Preview Newsletter
Ethicon Media Monitoring 12/13/2017
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J&J New Jersey Mesh Trial Wraps Up
Dec 12, 2017 | Mesh Medical Device Newsdesk
The pelvic mesh trial of plaintiff Elizabeth Hyrmoc will wrap up this week with closing arguments presented Wednesday, December 13. -
New Zealand Restricts All Transvaginal Mesh Implants
Dec 12, 2017 | Mesh Medical Device Newsdesk
Whether petitioning Parliament, partaking in on-camera interviews or newspaper stories, anti-mesh campaigners from around the world are seeing the results of their efforts. -
New Zealand becomes first country to fully ban controversial vaginal mesh procedures
Dec 12, 2017 | The Independent
By Harriet Marsden
New Zealand has become the first major country in the world to ban all vaginal mesh procedures, which have been called “the biggest health scandal since thalidomide”. -
New Zealand bans vaginal mesh implants
Dec 12, 2017 | The Guardian
By Hannah Devlin
New Zealand has become the first major country to effectively ban vaginal mesh implants in response to safety concerns over the surgery. -
New Zealand bans vaginal mesh over safety fears
Dec 12, 2017 | Sky News
By Charlotte Lomas
New Zealand has banned the use of vaginal mesh for the repair of prolapse and stress urinary incontinence. -
New Zealand Has Basically Banned Mesh Products Until Suppliers Can Prove They Are Safe
Dec 13, 2017 | Buzzfeed
By Gina Rushton
“We’re always cautious about the use of the word ‘ban’, but effectively the companies are agreeing no longer to sell these products ... in New Zealand from the 4th of January," the ministry's spokesman Dr. Stewart Jessamine said on Monday. -
New Zealand Effectively Bans Vaginal Mesh
Dec 12, 2017 | Jezebel
By Kelly Faircloth
Citing safety concerns, New Zealand has introduced restrictions on vaginal mesh implants, which practically speaking puts the kibosh on their surgical use for the immediate future. -
Restriction on surgical mesh not enough, sufferer of 11 years says
Dec 13, 2017 | Stuff
By Miri Schroeter
In an 11-year battle since surgery, Glenys Mahoney has lost her job and her mobility. -
Family of Gore victim calls for wider ban on surgical mesh use
Dec 13, 2017 | Southland Times (In Stuff)
By Richard Davison
Following a partial ban on the use of surgical mesh, calls for a wider ban have been voiced. -
I’m representing women injured by vaginal mesh. This is what they have told me.
Dec 12, 2017 | iNews
By Kate O'Brien
Vaginal mesh has been used for a number of years, typically to help women who experience mild bouts of incontinence or prolapse following childbirth, hysterectomy or menopause. -
Doctors weren’t properly informed of vaginal mesh
Dec 12, 2017 | Infosurhoy
By Toby Murphy
A company owned by a multi-billion pound pharmaceutical failed to fully inform doctors of how dangerous vaginal mesh can be, a BBC Panorama investigation has found. -
Pennsylvania Judge Denies Ethicon’s Bid to Toss 100+ Transvaginal Mesh Lawsuits from Philadelphia Mass Tort Program
Dec 12, 2017 | RX Injury Help
By Laurie Villanueva
A Pennsylvania state court judge has denied Ethicon’s motion seeking to dismiss more than 100 transvaginal mesh lawsuits from a mass tort program currently underway in the Philadelphia Court of Common Pleas.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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J&J New Jersey Mesh Trial Wraps Up
Dec 12, 2017 | Mesh Medical Device Newsdesk
The pelvic mesh trial of plaintiff Elizabeth Hyrmoc will wrap up this week with closing arguments presented Wednesday, December 13.
Hrymoc was implanted with two mesh products made by Johnson & Johnson – the TVT-O and the Prolift.
Jurors in the New Jersey trial of Elizabeth Hrymoc are listening to lawyers for defendant Johnson & Johnson make its final plea about the safety of its pelvic mesh products. Closing arguments will be Wednesday in this Bergen County trial after an unusually short trial, just 17 days.
Ms. Hrymoc was implanted with Prolift transvaginal mesh, used to treat pelvic organ prolapse, and a TVT-O used for incontinence.
Elizabeth Hyrmoc is represented by Adam Slater (Mazie Slater) who also represented Linda Gross and Joan Budke. He called Prolift, “a stupid idea” with too much mesh that incites a foreign body reaction.
The case is Elizabeth Hrymoc v Ethicon, Case No. L-13696-14, heard in New Jersey Superior Court, Bergen Co. NJ, before the Honorable Rachelle Harz. This is the second pelvic mesh case heard in New Jersey. The cases in that state were moved from the original New Jersey venue of Atlantic City to Hackensack.
Adam Slater, Courtroom View Network
Slater told jurors during the trial that polypropylene (PP) mesh mixing with bodily fluids causing the PP mesh to be come brittle and completely impossible to remove. Defense has compared mesh to PP suture. Ms. Hyrmoc suffers from pain, infection and dyspareunia.
Dr. Elizabeth Kaveler, urologist witness for Ethicon, CVN, Gross trial
Representing Ethicon is Judy Wahrenberger, Ruprecht Hart Weeks and Ricciardulli LLP; Riker Danzig Scherer Hyland & Perretti LLP; and Butler Snow. Wahrenberger said Hrymock had a long history of pelvic problems and that all surgeries carry risks.
Hrymoc, 71, a research technician from South River in Middlesex County, sat with her husband, Tad, listening to Slater’s opening. They are seeking damages in what NorthJersey.com calls the “largest tort claims litigation in history.”
Dr. Elizabeth Kavaler, a New York City urogynecologist appeared as an expert witness on the stand for Johnson & Johnson Tuesday, where she was cross-examined by Slater. She was also an expert in the Beltz and the Gross cases.
She has testified she was a “big mesh user” and is a consultant or preceptor for Ethicon. She has testified that mesh “does not have a life of its own,” and does not move around within the pelvis.
This was the first case in New Jersey since the Gross trial wrapped up in 2013 where jurors delivered $11.1 million to the nurse from South Dakota.
J&J is a company worth $70 billion and it should pay for its mistakes. “We know the only language they speak is money….. the only way to deter them and to punish them is to make them pay,” Slater told jurors.
The ten jurors (six men, four women) will decide if the Prolift has a design defect and whether J&J failed to warn doctors about its risks. For the TVT-O jurors will decide if Ethicon adequately warned doctors about its risks. Jurors have the option to award punitive damages, which typically exceed compensation for injuries in these pelvic mesh trials
Prolift has been found defectively designed in two cases heard in the Philadelphia Court of Common Pleas – Hammons ($12.5 million) and Beltz ($2.16 million). Nearby Philadelphia pelvic mesh trials have yielded jury awards ranging from $2.16 million to $57 million.
Defendants have been successful in just seven trials versus 22 plaintiff wins in courts around the country.
https://www.meshmedicaldevicenewsdesk.com/jj-new-jersey-mesh-trial-wraps/
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New Zealand Restricts All Transvaginal Mesh Implants
Dec 12, 2017 | Mesh Medical Device Newsdesk
Whether petitioning Parliament, partaking in on-camera interviews or newspaper stories, anti-mesh campaigners from around the world are seeing the results of their efforts.
The new restrictions on transvaginal mesh implants are the result of greater awareness on the part of the public and front-page news headlines.
New Zealand has gone one step further than any other country in its attitude toward the controversial polypropylene transvaginal mesh.
Early next year, New Zealand will restrict the use of all transvaginal mesh implants- those used to treat stress urinary incontinence (SUI) as well as pelvic organ prolapse (POP).
That means the small island nation is going one step further than its nearby neighbor, Australia, which announced last month, a ban on the use of mesh for POP only.
Hernia mesh, made of the same polypropylene plastic, is not included in the ban, even though many complain the implant mesh has left them with life-altering injuries as well.
The regulatory agency, Medsafe, similar to the U.S. Food and Drug Administration (FDA), will required four companies provide assurances safety about the safety of their devices.
Boston Scientific NZ, Johnson & Johnson Medical NZ, Culpan Medical, and Endotherapeutics NZ, both medical device suppliers, will comply with the requirements by January 4, 2018, according to a Medsafe news release here.
Carmel Berry, founder of the Mesh Down Under campaign, appeared on Radio New Zealand Monday morning. The group has been pushing for a ban since 2014.
“This is a complete about face and validation to what we’ve been saying all along is true. It shouldn’t have taken health officials this long….all the evidence we supplied obviously wasn’t enough…”
The health ministry now says there is enough evidence that the benefits of transvaginal mesh do not outweigh the risks. That is based on a PROSPECT study (here) released last year in the UK which came to the same conclusion after reviewing the results of more than 1,300 surgical procedures using either native repair (one’s own tissue) or a mesh graft.
Regulators in both Australia and New Zealand typically follow the lead of the FDA, which like Australia, is putting restrictions only on the larger POP mesh, used to treat pelvic organ prolapse.
In the U.S. the FDA gave POP mesh makers 30 months, beginning last January, to assure the safety of the larger polypropylene mesh implants or remove them from market. That period will end mid-2019. See MND story here.
The FDA has the authority to recall drugs and medical devices and consumer products, but more often asks for a voluntary removal from market. That move avoids protracted litigation.
New Zealand resembles the U.S. in that it does not require clinical trials before a manufacturer can sell its medical devices.
Product LiabilityUnlike the U.S. where product liability lawsuits address defective products, the government pays claims of the injured under ACC, the Accident Compensation Corporation.
ACC has paid $13 million in claims of chronic and infection to more than 800 patients over a dozen years, it was revealed last October.
ACC claims are the only way the government assesses complications as there is no national registry for mesh devices, something campaigners say is vitally needed to get some sort of handle on the actual number of injured patients.
The U.S. also has not definitive device registry, though medical records are supposed to contain a tag to identify the lot number of a medical device.
Products Affected
Products that will be affected include Boston Scientific Uphold Life, Solyx, Obtryx, Lynx, Advantage, Upsylon and Zenform Soft Tissue Repair.
Cuplan Medical’s Coloplast and its nine models. The TVT family of meshes from Johnson & Johnson including Gynemesh PS, TVT, TVT-O, Abbrevo, and Exact, the same type of mesh implanted in late campaigner from Canada, Chrissy Brajcic.
Doctors Weigh In
As one might expect, there is dissent among some medical doctors who still want the option of using a “sling” or “tape” as SUI mesh is often referred to.
Speaking on Radio NZ, gynecologist, Dr. Hanifa Koya, says she is in agreement with restrictions on POP mesh but she wants Medsafe to reconsider its “blanket rule “ ban on surgical mesh, which she uses to refer to SUI tape, a smaller piece of the same polypropylene mesh.
Dr. Koya says she used retropubic sling mesh for 21 years with a high success rate. Australia has not removed the incontinence sling and we should not either, she says.
Complications from a SUI polypropylene mesh are estimated to be a minimum of 15%, according to one report,
She does not feel the same way about SUI mesh that passes through the obturator space, also known as TVT-O mesh.
“The transobturator goes thru the groin and 20 percent of women suffer leg and groin pain,” she tells Radio NZ.
Dr. Hoya has observed that no single surgeon does vaginal repair the same way and that’s part of the problem. She has done 75 complicated mesh removal surgeries and wants to teach others how to do implants safely.
Also speaking on Radio NZ, International Urogynaecological Association president Lynsey Hayward, insists that SUI mesh is absolutely fine, she said, calling stress urinary incontinence an “extremely disabling condition.”
That’s the same language that jurors in the U.S. hear from defense attorneys at transvaginal mesh trials.
Hayward says the “tapes” that are used for urinary incontinence are safe and well-studied and the most widely used retropubic tape (also called a TVT), is used internationally, the majority of time very successfully.
AUSTRALIA
Last month, Australia’s Therapeutic Goods Administration banned surgical mesh implants for pelvic organ prolapse (POP), but left alone the meshes used for stress urinary incontinence (SUI).
Mesh Down Under’s Carmel Berry says the government’s position that SUI mesh is safe “when used in accordance with the manufacturers’ instruction by an appropriately trained surgeon,” should be removed from the website. Instead they should say new information shows that was wrong.
The ban applies to POP mesh and single incision mini-slings such as the TVT Secur (discontinued in March 2013), to treat SUI.
Outside federal court, Sydney, AU
The class action lawsuit filed by 700 women continues in a Sydney, Australia courthouse against Johnson & Johnson and its Ethicon division.
The case may wrap up this month. ###
https://www.meshmedicaldevicenewsdesk.com/new-zealand-restricts-transvaginal-mesh-implants/
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New Zealand becomes first country to fully ban controversial vaginal mesh procedures
Dec 12, 2017 | The Independent
By Harriet Marsden
New Zealand has become the first major country in the world to ban all vaginal mesh procedures, which have been called “the biggest health scandal since thalidomide”.
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) declared it would remove from supply and limit the use of surgical mesh products.
According to its statement, most suppliers in New Zealand have indicated that by January 2018, medical companies will "be taking the same steps to limit supply as they are in Australia”.
It comes just two weeks after the death of Chrissy Brajcic, a prominent anti-mesh campaigner who developed an antibiotic resistant infection due to mesh complications, which led to sepsis.
It also follows the decision by the Australian Therapeutic Goods Administration (TGA) toban single-incision minislings and transvaginalmesh implants specifically for treating pelvic organ prolapse.
In contrast, the health minister of New Zealand, Julie-Anne Genter, told companies they are not permitted to supply surgical mesh for any pelvic operations – including both urinary incontinence and prolapse.
Ms Genter said: “This is an important step to preventing more women from being put in the potentially harmful situation too many New Zealand women have already experienced.”
Surgical mesh will still be available for other conditions, such as hernias. Such treatments have also courted controversy.
Kath Sansom, founder of campaign group Sling the Mesh, told The Independent: “We are thrilled that New Zealand is leading the way in stopping the devastation caused to women by pelvic mesh implants.
"Full credit must go to campaigners Carmel Berry and Charlotte Korte, who have successfully made political leaders realise the serious harm caused by these devices.
“For some women, problems do not cut in until years later – which means the mesh is merely a ticking time bomb with an unknown future for all those who have it."
She added: “It is now time for Westminster and governments globally to do the right thing and ban all pelvic mesh. It is a huge injustice to women whose lives have been shattered for two decades, in this profit-before-patient safety, money-making tragedy.”
In October, Ms Sansom and Labour MP Emma Hardy took a cross-party campaign to Westminster to push for a suspension and full inquiry into the scandal.
However, minister for care and mental health Jackie Doyle-Price maintained that the risks were associated with clinical practice, not the mesh implants themselves, and ruled out a suspension or inquiry.
The Urological Society of Australia and New Zealand (USANZ) has condemned the decision, saying it left women in New Zealand without options.
A spokesperson said: “The Australian TGA decision to ban transvaginal mesh for pelvic organ prolapse is accepted by the urological community in Australia and New Zealand, but our health minister’s decision to ban all forms of mesh for incontinence as well as prolapse in women in New Zealand is more far-reaching than the Australian decision.
“This will leave women without effective surgical options for these debilitating conditions.”
One of the products specifically targeted by the New Zealand ban is the Johnson & Johnson “Gynecare TVT” device.
A BBC Panorama documentary on the vaginal mesh scandal, “The Operation that Ruined my Life”, revealed that the Gynecare TVT was only trialled on 31 women – and some sheep.
It also discovered that Ethicon, a wholly-owned subsidiary of Johnson & Johnson, failed to update doctors with the full extent of risks associated with the device.
There has been significant backlash to the suggestion in the documentary that only a minority of the women implanted with a mesh device experienced chronic and debilitating side effects.
Based on the available data and testimony from device experts, gynaecologists and policy organisations including the Food and Drug Administration, the US regulatory body, the risks of such effects are estimated between 10 and 40 per cent.
http://www.independent.co.uk/news/world/australasia/vaginal-tvt-mesh-scandal-incontinence-prolapse-ban-suspension-new-zealand-australia-nice-guidelines-a8105861.html
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New Zealand bans vaginal mesh implants
Dec 12, 2017 | The Guardian
By Hannah Devlin
New Zealand has become the first major country to effectively ban vaginal mesh implants in response to safety concerns over the surgery.
The country’s Ministry of Health announced on Monday that it had written to leading mesh suppliers asking them to stop marketing the products from January – or prove that their products are safe.
Ministry of Health spokesman, Stewart Jessamine, told a New Zealand radio station: “We’re always cautious about the use of the word ‘ban’, but effectively the companies are agreeing no longer to sell these products ... in New Zealand from the 4th of January.”
The move goes considerably further than recent announcements in other countries, such as Australia and the UK, which only restrict the use of pelvic mesh operations for organ prolapse. In New Zealand, the use of mesh implants to treat urinary incontinence, which accounts for the vast majority of mesh operations, will also be effectively banned, according to an announcement posted on the government website.
The decision has been applauded by campaigners, many of whom argue that the potential complications of mesh surgery, which include chronic pain and implants cutting through the vagina, are unacceptable. However, doctors expressed concern at the far-reaching nature of the ban.
It is now widely accepted that vaginal mesh should not be routinely offered for prolapse, where the pelvic organs bulge into the vagina. But many doctors maintain that mesh surgery to treat stress urinary incontinence can have advantages over traditional surgery and believe that these procedures should continue to be offered.
“This makes New Zealand the only country in the world to have banned all of these procedures and will leave women without effective surgical options for these debilitating conditions,” said Giovanni Losco, a urologist in Christchurch and spokesman for the Urological Society of Australia and New Zealand.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, says the medical profession needs to acknowledge that there have been major failings in regulation and act to address the issue. If they don’t then other regulators may also react with outright bans.
“[New Zealand] is basically saying ‘we can’t guarantee patient safety’,” he added.
Jessamine said that the decision had been taken after reviewing data on mesh safety provided in November by the Australian government, which had been carrying out its own inquiry into the use of pelvic implants. “We’ve reviewed that data and come to the opinion that the data is sound and we now believe the risks of the use of these products in the pelvis for prolapse and stress incontinence far outweighs the benefits,” he said.
“We’ve got an ability within our legislation to limit the use of those products, to discourage and ultimately remove those products from the market,” he added.
Owen Smith, a shadow cabinet minister, who chairs the all-party parliamentary group on surgical mesh implants, described the announcement as “hugely significant”. “It’s the first major country to effectively ban mesh for all pelvic operations. It’s precisely what we’ve been calling for in the UK.”
https://www.theguardian.com/science/2017/dec/12/new-zealand-bans-vaginal-mesh-implants
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New Zealand bans vaginal mesh over safety fears
Dec 12, 2017 | Sky News
By Charlotte Lomas
New Zealand has banned the use of vaginal mesh for the repair of prolapse and stress urinary incontinence.
The country's medical watchdog, Medsafe, said the mesh will be removed from supply by early January following safety concerns with the devices.
The decision comes after Australia became the first country to restrict the use of mesh in prolapse surgery.
Medsafe said: "As a consequence of the Australian TGA review of surgical mesh for urogynaecological use, and subsequent regulatory action, there is a case for Medsafe to question the safety of certain devices."
Vaginal mesh implants have been the subject of growing controversy after thousands of women said the mesh has left them in chronic pain, unable to work or unable to have sex.
One of the problems is that mesh, which is made out of polypropylene plastic, can erode, stiffen and slice through organs like the bladder.
Earlier this month, vaginal mesh campaigner Chrissy Brajcic died from sepsis after a four-year battle. It is reported that the sepsis had been caused by her mesh implant, which gave her recurrent infections.
Owen Smith, who set up an all-party parliamentary group on the mesh implants, said the news was a "significant step forward".
The MP added: "New Zealand is the first country to declare that the risks for women of all pelvic operations using mesh far outweigh the benefits and have acted on that conclusion with a ban on mesh from next year.
"That is precisely what we have been calling for here in the UK and we now need our ministers, regulatory authorities and medical professions to show similar leadership and ban mesh in the UK."
The UK regulator the MHRA says that mesh implants are effective for the majority of women and in an interview with Sky News earlier this year said: "There was no evidence from a regulatory point of view that mesh devices were inherently unsafe."
The MHRA insist the complication rate of vaginal mesh implants is between 1-3%. That's despite latest NHS figures obtained by Sky News showing it to be at least 10%.
Vaginal mesh has also been the subject of huge litigation around the world.
https://news.sky.com/story/new-zealand-bans-vaginal-mesh-over-safety-fears-11167897
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New Zealand Has Basically Banned Mesh Products Until Suppliers Can Prove They Are Safe
Dec 13, 2017 | Buzzfeed
By Gina Rushton
“We’re always cautious about the use of the word ‘ban’, but effectively the companies are agreeing no longer to sell these products ... in New Zealand from the 4th of January," the ministry's spokesman Dr. Stewart Jessamine said on Monday.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
"The [New Zealand Medicines and Medical Devices Safety Authority] response is effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence," the authority said in a statement, adding suppliers had already been contacted.
"Most of [the suppliers] have already indicated by early next year that they will be taking the same steps here to limit supply, as they are in Australia."
The decision comes less than a fortnight after the devices were banned by Australia's Therapeutic Goods Administration (TGA) after a review found "the benefits do not outweigh the risks these products pose to patients".
The TGA also cancelled single incision mini-slings to treat stress urinary incontinence due to evidence the risks to women outweighed the benefits.
But, unlike New Zealand, Australia's review found the use of urogynaecological surgical mesh devices for stress urinary incontinence and abdominal-pelvic organ prolapse repair was "adequately supported by the evidence".
An Australian Senate inquiry into transvaginal meshes is expected to report back in February next year.
It was established to find out exactly how many women have had transvaginal mesh implants and, of those, how many experienced adverse side effects.
Queensland associate professor of urogynaecology Christopher Maher has estimated more than 200,000 mesh implant surgeries have been performed in Australia to date.
Half of the women who experienced adverse physical and psychological side effects after receiving a vaginal mesh implant have also suffered from a relationship breakdown after the procedure, the inquiry heard in September.
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, the inquiry heard in August.
More than 100 women have written to the inquiry — here are the most heartbreaking submissions.
https://www.buzzfeed.com/ginarushton/new-zealand-has-basically-banned-mesh-products-until?utm_term=.yeBZWx2Zn#.polqoakqB
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New Zealand Effectively Bans Vaginal Mesh
Dec 12, 2017 | Jezebel
By Kelly Faircloth
Citing safety concerns, New Zealand has introduced restrictions on vaginal mesh implants, which practically speaking puts the kibosh on their surgical use for the immediate future.
The Guardian reports that New Zealand’s Ministry of Health told companies who make the technology—often used to treat all-too-common postpartum complications like stress urinary incontinence and even pelvic organ prolapse—they either had to prove they were safe or quit selling come January, and apparently, the answer was to quit selling. Via the Guardian:
Ministry of Health spokesman, Stewart Jessamine, told a New Zealand radio station: “We’re always cautious about the use of the word ‘ban’, but effectively the companies are agreeing no longer to sell these products ... in New Zealand from the 4th of January.”
The move goes considerably further than recent announcements in other countries, such as Australia and the UK, which only restrict the use of pelvic mesh operations for organ prolapse. In New Zealand, the use of mesh implants to treat urinary incontinence, which accounts for the vast majority of mesh operations, will also be effectively banned, according to an announcement posted on the government website.
New Zealand’s move is the most sweeping yet in the wake of building controversy over the mesh. The BBC program Panorama just recently did a piece on whether the pharmaceutical company Ethicon had kept doctors updated about potential risks; in their review, the Guardian noted that while it’s successful for most patients, who don’t see any complications, “As many as one in 15 women later require full or partial removal of the implant,” according to numbers from NHS Digital and NHS Wales. Other doctors, however, argue that a ban would remove a valuable option—see this BBC coverage—and the Urological Society of Australia and New Zealand condemned the move, according to the Independent. Said a spokesperson:
“The Australian TGA decision to ban transvaginal mesh for pelvic organ prolapse is accepted by the urological community in Australia and New Zealand, but our health minister’s decision to ban all forms of mesh for incontinence as well as prolapse in women in New Zealand is more far-reaching than the Australian decision.
“This will leave women without effective surgical options for these debilitating conditions.”
As always, it’s amazing that as long as humanity has been having babies, we don’t have better solutions for these fairly common complaints.
https://jezebel.com/new-zealand-effectively-bans-vaginal-mesh-1821222782
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Restriction on surgical mesh not enough, sufferer of 11 years says
Dec 13, 2017 | Stuff
By Miri Schroeter
In an 11-year battle since surgery, Glenys Mahoney has lost her job and her mobility.
The Palmerston North woman is glad the use of vaginal surgical mesh is being restricted in New Zealand, but she says it's not enough.
In 2006, Mahoney had surgery for a pelvic organ prolapse, which left her in debilitating pain.
She's had 12 operations to attempt to correct it but there's still mesh in her body, which leaves her unable to sit for prolonged periods, and unable to bike or drive.
"Every time you move it's like a saw."
She lost her job of 26 years as a radiation therapist, her 14-year-old son also died five years ago, and her mental and physical health have deteriorated.
"I have lost everything in life."
This week, Medsafe announced surgical mesh used for some gynaecological procedures will be removed from New Zealand's supply by January 4.
Mahoney said restricting mesh was a good start but there needed to be more action.
"They've sort of done it half-heartedly."
There was still no registry set up to monitor how many people were living with surgical mesh, Mahoney said.
Ministry of Health spokesman Stewart Jessamine said a cost-benefit analysis was under way, but he could not confirm whether a registry would be formed.
Mahoney said a registry was needed for accurate data on complications associated with surgical mesh.
In 2006, she had three mesh slings implanted at what was then Palmerston North's Southern Cross Hospital.
In mid-2017, she had two mesh slings removed, but gynaecologist Dr Hanifa Koya could not take out a third mesh implant in the groin, which was more complicated, Mahoney said.
"I'm better than I was. If it wasn't for Hanifa Koya I wouldn't be able to walk."
Koya said Mahoney's leg was like a cadaver and she needed the mesh removed.
In many cases patients had already had several previous surgeries, which left them with a lot of scarring and made the surgeries high risk, Koya said.
Koya has worked on more than 75 complex cases requiring pelvic mesh removal since 2005.
She is concerned that restricting use of some mesh, such as incontinence slings, could limit options.
Koya supported a ban on mesh for pelvic organ prolapse, but believed mesh slings could still be used for women with urinary incontinence when carried out by competent surgeons.
Medsafe needed to discuss the use of mesh products for urinary incontinence treatment with medical professionals, Koya said.
Gynaecologist Dr Digby Ngan Kee said the Crest Hospital – which came out of a merger of Aorangi Hospital and Southern Cross Palmerston North in 2013 – did not use surgical mesh. But that did not mean it wasn't used at Southern Cross before the merger.
MidCentral District Health Board spokeswoman Paula McCool said MidCentral's gynaecology department also did not use mesh in surgery.
Surgical mesh will still be able to be used for other procedures such as hernia repairs.
Associate Minister of Health Julie Anne Genter said Medsafe concluded that surgical mesh was not suitable for transvaginal surgery regardless of the competence of clinicians.
"We have asked the companies to prove surgical mesh is safe, which if they can prove, then there is a chance that surgical mesh could still be used."
https://www.stuff.co.nz/national/health/99729238/restriction-on-surgical-mesh-not-enough-sufferer-of-11-years-says
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Family of Gore victim calls for wider ban on surgical mesh use
Dec 13, 2017 | Southland Times (In Stuff)
By Richard Davison
Following a partial ban on the use of surgical mesh, calls for a wider ban have been voiced.
Surgical mesh used for some gynaecological procedures will be removed from New Zealand's supply by January 4, Medsafe announced on Monday.
But relatives of a Gore grandmother - who died while recovering from surgery to remove mesh implanted for a hernia repair - want to see a ban on its use for other procedures, including hernia treatments.
In June 2014, Karyn Freer died in Southern Cross Hospital, Invercargill, after having surgery to correct a hernia mesh procedure that had left her in constant pain.
The use of mesh for hernia repair is strongly supported by surgeons and is used routinely for thousands of procedures in New Zealand each year.
However, evidence suggests the risk of complications, including infection, severe chronic pain and death, are higher for procedures using mesh.
Karyn's daughter Sharleen Greer, who lives in Alexandra, said the ban was good news, but didn't go far enough.
"It will help a lot of people, and is a massive step in the right direction, but hernia mesh still needs to be looked at properly, and included in the ban."
Since viable alternatives such as patient and pig skin grafts existed, mesh continued to be used only because it was "an easy option" for medical staff, Sharleen believed.
"We've always thought if mesh hadn't been used originally on Mum, she wouldn't have had the second operation to remove it, and so would have been with us here now. There was just no need."
Although Sharleen believed medical professionals were partly to blame for using a product without proper research and training, ultimate responsibility lay at the door of mesh manufacturers.
"So many people have suffered as a result of this product just being thrown on the market without proper testing. They've lost jobs, marriages, homes, everything," she said.
Sharleen and her family's own loss remained acute.
"Mum's loss is still raw, and hard to bear sometimes," she said.
"She was just such a kind, caring and loving person, who would do anything for you. She's always in our thoughts, every day."
However, Kiwi doctors have condemned Medsafe's move to restrict surgical mesh in gynaecological operations, citing potential implications for women with urinary incontinence (UI).
Gynaecologist Dr Hanifa Koya said New Zealand "cannot have a knee-jerk reaction, or blanket rule, and remove all the meshes".
"Australia has not removed the incontinence slings, and we should not either," she said.
"The Therapeutic Goods Administration had already undertaken a robust process to confirm the benefits and risks, and that is why Australia did not withdraw the [mid-urethral] incontinence slings."
Koya has worked on more than 75 complex cases requiring pelvic mesh removal since 2005, and has been advising against mesh surgery for years.
She supported a ban on mesh for pelvic organ prolapse, but believed mesh slings were still appropriate to implant in women with UI when carried out by competent surgeons.
"A device itself is not the only problem, but rather the regulation, training, oversight, and competence of surgeons," Koya said.
The alternatives to UI slings in New Zealand – the Rectus Sheath Sling and Burch Colposuspension – also posed significant risks to health, she said.
Koya said Medsafe's decision had also robbed women of an important choice. "The retropubic vaginal sling should remain a choice for women."
Urologists, urogynaecologists, and gynaecologists needed to be approached by Medsafe for a robust discussion about the use of mesh products for UI treatment, Koya said.
"These specialists have been doing these procedures for many, many years and can provide evidence."
Associate Minister of Health Julie Anne Genter said Medsafe reviewed what Australia's committee decided, and "agreed that surgical mesh is not suitable to be used for transvaginal surgery, regardless of the surgical competence of the clinician".
"We have asked the companies to prove surgical mesh is safe, which if they can prove, then there is a chance that surgical mesh could still be used," she said.
"Hundreds of women have suffered and this Government is committed to ensuring that complaints from patients are taken seriously."
Genter said Medsafe had worked closely with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and other sector groups on the issue.
"I gladly welcome changes to restrict usage," she said.
https://www.stuff.co.nz/southland-times/news/99790154/family-of-gore-victim-calls-for-wider-ban-on-surgical-mesh-use
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I’m representing women injured by vaginal mesh. This is what they have told me.
Dec 12, 2017 | iNews
By Kate O'Brien
Note: The author of this piece, Kate O’Brien, is a Solicitor in the medical negligence team at Bolt Burdon Kemp.
Vaginal mesh has been used for a number of years, typically to help women who experience mild bouts of incontinence or prolapse following childbirth, hysterectomy or menopause. Made from the same material used to make drinks bottles, the plastic mesh is usually inserted into the vagina to support the neck of the bladder or urethra.
According to NHS data, over 92,000 women have had vaginal mesh implants in England alone.
For most women the procedure is a success. However, far too many have suffered debilitating complications including chronic pain, urinary problems, pain during intercourse and exposure of mesh through the vagina.
There has been a great deal of coverage in the media recently surrounding the vaginal mesh scandal. The health watchdog NICE recently published draft guidelines recommending a ban on mesh to treat prolapse in England. This will come as a welcome announcement to many who are familiar with the problems caused by vaginal mesh, not least to those who have suffered life-changing injuries as a result.
What women have told me
I recently spoke with a woman in her thirties who reported a complete loss of sex life. The mesh had completely eroded through the vaginal wall. Not only did she find sex excruciatingly painful, but the protruding mesh had even injured her husband during sex.
Another woman I’ve advised was previously fit and active, attending the gym daily. Following mesh repair, she is no longer able to exercise and suffers severe pelvic pains which worsen with activity. She also gets persistent urinary tract infections, as frequently as twice per month, and has been forced to give up her job.
Although some women can have surgery to remove the mesh, it is not straightforward. As the mesh is designed to be permanent, it becomes embedded in the surrounding tissues. It can often take multiple surgeries to remove, and still some may be left behind, continuing to cause symptoms. One of my clients has already had three procedures to remove the mesh, with further surgery planned. She is terrified that she will never fully recover from her life-altering injuries.
Frequency of complications
The frequency of complications is a controversial subject. The Medicine and Healthcare Products Regulatory Authority (MHRA) has put the complication rate at just one to three per cent. Some argue that these figures do not account for those who don’t report their symptoms to their doctors due to embarrassment, or for the surgeons who might not report complications to the MHRA for fear of criticism.
For these reasons, some independent studies have found that the true complication rate is more like 10 to 15 per cent, and perhaps even higher. Over 800 women are currently suing either the NHS or the mesh manufacturer having suffered serious health problems, and my firm has advised a number of those affected regarding their options.
Why is the mesh still being used?
The potential mesh ban recommended by NICE only relates to surgeries for prolapse, and not incontinence. Although it is a step in the right direction, it has come too late for many. If mesh is to continue, then mandatory reporting of all complications to the MHRA must at least be introduced to ensure the true scale of the problem is highlighted. It is also imperative that women are informed about the risks and potentially devastating complications of mesh before proceeding with a surgery that could change their lives irreparably.A spokesperson for the MHRA said:
“Patient safety is our highest priority and we recognise some women do develop serious complications which can be very significant for the affected women. We also know many women derive benefit from these surgical procedures for what can be extremely debilitating conditions. We continue to work closely with NHS England, National Institute for Health and Care Excellence (NICE) and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications.
We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card scheme. Currently, from a regulatory perspective these devices are acceptably safe when used as intended and as part of an appropriate treatment pathway in accordance with the recommendations made by NICE and the English and Scottish reviews.
MHRA and others in the healthcare system are aware of recent work and they continue to monitor the situation and will act as necessary. These reviews have all reviewed the totality of the data available at a given point in and put in context the different conditions being treated with mesh products, whether Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP), which need to be considered separately.
The publication of more data is a natural process, occurring as more experience is gained into the use and complications associated with these procedures. As always, the evidence of complications must be balanced by the majority of women who the data suggest are helped by these procedures. In addition, the use of any medicine or medical device carries risks and the decision whether to offer a particular treatment is for clinicians following conversations with their individual patients, considering their particular circumstances and having weighed up the benefits and risks for and to them.
We continue to work together with other regulators in the EU and wider, and colleagues across the health sector to monitor and examine evidence as it comes available, and will take action as appropriate to protect public health. It is, however, important for all parties to continue to consider the place of these devices in the treatment pathway, recognising the risks, and benefits, in the context of the distressing conditions being treated.”
Manufacturers Ethicon declined to comment. NHS England also declined to comment.
https://inews.co.uk/opinion/im-representing-women-injured-vaginal-mesh-wonder-mesh-still-used/
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Doctors weren’t properly informed of vaginal mesh
Dec 12, 2017 | Infosurhoy
By Toby Murphy
A company owned by a multi-billion pound pharmaceutical failed to fully inform doctors of how dangerous vaginal mesh can be, a BBC Panorama investigation has found.
The programme, airing tonight, will also reveal how an implant made by Ethicon was only tested on 31 women and in sheep before being used in patients.
The company, owned by Johnson and Johnson, sells its scandal-hit products in the UK under the brand name Gynecare TVT.
An investigation reveals how a director at the company asked for the wording to be changing in the safety leaflets for mesh implants to recognise the dangers – but her request was ignored.
It comes amid mounting pressure for the ban of controversial vaginal mesh implants, which have left thousands of women on the brink of suicide.
The revelation follows the death of a prominent vaginal mesh campaigner, who reportedly died from sepsis triggered by her implant.
Christina Brajcic, 42, from Ontario, Canada, passed away last Thursday following a four-year battle with persistent infections – as a result of her mesh.
Her death last week followed landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
It is expected that the NHS will follow the guidance from Nice, the Government’s healthcare adviser – despite not being obliged to do so.
The verdict comes after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found ‘the benefits do not outweigh the risks’.
However, vaginal mesh remains a viable option in both countries for surgeons operating on women suffering from incontinence.
The BBC Panorama investigation reveals that Ethicon produces ‘Instructions for Use’ (IFU) leaflets to accompany mesh products to explain how doctors should insert them.
They also explain the ‘adverse reactions’, or risks, associated with surgery to help surgeons explain these to patients.
But in 2009 an associate medical director at Ethicon warned that the statements about side effects in the IFU leaflets for mesh products were not sufficient.
At the time the leaflets said that side effects were ‘transitory’, the BBC Panorama investigation will reveal.
In an email in January 2009 the associate medical director wrote about three Ethicon Gynecare TVT mesh implants suggesting that the wording be changed.
She wrote: ‘From what I see each day, these patient experiences are not “transitory” at all.’
However, Ethicon did not update them to remove the word ‘transitory’ at the time. The company’s latest IFUs, updated in 2015, say some effects may be permanent.
Ethicon, who spoke to Panorama as part of the investigation, confirmed it did not change the wording of the IFUs at the time.
It concluded: ‘The wording in the IFU was appropriate for the intended users – trained pelvic floor surgeons.’
Dr Wael Agur, a consultant urogynaecologist, told BBC Panorama the IFUs are very important.
He said: ‘It’s so important for me as a surgeon to understand full the risks of a medical device I’m about to implant during a surgical procedure and my first resource would be the IFU.
‘I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the instructions for use so I fully understand these and communicate them.’
Ethicon launched the TVT-Secur implant in 2006 worldwide. It was intended to be the company’s safest and most effective pelvic mesh product.
The product, which Johnson & Johnson has since paid one sufferer who became reliant on a walking stick $57 million, was withdrawn from the market in 2012.
Ethicon told Panorama: ‘While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives.
‘All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.’
The MHRA, the UK medical devices regulator, told Panorama it recognises some women develop serious complications.
It said: ‘Currently, from a regulatory perspective these devices are acceptably safe when used as intended and as part of an appropriate treatment pathway.’
The Panorama investigation follows the warning that there is inadequate regulation for vaginal mesh products which has exposed women to unnecessary harms.
Writing in the BMJ Open, Professor Carl Heneghan said they can’t be considered safe as they didn’t undergo scrutiny in properly conducted scientific studies.
The professor of evidence-based medicine at Oxford University has previously described the mesh scandal as akin to thalidomide.
The controversial implants, which can shrink, twist, curl and cut through tissue, have left thousands of women on the brink of suicide, unable to work and even walk.
They have been used since the late 1990s to help women overcome incontinence and pelvic organ prolapse – often two major issues of childbirth.
Despite the risks, which have been widely publicised in recent months, most women experience no problem and doctors are adamant the procedure is beneficial.
The scandal came to light in April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some saying the scandal was comparable to thalidomide.
Figures estimate 100,000 women across the world are looking at taking legal action against the device manufacturers.
Mesh, introduced 20 years ago and dubbed ‘gold-standard’, was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
Because it did not require specialist training to implant, outraged women have since begged for tougher regulations to conduct such surgery.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
More than 10,000 women a year are fitted with mesh in the UK – but around 4,800 have since come forward to reveal they have been left in agony from the mesh.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more – but they have been kept silent.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million in September to a woman fitted with the implant.
Ella Ebaugh, 51, from Philadelphia, was awarded the eight-figure sum after a jury found the company to be negligent and its product defective.
In her first UK interview, she told BBC Panorama: ‘The pain that I have I will have to live with for the rest of my life. There’s nothing they can do to help me.’
http://www.infosurhoy.com/cocoon/saii/xhtml/en_GB/health/doctors-werent-properly-informed-of-vaginal-mesh/
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Dec 12, 2017 | RX Injury Help
By Laurie Villanueva
Note: The author of this piece, Laurie Villanueva, is an attorney with Bernstein Liebhard LLP RX Injury Help.
A Pennsylvania state court judge has denied Ethicon’s motion seeking to dismiss more than 100 transvaginal mesh lawsuits from a mass tort program currently underway in the Philadelphia Court of Common Pleas.
Order Dismisses Only One Ethicon Transvaginal Mesh Lawsuit
All of the cases in question were filed on behalf of out-of-state plaintiffs. In seeking to have the claims tossed, attorneys representing Johnson & Johnson and its Ethicon unit cited the U.S. Supreme Court’s recent decision in Bristol-Myers Squibb v. Superior Court of California, which limited plaintiffs to filing suit in jurisdictions where defendants are headquartered or where a plaintiffs’ injuries are alleged to have occurred.
While the defendants are headquartered outside of the state, the Prolene filaments used in Ethicon’s transvaginal mesh implants were manufactured and supplied by a Pennsylvania company called Secant. In seeking to have the out-of-state claims dismissed, Ethicon asserted that its limited contractual relationship with the company was not enough to establish jurisdiction in accordance with the Bristol-Myers Squibb decision.
But in an Order dated December 5th, Judge Arnold New ruled that only cases involving out-of-state plaintiffs who had received a Prolift +M implant would be dismissed for jurisdictional issues. A single lawsuit – Moore vs Ethicon (130701485) – was tossed, while the remainder of Ethicon’s motion was denied.
Transvaginal Mesh Complications
Transvaginal mesh devices are implanted in women who suffer from pelvic organ prolapse and stress urinary incontinence. Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding the serious complications that may occur with these devices, including mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. In 2011, the agency retreated from its earlier position that complications associated with transvaginal mesh prolapse repair were a rare occurrence.
Just last year, the FDA reclassified transvaginal mesh implants indicated for use in pelvic organ prolapse surgery as high-risk medical devices. Among other things, the reclassification made those implants ineligible for the agency’s 510(k) clearance program, which does not require a device to undergo human clinical trials before coming to market.
The Philadelphia mass tort litigation has already concluded six trials involving Ethicon’s transvaginal mesh implants. Plaintiffs have prevailed in five of these cases, winning damages of $2.16 million, $12.5 million, $13.5 million, $20 million, and $57 million.
While one jury did rule in favor of Ethicon, the judge overseeing the case recently granted that plaintiff a new damages hearing after finding that the verdict was inconsistent with the evidence.
https://www.rxinjuryhelp.com/news/2017/12/12/pennsylvania-judge-denies-ethicons-bid-to-toss-100-transvaginal-mesh-lawsuits-from-philadelphia-mass-tort-program/
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