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Ethicon Media Monitoring 1/10/2019
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Mesh implants: women who need corrective surgery have higher risk of depression and self harm, finds study
Jan 9, 2019 | British Medical Journal
Women requiring a surgical intervention for complications following a midurethral mesh sling procedure have significantly increased risk of new onset depression and self harm compared with those not needing corrective procedures, a Canadian population based study has found. -
Women with pelvic mesh complications at higher risk of depression, suicidal thoughts
Jan 9, 2019 | CTVNews
A Canadian study that tracked more than 57,000 women has found patients with complications after pelvic mesh implants are at increased risk of depression, self-harm – even suicide. -
Failed vaginal mesh implants for stress incontinence boost depression risk, study says
Jan 9, 2019 | The Canadian Press (in The Toronto Star)
By Sheryl Ubelacker
Women who develop complications after having vaginal mesh surgery to treat urinary leaks brought on by a sneeze, cough or exercise have an increased risk of depression and self-harm, a study suggests. -
London researchers examine psychological fallout of incontinence surgery complications
Jan 9, 2019 | The London Free Press
By Jennifer Bieman
London researchers are zeroing in on the potential psychological effects of complications from women’s incontinence surgery, uncovering an increased risk of depression and self-harm after the corrective surgery. -
Vaginal mesh: Northern Ireland centre progress 'frustrating'
Jan 10, 2019 | BBC News
By Marie-Louise Connolly
Progress on a regional centre to treat women affected by the vaginal mesh scandal has been slow and frustrating, Sinn Féin has said.
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Jan 9, 2019 | British Medical Journal
Women requiring a surgical intervention for complications following a midurethral mesh sling procedure have significantly increased risk of new onset depression and self harm compared with those not needing corrective procedures, a Canadian population based study has found.
Midurethral mesh sling procedures are the standard treatment for stress incontinence in women, but investigations and regulatory warnings about transvaginal mesh complications have led to ongoing concerns about their safety.
The new study analysed routinely collected data from the universal healthcare system in Ontario, Canada, for 57 611 women who had their first midurethral mesh sling procedure between 1 January 2004 and 31 December 2015.
The researchers looked at how many of the 1586 women (2.8%) requiring a corrective surgical procedure had evidence of depression or self harm compared with the 56 025 (97.2%) who did not require a corrective procedure.
Results, reported in JAMA Surgery, showed that the risk of new onset depression was 21% higher among women requiring corrective surgery compared with those who did not, after adjusting for age and frequency of medical consultations before the sling procedure (adjusted hazard ratio [HR] 1.21; 95% confidence interval, 1.04 to 1.41; P=0.01).
Just over one in 10 (11.0%, 175 of 1586) of the women who had corrective surgery were diagnosed with depression compared with 7.98% (4470 of 56 025) of those who did not need further surgery.
The risk of self harm was more than twice as high in women needing corrective procedures (adjusted HR 2.06; 95% CI, 1.52 to 2.80; P<0.01).
“Women can be profoundly affected by complications from a midurethral mesh sling procedure, and even with surgical revision the symptoms of these complications may not be completely corrected,” said the researchers, led by Blayne Welk, from Western University, London, Ontario, Canada.
The study authors acknowledged that limitations of their study, which was funded by non-profit health research organisations, included the inability to determine the degree of causality between transvaginal mesh complications and depression or self harm episodes. But they advised, “When managing women with complications, surgeons should be aware of the potential serious psychological implications of these complications.”
The UK National Institute for Health and Care Excellence recently recommended in new draft guidance2 that surgical mesh or tape should be used to treat stress urinary incontinence or pelvic organ prolapse only after all non-surgical options had been reviewed. And all procedures using mesh or tape and any related complications should be recorded in a national database.
This guidance is out for public consultation and will be finalised in April.
https://www.bmj.com/content/364/bmj.l109.full
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Women with pelvic mesh complications at higher risk of depression, suicidal thoughts
Jan 9, 2019 | CTVNews
A Canadian study that tracked more than 57,000 women has found patients with complications after pelvic mesh implants are at increased risk of depression, self-harm – even suicide.
The study published in the journal JAMA tracked more than 57,000 women in Ontario who had complications like pain and infections after receiving the polypropylene implants used to treat incontinence. The study found that:
Of those referred for mesh removal surgery, 11 per cent were treated for depression
Meanwhile, 2.7 per cent suffered from self-harm/suicidal behavior, almost double the rate in the control group
Dr. Blayne Welk, senior author of the study and assistant professor at Western University’s Schulich School of Medicine, says doctors need to recognize this complication and help women who are suffering with counselling, medications and, where possible, mesh removal.
Dr. Welk says the study shows that “these complications are severe and do cause a lot of emotional distress for patients.”
“There is a real risk of psychiatric illnesses that go along with these complications,” Dr. Welk added.
‘Women are not believed’
The plastic implants are still widely used to help women suffering from incontinence, with doctors reporting good success rates and low rates of complications.
But CTV News has spoken to dozens of women who say the implants triggered severe pain, infections and in some cases punctured tissue in the bladder, colon or vagina. There have been various lawsuits across the country.
In some cases, doctors blamed the womens’ distress and pain on psychological problems rather than complications from the mesh.
Nonie Wideman, who had pelvic mesh removed after the pain left her suicidal, said the research validates “that women are suffering not only physically but mentally.”
Wideman now runs online support groups for women suffering from mesh-related pain. She says depression is a common complication.
Women are often “not believed about how mesh is causing them pain or how much pain the mesh is causing them,” according to Wideman.
“We do kind of suicide watches when women start talking like they’re done, they’re finished, they can’t go on anymore,” she said from Montney, B.C.
Wideman said she is aware of one suicide in the United States as a result of mesh.
There has also been a suicide reported in Australia, where some pelvic mesh implants are now banned.
“This study validates that women are going through horrendous emotional trauma over the mesh,” Wideman said.
One woman from B.C., who asked not to be identified, told CTV News that she has been in agony for many months and has been unable to find a doctor willing to remove her implant. She said she has “filled out paperwork for assisted dying due to the agonizing pain of mesh and the fact that I have no medical care regarding mesh.”
‘It really gets you down’
Lila Windley, who had pelvic mesh implanted for incontinence in 2011, says her pain has become so unbearable that she can barely walk.
“Every time I walk, it is poking,” she said from Courtenay, B.C.
“The pain has been incredible,” she added. “I spent five weeks on the floor, going from the floor to the bed, screaming in pain, crying.”
Windley says depression has become part of her reality. She has been seeking surgery for three years, but still doesn’t have one scheduled.
“I phone every month to see when my surgery date is going to be and then I cry and cry and cry because they can’t tell me,” she said. “The first time I saw the specialist was three years ago this month, I believe and still no surgery date. And every day I get up hoping they are going to phone.”
At first, doctors dismissed her altogether, adding to her intense suffering, she said.
“That’s a huge problem when the physicians are not believing you and you have to go to research on your own and you know you are not crazy, but they make you feel like you are crazy,” she added.
“There’s days I lay on the couch all day because I can’t go out and do things I used to,” she went on. “It really gets you down.”
Windley said she was encouraged by the new study. “We need this (type of research) to happen so that other people are aware of how depressed we get,” she said. “So many of us are hurt by the mesh.”
Canada and the U.S. are reviewing the use of some pelvic mesh products. Some European Agencies say they should be used only as a last resort.
https://www.ctvnews.ca/health/women-with-pelvic-mesh-complications-at-higher-risk-of-depression-suicidal-thoughts-1.4247100
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Failed vaginal mesh implants for stress incontinence boost depression risk, study says
Jan 9, 2019 | The Canadian Press (in The Toronto Star)
By Sheryl Ubelacker
Women who develop complications after having vaginal mesh surgery to treat urinary leaks brought on by a sneeze, cough or exercise have an increased risk of depression and self-harm, a study suggests.
Known as stress urinary incontinence, the condition is primarily treated by implanting a polymer mesh sling in the vaginal wall, which is wrapped around the urethra to prevent leakage.
But in some cases, implants can lead to serious complications such as chronic pelvic pain and erosion of tissue in the urethra or vagina, outcomes that have spawned a slew of lawsuits in Canada, the U.S. and elsewhere against manufacturers of the medical devices.
“The vast majority of women do quite well after the surgery,” said lead researcher Dr. Blayne Welk, a urologist at Western University who specializes in incontinence surgery. “But there is the small number of women who do have complications afterwards.
“The challenge with transvaginal mesh for incontinence is there definitely are complications that women may experience from these slings,” he said from London, Ont. “They can be serious and they can be life-changing in some cases.”
The study, which excluded subjects with a previous psychiatric diagnosis, found the risk of depression was five per cent higher among women who had reparative vaginal mesh surgery compared with those that didn’t require a second operation.
To conduct the study, Welk and colleagues analyzed data from the Institute for Clinical Evaluative Sciences. The researchers looked at almost 60,000 Ontario women in their 20s to 80s who had transvaginal meshes implanted between 2004 and 2015.
They found that nearly 1,586 of these women had undergone surgical revisions of the devices aimed at eliminating or reducing deleterious effects.
Of those women needing a corrective operation, 11 per cent were treated for depression and almost three per cent had engaged in some form of self-harm behaviour, such as attempted suicide, that led to an emergency department visit or admission to a psychiatric hospital.
“The big challenge with these complications is that in some cases they can be very hard to correct completely,” said Welk. “And then the second thing is there’s an element of decisional regret for a lot of women who have these procedures done.
“I’ve seen a lot of patients referred with complications and a lot of them, they were quite emotional about it and described a long journey trying to find someone to evaluate them and help them with the complications.”
The study, published in Wednesday’s issue of the journal JAMA Surgery, found that psychological distress seemed to depend on a woman’s age. Those 45 or younger were at greater risk for depression, likely because complications from vaginal meshes can affect sexual intimacy, Welk speculated.
“So women over 65 did not have an increased risk,” he said, “whereas the younger women tended to be the ones that were at increased risk of depression and self-harm as a result of these complications.”
Welk said about 90 per cent of stress incontinence cases are treated with vaginal mesh surgery. A 2015 study he led found that over 10 years, about three per cent of Ontario women treated for stress incontinence with this method needed another surgery to remove or alter the implant.
While that complication rate is relatively low, he said surgeons need to recognize that there can be serious psychological consequences for those women who experience adverse outcomes, which also can include persistent pelvic infection.
“I think this sort of reinforces the message that we need to make sure women do have timely and appropriate evaluation for complications if they do occur and that people keep in mind that they might need support for psychiatric illness that may be occurring at the same time.”
In December, Health Canada announced a plan to improve the safety of medical devices, including the creation of an expert advisory committee on women’s health issues that will evaluate medical devices such vaginal meshes and breast implants.
https://www.thestar.com/news/canada/2019/01/09/failed-vaginal-mesh-implants-for-stress-incontinence-boost-depression-risk-study-says.html
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London researchers examine psychological fallout of incontinence surgery complications
Jan 9, 2019 | The London Free Press
By Jennifer Bieman
London researchers are zeroing in on the potential psychological effects of complications from women’s incontinence surgery, uncovering an increased risk of depression and self-harm after the corrective surgery.
Researchers at the Western University branch of Toronto-based Institute for Clinical Evaluative Sciences and Lawson Health Research Institute — the research arm of the London Health Sciences Centre and St. Joseph’s Health Care London — examined patient outcomes after pelvic mesh implants from January 2004 to December 2012.
Using 12 years of data from Ontario’s public health-care system, researchers studied the files of 57,611 women who underwent the midurethral mesh sling procedure during the study period. Of those, 1,586 went under the knife again to correct a complication from the mesh.
Study authors excluded women who had undergone previous stress incontinence procedures and ones with a history of depression or self-harm behaviours.
Researchers found an increased risk of mental health issues in women who had surgery to correct a complication when compared to the group whose initial procedure was successful.
“It’s important to look at quality of life and psychological well-being for these women,” said Dr. Blayne Welk, senior study author and urology surgeon at St. Joseph’s. “It’s something I’ve sort of anecdotally noticed in clinic when I was seeing patients, that there was a lot of emotional distress associated with a lot of these patients.”
The population study found 11 per cent of women who underwent surgery to fix a mesh complication were treated for depression, compared to eight per cent of patients who didn’t require a corrective procedure. The study found 2.77 per cent of women who went under the knife again to fix a mesh complication reported self-harm behaviour, compared to 1.15 per cent who didn’t need a corrective surgery.
The psychological risks were higher in women younger than 46, the study says.
The mesh implant is a common treatment option for stress urinary incontinence in women — urine leaks that happen when they are physically active.
The plastic mesh sling, implanted through a minimally invasive surgical procedure, gives extra support to the urethra so urine can’t seep out when the bladder is put under pressure by physical movements including lifting, coughing, sneezing or laughing.
A successful sling operation can be a life-improving procedure that allows patients to move and go about their daily activities leak-free, Welk said.
But like any other surgery, there are risks of complications.
Some patients can experience chronic pain after the procedure. Others might still experience incontinence. In some cases, tiny bits of the mesh could become exposed and poke through other tissue.
Complications from mesh implants, including midurethral slings, have sparked class action lawsuits and Health Canada alerts in recent years.
Lingering post-operative issues – and the private suffering that can accompany them – can make patients question their decision to seek surgery, Welk said.
“I think a lot of it is decisional regret almost. Women elect to undergo a procedure that’s minimally invasive that’s meant to treat a quality of life issue,” Welk said. “There’s that small proportion of women that do have significant complications and in some cases they can be life-changing complications. That can be a big thing (to live with).”
The psychological impact of the mesh complications – or other unforeseen post-surgery issues – shouldn’t be understated, Welk said.
“I think we don’t often think about the psychological impact of complications after surgery. I think what this research shows is there’s a considerable burden placed on women, particularly young women, who suffer complications after a midurethral sling,” Welk said. “That’s something to take into account when evaluating these patients.”
The study is published online in the latest edition of JAMA Surgery, an American Medical Association research publication.
https://lfpress.com/news/local-news/london-researchers-examine-psychological-fallout-of-incontinence-surgery-complications
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Vaginal mesh: Northern Ireland centre progress 'frustrating'
Jan 10, 2019 | BBC News
By Marie-Louise Connolly
Progress on a regional centre to treat women affected by the vaginal mesh scandal has been slow and frustrating, Sinn Féin has said.
Sinn Féin MLA Órlaithi Flynn made the comments in an interview with BBC News NI.
Ms Flynn received a letter, seen by the BBC, from the Permanent Health Secretary Richard Pengelly in December.
The letter said that a business case for the centre had been submitted and funding had been allocated.
Mr Pengelly also said the Belfast Health and Social Care trust had informed him the centre would be "fully operational by March 2019".
Ms Flynn said that while the delay was disappointing, it was important that funding was approved and a date set.
"The positive thing is that the Department of Health has given us the reassurance that by March 2019, the mesh centre will be fully operational and open for women to avail of."Case studies: Mesh led to 'excruciating pain'Hundreds suing NHS over vaginal implantsWhat's the issue with mesh implants?
In June 2017, a number of local women told the BBC how mesh implants had left them physically and mentally scarred.
Since then, an increasing number of women and men have come forward with personal stories of how mesh has created complications for their physical and mental health.
Women described how the mesh had cut into the vagina causing severe discomfort.
While official figures show that about 7,000 women have had vaginal mesh implants, it is unclear how many have been adversely affected.
A review of vaginal mesh surgeries in Northern Ireland last year found most surgeons failed to keep to guidelines on how many operations they had performed.
The mesh centre, or unit, is a joint initiative between the Health and Social Care Board and the Public Health Agency.
In an interview with the BBC, in February 2018, Dr Christina McMaster said a specially accredited unit had been set up to deal with women who are coping with problems following vaginal mesh implants.
According to the Health and Social Care Board, the centre has been treating women, and at least four women have had mesh removed.
However, the support group, Sling the Mesh NI, said there had been a breakdown of trust between women and local clinicians with many women opting to travel to England instead for mesh removal surgery.
A translabial scanner, which is used to detect surgical mesh, has been purchased by the trust, but in order for the centre to be fully operational, theatres and specialist surgeons are also required.
Ms Flynn says she continues to be contacted by women who are affected.
On a positive note, one woman who had mesh removed at the end of last year said it was a positive experience.
"Until they get the surgery a lot of these women are suffering on a daily basis," she said. "They become immobile and are suffering mentally too.
"I understand that the mesh centre will be able to provide therapy for their mental health too."
A review of vaginal mesh implants is underway and until the results are published, a temporary ban is in place.
https://www.bbc.com/news/uk-northern-ireland-46810171
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