Preview Newsletter
Ethicon Media Monitoring 11/29/2018
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Manufacturer ‘KNEW vaginal mesh would leave women in agonising pain’ – but sold it anyway
Nov 28, 2018 | The Sun
By Andrea Downey
The manufacturer of a vaginal mesh implant was warned it could harden and shrink inside the body but launched it anyway, an investigation has revealed. -
Common law damages claim over vaginal mesh product to proceed to full hearing
Nov 28, 2018 | Scottish Legal News
A common law case brought by a woman who claims to have suffered “loss, injury and damage” as a result of medical treatment involving a vaginal mesh product will proceed to a full hearing despite the manufacturer’s attempts to have the action dismissed. -
13 DHBs no longer doing mesh surgery for incontinence
Nov 29, 2018 | Stuff.co.nz
By Cate Broughton
Thirteen out of 20 district health boards have scrapped controversial vaginal mesh surgeries. -
FDA recommends “modernizing” review of devices in wake of global investigation
Nov 27, 2018 | British Medical Journal
By Jeanne Lenzer
The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry. -
Medical devices probe uncovers need for “drastic regulatory changes”
Nov 28, 2018 | PMLive
By Gemma Jones
A report linking 83,000 deaths and 1.7m injuries to faulty medical devices was released this week, calling for radical reform of a “lax” regulatory system in Europe. -
Poole woman Lesley Elder in contempt of court bid
Nov 29, 2018 | Bournemouth Echo
By Faith Eckersall
Facebook posts shown in court are said to reveal that Lesley Elder was 'partying after midnight' and was photographed in a club with her daughter, wearing a sash and a straw hat.
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Manufacturer ‘KNEW vaginal mesh would leave women in agonising pain’ – but sold it anyway
Nov 28, 2018 | The Sun
By Andrea Downey
The manufacturer of a vaginal mesh implant was warned it could harden and shrink inside the body but launched it anyway, an investigation has revealed.
Despite alleged risks of excruciating pain to patients the Prolift implant was launched in 2005 and marketed for seven years.
Staff at Johnson & Johnson (J&J) were concerned the mesh implant would turn "hard as a rock" and shrivel like a "folded potato chip" inside patients, internal emails seen by The Guardian have revealed.
The documents are among hundreds submitted to a US court as part of a civil case brought by Suzanne Emmett from Pennsylvania - one of many who claim they suffered traumatic complications from the implant.
The Prolift was designed to treat pelvic floor prolapse, when the organs in the pelvis weaken and drop into the vagina.
It was reportedly launched in 2005 without approval by the US Food and Drugs Administration(FDA) and only received clearance three years later when the regulator was alerted to it being on the market.
At the time J&J claimed the implants were so similar to other vaginal mesh they didn't think they needed approval.
The company reportedly cannot confirm if the implant has the CE mark of approval - Europe's regulatory approval mark - due to "ongoing litigation".
Suzanne, 60, was given the implant in 2007 but claims several months later the mesh cut through her vagina.
Her husbands penis was scratched by the wire during sex, something he described as "like barbed wire".
Documents submitted to the court reveal J&J allegedly discussed the potential risks of the implant before launching it.
In a message dated May 2004, a product director at J&J’s Ethicon unit, which sold the implants, warned of the potential for the mesh to harden and fold, according to The Guardian.
The company also received correspondence from surgeons raising concerns about the device.
In 2005, months after the device was launched, Prof Linda Cardozo, from King’s College hospital in London, told a senior J&J manager that she found Prolift’s safety "quite worrying" and doctors had "no efficacy data to review".
"I still have major concerns regarding the erosion rate and possible problems with [sex becoming painful]," she wrote.
Documents also reference a study that followed 90 women who were given the implant between 2004 and 2006.
Their doctors reported an 18 per cent failure rate, the mesh had eroded into the vagina in nine per cent of women and some 13 per cent had "moderate or severe vaginal retraction".
In the largest trial of mesh and traditional surgery for prolapse, published in The Lancet, showed that about 30 per cent of women still had prolapse in the following year, for both procedures.
But there was higher complication rates in vaginal mesh surgery, with more than one in ten patients experiencing problems.
J&J withdrew Prolift from the market in 2012 after the FDA ordered further testing.
The company declined to comment to the Guardian about the documents in the civil case, but said in a statement: "We think it is inappropriate to litigate these issues in the media or for conclusions to be drawn based on references to selectively chosen documents taken out of context."
It's not the first time J&J have come under fire for it's vaginal mesh implants.
Last year a BBC Panorama investigation found Ethicon, owned by J&J, had failed to mention the implants had caused chronic pain in some women.
It also found that the mesh, marketed under the brand name Gynecare TVT (trans-vaginal tape) in the UK, had only been tested on 31 women and in sheep before being prescribed to patients.
The investigation formed part of a wider investigation involving 58 media organisations including the International Consortium of Investigative Journalists and the British Medical Journal, which revealed manufacturers of the implants didn’t carry out basic safety tests before selling them to the public.
The devices included breast implants, vaginal mesh, hip replacements and pacemakers.
https://www.thesun.co.uk/news/7846183/manufacturer-vaginal-mesh-pain-sold/
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Common law damages claim over vaginal mesh product to proceed to full hearing
Nov 28, 2018 | Scottish Legal News
A common law case brought by a woman who claims to have suffered “loss, injury and damage” as a result of medical treatment involving a vaginal mesh product will proceed to a full hearing despite the manufacturer’s attempts to have the action dismissed.
A judge in the Court of Session allowed a proof before answer after ruling that the pursuer, who alleges that the manufacturer breach its duty of care, had pled a relevant case.
Lord Boyd of Duncansby heard that the action brought by the pursuer “GR” against Greater Glasgow and Clyde Health Board and Johnson and Johnson Medical Limited was one of a large number of cases relating to vaginal mesh implants.
In four related actions heard by the same judge, AH v Greater Glasgow Health Board [2017] CSOH 57, two of the cases against Johnson & Johnson were based on an alleged breach of the Consumer Protection Act 1987 and a breach of their common law duty of care, but the common law case was subsequently dropped.
However, there remain a number of cases based only on an alleged breach of common law duty, and the judge allowed a legal debate in the present case on the issue of whether or not the pursuer had pled a relevant case at common law against the second defenders, and to give guidance on those cases which relied solely on the common law.
The court was told that the pursuer, 72, was referred by her GP to a consultant at the Southern General Hospital in Glasgow in 2002, having experienced long-standing problems with stress urinary incontinence (SUI) and urge incontinence.
Initial treatment involving physiotherapy and anticholinergic medicine did not assist and following surgery in 2003 she was advised to undergo a new procedure to address her SUI.
In February 2004 she underwent surgery involving insertion of a pelvic mesh product, which was a Gynecare TVT manufactured by the second defender and supplied by them to the Southern General.
But the pursuer claims that immediately after surgery she suffered in a number of ways.
The product is made from polypropylene, which the pursuer claims is “not a suitable substance” for a permanent prosthetic implant in the pelvic region because is “degrades over time” and causes “foreign body reactions”.
She raised an action alleging that the first defenders were “vicariously liable” for the acts and omissions of the doctor who carried out the surgery, and that the second defenders were “negligent” at common law for the injuries she suffered as a result, having failed in their duty to exercise “reasonable care” in the design, manufacture, marketing and supply of their products.
The pursuer claims that the second defenders failed to “adequately test” the TVT product before supplying, distributing marketing or promoting them in the UK, and that had she been made aware of the lack of testing and the number of complaints about the product, she would not have permitted it to be included in her surgical procedure.
Had the second defender not failed in their duty of care to the pursuer, she would not have suffered the loss, injury and damage.
On the issue of relevancy and specification, on behalf of the pursuer it was submitted that the common law case was very similar to the statutory case and proceeds on the same factual hypothesis.
At common law, a manufacturer has a duty to ensure that its product is safe for the intended use and will not cause “further” damage to the recipient or consumer of the product.
However, the second defenders argued that the pursuer could not rely upon a general duty of care, and must particularise the specific way in which it is said to have been breached, but the pleadings did not identify the way in which the TVT product was said to be defective.
It was argued that the pleadings also failed to address causation.
The pursuer failed to identify the respect in which the product was unsafe, by what means the second defenders in exercise of their duty of care could have eliminated the risk and how the duty was breached, it was submitted.
However, the judge ruled that the pursuer’s pleading were sufficient for a proof before answer.
In a written judgment, Lord Boyd said: “Where a manufacturer having developed, manufactured and put on the market a product which he intends should be used by an end user he has a duty to take reasonable care in the developing, manufacturing and marketing of the product not to cause injury to the user. The fact that the product in question is one which could only be used by means of invasive surgery does not alter the duty of care but emphasises its importance.
“In condescendence 4 the pursuer sets out something of the history of the use of synthetic mesh. I reject the submission that this is irrelevant as it does not relate to the actual product used in this case. As I understand these pleadings they relate to the use of polypropylene which the pursuer says is not a suitable substance for use in vaginal mesh products.
“The averments continue that the pelvic mesh products were placed on the market with little or no clinical data from randomised studies and that there was little evidence in relation to mid and long term safety and efficacy. She then particularises the injuries, conditions and complications suffered due to Gynecare TVT insertion with a list of such injuries.
“The pursuer has thus set the ground for the averments of breaches of duty of care…The specific duties averred relate to the ‘design, manufacture, marketing and supply of their products’; ‘that the product was safe for surgical use and would not cause further (sic) injury to patients such as the pursuer’; and ‘not to supply to hospitals a product they knew or ought to have known was untested for efficacy and safety’. Later the pursuer avers that having become aware of adverse events and failure they failed in their duty either to withdraw the product from the market or to take reasonable steps to ensure that patients were made aware of the risks.”
He added: “In any proof before answer the pursuer will first have to prove that the product which was implanted in her caused her injury; that the second defenders were aware or ought to have been aware (for example by testing of the product) of the risks; despite that the second defenders put the product on the market or did so without adequate warnings; or, having later become aware of the risks failed to withdraw the product or warn of risks. That may be a difficult goal to achieve but I am not persuaded that the pursuer has not pled a relevant case.
“So far as causation is concerned the pursuer has set out the injuries which she says she suffered. At this stage I am not entirely clear what more is required of the pursuer. Both parties will no doubt have the pursuer medically examined and the question of causation of damage is then a matter for proof.”
https://www.scottishlegal.com/article/common-law-damages-claim-over-vaginal-mesh-product-to-proceed-to-full-hearing
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13 DHBs no longer doing mesh surgery for incontinence
Nov 29, 2018 | Stuff.co.nz
By Cate Broughton
Thirteen out of 20 district health boards have scrapped controversial vaginal mesh surgeries.
Associate Minister for Health Julie Anne Genter says tighter surgical standards will improve patient safety. .
Genter said in Parliament on Wednesday the Government had taken action to protect women from the dangers of mesh.
Thirteen DHBs were no longer offering the controversial surgical treatment used to treat women with Stress Urinary Incontinence (SUI) following a request in September for surgeons to meet new Australian standards, Genter said.
Yet advocates for the injured called the measure an "an epic fail", saying it would not reduce the number of procedures or the level of harm.
An Australian Senate inquiry highlighted devastating complications that can occur as a result of the mesh procedures and the Australian Therapeutic Goods Authority (TGA) developed specific credentials for surgeons to help reduce the number of women affected.
In September the director general of health Ashley Bloomfield wrote to all DHBs asking them to ensure their surgeons met new Australian guidelines for vaginal mesh procedures.
A Ministry spokesman said 21 surgeons had met the credentialing guidance and the procedure would continue to be offered by seven DHBs — Auckland, Canterbury, Capital & Coast, Counties Manukau, Southern, Waikato and Waitemata.
The remaining 13 DHBs had either suspended the surgeries until they could meet the requirements or stopped offering the treatment altogether.
The Ministry did not know how many surgeons were performing the surgery prior to Bloomfield's request.
Mesh Down Under advocate Charlotte Korte said surgeons were not required to show they could remove mesh if there were complications.
The majority of mesh procedures occurred in private hospitals but those providers were not required to meet Ministry requirements on credentials, Korte said.
Information released to Korte under the Official Information Act (OIA) showed the Ministry wrote to 24 private hospitals asking them to meet the Australian standards and only four responded.
"The Ministry has asked them nicely to comply but they have no mandate to make them."
A global investigation by the International Consortium of Investigative Journalists published this week revealed the scale of harm from a poorly regulated medical device industry.
Over 250 journalists in 36 countries discovered 1.7 million injuries and nearly 83,000 deaths linked to medical devices over 10 years, reported to US agencies alone.
New Zealand has no pre-market approval process for medical devices but manufacturers are required to list their product on a Medsafe database 30 days before being sold.
Mesh Down Under has been calling for the Government to set up a registry for mesh procedures to better track the scale of complications.
This month the National party promised to establish a register which would retrospectively capture past procedures as well.
A cost-benefit analysis by Deloitte Access Economics this year showed a mesh registry would cost $15 million over 10 years. The benefits were estimated at $45 million resulting in a three to one benefit-cost ratio.
Establishing a registry remained "under consideration" but the Ministry had asked DHBs to hold and maintain local mesh registers, a Ministry spokesman said.
ACC received over 1018 treatment injury claims for mesh procedures (including hernias, pelvic organ prolapse and SUIs) between 2005 and June 2018.
A draft Therapeutic Products Bill was expected to be released for public consultation by the end of the year. The bill would replace the Medicines Act 1981 and increase regulatory controls over medical devices, a Ministry spokesman said.
Genter said the Government launched a website on Thursday for people badly affected by surgical mesh to register interest in sharing their views and experiences.
"This is an opportunity to hear from New Zealanders about their lived experience of surgical mesh, and what else needs to be fixed to ensure this doesn't happen again," she said.
https://www.stuff.co.nz/the-press/108945303/13-DHBs-no-longer-doing-mesh-surgery-for-incontinence
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FDA recommends “modernizing” review of devices in wake of global investigation
Nov 27, 2018 | British Medical Journal
By Jeanne Lenzer
The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.
The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.1
Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) pathway that is used to clear four in every five devices for sale.2 The pathway approves devices not on the basis of testing in humans but on how similar devices are to previous devices, called “predicates,” some of which were approved decades ago.3
Gottlieb and Shuren said that about a fifth of devices were cleared on the basis of predicates that were more than 10 years old. They said they were “encouraging” manufacturers to “use more modern predicates,” adding that the use of older predicates didn’t mean a device was unsafe. This change, they said, was the “most impactful” change they could make to “modernize” 510(k).
However, the reform didn’t go far enough, said Diana Zuckerman, epidemiologist and president of the National Center for Health Research in Washington, DC. She told The BMJ that using more “modern” predicates says nothing about safety or effectiveness. She said that “newer doesn’t mean better” and that “since less than 5% of 510(k) devices undergo any type of clinical trials, there’s no assurance that any devices cleared through that pathway are safe or effective.”
In 1996 the US Supreme Court concluded that “since the 510(k) process is focused on equivalence, not safety . . . if the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”4
A recent study found that 16% of mesh clearances were based on recalled devices.5 When the FDA was asked why it cleared mesh implants on the basis of predicate devices that had been withdrawn because of safety concerns, the agency said that it didn’t evaluate the performance of predicate devices when clearing devices for sale.
A study of high risk implanted cardiac devices found that only 5% underwent clinical testing that even partly approximated the testing required for drug approvals.6
Nor is safety surveillance reliable. A Government Accountability Office analysis found that 99% of device related “adverse events” were never reported to the FDA and that the “more serious the event, the less likely it was to be reported.”7
https://www.bmj.com/content/363/bmj.k5026
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Medical devices probe uncovers need for “drastic regulatory changes”
Nov 28, 2018 | PMLive
By Gemma Jones
A report linking 83,000 deaths and 1.7m injuries to faulty medical devices was released this week, calling for radical reform of a “lax” regulatory system in Europe.
Led by the International Consortium of Investigative Journalists (ICIJ) and its partner news organisations (The BMJ and BBC Panorama), the year-long investigation concluded that safety regulations in Europe were unable to keep up with advancements in med tech, and were too open to gaming by the medtech industry.
Europe has no single EU or governmental authority that reviews medical devices before they reach the market. Instead, medical device companies seek approval from one of 58 private notified bodies across the continent in order to gain the CE seal of approval.
However, if one of these notified bodies deems a medical device unsuitable, then the manufacturer can go to a different one until it gets the green light.
On top of this, devices’ safety and efficacy profile are not subject to the same transparency rules as medicines; so much so that surgeons performing these procedures don’t always see the evidence related to the devices.
The UK’s Royal College Of Surgeons has responded to the report, calling for “drastic regulatory changes” in the way medical devices are evaluated.
Derek Alderson, president of the Royal College of Surgeons (pictured above), said, “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long term.”
The approval process was probed after Dutch investigative journalist and broadcaster Jet Schouten convinced one notified body that mesh netting from a bag of oranges was surgical mesh.
MedTech Europe, which represents the European industry, responded to the investigation. “Medical devices undergo strict regulatory controls that give patients continued access while safeguarding high levels of safety”.
It added: “The ICIJ investigation shares the same fundamental belief that it is important to provide products that work and are safe. Its perspective, however, on how the industry works does not align with ours. Delivering safe, effective products, as our industry does, means that every day millions of people benefit from medical devices. They live healthier, more productive and more independent lives.”
In light of the report, the ICIJ has launched a database allowing users to explore more than 70,000 recalls, safety alerts and field safety notices issued across the globe.
An additional report by the ICIJ looks into industry lobbyists overhauling safety regulations for medical devices in Europe.
It says leading surgeons, regulators, lawyers and campaigners have said Europe’s approach to evaluating and approving new implants means that citizens are treated “like guinea pigs”.
The EU is currently reviewing shared public information on a system called Eudamed, but despite this, the European Commission told ICIJ that injury and malfunction reports were “likely to remain confidential as they are commercially sensitive for manufacturers”.
The investigation has coincided with further allegations around Johnson and Johnson (J&J) and its faulty vaginal mesh implant. New allegations say the company allowed the product to be used in patients despite warnings that the plastic material could shrink and harden inside the body.
According to the Guardian, emails shared between executives detailed that the mesh could become “hard as a rock” and roll up like a “folded potato chip” inside patients.
The implant was launched back in 2005, with FDA approval based on similar existing products, which allowed the device to be approved without a comprehensive review of data.
J&J is facing court cases from hundreds of patients worldwide who were fitted with the implant, with one patient reporting nine surgeries post-implant to help alleviate the pain.
http://www.pmlive.com/pharma_news/medical_devices_need_drastic_regulatory_changes,_says_rcs_following_report_1266399
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Poole woman Lesley Elder in contempt of court bid
Nov 29, 2018 | Bournemouth Echo
By Faith Eckersall
Facebook posts shown in court are said to reveal that Lesley Elder was 'partying after midnight' and was photographed in a club with her daughter, wearing a sash and a straw hat.
Mrs Elder received a vaginal mesh to cure incontinence problems in 2010 at Nuneaton's George Eliot Hospital NHS Trust. She later attempted to sue the NHS for £2.5 million.
However, whilst a High Court judge said in 2017 that Mrs Elder had a valid case, she was awarded £120,000 - less than five per cent of the payout she wanted - because, it was alleged, her claim had been 'inflated beyond reason'.
Now George Eliot Hospital NHS Trust has taken her to court for alleged contempt for 'exaggerated' and 'dishonest' claims of grave disability.
In 2017, in a tearful interview with the Bournemouth Echo, she claimed the controversial mesh implant had ended her marriage because she couldn't have sex and couldn't work, had depression and post-traumatic stress disorder.
She said she had endured 13 operations to try to end the pain by removing the mesh but it had become embedded inside her.
“It’s been horrendous. I don’t feel like a woman anymore," she said. "I feel everything has gone out of my life. I’ve been back and forwards to hospital constantly. My life has not even been worth living anymore.”
And, she added: “Some days my mobility is fine but other days it really isn’t. It is a living nightmare.
Vaginal mesh implants are offered to women with incontinence or prolapse after childbirth yet but hundreds are suing the NHS and the implants manufacturers after suffering crippling pain.
Mrs Elder's lawyers deny she had lied to the court. The hearing is expected to return to court in January.
A spokesman for George Eliot Hospital NHS Trust said: “This is an ongoing legal court case and we cannot comment at this stage of the proceedings.”
https://www.bournemouthecho.co.uk/news/17263669.poole-woman-lesley-elder-in-contempt-of-court-bid/
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