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Ethicon Media Monitoring 10/1/18
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Surgical mesh itself not tied to increased complications
Oct 1, 2018 | Medical Xpress
This article reports on a study published in the August issue of The Journal of Urology that found that mesh is not independently associated with an increase in the rate of complications of pelvic organ prolapse repair. -
Scientists find superbugs thrive on plastics used in mesh implants
Oct 1, 2018 | The Sunday Post
By Marion Scott
Scientists have found evidence showing bacteria congregating on the surface of polypropylene mesh implants used to treat bladder and pelvic organ prolapse. The family of the first UK patient whose death was officially linked to the controversial implants yesterday said the findings underline the dangers linked to mesh. -
Questions raised over whether Kiwi surgeons have enough experience and skill for transvaginal mesh implants
Oct 1, 2018 | stuff
By Cate Broughton
Surgical mesh procedures have left hundreds of Kiwi women suffering life-altering pain and disability. Some mesh products were banned last year but in the last week a new Government proposal has put the spotlight on surgeons, with their competency in the firing line.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Surgical mesh itself not tied to increased complications
Oct 1, 2018 | Medical Xpress
Use of mesh is not independently associated with an increase in the rate of complications of pelvic organ prolapse repair, according to a study published in the August issue of The Journal of Urology.
Kai B. Dallas, M.D., from the Stanford University School of Medicine in California, and colleagues used data from the Office of Statewide Health Planning and Development to identify all women who underwent pelvic organ prolapse repair in California from 2005 to 2011 (110,329 women). Patient, surgical, and facility factors associated with repeat surgery for a complication due to mesh or recurrent pelvic organ prolapse were evaluated.
The researchers found that mesh was used in 16.2 percent of the repairs performed over the study period. In women who underwent mesh repair, the overall repeat surgery rate was higher (5.4 versus 4.3 percent). Mesh itself was not independently associated with repeat surgery, in multivariate modeling. However, repair at a facility where there was a greater propensity to use mesh was independently associated with repeat surgery (highest versus lowest mesh use quartile odds ratio, 1.55). Using mesh in 5 percent of anterior and 10 percent of anterior apical repairs was associated with the lowest risk of repeat surgery.
"Our findings demonstrate that mesh is not independently associated with an increase in the rate of complications of pelvic organ prolapse repair on a large scale," the authors write. "We present a model that supports judicious use of the product on the population level which balances the risk of complications against that of recurrent pelvic organ prolapse."
https://medicalxpress.com/news/2018-09-surgical-mesh-tied-complications.html
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Scientists find superbugs thrive on plastics used in mesh implants
Oct 1, 2018 | The Sunday Post
By Marion Scott
Scientists have found evidence showing bacteria congregating on the surface of polypropylene mesh implants used to treat bladder and pelvic organ prolapse.
The family of the first UK patient whose death was officially linked to the controversial implants yesterday said the findings underline the dangers linked to mesh.
Researchers in Europe and Australia discovered a super-strain of common bacteria staphylococcus epidermidis, found on skin, is becoming resistant to antibiotics.
Alex Friedrich, professor of medical microbiology at Groningen University, in the Netherlands, said: “Our medicine uses more and more implants of plastic and other materials and that is the place where this bacterium thrives.”
He believes patients who are carriers should be placed in isolation if they are being treated in intensive care units in a similar way cases of the hospital superbug infection MRSA currently are.
Researchers at the University of California Los Angeles found bacterial clusters, known as bio-films, which are up to a thousand times more resistant to antibiotics when they group together.
High levels of infection-causing bacteria can also be found when mesh is inserted through the abdomen, such as those named in the death certificate of Midlothian gran Eileen Baxter, 75, whose family are campaigning to have the procedure stopped.
Eileen, from Loanhead, was the first patient in the UK to have mesh listed as one of the causes of death.
Despite a halt on transvaginal implants in Scotland, the procedure Eileen had is still being permitted under special vigilance rules.
Son Mark Baxter said: “This new evidence is truly an eye opener and shows we are nowhere near understanding all the dangers of using plastic mesh inside our bodies.”
MSP Neil Findlay is calling for Health Secretary Jeane Freeman to meet mesh victims.
Dunoon mum Nancy Honeyball, 49, has twice survived the sepsis which has killed other mesh victims, but says she is terrified the treatment-resistant infection could claim her before she has the final part of her surgery to remove the implant which destroyed her life.
Nancy had to fight to get the final part of her surgery funded by NHS Highland at a London hospital which specialises in mesh removal.
https://www.sundaypost.com/fp/scientists-find-superbugs-thrive-on-plastics-used-in-mesh-implants/
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Oct 1, 2018 | stuff
By Cate Broughton
Auckland woman Sam Bennett didn't question the credentials of her surgeon when she went to hospital for a hysterectomy and a transvaginal mesh (TVM) implant procedure in 2013.
In the weeks before the operation, doctors told the mother of two they could fix her urinary incontinence problems with a vaginal sling.
Bennett had never heard of mesh and believed it to be a routine procedure.
She met her surgeon on the day. Minutes before she went under, the surgeon asked if she had been told about potential complications from the bladder sling.
"I said no. And that was the end of the conversation."
So she didn't hear about about the risks of mesh erosion, infection, and chronic, life-changing pain. CHRIS MCKEEN/STUFF The situation left Bennett in "excruciating" and she had to give up her career.
In the months following the procedure Bennett said she felt a "heavy, period-like pain" but, keen to get on with her life, she ignored it.
By early 2017 the pain had become excruciating and at a routine cervical cancer screen her GP discovered the polypropylene mesh had eroded and was poking through into her vaginal canal.
Bennett likened the pain to a cheese grater constantly cutting her insides. A surgical mesh implant used to treat stress urinary incontinence.
"It was excruciating. I'd just have to curl up in bed and take pain killers."
She was forced to abandon her real-estate job and career.
"I'd been doing that for 10 years and absolutely adored it but because of the pain I gave it up." KEVIN STENT/STUFFDirector General of Health Ashley Bloomfield wrote to district health boards requesting them to apply Australian credentialing standards to surgeons performing transvaginal mesh surgery.
Bennett was referred to a surgeon who prescribed cream to fix the problem.
When it didn't work she was sent for another test and a hospital staffer told her about a surgeon who could remove the mesh. The surgery in March rid her of the mesh pain but also left her incontinent.
"Unfortunately my bladder gave up the ghost completely and so it's worse than it ever was, I have no control." HAMISH MCNEILLY/STUFF Patricia Sullivan, left, and Charlotte Korte from surgical mesh support group Mesh Down Under.
She has ongoing nerve pain and has suffered from deep depression throughout the ordeal.
"I loved my career but I'm even looking at selling my house because I can't financially... live. It's been quite devastating."
She warned other women never to "go near mesh".
Bennett has laid a complaint about the implanting surgeon with the Health and Disability Commissioner.
This week the Ministry of Health asked district health boards (DHBs) to assess the credentials of surgeons against Australian standards for urogynaecological mesh procedures.
Bennett was not impressed.
"It needs to be removed, it needs to not be around. It shouldn't be put in anyone's body at all.
"Them having credentials to do it – that just means they are still going to be putting this stuff in people and it's just not good enough."
SURGICAL SKILL QUESTIONED
From January 4, 2018 the Ministry of Health and Australia's Therapeutic Goods Administration banned all mesh devices for another urogynaecological procedure, pelvic prolapse repair, and some used for SUI.
But the supply of other mesh devices for SUI continued.
This week the Ministry applied a recommendation made by the Australian Senate inquiry on transvaginal mesh implants, published in March.
One of 17 recommendations from the year-long, Australia-wide inquiry was for Health Ministers to require credentialling standards developed by the Australian Commission on Safety and Quality in Health Care to be applied in all public hospitals and work with private hospitals to encourage the adoption of a similar requirement.
In its submission to the inquiry the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (Ranzcog) had stated there was "evidence which indicates more highly-skilled surgeons with big caseloads tend to have fewer complications" and this was true for any surgical procedure.
Despite this there was no way to ensure only those with sufficient experience and skill performed the procedures.
In July the UK government ordered an immediate but non-binding pause on mesh urogynaecological procedures in public hospitals until better protections were in place to prevent injuries. Conditions hospitals have to meet include ensuring only surgeons with appropriate training and experience perform the procedure.
The Ministry of Health this week sought assurance surgeons performing the procedures here are adequately trained and informing patients of risks.
If DHBs can't ensure this, the procedures should not go ahead, chief executive Ashley Bloomfield said in his letter.
A 2016 audit of transvaginal mesh procedures from one large urban hospital obtained by Stuff showed surgeons had varying levels of success in the procedure.
A "significant minority" of patients had persistent groin or vaginal pain two years after surgery and there was too much variation between surgeons in outcomes and re-operation rates, the report noted.
The procedures at the hospital were suspended for three out of five surgeons in the team while an improvement in credentialling and training could take place.
The report author, who Stuff agreed not to name, said the mesh procedure should only be done by "a select group of highly-trained practitioners".
"The process ... initiated at our DHB can and should be replicated throughout New Zealand so that we can give assurance to the public that we have a robust clinical governance structure for this type of treatment."
The report was presented to a surgical mesh working group including representatives from the Ministry of Health this year.
A mesh working group will begin work on a New Zealand credentialling system at a meeting on October 8 as there was disagreement among different surgical colleges and patient advocates about what was sufficient, with some critical the Australian standards did not go far enough to ensure safety.
In the meantime Bloomfield has asked DHB surgeons to meet the Australian standards.
These require urologists or gynaecologists without any experience of the procedure to have additional specialist training.
Those surgeons already performing the surgery would not need the specialist training but would have to show they had performed the procedure for two years and "can undertake the procedure safely and efficiently, and in cases where appropriately indicated".
Surgeons were required to be performing at least 10 procedures a year.
Most surgeons performing TVM procedures would have been doing it for a number of years and a minority had additional specialist training in urogynaecology.
HOW DO NZ SURGEONS RATE?
Most DHBs contacted by Stuff this week said they were confident in the credentials of their surgeons performing transvaginal mesh surgery but were working with the ministry to ensure they met the Australian standards.
Christchurch Hospital clinical director of urology Sharon English said she was confident urologists in her department performing the surgery would meet the Australian standards.
But she could not vouch for other surgeons in New Zealand.
She supported the ministry's action to check surgeons were practising safely and said this could be done by looking at regular department audits, which show procedure outcomes and complication rates.
English said the action by the ministry would reduce the number of surgeons implanting mesh.
"It will make it that people just don't do the occasional one, so it will be something people with more experience will continue to do."
Complications were caused by the mesh being placed incorrectly or a bad reaction to the mesh.
Accreditation standards covered diagnosis of incontinence, which was also an important factor in avoiding adverse outcomes, English said.
"We are trying to ensure that the right person gets the right procedure, so it's more than just the surgery itself."
English said patients often asked how many procedures a surgeon had done but this did not necessarily indicate competence.
"We are asking have they been well trained. Some people can do 30 and still do them badly and some people can do 20 and be very good at the operation so it's a bit hard."
She said surgeons in her department shared their success rate with patients as part of the informed consent process.
Across the department the success rate was 80 per cent, which meant the decision to have the procedure was challenging for patients.
"I think patients have to get quite bad before they come forward for surgery. When they have a good outcome they say why didn't I do that before?
"But they have to get over their own threshold before they decide it's bad enough to do something and everyone's threshold is different."
Support for patients who suffered complications was mixed because not all were covered by ACC, English said.
"ACC does not cover pain so if you have erosion or obstruction they will cover it, but if it's pain they won't cover it."
She wanted to see specialist mesh clinics and a national registry established to better support mesh patients.
LISTENING TO MESH INJURED
Charlotte Korte from mesh support group Mesh Down Under said health authorities in New Zealand needed to listen to patients and take their complaints seriously.
"The real stories about how patients have been treated and the barriers that they face doesn't come out because no-one has actually spoken to the patients about what has gone on."
Korte said any woman considering a mesh procedure should ask about complications.
"It's about knowing the actual risks, the potential risks and if these complications happen what can you do... as in can you get the implant out fully and if you can't what's going to happen to me?"
She said patients should expect full and transparent informed consent.
Assessing a surgeon's competency was extremely difficult because there was not enough data collected to know the real rate of complications, Korte said.
Surgeons did not always know about adverse outcomes.
"The problem is that when you first go back to your surgeon with a problem and they palm it off as not a mesh complication you never generally go back to the same surgeon, especially if you're not heard the first time."
Audits of mesh procedures were not standardised which meant assessments of outcomes varied from surgeon to surgeon.
In 2016 a survey of group members revealed a number of surgeons who had not informed patients of complication risks and had high complication rates.
Korte and fellow Mesh Down Under advocate Patricia Sullivan took their concerns to the Medical Council in the hope the surgeons would be investigated but were told the patients would need to lodge a complaint with the HDC themselves.
The HDC has received 33 complaints regarding surgical mesh since 2012 but has not investigated any of them.
It has 11 complaints currently "under assessment".
Sullivan said it was unacceptable and a breach of the patients' code of rights there had been no investigations into mesh complaints.
For those injured from a mesh procedure it was a very difficult step to take.
"How can you expect people who are so traumatised both physically and mentally to cope with fighting against and complaining to their GP, their surgeon, to ACC, to Medsafe, to HDC and to try and keep their family and relationships and income working?"
A spokeswoman said the HDC "has a wide discretion as to what action he takes following an assessment".
"HDC is aware of the concerns with surgical mesh products and the information provided to consumers. HDC continues to liaise with relevant agencies regarding this matter and attends the surgical mesh round table convened by the Ministry of Health to respond to this significant health issue."
MESH BACKGROUND
TVM surgery involves implanting a mesh "tape" or "sling" through the vagina to support the bladder neck for women suffering Stress Urinary Incontinence (SUI).
One in three women who have given birth will experience SUI at some point in their life – sporadic urine leakage that comes with certain movements such as coughing, sneezing or laughing.
For most women transvaginal mesh (TVM) procedures were successful but a minority experienced severe and life-altering complications including erosion, infection, nerve damage and chronic pain.
Around 1000 devices for SUI procedures have been supplied in New Zealand annually since 2005. In 2017 this dropped to 827.
As complications from the devices increased it became clear that they had not been subjected to rigorous testing before being launched onto the market for use.
An international backlash led by injured and disabled patients has resulted in class action lawsuits against some manufacturers.
Some products have been withdrawn by the manufacturers.
Surgeons have stopped using mesh devices to treat pelvic organ prolapse after investigations found a lack of evidence to support their use for those procedures.
But three types of procedures with a Mid-Urethral Sling mesh device continue to be used to treat SUI when non-surgical options have failed.
A statement by Ranzcog says the "procedures have good success and safety profiles, however surgical failures and complications are possible".
"Patient factors and surgical experience" dictate the success or failure of the procedures, the statement says.
https://www.stuff.co.nz/auckland/107370097/Questions-raised-over-whether-Kiwi-surgeons-have-enough-experience-and-skill-for-transvaginal-mesh-implants
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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