Preview Newsletter
Ethicon Media Monitoring 5/6/2019
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80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.
May 4, 2019 | The New York Times
By Editorial Board
When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh. -
Mesh victim appeals to health minister to let US surgeon try to remove crippling implant before it’s too late
May 6, 2019 | The Sunday Post
By Marion Scott
Claire Daisley is due to have both organs removed this summer. But, rather than undergo the life-changing operation, she has appealed to health bosses to send her to the United States where specialist surgeons could instead remove the implant. -
Norfolk women to join protests over pelvic mesh implant crisis
May 3, 2019 | Eastern Daily Press
By Geraldine Scott
Members of campaign group, Sling The Mesh, are protesting against new health guidelines which they say pave the way for generations of women to be harmed. -
Chief of medical device watchdog resigns amidst accusations from vaginal mesh survivors
May 5, 2019 | Woman & Home
By Samantha Simmonds
John Wilkinson is set to step down from his role as MHRA medical device chief in October, after vaginal mesh campaigners claimed the agency didn't take the scandal 'seriously'. -
FDA Ban on Transvaginal Mesh for Prolapse Stirs Controversy
May 3, 2019 | Medscape
By Marcia Frellick
The ban on further sales of transvaginal mesh for pelvic organ prolapse (POP) imposed by the US Food and Drug Administration (FDA) last month has some people cheering, some saying that an important choice for physicians has been lost, and some saying that the decision came too late. -
Study reveals reasons for delay in pelvic organ prolapse treatment
May 6, 2019 | News-Medical.net
Many women do not seek early treatment for pelvic organ prolapse due to confusion and a lack of awareness around the condition’s symptoms – and feelings of shame and embarrassment – according to new research. -
Is Your Pelvic Mesh Case Lingering? Are you On this Order?
May 5, 2019 | Mesh Medical Device News Desk
By Jane Akre
In this latest order from Judge Goodwin, more than 3-thousand woman have been removed from the inactive docket in the pelvic mesh MDL and put on the active docket, ready for trial or settlement.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.
May 4, 2019 | The New York Times
By Editorial Board
When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh.
The mesh, which is used to hold pelvic organs in place when muscles become too weak to do the job, has long been tied to life-altering injuries, including nearly 80 deaths as of 2018. In the past decade, seven companies have spent a collective $8 billion to resolve more than 100,000 patient claims — making litigation over vaginal mesh (or pelvic mesh, as it is sometimes called) one of the largest mass tort cases in United States history. As those lawsuits have made clear, most of these medical devices were approved for market with nearly no clinical data.
It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy. But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.
Problems can take years to emerge and can be impossible to correct, in part because permanent implants are not easily extracted from the body. (Removing mesh from pelvic tissue has been likened to removing chewing gum from long, thick hair). When trouble does arise, device makers often equivocate, regulators dither and patients seeking redress are forced into lengthy and expensive court battles. In the end, faulty products can remain on the market for years.
The F.D.A. finally pulled the remaining vaginal mesh products off the market last month (although most companies had already stopped selling them because of all those lawsuits). But on Thursday, the agency said it would not ban a breast implant linked to a rare form of cancer and so many other side effects that doctors have coined a new term — “breast-implant illness.” Like mesh, the breast implant was approved years back, based on meager safety evidence. Regulators now say there is not enough proof of harm to justify reversing that decision.
The risks of waiting loom large: In the past decade, nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices, many approved with little to no clinical testing, according to a global investigation by the International Consortium of Investigative Journalists.
Women are particularly well acquainted with this cycle. Essure, a permanent birth control device consisting of two metal coils injected into the fallopian tubes, has been linked to autoimmune disorders and more than 800 pregnancy losses. The product was pulled from the market last year — by the device maker, which cited declining sales, not by the F.D.A. And the power morcellator — a spinning blade that shreds uterine tissue so it can be more easily extracted from the body — has proved deadly for some women, whose cancer was spread by the device. As The Times has reported, the morcellator was widely used for 20 years before regulators realized there was a problem.
But that’s not to suggest that only women are affected: There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.
In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.
After searing investigations by journalists and patient advocates, the F.D.A. has promised to make “transformative” changes to medical device regulation. But so far, the agency’s suggestions have been meager at best. And in the meantime, regulators have accelerated the device approval process, not slowed it down.
Dr. Jeffrey Shuren, head of the agency office in charge of device regulation, has suggested that the benefits of bringing innovative products to market quickly are worth the increased risks.
It’s true that devices have restored hearing, vision and the ability to walk and have provided many other benefits to millions of people. But the drive to innovate does not justify the growing catalog of medical device disasters. Patients should not have to wonder whether devices will save their lives or destroy them. Reasonable changes could greatly improve the current system.
Tighten approval standards. Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “updated” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. Eight years ago the Institute of Medicine advised the F.D.A. to abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested.
Fix post-market surveillance: Industry proponents say that medical devices can be brought to market quickly and safely by having companies conduct rigorous testing after products go to market instead of beforehand. But companies often fail to complete such studies, even when they’re ordered by regulators. What’s more, device makers frequently skirt rules requiring them to report publicly all incidents of malfunction, injury or illness — often through mechanisms that the F.D.A. itself created. And after years of wrangling, the industry and its regulators have still not fully put a system in place to better notify patients of product recalls and other safety issues.
The F.D.A. has vowed to fix some of these lapses. They’ve promised to abolish reporting exemptions that keep safety issues hidden from the public and to promote breast implant registries that monitor patient outcomes.
That’s a good start, but more can be done. An industry that prides itself on innovation, and earns some $400 billion in annual revenue, should be well equipped to build a global medical device registry where patient outcomes for all medical devices are openly monitored, and where doctors and patients can log concerns and obtain information.
Loosen industry’s grip. Dr. Shuren reportedly referred to device makers, not consumers, as his office’s main customers at a recent industry gathering. As misguided as that statement may sound, he’s not wrong: The medical device industry funds 35 percent of the office’s work, and by law, that funding is contingent upon the agency’s approving devices quickly, and through the least restrictive pathway possible.
It’s not solely those laws that give medical device makers influence over regulators. The industry maintains a well-oiled revolving door with the F.D.A. — as The Associated Press has noted, the last four people to hold Dr. Shuren’s position have gone on to lucrative industry gigs. Device makers also spent more than $300 million lobbying Congress in the decade ending in 2017, according to the Center for Responsive Politics. What’s more, they pay doctors and hospitals hundreds of millions in consulting fees every year, according to the National Center for Health Research. None of this violates any rule, but all of it contributes to the current crisis.
Medical institutions and professional societies should establish, or amplify, guidelines discouraging such payments. Stronger laws that provide more funding for the work of device regulation — so that the F.D.A. is not as reliant on industry dollars — would also help the agency to fulfill its mission.
That mission is to protect patients.
https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html
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May 6, 2019 | The Sunday Post
By Marion Scott
Claire Daisley is due to have both organs removed this summer. But, rather than undergo the life-changing operation, she has appealed to health bosses to send her to the United States where specialist surgeons could instead remove the implant.
Dr Dionysios Veronikis, the acclaimed Missouri-based mesh expert, backed her plea, saying: “Removing Claire’s bladder and bowel will not remove the pain caused by mesh.
“Only removing her mesh will do that. She deserves the chance to avoid the irreversible removal of both organs if at all possible.”
Health Secretary Jeane Freeman met with victims more than two months ago and was told they no longer trusted domestic mesh experts.
But the government is no closer to bringing the eminent surgeon to Scotland and, instead, Ms Freeman has appointed a committee, due to report in the autumn, to look at access to overseas surgeons.
But Claire, 49, from Greenock, is not prepared to wait for “yet another faceless government committee” to decide her fate.
She said: “After destroying my life so they could save £200 on the cost of a bladder operation by using mesh, all the NHS has done for me so far is give me a partial removal which caused even more pain and put me in a wheelchair.
“Now they are proposing removing two of my organs, and I have less than two months before this irreversible surgery.
“If I lose my place on the waiting list, it’s another year of living with constant pain, being doubly incontinent and unable to walk more than a few steps without falling over.”
In 2011, Claire was fitted with a transobturator sling implant which was widely used in Scotland to treat bladder issues.
Last week, the device was once again ruled to be defective by a US jury which awarded the largest single punitive damages claim of £100 million to Susan McFarland, 68, of Philadelphia.
The implant was described as “gold-star treatment” by mesh manufacturer Johnson & Johnson firm Ethicon which last week also settled a £10m legal action by the Washington DC Attorney General for withholding risk of injuries.
Claire said: “I know our NHS surgeons are trying their best, but they haven’t addressed full mesh removal. Dr Veronikis has at least given me some hope.
“If just one organ can be saved, I should get that chance. The £12,000 to send me to Missouri would be a fraction of the cost of treating me for the rest of my life with two stoma bags.
“I’ve been in constant pain for seven years, having to spend my life on walking sticks and in a wheelchair.
“The government should be pursuing mesh companies to pay for the damage they’ve caused, and that would cover the costs of me seeing Dr Veronikis.”
Campaigners have for months been appealing to the Scottish Government to bring the surgeon, who developed a unique muscle and tissue-sparing procedure to completely remove mesh implants, across the Atlantic to ease the agony of mesh victims in Scotland.
Dr Veronikis said: “Until I physically examine Claire, it’s difficult to give promises.
“But I do believe I can fully remove the mesh and that will certainly relieve pain. Claire’s situation is complex but, in my experience, once mesh is removed and the body has a chance to heal and is free from pain, there are often other things that can be done to alleviate other issues.
“Removing any organ should be a last resort.
“Claire deserves options. If they cannot be provided locally, consideration should be given for what could be done outside Scotland.”
In a heated debate in Parliament on March 5, cross-party MSPs demanded Dr Veronikis be brought to Scotland after mesh-injured women told how surgeons caused even more damage by partially removing the implants responsible for injuries to hundreds of thousands of women around the world.
Manufacturers have already paid more than £10 billion to US victims.
During a meeting in March, Claire told the Health Secretary she “no longer trusted” Scottish surgeons who continued to implant almost 800 more women despite a suspension instigated in July 2014.
Those surgeons, from Scotland’s two largest health boards, NHS Greater Glasgow and NHS Lothian, have since been appointed to mesh “centres of excellence”.
Campaigning MSP Neil Findlay said Scotland’s mesh victims “did not have the luxury of waiting for yet another government-appointed committee to drag out this scandal unnecessarily”.
He added: “The women are the only evidence needed for government to get on and do the right thing.
“These women are living on a knife-edge, in chronic pain and terrified for the future.
“They have already told the Health Secretary to her face that they do not want the surgeons who put mesh inside them to have anything to do with future treatment – it should come as no surprise they have little faith in them.
“They need a surgeon with a recognised track record of safely and fully removing mesh, and that is Dr Veronikis.
“Why should Claire Daisley be subjected to the horror of losing two organs when there is a chance Dr Veronikis can help her?”
The Scottish Government said: “As the Health Secretary promised, a short-time working group is considering how to enhance the treatment and support given to women who have experienced complications as a result of having mesh procedures.
“Meetings will continue to look at sharing experience, techniques and learning with colleagues in Europe and the US, and to examine the complex education and training requirements we must have to ensure a sustainable, resilient and high-quality service.”
https://www.sundaypost.com/fp/mesh-victim-appeals-to-health-minister-to-let-us-surgeon-try-to-remove-crippling-implant-before-its-too-late/
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Norfolk women to join protests over pelvic mesh implant crisis
May 3, 2019 | Eastern Daily Press
By Geraldine Scott
Members of campaign group, Sling The Mesh, are protesting against new health guidelines which they say pave the way for generations of women to be harmed.
They are also fighting to keep open a specialist mesh removal service in London which was closed without warning meaning complex mesh removal operations - which some women had waited for up to two years for - were cancelled with just a few days' notice.
The mesh scandal has seen thousands of women complain of being left in constant pain after having the implants, which have been offered to treat pelvic organ prolapse and incontinence after childbirth.
Last July, the use of mesh implants was immediately suspended after a Medical Devices Safety Review, led by Baroness Cumberlege.
But the National Institute of Health and Care Excellence (NICE) has now issued fresh guidance paving the way for the implants to be used again, despite the review still going on.
The organisation said this was published within their normal timeframe, and that the guidance advises clinicians to continue to abide by the national pause on using the implants.
But it has prompted even more urgent calls for the government to carry out a 20-year retrospective audit to track the outcome for every single woman who has had a mesh operation. Campaigners say it is the only way the magnitude of suffering will be revealed making the call for mesh implant operations to be banned unanswerable.
Lorraine Lodge, 53, from Great Yarmouth, said there was a lot of anger over the new NICE guidelines but also at surgeries being cancelled.
She said: “We've been guinea pigs once and we're not being guinea pigs again.”
Mrs Lodge said she had been on the phone with woman who was so desperate she wanted to try and remove her mesh implant at home, before Mrs Lodge persuaded her not to.
“It's really scary,” she said.
A NICE spokesperson said: “The committee had at the forefront of their minds the distressing symptoms that some women experienced because of the adverse effects of mesh surgery. As such, they recommended that surgery using mesh to treat these conditions should only be considered as a last resort when a number of conditions are met, including making sure the woman fully understands the benefits and risks of such a procedure.
“In England there is currently a high vigilance restriction (pause) on a group of procedures, including vaginally inserted mesh and tape to treat SUI and POP. The publication of our guideline is just one of the conditions set for the high vigilance restriction to be lifted. However a number of other conditions still need to be met and whilst the national pause remains in place, professionals should continue to follow its requirements.
“We will review our guidance if new evidence is published, if there is a substantial change in policy or legislation, or if there is a significant safety update from the Medicines and Healthcare products Regulatory Authority.”
In Manchester, women will be outside the Hilton Hotel in Deansgate, from 8am to 9.30am on May 9 to greet delegates arriving for the NICE annual conference.
In London women will be outside University College London Hospital (UCLH) on the same day from noon to 2pm. The mesh removal service by surgeon Suzy Elneil at the hospital has been stopped by chief executives until further notice.
A spokesman for the UCLH said: “UCLH has taken a decision to pause mesh removal operations by one surgeon. This decision affects 13 patients given provisional dates for surgery in May.
“The decision was not made lightly. We deeply regret the distress this has caused this group of patients who are living with a very difficult and complex condition.
“We have written to all these patients offering them alternative options, including a referral to one of the eight other surgeons qualified to carry out mesh removal.
“Mrs Sohier Elneil is widely recognised as an expert in her field and her skill and expertise is much sought after by patients from all over the country. This high demand in referrals has led to lengthy waiting times for clinic appointments, investigations and dates for surgery.
“Unfortunately, she is the only urogynaecologist carrying out mesh removal at UCLH who is not accredited by the British Society for Urogynaecology (BSUG) and we are keen to support her to achieve this.
“We have therefore decided to pause operations by Mrs Elneil to help her manage her waiting lists and allow her the space and time to make improvements to her service.
“This will make the service safer for patients and protect its long term future, and in time this will mean we can help more patients.”
For more information search Norfolk and Suffolk Meshies or the Sling the Mesh on Facebook.
https://www.edp24.co.uk/news/health/sling-the-mesh-norfolk-women-join-london-and-manchester-implant-protests-1-6032325
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Chief of medical device watchdog resigns amidst accusations from vaginal mesh survivors
May 5, 2019 | Woman & Home
By Samantha Simmonds
John Wilkinson is set to step down from his role as MHRA medical device chief in October, after vaginal mesh campaigners claimed the agency didn't take the scandal 'seriously'.
Last month, health watchdog NICE caused outrage when it ruled that vaginal mesh could be used by the NHS under certain circumstances. But pelvic mesh campaigners celebrated a major win later on in the month, when medical giant Johnson & Johnson was forced to pay almost $10 million to avoid going to trial over its role in the scandal.
And now it’s been announced that John Wilkinson, the director of devices at the UK Medicines and Healthcare products Regulatory Agency, will step down in October.
Wilkinson has spent seven years in the role, helping to shape European device regulations as well as procedures at MHRA.
But vaginal mesh campaigners say the agency didn’t do enough to support patients and survivors.
Vaginal mesh has been linked with a number of serious complications, which are often permanent. Reported side effects include chronic urinary tract infections, pain during sex and irreversible nerve damage. Some women even say that they have been left housebound as a result of the procedure.
‘The agency is not an effective watchdog,’ Scottish Mesh Survivors campaigner Elaine Holmes told the Scottish Parliament in 2014. ‘It does not take our concerns seriously. We have written to it a number of times and telephoned it, but we get standard copy and paste replies. The agency does not listen to us.’
Politicians have also pitched in to criticise MHRA’s handling of the pelvic mesh scandal. ‘When the public petitions committee took evidence from it, we learned that its “detailed analysis” amounted to three postgraduate students doing a desktop exercise for two weeks at a cost of £20,000,’ Jackson Carlaw revealed during a parliamentary debate in 2016.
In another debate, he suggested that the figure might actually be as high as £40,000.
Others agreed that this evidence showed that the agency’s device review process was ‘not fit for purpose’ and ‘completely inadequate’.
https://www.womanandhome.com/health-and-wellbeing/health-wellbeing-news/chief-mhra-resigns-mesh-scandal-320395/
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FDA Ban on Transvaginal Mesh for Prolapse Stirs Controversy
May 3, 2019 | Medscape
By Marcia Frellick
The ban on further sales of transvaginal mesh for pelvic organ prolapse (POP) imposed by the US Food and Drug Administration (FDA) last month has some people cheering, some saying that an important choice for physicians has been lost, and some saying that the decision came too late.
"I support this decision," said Una Lee, MD, a urologist at Virginia Mason Medical Center in Seattle. "Many in the medical community probably do not because I think doctors like choices. They like having all choices available at their disposal."
The ruling pertains only to transvaginal mesh for prolapse, not mesh placed abdominally for prolapse or slings for urinary stress incontinence, which has caused confusion. Some patients are concerned slings will be pulled off the market, but "it's a whole different set of evidence and data. It's apples and oranges," Lee told Medscape Medical News.
Many transvaginal mesh products had already been voluntarily pulled off the market by manufacturers, but there were three left: two made by Boston Scientific and one made by Coloplast. On April 16, the FDA gave both companies 10 days to come up with plan to pull them from the market, saying they "had not demonstrated reasonable assurance of safety and effectiveness for these devices."Companies Say Physicians, Patients Should Have Choice
In response, Boston Scientific issued a statement: "We are deeply disappointed by this decision and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the US who will suffer from POP during their lives."
Coloplast followed suit: "While mesh sales to treat POP in women account for approximately 0.2% of our global revenue, we firmly believe that patients and their physicians should have a choice of therapies."
But Lee said she sees the effects of complications every day in her practice.
"I have personally treated hundreds of women with complications specific to mesh, so I am an advocate for women who have suffered," she explained. Only a minority of women "suffer these serious, life-altering complications related to transvaginal mesh, but they're real."
"My perspective, therefore, may be different from someone who doesn't see those complications," said Lee, who specializes in pelvic floor repair and will present some of her research at the American Urological Association (AUA) 2019 Annual Meeting this weekend.I have personally treated hundreds of women with complications specific to mesh, so I am an advocate for women who have suffered.
Transvaginal mesh is only one option for pelvic organ prolapse. It can also be treated with conservative management, pelvic floor physical therapy, nonsurgical pessary use, and other surgery options.
None of the surgeons at Virginia Mason implant transvaginal mesh for prolapse, Lee reported, adding that most there do native tissue repairs, using patients' own tissue to reconstruct their pelvic floor.
Among the possible complications with mesh are that it can come through the wall of the vagina or erode into the bladder.
"Some people say if there's an erosion, just remove it and they're good," Lee said. However, "even when you remove the mesh, patients continue to have chronic pelvic pain and lack of sexual function. Anyone who tries to minimize these patients has not listened to them."
"I feel that the FDA did something on behalf of the women," said Lee, although she acknowledged that "it was not the best solution, per se. In taking it off the market, people will say, 'What about those who need it?' I say, 'What about those who suffered?'""Mesh Is a Good Tool"
"I think it's good to have a full armamentarium when planning surgery for patients," said Elise De, MD, a urologist at Massachusetts General Hospital in Boston who specializes in women's pelvic medicine.
In rare cases, "mesh is a good tool to have," although it is not needed in "about 90% of cases," said De, who was involved in research that will be presented at the AUA meeting.
The way mesh was initially used and the marketing were misguided. "Mesh was launched as first-line, which it really never should have been. You should never use mesh in a surgery-naïve patient," she told Medscape Medical News.
"Marketing was directed at expanding the repertoire of surgeons who wouldn't normally be doing pelvic reconstruction by offering them 'an easier way to do it'," she explained. "Those marketing strategies put various levels of safe mesh products into the hands of people who weren't necessarily comfortable with the tissue planes and it was a disaster."
In 2008, "people were learning on cadavers and then going to do the surgery on humans," said De, who said she hasn't implanted transvaginal mesh for prolapse for many years.
She stopped when she started seeing patients with complications being sent to her practice. "I would often feel that it was more the surgical technique than the actual mesh, but certainly there were cases where I thought the mesh itself was the culprit, De said.
"It's traumatizing when you take care of a patient with a complication," De added. "Having seen some pretty significant poor outcomes sent in for salvage, the less excited I became about using mesh."
There is a lack of new products on the market, but there are biologic products, such as human cadaveric tissue, that are long-standing options, she pointed out. There has never been a gold standard for prolapse repair because the anatomy is so variable and research data have not been perfectly randomized, she added.
"I think the human cadaveric products are the best alternative for polypropylene mesh," she said, although she acknowledged a lack of long-term data on those."This Ban Comes Too Late"
"Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits," Michael Carome, MD, director of the health research group at Public Citizen, said in an April 16 statement.
"Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had 'not demonstrated a reasonable assurance of safety'," he added.
For women who have had the transvaginal mesh implanted with no complications, experts agree it should stay in place.
However, "if you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor," according to the FDA statement.
https://www.medscape.com/viewarticle/912557
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Study reveals reasons for delay in pelvic organ prolapse treatment
May 6, 2019 | News-Medical.net
Many women do not seek early treatment for pelvic organ prolapse due to confusion and a lack of awareness around the condition’s symptoms – and feelings of shame and embarrassment – according to new research.
The study, led by the Nursing, Midwifery and Allied Health Professions Research Unit (NMAHP-RU) at the University of Stirling, also found that a lack of awareness among GPs, their dismissive responses to women’s symptoms and a lack of proactive care further contributed to delays in diagnosis and treatment of prolapse.
Pelvic organ prolapse is very common – affecting about 40 per cent of women over 40 years of age. It occurs when pelvic organs – the bladder, bowel or womb – descend into the vagina, causing distressing symptoms that adversely affect quality of life.
The condition often causes pain and discomfort, incontinence, sexual difficulties and psychological distress. Conservative treatments – such as physiotherapy, pessaries and lifestyle changes – can be effective if prolapse is detected early, before needing surgical repair.
Dr Purva Abhyankar, a lecturer at the University of Stirling who led the new study, said:
As part of our research, we conducted focus groups with women receiving prolapse care across three UK regions. This provided a valuable insight into women’s experiences of care and identified important gaps in the care and services offered to patients with prolapse.
We found that women’s own confusion and lack of awareness around prolapse symptoms, coupled with feelings of shame and embarrassment, prevented them from seeking early help for symptoms.
Even when they did seek assistance from their local doctor, symptoms were often dismissed as being ‘not too bad’ or a ‘bit loose’. Women reported that they were ‘not taken seriously’ until their symptoms became more severe.
By the time prolapse was suspected and a specialist referral made, the condition had progressed to the extent that surgery was the only viable option left.”
The study – involving the NMAHP-RU unit at Glasgow Caledonian University, the University of Leicester and NHS Greater Glasgow and Clyde – involved four focus groups with a total of 22 women who have received prolapse care through urogynaecology services across three NHS UK regions.
Women were asked about their experiences of living with prolapse and of interacting with health professionals when seeking help for symptoms, receiving a diagnosis, making treatment decisions, undergoing treatments, and follow-up care. They were also asked about their thoughts on improving services and care in future to meet the needs of women.
The team found that women received little or no choice in terms of prolapse treatment and had little involvement in decision-making. Health professionals often influenced treatment decisions by the way they outlined the available options and there was little or no discussion around the pros and cons of certain treatments, women’s lived experience of prolapse, and experience of any prior treatments.
In addition, the study found that women regarded the process of undergoing different prolapse treatments – such as pelvic floor muscle training (PFMT), vaginal pessaries, or surgery – as one of trial and error. Physiotherapy-based treatments, including PFMT, were valued by women as it helped them to regain control over their symptoms, improving their quality of life.
Dr Abhyankar said:
Our findings echo women’s experiences from across the world – including Europe, America and Asia – but also provide new evidence and unique insights into their experiences of involvement in decisions around diagnosis and treatment.
The study highlights a need for greater awareness and education among women, as well as healthcare professionals about prolapse and its treatment. Women presenting with prolapse symptoms need to be listened to by healthcare professionals, offered better information about treatment choices, and supported to make a decision that is right for them.
We hope our research will provide a foundation for designing and improving health services in the UK and internationally.”
https://www.news-medical.net/news/20190503/Study-reveals-reasons-for-delay-in-pelvic-organ-prolapse-treatment.aspx
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Is Your Pelvic Mesh Case Lingering? Are you On this Order?
May 5, 2019 | Mesh Medical Device News Desk
By Jane Akre
In this latest order from Judge Goodwin, more than 3-thousand woman have been removed from the inactive docket in the pelvic mesh MDL and put on the active docket, ready for trial or settlement.
This will be Wave 12 in the Ethicon MDL and the schedule, if followed by plaintiff law firms, should see thousands of pelvic mesh cases settled or tried before the end of the year.
Can you find your name here?
In Pretrial order #337 (here), filed Wednesday, May 1, 2019, Judge Joseph Goodwin orders 3,264 cases off the inactive docket and tells plaintiff law firms they should be ready for trial.
Of those cases, most are Ethicon (Johnson & Johnson) with an exception of 36 cases filed against Boston Scientific. All are defective product cases filed against makers of pelvic mesh implants used to treat incontinence and prolapse in women.
Law firms representing the 3,264 plaintiffs have to follow the schedule for trial preparation which ends November 25, 2019. After that time the cases will be tried, either in Charleston, West Virginia, or in the home state where they were remanded for trial.
As part of Judge Goodwin’s orders, the depositions are limited to 3 hours and she can have four treating physicians deposed.
The November date is when the final response should be in to the Daubert motions- that is the criteria used to determine whether or not someone is an expert witness who can testify in federal court. Is the expert reputable and relevant? Is her testimony based on scientifically valid reasoning and does it apply to the facts of the case? A failure to answer those question can have your expert tossed.
Fast-Track
Judge Goodwin has been on the fast-track to have the cases removed from multidistrict litigation (MDL) in his court where some have lingered for a year or two. At last count, there were 107,136 product liability lawsuits filed against seven manufacturers of pelvic mesh used to treat incontinence and prolapse. Ethicon has always had the largest number of cases filed, at this writing 40,546.
The MDL was created in early 2012 to consolidate the many product liability cases that were being filed around the state for pretrial purposes.
An MDL is supposed to have a few test cases, called bellwethers, to see the relative value for settlement purposes. But Johnson & Johnson,(Ethicon) has refused a global settlement, instead opting to settle the inventory of an individual law firm, one at a time.
In other MDL News- Common Benefit Battle Continues
These law firms are pushing back against the Fees and Cost Committee (FCC) of the MDL headed by attorney Henry Garrard.
His firm, Blasingame Burch Garrard, of Athens, Georgia is also on the receiving end of $56 million, the highest rate of compensation among the 94 firms involved in the MDL.
Eight law firms are challenging Garrard and the back and forth is full of accusations of bias and greed.
The challengers say they have tried more cases than Garrard, who has taken one C.R. Bard case to trial (Cisson), and that in developing legal theories and in deposing experts and company executives, they have done the bulk of the work that has led to successful plaintiff outcomes.
Those law firms, Mazie Slater and Kline Specter, have concentrated their cases outside of the MDL, in New Jersey or Philadelphia respectively.
They are two of the eight law firms that say they deserve to receive more from the FCC than they’ve been granted.
Common Benefit Fees
The 5% common benefit fund was set aside from each settlement of jury award, which so far have totaled $7 billion. The common benefit fund is projected to swell to $550 million as the cases continue to resolve.
Judge Goodwin never specified who was to pay the 5%. Some firms have split the 5% with their client, while others pay all of it. More often than not, according to readers reporting to MND,women will see the 5% fee tacked onto their settlement that the woman is expected to pay.
In the MDL, 94 law firms submitted more than 900,000 hours of work which generated more than 199 million pages of documentation, all considered for the common benefit, or shareable. The Fees and Cost Committee (headed by Garrard) reduced the recognized hours to 679,191.20. Many of the objectors were the same firms to have their hours cut.
Kline Specter, Mazie Slater, Anderson Law and a pro se plaintiff all submitted rebuttals to Henry Garrards’ argument that their fees and costs should be reduced, filed April 8, 2019. Docket #7816.
You will need a Pacer account to open up these documents inside 2:12-md-02327, MDL, So District of WV:
Docket #7841 Mazie Slater Reply to Benefit Rejection, April 15, 2019
Docket # 7842 Kline Specter Replies to Common Benefit Rejection, April 15, 2019
Docket #7844 Anderson Law replies, April 15 2019
Docket #7851 Lana Keeton Reply, April 16, 2019https://www.meshmedicaldevicenewsdesk.com/is-your-pelvic-mesh-case-lingering-are-you-on-this-order/
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