Preview Newsletter
Ethicon Media Monitoring 4/2/2018
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Vaginal mesh scandal - Scotland's unlikely political allegiance
Mar 30, 2018 | Holyrood
By Tom Freeman
An unlikely alliance struck up over the mesh scandal: "We have struck up a relationship on this issue. On other issues, we’ll tear each other to shreds" -
The simple jab helping women get over a wee problem... Thousands spared risky surgery to cure embarrassing bladder leaks with a 15-minute injection treatment
Mar 31, 2018 | The Daily Mail
By Martyn Halle
... Bulkamid was originally developed in 2006, and experts say there is now enough evidence on its effectiveness that it can be considered a viable alternative to mesh surgery. -
Regulators, doctors in firing line after Senate report on pelvic mesh scandal.
Apr 2, 2018 | Newcastle Herald
By Joanne McCarthy
WOMEN victims of Australia’s pelvic mesh scandal say a Senate report released last week has not gone far enough to hold regulators, health bureaucracies, doctors and doctors’ groups accountable. -
These Breast Implants Left Women With ‘Rotting Pelvises’
Mar 30, 2018 | New Beauty
By Julie Ricevuto
Childbirth can lead to a lot of complications within a woman’s body, with one of the more common effects being a prolapsed bowel and bladder. In order to combat this, many women opt for a pelvic mesh implant, however, new findings are revealing that this might not be the best solution. -
This Birth Control Device Kept Making Women Sick. The FDA Kept It On The Market.
Apr 1, 2018 | Huffington Post
By Jennifer Block
Last month, Food and Drug Administration Commissioner Scott Gottlieb met with a group of women who’ve been knocking on the agency’s door for years. -
McGinnis Ends Testimony in Bard Transvaginal Mesh New Jersey Trial
Mar 31, 2018 | Mesh Medical Device Newsdesk
As the second week of the latest C.R. Bard transvaginal mesh wraps up in New Jersey, jurors appear to be impressed with the North Carolina plaintiff and her husband. -
Ethicon Physiomesh Bellwether Trials to Start in September, 2019
Mar 30, 2018 | Lawyers and Settlements
By Gordon Gibb
Physiomesh lawsuits are expected to grow as Multidistrict Litigation housed in Georgia readies for bellwether trials to begin within eighteen months. By then, lawsuits could number into the thousands.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Vaginal mesh scandal - Scotland's unlikely political allegiance
Mar 30, 2018 | Holyrood
By Tom Freeman
An unlikely alliance struck up over the mesh scandal: "We have struck up a relationship on this issue. On other issues, we’ll tear each other to shreds"
When the Scottish Government released the findings of the independent review into the use of synthetic transvaginal tapes and meshes, it hit the headlines.
Campaigners branded the report “a whitewash” after it was significantly altered before the final draft was published, recommending that the controversial procedure should be reinstated in Scotland, albeit not “routinely”.
The complications some women have suffered as a result of these invasive implants have been devastating. These can include repeated infections, organ failure and even death.
The reaction by the women campaigning against the use of mesh to the report was understandable.
However, in the chamber of the Scottish Parliament, the most impassioned articulation of disappointment at the report came from three male MSPs – the former health secretary Alex Neil and two former shadow health secretaries, Labour’s Neil Findlay and Conservative Jackson Carlaw.
This was notable not just because of their gender, but also because they are normally vociferous political rivals.
Carlaw called the report “a whitewash of damning evidence now traduced and downgraded”.
Findlay called the episode “a tragic tale of corporate power and greed, institutional arrogance by the medical establishment and government ambivalence.”
And Neil said he was “disturbed and disappointed” by the outcome of an inquiry that, after all, he himself had established when he was health secretary.
In a debate on the subject in December, Neil went further and said he had “not been told the whole truth” by civil servants when he went against their wishes and ordered the inquiry in the first place.
Holyrood gathered the three together over breakfast to find out how such an unlikely alliance came about.
“We’re forming a new party,” jokes Neil.
There is a recognition from all three that the issue has not been an easy one to win allies on, given it involves discussing pelvic organ prolapse in women.
Findlay says he has been surprised by “a reluctance” from female party colleagues to get involved in the campaign.
“It’s not the issue somebody like me would naturally discuss with older and middle-aged women. It’s just not the kind of thing you’d normally discuss,” he says.
“There has been a reluctance, not just from female colleagues but also from colleagues across the piece, to talk about this. Even a case of ‘we’ll call it mesh, don’t call it vaginal mesh, because it’s easier’.”
Findlay remembers telling campaigners Elaine Holmes and Olive McIlroy that the conversation would be “more embarrassing for me than you, so let’s forget being embarrassed about it and just get on with it.”
Carlaw picked up on Holmes’s apprehensiveness when she first came to visit him in his constituency surgery.
“I immediately realised the only way to approach it was in a completely business-like discussion to put her at ease. The minute she realised that, it was perfectly easy.
“But I agree with Neil, there’s almost a slight Presbyterianism, if I can put it that way, among some of my female colleagues here at the parliament about just the sheer bluntness of the terminology and the issue at hand.
“I was quite struck, because I think in terms of a potential ongoing health scandal this is every bit as big as thalidomide was, in its own way. But thalidomide was an easy picture, it’s an easier scandal to discuss.”
This has been “an impediment” to proper scrutiny and parliament taking action on the issue, he suggests.
Some notable exceptions have taken up the issue, adds Neil, including Johann Lamont, Rona Mackay and Rachel Hamilton, while Michelle Ballantyne admitted in the debate she had had a mesh operation.
“So, the situation is beginning to change. But the interesting thing is all the decision-makers on this are women, including the chief medical officer. Yet we feel as though we’re still battling people who have not fully come on board. They have admitted the issue and all the rest of it.
“I think the chief medical officer certainly gives the impression she’s one of the ones reluctant to go for a full ban. I might be misrepresenting her, but that’s certainly the impression I get. I find that surprising, especially now that Australia and New Zealand have imposed a total ban.”
When the overwhelming preference is for patient choice, banning a treatment completely may seem a difficult moral quandary, but Neil argues that a growing understanding of the scale of the scandal means fewer women are likely to choose it anyway.
There was no particular moment when the three MSPs decided to work together.
“We had a reshuffle and I took over the shadow health post from Jackie Baillie, and she passed on a folder with topics on the agenda, and at the very back there was a couple of pages of articles from newspapers about mesh, and I thought, ‘I wonder what this is?’” remembers Findlay.
He set up a meeting with the campaigners.
“We sat down and one woman in particular struck me. She could have been my auntie, my cousin or my sister. She was a straightforward, no messing, working-class woman, and she told me she had lost a kidney because of this. And the way in which she articulated her case, I just thought, ‘Well, something has to happen here’.”
Carlaw then met Holmes as she was his constituent.
Findlay continues: “Alex was the health secretary and we put a lot of pressure on him at the time and eventually, eventually we got him to do something. He didn’t do it right away, and he was listening to his civil servants or whatever who were telling him a different story.
“Ultimately, it comes down to people and believing the people who were presenting us with ‘this has ruined our lives’. Thankfully, because all of us have form with each other disagreeing vehemently. I mean, I tried to get him sacked one time.”
Alex Neil quips: “This is the first time Neil’s been on the right side of the argument.”
Findlay goes on: “But we have struck up a relationship on this issue. On other issues, we’ll tear each other to shreds.”
Carlaw adds: “Although I would say, actually, it is encouraging the atmosphere where we can talk about other issues as well.
“The image that was striking, actually, was when Neil came along to one of the petitions committees when this was being discussed,” Carlaw remembers.
“At that time, the petitions committee was all men. Alex was giving evidence as the cabinet secretary. So, from Alex and all the way in the other direction of the room was all men, and sitting behind Alex were about fifty or sixty women who were suffering from mesh.”
Findlay describes the moment as “a game changer” and Neil agrees.
Carlaw adds: “Maybe there was a sense of the three of us realising that there was a responsibility on us to do something.”
Neil ordered an independent review and suspended the procedure in Scotland, which was against the advice of his officials.
“To be fair on some of the people providing the advice, they hadn’t twigged just how serious this was, but, ironically, every one of them was a woman,” he says.
“I was pushing them internally. I couldn’t put my finger on it, but the more I listened to the [campaigners], the more I was convinced that the women were right and the advice I was getting was wrong and decided to act.”
For Neil, being influenced by the petitions committee raises a more fundamental issue about how parliament works.
“The official committees of the parliament are supposed to be the ones to give ministers a hard time. My experience as a minister, in every one of the four jobs I’ve been in, is actually, the committees are run by the whips in reality, for all the parties.”
Carlaw suggests that if an issue emerges out of the spotlight and is therefore not picked up by the party machines, it is more likely to engender cross-party alliances.
“The minute the spotlight lands on an issue, everybody runs to the four corners of the boxing ring to prepare for battle,” he says.
“But if the issue emerges despite the party process, it’s amazing how much more common ground and common sense is applied to whole discussion. This is one of those issues.”
If it had emerged from a party-political campaign, the three agree, their alliance would not have been formed.
“Everybody would be in their bunker,” suggests Neil.
That lack of a spotlight is partly the fault of a reluctant press, though. Carlaw remembers being told by one national broadcaster “We don’t do fanny politics”, while a newspaper journalist told him, “We don’t do icky women’s issues, Jackson.”
Findlay says the first press conference he called on the mesh scandal saw only two journalists turn up.
“After it I spoke to some of them and they said, ‘Oh no, we don’t do that stuff.’ I thought, ‘It’s 2015 or 2016, is this where we are? Running away from issues around a woman’s reproductive system?’ Jesus.”
Neil points to the fact the numbers in the press offices in the parliament have reduced considerably since 1999.
“The press pack move even more as a pack now because they rely on each other to get their stories. They don’t have the resources.”
Former Sunday Mail journalist Marion Scott is the notable exception when it comes to writing on mesh, the three agree, for her empathy and thorough approach. Findlay also credits the Sunday Mail for running the ongoing story too.
“I mean, you pick up the Sunday Mail and look for the back page to the front, as you do on a Sunday morning, eating your rolls, and getting to a thing like that is not really what you’d expect. But it’s been dogged and they’ve pursued every single twist and turn of this.”
There are further twists and turns in the mesh story ahead.
The UK Government ordered a retrospective review of the use of the implants and they have been banned outright in Australia and New Zealand, using the evidence gathered in Scotland.
Meanwhile back home, Health Secretary Shona Robison commissioned a further review by health academic Alison Britton, which is due to be published this year. It is looking at the process of the independent inquiry, and why it was changed between drafts.
The three MSPs credit the persistence of the two women who brought the petition to parliament and the work of the petitions committee, which also has a final report to produce.
“You don’t have the equivalent in Westminster,” says Neil.
“I mean, there is a committee that will look at petitions, but it’s not the same. I think the petitions committee has been one of the outstanding successes of this parliament from day one.
“I think John McAllion was the first convener of it. It’s always been a great committee.
“We’ve got this ridiculous system where the party leaders decide who sits on what committee, which I think needs fundamentally changed, but that’s a separate issue for another day. But the party leaders, from day one, have put people on the petitions committee who were perhaps regarded as a bit of an awkward squad. People who have, you know, been a bit…”
Carlaw, once a longstanding member of the committee, interrupts: “I think particularly when the parliament was initially founded and there was still a Westminster experience in the leadership, they saw the petitions as it was seen at Westminster.”
“They saw it as a side show,” adds Neil.
Carlaw continues: “Yes, and I actually thought it was interesting when Jim Murphy became leader of the Labour Party, he kind of downgraded the petitions responsibility within the party because he didn’t think it mattered terribly much, whereas those of us who have grown up through the system here know that it’s a much more powerful committee than that.”
Neil agrees. “It’s one of the most powerful committees in the parliament,” he adds.
The committee recognises that the petitioners were let down in this case, he says.
“The review of the review wouldn’t have happened without the petitions committee, quite frankly, and I think the review of the review is going to be what blows this whole thing open,” he predicts.
Carlaw remembers: “The electrifying moment for me was when the man from the [UK Medicines and Healthcare products Regulatory Agency] MHRA turned up and said there was only about half a dozen women affected, when sitting behind him were about 60 women who were affected. They absolutely couldn’t contain themselves at that point.”
Carlaw suggests petitioners could get more support when facing the committee, an idea he fed into the Presiding Officer’s commission into parliamentary reform.
“I sat in one petition when somebody passed out during the course of giving evidence so we had to suspend proceedings,” he remembers.
“Only because they were listening to you,” quips Findlay.
In the case of the mesh survivors, the group established its own support network, which Carlaw describes as “a rock for Elaine and Olive through all of this.”
“They’ve done it with tremendous clarity and persistence and courage. That’s been a key thing too. That spurs us on, actually.”
“Yes,” says Neil.
“Totally,” agrees Findlay.
At one point, Neil had suggested Scotland could host an international conference on mesh, and he and Carlaw are still hopeful such an event could happen, but Findlay suggests that the moment has passed.
“We had the opportunity to lead and we blew it. We flunked it,” he says.
“But now we’ve started to penetrate the political system in England, where it was not on the agenda at all.”
Findlay’s former aide Tommy Kane, who originally drafted the petition alongside the campaigners, now works in Westminster and has supported Owen Smith MP to form an all-party parliamentary group (APPG).
“Plus, my colleague Paul Masterton, who is of course Elaine’s MP now,” adds Carlaw.
“He was very good in the Westminster Hall debate,” says Findlay, “so it’s now starting to get through into the consciousness down there.”
Neil suggests the three of them should go down and talk to the APPG at Westminster, to advocate replacing the MHRA.
“This is not the only issue they have failed on,” he says.
“We’ve all agreed with that,” says Carlaw.
Like the vaginal mesh scandal, this unlikely alliance seems set to continue.
https://www.holyrood.com/articles/inside-politics/vaginal-mesh-scandal-scotlands-unlikely-political-allegiance
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Mar 31, 2018 | The Daily Mail
By Martyn Halle
· Stress incontinence is more common with overweight women and mothers
· Eight out of ten women treated with a new jab have seen an improvement
· Previous treatments have included inserting a mesh into the affected area
· The new injection treatment can be completed in as little as 15 minutes
Thousands of women suffering embarrassing bladder problems could be spared risky and invasive surgery thanks to a simple jab.
The injections treat a form of the condition called stress urinary incontinence (SUI), which is more common with age and among women who are overweight or who have had children.
Studies show that eight in ten women find the procedure effective, meaning it could be a viable alternative to the now banned mesh-implant operation previously offered to patients.
Four out of ten mothers experience difficulties ‘holding on’ after giving birth. Among those affected is actress Kate Winslet, 42, who owned up in 2015 to suffering accidents while sneezing.
Five million British women are said to suffer from some sort of urinary incontinence.
SUI is caused by a weakness in the pelvic-floor muscles and prevents the urethra, the tube that carries urine out of the body, from closing fully. When sudden pressure is put on the bladder, urine can leak out – and this can happen during normal daily activities such as walking, or when coughing or laughing.
Until recently, the most popular and effective treatment for moderate to severe SUI was to insert a mesh implant to support the bladder. But health watchdogs last year warned against offering the procedure after reports of post-operative complications with healing, which left women suffering severe pain. Now there could be a safer, non-invasive alternative. Called Bulkamid, it involves having up to four injections in the tissue surrounding the neck of the bladder.
The injections contain a smooth, watery gel that stays pliable. This plumps or bulks up the tissue in the neck of the bladder to stop urine leaking.
The injections are administered under local anaesthetic in a procedure lasting just 15 minutes.
Bulkamid was originally developed in 2006, and experts say there is now enough evidence on its effectiveness that it can be considered a viable alternative to mesh surgery.
The treatment was originally reserved for older women who were considered not fit for surgery. Initial trial results showed the success rate – defined as patients needing only one round of treatment – was about 50 per cent.
But changing the positioning of the injections around the neck of the bladder and offering them also to younger women has pushed up the success rate to 80 per cent. There are no known side effects, apart from the pain of the injection, which has been likened to a dental anaesthetic jab.
Success rates with the mesh had been quoted as high as 90 per cent.
A 2015 study published in the Central European Journal Of Urology looked at how effective injections were among 250 women after three years. It showed 82 per cent were either cured or had a significant improvement in their symptoms.
Meanwhile, British research presented to the International Continence Society meeting showed a success rate of 89 per cent.
Helen Johnson, a leading specialist in urogynaecology at Hinchingbrooke Hospital in Cambridgeshire, has been using the injections for years as an alternative form of treatment. She says: ‘The injection has taken a back seat in recent years while the mesh and tape – another surgical option that is still available – have been promoted. Initially, that made sense as results from injections were nowhere near as good.
‘Now, thanks to advances with the injection, its success rate is not far off the mesh or tape. Therefore it makes sense to offer many the injections as a first choice.
‘Some patients suffer stress urinary incontinence because of a prolapse of the womb due to childbirth. In severe cases, surgery is likely still to be the best option.’
Steve Foley, a urogynaecologist at the Royal Berkshire Hospital in Reading, adds: ‘The great thing about the injections is they are minimally invasive and we now have good data on safety and effectiveness.’
During the procedure, 2mm of gel is injected into three or four areas of the bladder neck and it looks like a puffed-up cushion when seen on a scan image.
Ann Wells, 71, from Reading, was first treated with Bulkamid five years ago. She then had a ‘top-up’ injection earlier this year. ‘Mr Foley recommended the injection as the most appropriate and least invasive option,’ she says.
‘It made such a difference to my life. I didn’t need to wear pads again and those embarrassing leaks when coughing, sneezing or walking up a hill were a thing of a past.
‘I was advised at the time that I might need a top-up jab within a few years. So when I became aware of a few little leaks again, I didn’t think twice about asking for a referral.
‘Once again, the results have been remarkable and I would have no hesitation in recommending the treatment to others.’
http://www.dailymail.co.uk/health/article-5565103/The-simple-jab-helping-women-wee-problem.html
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Regulators, doctors in firing line after Senate report on pelvic mesh scandal.
Apr 2, 2018 | Newcastle Herald
By Joanne McCarthy
WOMEN victims of Australia’s pelvic mesh scandal say a Senate report released last week has not gone far enough to hold regulators, health bureaucracies, doctors and doctors’ groups accountable.
Peak health consumer groups across the country have called for a new inquiry into Australia’s device regulator, the Therapeutic Goods Administration (TGA), after the Senate report said criticism of the lag between mesh complaints and regulatory responses was justified.
The consumer groups have backed women’s groups that say the Senate report’s recommendations and findings could have gone further.
“The TGA is culpable for a shocking lag in regulatory response to emerging evidence of complications relating to mesh implanted through the vagina,” said Australian Pelvic Mesh Support Group spokesperson Linda Schultz.
The support group, representing mesh-injured women from across the country, said the Senate report acknowledged the significant financial impacts of failed mesh surgery, including many women forced to stop work, suffering marriage breakdowns and losing their homes. But it gave no specific solutions, the group said.
The committee can find no reasonable justification for the dismissive and disrespectful treatment many women have experienced from trusted medical professionals. Senate inquiry report into pelvic mesh device scandal
“There are a few glimmers of hope for mesh-injured women in the report, but the wording used in the recommendations is so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual,” said Ms Schultz.
The Senate report recommended broad reforms across the health system, including mandatory reporting of adverse events by doctors, a national registry for all high risk implantable devices, a more comprehensive monitoring scheme for devices approved for use in Australia, an audit of all mesh devices implanted and establishment of specialist medical units for mesh victims.
It also recommended a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements” to doctors and teaching hospitals.
The Senate committee was concerned that it is not possible to accurately identify the number of women who have received mesh implants after evidence that Medicare item numbers do not distinguish mesh surgery from other incontinence and prolapse surgery.
“The committee considers that an understanding of the true scale of the risk posed by mesh devices, or any implantable medical device, is fundamental to tailoring an effective regulatory response,” the report said.
Pelvic mesh inquiry chair Senator Rachel Siewert said she was “deeply concerned” that in 2015-16 there were 17,599 prolapse services funded under Medicare and 5339 services for incontinence, but the committee could not determine how many were for mesh implants rather than surgery without mesh.
The figures showed that prolapse surgery was funded at more than three times the rate of incontinence surgery, despite strong evidence and warnings from Australian and American regulators by 2015-16 that mesh implants for prolapse had significantly higher complication rates than incontinence “sling” meshes.
Senator Siewert said it was a concern that lack of data meant the figures could not be examined to see if doctors were implanting the problem prolapse meshes at a much higher rate than incontinence slings despite the warnings.
The Senate inquiry committee said it was “deeply concerned” by women’s accounts of how some doctors treated them.
“They present the medical profession in a very poor light. The committee can find no reasonable justification for the dismissive and disrespectful treatment many women have experienced from trusted medical professionals,” the Senate report concluded.
Ms Schultz said mesh-injured women faced “chronic gender discrimination, ignorance, complacency and abusive treatment” from doctors and others in the health system.
Peak health consumer group spokesperson Melissa Fox said a key question for governments was why it had taken a decade since the TGA first reviewed the safety of pelvic mesh devices, and the need for women to lobby for a Senate inquiry, to “shine a light on this issue”.
“We call on the federal, state and territory governments to hold a separate inquiry into the responsibilities, operations and funding of the TGA, with special emphasis on its failure to provide timely warnings,” Ms Fox said.
The inquiry needed to include investigating why state and federal health service complaints processes failed to identify a pattern of mesh failure, despite many women repeatedly complaining for years, she said.
The peak health consumer groups said they were disappointed the Senate committee had not recommended suspension of all mesh until data confirms their safety and efficacy.
“These devices will continue to be implanted in women in hospitals across Australia tomorrow, and not one more woman should be unwittingly subjected to this high-stakes surgical intervention until we can be assured of their safety,” Ms Fox said.
The peak health groups have backed mesh-injured women who say the need for long-term, compassionate, specialist support units across the country has to be a priority for governments.
While different states have established some services, the report acknowledged they may be “inadequate” after the committee was advised initial consultation had been confined to doctors and doctors’s groups.
The report recommended governments provide services after speaking with mesh-injured women about their needs. The recommendation was backed by the mesh support groups.
“We strongly welcome the recommendation that mesh-injured women are involved in the co-design of all specialist mesh clinics and insist that it happen,” said Ms Schultz on behalf of the mesh support groups.
“Women will not regain trust in the health system if these clinics do not treat them holistically and with empathy. It also requires full disclosure of the level of experience, and interests, of the clinicians treating patients.”
http://www.theherald.com.au/story/5313689/countdown-to-a-mesh-scandal-how-a-system-failed-women/
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These Breast Implants Left Women With ‘Rotting Pelvises’
Mar 30, 2018 | New Beauty
By Julie Ricevuto
Childbirth can lead to a lot of complications within a woman’s body, with one of the more common effects being a prolapsed bowel and bladder. In order to combat this, many women opt for a pelvic mesh implant, however, new findings are revealing that this might not be the best solution.
Like many women, Linda Schulz—a 48-year-old woman from Australia—had a pelvic mesh implant surgically inserted into her body after giving birth. According to CNN, her right leg went numb almost immediately after the procedure and after just a few weeks, she claims the mesh felt like a knife constantly cutting her up from the inside.
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"The mesh cut through my vagina wall and came through my skin,"Schulz tells CNN. "Any movement, whether I moved my legs or not, felt like a serrated-edge knife was cutting me."
Another Australian woman with the implant, Justine Watson, had pain so severe after her implant was inserted, that she tried to take her own life after doctors didn’t believe her pain was real. “As these devices were to be permanent, we are meant to live with rotting pelvises forever," said Watson to CNN.
Because of this harrowing complication, Schulz and hundreds of other women with similar experiences petitioned the Australian Senate to investigate the mesh implants. As a result, the Senate released a report advising that the implant should only be used as a “last result” because it had been brought to light that doctors had “overused” the procedure “without considering alternative options.”
"Women who have had those implants, who have those outcomes...have been failed in a monumental way by the system and by certain people in the medical profession who they trusted," said Senator Rachel Siewert when introducing the report to the Senate. "I hope we never have to have another inquiry where we see such suffering from the witnesses."
In the United States, the Food and Drug Administration estimates 75,000 procedures involving pelvic mesh implants occur each year. However, in 2011, there were 2,874 cases of injury, death or malfunction related to the implants reported. With numbers like this, it’s important to know the risks before opting for one, which is why this report announced by the Australian Senate is such a big deal.
While this is certainly a step in the right direction, it’s not enough to completely eliminate the risks of pelvic mesh implants. However, hopefully it’ll spark research into other options for post-childbirth complications such as this so women won't experience this again.
https://www.newbeauty.com/blog/dailybeauty/12104-pelvic-mesh-implants-rotting-pelvises/
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This Birth Control Device Kept Making Women Sick. The FDA Kept It On The Market.
Apr 1, 2018 | Huffington Post
By Jennifer Block
Last month, Food and Drug Administration Commissioner Scott Gottlieb met with a group of women who’ve been knocking on the agency’s door for years.
Online, they’re known as E-sisters: women who were implanted with the permanent “non-incisional” contraceptive called Essure, which consists of metal coils that are implanted into the fallopian tubes and contain nickel. The E-sisters believe Essure has caused them ― and tens of thousands of others ― a constellation of health problems, from bleeding, bloating and pelvic pain to more obscure symptoms like rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction.
The women asked the commissioner to take Essure off the market. They brought with them a large photo album of sister sufferers and their grisly symptoms. They also brought Madris Tomes, a former FDA analyst who launched her own software company to better track adverse events reported to the agency. These are public files, but are not easily searchable by the public or even the FDA, according to Tomes. She told Gottlieb she had logged more than 26,000 reports about Essure to date, including eight adult deaths. At the time, the FDA told BuzzFeed News it was still counting reports from 2017.
The women asked if a ban might be on the table. Everything is on the table, they recall being told. On March 7, Gottlieb gave them his official answer: Essure will remain on the market.
It shouldn’t come as a surprise that the FDA didn’t ban the device. The agency has only withdrawn two devices from the market, ever: prosthetic hair fibers and powdered medical gloves. Instead, FDA favors “black box” warnings to alert the public to possible dangers, or it may require further study, during which time devices are kept on the market.
“Once medical devices get on the market, it’s extremely difficult to get them off the market, even in the face of evidence suggesting that either they’re ineffective, or worse causing harm,” says Michael Carome of the consumer advocacy group Public Citizen. This loose oversight might concern consumers— and women in particular. In addition to Essure, two other risky gynecological devices remain in use: the power morcellator and pelvic mesh.Once medical devices get on the market, it’s extremely difficult to get them off the market.Michael Carome, Public Citizen
The morcellator is essentially a surgical hand blender that has been used to chop up fibroids and uteruses inside the abdominal cavity so they can be removed piecemeal through “minimally invasive” laparoscopic surgery. The process has the potential to spread malignant cells, causing a hidden cancer to proliferate in new locations. The FDA estimates this cancer is found in 1 in 350 women undergoing fibroid removal surgery, though a recent study suggests the likelihood is closer to 1 in 100.
The agency ultimately gave it a black box warning, which puts the onus on surgeons to either avoid the device or warn patients of this possible outcome. But the practice continues in various forms with equivocal encouragement from professional medical societies like the American Congress of Obstetricians and Gynecologists and the Association of Gynecologic Laparoscopists. Late last year, the FDA reiterated its black box warning and reported that “some groups continue to request that we scale back our recommendations.”
You’ve likely run into pelvic mesh in news headlines or late-night lawyer ads. These pieces of polypropylene netting were packaged and marketed specifically to OB-GYNs for “minimally-invasive” vaginal surgery. The goal was to hand them a tool with which they could resolve urinary incontinence or pelvic organ prolapse themselves, rather than referring out to specialized surgeons.
Studies have shown that around 10 percent of meshes used for prolapse result in “erosion,” which is when the mesh works its way into the surface of the vagina or into an organ. One woman described it to the FDA as “a cigarette burn that leaves the entire vaginal wall red and inflamed, and each step you take rubs the open wound against the other side.”
In 2008, the FDA issued a “public health notification” about transvaginal mesh designed to treat prolapse, and in 2016, the agency reclassified it as a Class III device. This means that any such meshes new to the market need to go through the more rigorous “premarket approval” process, and applications need to be submitted for those already on the market.
It also means that untold numbers of women have been harmed in the meantime; around 100,000 have sued mesh manufacturers. Yet mesh is still the standard of care for female incontinence.
Both the power morcellator and modern pelvic meshes were approved by the FDA without a single clinical trial, through what’s called the 510K process. Devices with this classification need only prove they are “substantially equivalent” to a previously approved device, which may have been equivalent to another device, and so on ― and the root device may never have been clinically tested. This was the case for both transvaginal mesh and the power morcellator.
Essure, by contrast, went through the more rigorous Class III approval process. The manufacturer at the time, Conceptus, had to conduct trials and present its application to an advisory committee. But even this process is flawed. At the hearing, the company touted Essure’s near-perfect effectiveness in preventing pregnancy and its high levels of satisfaction among women.But in the following years, independent research challenged these claims. A Yale review found the clinical trials “inadequately rigorous.” A recent JAMA study found that 5 percent of women who had hysteroscopic sterilization, accomplished with devices like Essure, required follow-up surgery. Another study found that women who had Essure were 10 times more likely to need follow-up surgery within a year than women who had their tubes tied.
That follow-up surgery, by the way, is not minor: After the Essure coils have embedded into the fallopian tubes and corners of the uterus, as they are designed to do, most surgeons feel a hysterectomy is the best way to get them out. The women online post pictures from their hospital beds holding an “E-Free” poster with the date of their surgery.
The U.S. is the only country in the world where Essure is still available. Since November, Bayer has removed Essure from every other market for “commercial reasons” that have, it has said, nothing to do with safety. But sales have been falling here as well. With demand waning, one has to wonder if current owner Bayer is just waiting for supply to run out. The U.S. is the only country in the world where Essure is still available.
As disappointing as Gottlieb’s announcement was to the E-sisters, it leaves the door open a crack for more regulatory pressure. The agency “is actively evaluating a significant collection of new medical device reports submitted to FDA on the Essure device.” The FDA said it received 12,000 reports in 2017 alone, and the majority were filed at the end of the year, prompted by litigation against Bayer. “We’re working to evaluate whether these cases reflect new safety concerns,” said Gottlieb.
There may be more cases to come. While reporting on Essure last year, I obtained inspection reports that pointed to some 32,000 complaints to Conceptus that were never officially reported to the FDA. Confronted with the complaints, the FDA said it had investigated a “random sample,” and with the exception of a couple hundred, these did not rise to the level of an adverse event.
But the agency would not turn over the actual files — Madris Tomes filed a Freedom Of Information Act request for them two years ago. It’s unclear whether this recent dump of old reports came from that pile.
The FDA, meanwhile, continues to say it is evaluating Essure’s “risk and benefits.” But when does the former outweigh the latter? It’s a question that nobody will put a number on. Politically, it doesn’t seem to matter. The thrust in Washington has been to “streamline” the FDA approval process — in December, Gottlieb made a point of noting that devices should have a “progressive” path to market.
But as the speed and number of approvals have increased, so has the number of black-box warnings — at least for drugs, which are studied more closely than devices are. In practice, manufacturers, rather than our regulatory agency, decide whether or not a product stays on the market.
Health watchdogs suspect all this has something to do with the substantial fees that pharmaceutical companies pay to the FDA. According to the Project on Government Oversight, the agency now depends on those fees for more than half its funding. The revolving door between the industry and the agency tasked with regulating that industry is also a concern. Gottlieb himself came straight from consultancies and board memberships with various pharmaceutical companies.
Less than a week before the E-sisters’ meeting with Gottlieb, one of the group’s leaders, Amanda Rusmisell, got a call from an adviser for Gottlieb. The adviser asked that no attorneys join the meeting because their presence would be a distraction toward the litigation against Bayer, according to Rusmisell.
This confused Rusmisell. She responded that the attorneys (who ultimately did attend) had important information to share about women’s experiences with the device. Wasn’t that the focus of the meeting? Isn’t that in line with the FDA’s mandate: to protect the public’s health?
The FDA didn’t respond when asked about this phone call.
Jennifer Block is an investigative journalist focused on health. She is the author of Pushed: The Painful Truth About Childbirth and Modern Maternity Care and a forthcoming book on women’s health in the age of empowerment (St. Martin’s).
This article was reported in partnership with The Investigative Fund at The Nation Institute.
https://www.huffingtonpost.com/entry/opinion-block-essure-contraception-fda_us_5abe8ec0e4b0f112dc9c2e69
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McGinnis Ends Testimony in Bard Transvaginal Mesh New Jersey Trial
Mar 31, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 31, 2018 ~ As the second week of the latest C.R. Bard transvaginal mesh wraps up in New Jersey, jurors appear to be impressed with the North Carolina plaintiff and her husband.
Mary McGinnis testified Thursday in the second week of her product liability transvaginal mesh trial being held in Bergen Co. New Jersey. She is represented by Adam Slater of Mazie, Slater, Katz & Freeman.
McGinnis, 62, was implanted with two meshes made by C.R. Bard, a Murray Hill, New Jersey company. The two polypropylene implants – Avaulta and Align – were used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Avaulta is intended to treat stage 3 or 4 POP. McGinnis is reported to have had stage 2.
McGinnis claims she lives in chronic pain from the implants and pudendal neuralgia nerve damage and that Bard failed to warn the doctors who implant them in patients. Defense claims Ms. McGinnis had preexisting conditions that cause her pelvic pain.
On Thursday, McGinnis took the stand.
She carefully explained to the jury about the childcare business she runs out of her North Carolina home. The eight-person jury listened to her description of the advanced, nurturing environment she tries to create for the children she cares for.
More of her personality unfolded as she described her relationship with her husband, Tom. She and Tom have been together since they were 15-years-old.
Tom testified Wednesday about what his wife is going through and their relationship today. In order to sleep, Mary has to have an ice pack to stop the burning that accompanies her nerve pain.
The five men and three women who make up the jury, reportedly seemed moved by the testimony.
PELVIC MESH LITERATURE ON SAFETY
On Monday, March 26, and Tuesday, March 27, plaintiff expert witness, Dr. Anne Weber, MD, a urogynecologist, who appeared at the Budke trial in Missouri and the Gross trial in New Jersey, provided an overview of key literature available before Bard sold the products.
All of the authors she cited said there was not enough data to support the safety of the transvaginal mesh implants.
A clinical evaluation report, prepared to sell a device oversees, showed articles cited for mesh use that didn’t support safety, such as literature by Drs. Michel Cosson, Daniel Altman, and the French TVM group. The meshes in this trial are intended for prolapse stage 3 or 4. Mary had stage 2.
You may recall, Dr. Weber called out the ACOG practice bulletin after it eliminated the word “experimental” in the description of the use of pelvic mesh implants, clearing the way for insurance coverage.
DR. SHLOMO RAZ
Back to the Bergen Co. courtroom, a video of Dr. Shlomo Raz was played Wednesday. He testified the polypropylene meshes are very dangerous and he’s never used a transobturator mesh with trocars. Instead, Dr. Raz used to cut his own mesh into strips from polypropylene mesh sheets. He stopped using mesh when he saw repeated long-term complications.
Dr. Raz did a groin removal of Mary’s meshes. The arms of the Align and Avaulta had fused together into a mass that was cemented into her pubic bone.
The world-famous mesh removal doctor reportedly got them out.
He said most doctors won’t use the products anymore because of long-term complications.
On cross-examination, an orthopedist called by the plaintiff, Dr. Samuel Snyder, countered the defense argument that McGinnis’ injury is due to arthritis.
Lori Cohen, a defense attorney with Greenberg Traurig, also said McGinnis refused to go for treatment to an orthopedist. However, it was revealed that the appointments were to treat a rotator cuff injury and tendonitis in McGinnis’ shoulder!
Slater paid the video of Bard VP of Research, Roger Darois, and Bard Chief Operating Officer, John Weiland who talked about liability concerns.
(Mesh News Desk has reported on Darois and his insistence that a third party company, Red Oaks, purchase raw polypropylene resin from the petroleum supplier Phillips Sumika for Bard, because Philips stated it didn’t want its resin to be used for implantable medical devices).
IMPLANTING PHYSICIAN
Implanting doctor, gynecologist, Dr. Elizabeth Barbee of Raleigh, North Carolina told jurors if she knew what Bard knew she would not have used the devices.
Under cross-examination from Lori Cohen, Barbee testified the device had not rolled or curled during the implant procedure. Dr. Barbee admitted there are risks associated with any surgery and that such mesh devices were referred to as the “gold standard” for POP and SUI in 2009.
Dr. Barbee was the implanting doctor in the Queen case, heard in Charleston, West Virginia in August 2013. Ms. Queen also received a Bard Avaulta. The case ended with an undisclosed settlement.
FIRST DAY OF TRIAL
According to Legal Newsline, on the opening day of trial, Slater told the jury the chemicals in the polypropylene devices caused vaginal tissue to become inflamed causing the body to attack the foreign invader.
“The body reacts to it,” Slater said. “Cells attack the foreign invader. Scar tissue forms and the reaction is permanent.”
The plaintiffs wrapped up their case Thursday.
What’s’ not allowed to be mentioned in this trial is that both Bard meshes, the Avaulta and Align, are off the market.
The jury will decide, perhaps as early as next week, whether each mesh was defectively designed and whether Dr. Barbee was adequately warned in order to be able to warn her patients.
Expect the defense case to pick up on Monday.
McGinnis v C.R. Bard is case No. L01754314 being heard in Bergen County state court, New Jersey Superior Court, before Judge James DeLuca. ###
LEARN MORE:
MND, August 18, 2013, Queen Trial Day one
https://www.meshmedicaldevicenewsdesk.com/wanda-and-greg-queen-v-c-r-bard-transvaginal-mesh-trial-day-one/MND, March 21, 2018, McGinnis v C.E. Bard- What We Know form Past TVM Trials
https://www.meshmedicaldevicenewsdesk.com/mcginnis-v-c-r-bard-know-past-tvm-trials/MND, April 7, 2016, Dr. Raz Tells Docs Why He Will Not use Synthetic Mesh Slings!
https://www.meshmedicaldevicenewsdesk.com/dr-raz-tells-docs-can-not-use-synthetic-mesh-slings/MND, Bard Execs Sell off Stock. February 22, 2015
https://www.meshmedicaldevicenewsdesk.com/dr-raz-tells-docs-can-not-use-synthetic-mesh-slings/MND, January 13, 2015, Urogynecologist Credibility Under Attack in Missouri Pelvic Mesh Death Trial,
https://www.meshmedicaldevicenewsdesk.com/urogynecologist-credibility-under-attack-in-missouri-pelvic-mesh-death-trial/MND December 10, 2015, Witnesses in Philadelphia Mesh Trial Tell Tale of Prolift Mesh Marketing
https://www.meshmedicaldevicenewsdesk.com/10023-2/https://www.meshmedicaldevicenewsdesk.com/mcginnis-ends-testimony-in-bard-transvaginal-mesh-new-jersey-trial/
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Ethicon Physiomesh Bellwether Trials to Start in September, 2019
Mar 30, 2018 | Lawyers and Settlements
By Gordon Gibb
Physiomesh lawsuits are expected to grow as Multidistrict Litigation housed in Georgia readies for bellwether trials to begin within eighteen months. By then, lawsuits could number into the thousands.
Atlanta, GA Plaintiff Sharon Smith would be understandably buoyed by news that the surgical mesh lawsuit file currently housed in multi-district litigation in Georgia is moving forward, with the first bellwether trials expected for September of next year. While nearly 500 lawsuits are currently housed in the MDL, a continuing barrage of cases have lead observers to believe that thousands of lawsuits could wind up in the MDL by the time bellwether cases begin in 18 months’ time.
Physiomesh was introduced with much fanfare eight years ago this month against the backdrop of an aging American population experiencing increasing issues with abdominal hernias and other internal issues requiring surgical repair. Increasing use of laparoscopic surgeries in an effort to simplify the surgical process, speed healing and spare hospital resources had fostered a parade of new products aimed at improving outcomes.
Yet another example of a next-generation product beset with problems
Ethicon’s Physiomesh, manufactured by the Johnson & Johnson subsidiary, featured a polypropylene mesh with the addition of a coating on each side of the mesh designed to absorb into the body and thereby helping the mesh to incorporate internally. Minimizing inflammation was also an oft-touted benefit.
But there were problems. An increasing array of surgical mesh complications and resulting revision surgeries prompted Ethicon to recall their Physiomesh product last year, with many a plaintiff lining up to file a hernia mesh lawsuit thereafter.
One of those plaintiffs is Sharon Smith, who filed her surgical mesh side effects lawsuit in January. The California woman reported that she continued to experience severe pain and discomfort following the implantation of Ethicon Physiomesh Flexible Composite Mesh in August, 2012. More than five years later, surgeons confirmed in October of last year that Smith’s problems linked back to surgical mesh complications associated with the mesh she had received in 2012.
“Defendants omitted the risks, dangers, defects, and disadvantages of the Products, and advertised, promoted, marketed, sold and distributed the Products as safe medical devices when Defendants knew or should have known that the Products were not safe for their intended purposes, and that the Products would cause, and did cause, serious medical problems, and in some patients, including Plaintiff, catastrophic injuries,” Smith’s lawsuit states. “Defendants have underreported information about the propensity of the Products to fail and cause injury and complications, and have made unfounded representations regarding the efficacy and safety of the Products through various means and media.”
While Smith’s lawsuit was originally filed in US District Court for the Central District of California, it is destined for the MDL under the supervision of US District Judge Richard Story in the Northern District of Georgia.
The process has begun to select cases for bellwether trials in September, 2019
An order issued in mid-January calls for the selection of 24 potential cases from a pool of cases that stood as at January 11. Plaintiffs would select 12, as would the defendants – with all selections to be complete in May.The Order calls for the selection of a further ten cases – 5 from each side – to be added to the previous pool and completion of the selection process due by June 22, with final fact sheets for all 34 cases due by August 21.
From that pool, 10 cases (5 each) would be selected for the trial pool by December 1 of this year, with bellwether trials expected to start in September, 2019.
The Smith lawsuit is Sharon Smith v. Johnson & Johnson & Ethicon Inc., Case No. 2:18-cv-00497, originally filed January 19 of this year at US District Court for the Central District of California.
The Ethicon Physiomesh multidistrict litigation is IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL No. 2782, in US District Court for the Northern District of Georgia, Atlanta Division.https://www.lawyersandsettlements.com/articles/mesh-complications/ethicon-physiomesh-bellwether-trials-start-in-september-2019-22898.html
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