeons has called for changes to regulation.
Its president Derek Alderson said: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long term.”
The BBC reports that the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) said the regulatory system had been in place for 25 years.
It said: "The need to protect public health, whilst not stifling innovation, must be carefully balanced. The MHRA welcomes innovative medical devices that can bring huge health benefits to people as long as this doesn't compromise patient safety.
A spokesperson from the Department of Health and Social Care said: "We will work with the regulator to see what future changes may be required.”
https://www.medicalplasticsnews.com/news/concerns-raised-following-media-probe-into-medical-implants/
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Investigative Report Casts a Troubling Light on the Medical Device Industry
Nov 26, 2018 | Medical Device and Diagnostics Industry
By Amanda Pedersen
The consumer media has not been kind to the medical device industry this year. A consortium of journalists released an investigative report on the industry over the weekend that blames poorly regulated medical devices for millions of patient injuries and thousands of deaths. The report, which is based on a year-long investigation by the International Consortium of Investigative Journalists (ICIJ), is the latest in a series of scathing reviews that have highlighted the darker side of medtech.
According to the ICIJ report, more than 1.7 million injuries and nearly 83,000 deaths linked to medical devices have been reported to FDA over the last decade. The journalists also point out that medical devices pulled off the market in some countries over safety concerns remain for sale in other countries.
The authors wrote that "medical implants sicken, maim and sometimes kill the very people they were designed to help," and that health authorities across the globe have failed to protect millions of patients from "poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm."
One of the industry's leading trade association has already pushed back against the ICIJ report, arguing that it fails to look at both the challenges and the accomplishments of the industry.
“We should never discount any patient's experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others," AdvaMed said in a statement issued as a response to the ICIJ report. "We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery."
The organization reiterated the reason medical device companies develop these technologies in the first place, which is to develop solutions to critical needs of patients who are often desperate for solutions.
Dubbed the Implant Files, the investigation included a team of more than 250 reporters and data specialists from 58 news organizations in 36 countries. These journalists examined hundreds of cases of medical device-related injuries and deaths from all over the world. The inquiry builds on reporting in the Netherlands by Jet Schouten, an investigative journalist for Dutch Public Broadcasting, who was part of the international team.
This is certainly not the first group to shed a troubling light on the medical device industry this year.
In May, a 60 Minutes segment brought unwanted attention to transvaginal mesh devices with a particularly harsh focus on Boston Scientific (the company spoke out about the controversial story in an interview with MD+DI soon after the report aired). The report claimed that the company made transvaginal mesh devices using counterfeit materials smuggled from China.
Boston Scientific denied any wrongdoing and received support from surgeons as well as the American Urogynecologic Society. These products, which tend to get lumped together as "pelvic mesh," are designed to treat women who suffer from pelvic organ prolapse or stress urinary incontinence. The implants are made with polypropylene resin, which has previously been linked to some patient complications. A month after the 60 Minutes report aired, a Massachusetts jury backed Boston Scientific in a product liability case involving two of the company's transvaginal mesh devices.
The next big blow to the medical device industry came in July following the Netflix release of The Bleeding Edge documentary, which offers a poignant look at specific medical device categories that have adversely impacted patients. MD+DI interviewed the filmmakers and published several pieces on the documentary, including a slideshow of the film's most powerful moments, an op-ed from a biomedical engineering expert, and a story based on reader feedback about the film.
One of the most controversial products highlighted in The Bleeding Edge is Bayer's Essure birth control system, which has been the subject of nearly 30,000 adverse event reports to FDA and thousands of patient lawsuits. Bayer announced in July that it would stop selling the Essure system in the United States at the end of the year, citing a decline in U.S. sales of the device and the conclusion that the Essure business is no longer sustainable. The company insisted that the decision to discontinue the product is for business reasons only, "not for any safety or efficacy concerns about Essure."
https://www.mddionline.com/investigative-report-casts-troubling-light-medical-device-industry
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Faulty medical implants: who is at risk?
Nov 26, 2018 | The Week
Faulty medical implants have caused the deaths of more than 1,000 people in just three years, a global investigation has found.
Between 2015 and 2018, UK regulators alone received 62,000 “adverse incident” reports linked to components including pacemakers, artificial hips, breast implants and contraceptives.
A third of the incidents “had serious repercussions for the patient, and 1,004 resulted in death”, reports The Guardian.
The new research into the dangers associated with the global $400bn (£310bn) industry was conducted by the International Consortium of Investigative Journalists (ICIJ), and involved more than 250 reporters in 36 countries.
The investigation “found a lax system of regulation in Europe that allows companies to ‘shop around’ dozens of safety organisations until one of them approves their product”, says the BBC.
It also found that “doctors can be left in the dark about the true risk of treatments they are recommending to their patients”, the news site adds.Who has been affected?
The Guardian says that examples of failure in the implant market include “replacement hips and vaginal mesh products sold to hospitals without any clinical trials; patients relying on faulty pacemakers when manufacturers were aware of problems; complications with hernia mesh that ruled one of Britain’s top athletes out of competing for years; and regulators approving spinal disc replacements that later disintegrated and migrated in patients”.
Among the many other instances, patients were given birth control implants that caused internal damage and bleeding; mesh implants for incontinence caused abdominal pain in some patients; and implanted defibrillators were also reported to misfire.
A panel of experts put together by the ICIJ is advising anyone with implants who may be concerned to seek help, adding: “Your first point of call should be the medical team that performed the operation. If you cannot go back to them for whatever reason, you should consult your primary care doctor.
“The doctor should be able to refer you to a specialist who is familiar with the device and the surgery you had.”What is the medical community saying?
The British Royal College of Surgeons (RCS) is calling for “drastic regulatory changes”. RSC president Professor Derek Alderson said: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”
Meanwhile, MedTech Europe, the body that represents the medical devices industry, said: “Millions of people have safely benefited from medical devices and can now live healthier, more productive and more independent lives.
“Life is unimaginable today without the hundreds of thousands of medical devices in our hospitals and in our homes.”
https://www.theweek.co.uk/98055/faulty-medical-implants-who-is-at-risk
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'People crying in the ward alone': Patients describe their experiences in Irish hospitals
Nov 26, 2018 | Thejournal.ie
By Michelle Hennessy
The majority of patients treated in Irish hospitals report good overall experiences, but a new survey has identified deficiencies in how healthcare staff communicate with people about their care.
The National Patient Experience Survey, led by the Health, Information and Quality Authority (Hiqa), ran for the second time in May this year. Over 13,000 people participated in the survey and the majority of patients (84%) said they had a good or very good overall experience in hospital.
In the survey 81% said they were always treated with respect and dignity in the emergency department and many of the comments described staff as helpful, friendly, professional and efficient.
Two areas that require improvement relate to waiting times in Emergency Departments before patients are admitted and the amount of access they have to doctors when they are in their wards.
The survey found 69% of people waited for more than six hours before being admitted to a ward. None of the 27 hospital Emergency Departments are meeting the six-hour waiting time target.
One patient in University Hospital Limerick said: “A&E is a complete zoo. Not enough beds and way too much pressure on staff.”
Another in St Vincent’s Hospital in Dublin said:I was on a trolley from my admission right through the night on a corridor until my operation the following day – I had to change from my clothes to a gown with no privacy. The staff were so busy that twice my drip was changed and not switched on, and only on both occasions a doctor saw me checking it – fixed it.
‘Frightening’
In the survey, 40% of people said they did not always have enough time to discuss their care and treatment with a doctor.
“The staff are so used to dealing with head injuries that they forget that this is all new and frightening to the patient and family. More empathy would make a big difference. They talk among themselves a lot,” one patient in Dublin’s Beaumont Hospital said.
Almost half of patients said they could not or could only to some extent find a member of hospital staff to talk to about their worries and fears.
Another patient in Beaumont said there should be someone on each ward to check in with patients to see how they are doing emotionally.I saw patients in [the] ward crying alone each evening.
Another said they had experienced a lot of kindness from staff and “whatever is wrong in the HSE it is not the doctors or nurses that are at fault”.36% said they were not or were only to some extent involved in enough decisions about their care and treatment.41% also said their families or people close to them did not have or only to some extent had sufficient opportunities to talk to a doctor.
Speaking at the launch of the report, Minister for Health Simon Harris said there is a “broader conversation that needs to happen in the Irish health service”.
He referenced recent examples like the vaginal mesh scandal, where patients did not feel they were given all of the information before their surgeries, or the Cervical Check scandal, where there were issues with “clarity regarding open disclosure”.
Harris said that in instances like these there was not adequate interaction between doctors and patients. He said this was not meant to be a criticism of doctors, but it is a sign that the relationship needs to change to ensure patients feel more empowered.So, I think we’re seeing is a continuation of that theme – patents don’t just want this kind of top-down discussion with medical professionals. They actually want a more engaging discussion.
Patient discharges
According to the survey, 38% of people said they were not adequately informed about the side effects of medication to watch for when they went home. And 40% said their family or home situation was not or was only to some extent taken into account when planning their discharge.
One patient at St Vincent’s Hospital in Dublin said: “You need to take into consideration a person’s age and living environment before sending them home. I’m nearly blind and live alone I was given no pain relief or advice on what to do. Why was I released with so much blood in my urine — not good enough.”
Another patients discharged from a hospital complained about having to make their own way out to meet their lift.
“Didn’t seem right as I was in pain and couldn’t even bend to tie my shoes.”
Minister Harris said he was delighted to see that there have been improvements from last year’s survey, but he recognised there is still room for improvement. He said his department is “determined to drive reform” and it is vital patients remain at the heart of that change”.
https://www.thejournal.ie/patient-experience-survey-2-4359873-Nov2018/
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