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Ethicon Media Monitoring 12/23/2016
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Ask for traditional surgery rather than pelvic mesh implants, says study out this week
Dec 22, 2016 | Cambs Times (also in Ely Times, Wisbech Standard)
By Kath Sanson
Mesh implants to fix pelvic organ prolapse have higher risks than traditional surgery but no extra benefits, according to a report released this week. -
Pelvic prolapse surgery using mesh or graft not more effective than standard technique, study finds
Dec 22, 2016 | News-Medical.net
Two controversial methods of surgical repair of prolapse in women have been found to be no more effective than the existing standard repair technique, up to two years after surgery. -
Study Supports Mesh Surgery for Incontinence But Not for Bowel or Bladder Prolapse
Dec 22, 2016 | MedicalResearch.com
Mesh surgery was introduced to overcome recognised limitations of traditional, non-mesh, surgery for these conditions, in particular extensive surgery and long hospital stays for incontinence and high failure/recurrence rates for prolapse.
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Ask for traditional surgery rather than pelvic mesh implants, says study out this week
Dec 22, 2016 | Cambs Times (also in Ely Times, Wisbech Standard)
By Kath Sanson
Mesh implants to fix pelvic organ prolapse have higher risks than traditional surgery but no extra benefits, according to a report released this week.
Pelvic floor exercises and pessaries for prolapse should be used as a first line treatment before women agree to go under the knife, the report adds.
The findings have been welcomed by campaigners who say it is vital the medical community properly inform women of the life changing risks of all mesh implants.
The future of mesh slings for incontinence in Scotland and England will be outlined in reports due to be published in the new year.
Elaine Holmes of Scottish Mesh Survivors, said: “There are no benefits of mesh so why take the risk?
“Alternative treatment options are available.”
Kath Sansom of Sling The Mesh said: “The study showed 12 per cent of women suffered complications after a prolapse fix using mesh but these women were only followed up for two years.
“Problems can cut in later so the true figure is likely to be higher. Women must demand traditional surgical fixes and surgeons must stop telling them that prolapse mesh is safe when in fact it carries unacceptable risk.”
The PROSPECT study, carried out by researchers at Aberdeen University, followed women in 35 hospitals across the UK having procedures with 65 surgeons.
It said women should try pelvic floor exercises and pessaries as a first line of treatment for prolapse.
“Women should be reassured that if they do need surgery, they ought to go ahead with standard operations,” the report said.
“The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy.
“Repair with mesh or graft material did not improve women’s outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication.
“Follow-up is vital to identify any longer-term potential benefits and serious adverse effects of mesh or graft reinforcement in vaginal prolapse surgery.
Prof. Cathryn Glazener health services research unit at the University of Aberdeen, said: “Prolapse is a condition that affects up to half of women after childbirth.
“Women who have surgery for prolapse have a three in 10 chance of needing at least one more operation, so the success rate is not great.
“Gynaecologists hoped that by reinforcing their repairs the success rate would get better.
“We found, in contrast to previous research, women were just as likely to be cured after standard surgery rather than reinforced repairs.
“They were just as likely to have other symptoms such as bladder or sexual problems, and other adverse effects such as infection, bleeding or pain.”
Around one in 10 women implanted with mesh suffered exposure - where a portion of mesh becomes visible through the vaginal wall, she added.
“About half of those women needed a small operation to remove or bury the exposed mesh,” she said.
“Synthetic mesh did result in some complications which posed extra risk.
“Researchers and clinicians need to work together to identify better operations, or reduce the prolapse symptoms using other means.”
Two other papers published this week draw attention to care for women with pelvic floor dysfunction.
Researchers from the Information Services Division (ISD) said long term results from mesh prolapse surgery are no better than from standard repair, echoing the PROSPECT findings.
The PrevProl study showed that pelvic floor exercises should be tried as a first line of treatment.
• The reports were released in the same week that a Freedom of Information request by the BBC showed that 404 women have been given mesh implants in Scotland despite a suspension being put in place by the Scottish health secretary in June 2014.
Health boards still using mesh implants said they discussed all the potential risks with patients before surgery.
• Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants.
• In England around 13,000 women a year are given mesh implants.
• The MHRA say the risk is around one to three per cent but figures calculated by campaigners say the risk is more like 8.56 per cent.
• The risk figure is calculated by women reporting their mesh complications to the MHRA Yellow Card system or surgeons reporting to the British Society of Urogynacology database. It is not mandatory for surgeons to report to either.
• Pelvic mesh implants are a global concern. Scottish MP Neil Findlay has called them the worst medical disaster of our time, Welsh MP Owen Smith said it is the worst health scandal he has seen in his time as a politician and Australian senator Derryn Hinch said it is a bigger scandal than Thalidomide.
http://www.cambstimes.co.uk/news/ask_for_traditional_surgery_rather_than_pelvic_mesh_implants_says_study_out_this_week_1_4826643
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Pelvic prolapse surgery using mesh or graft not more effective than standard technique, study finds
Dec 22, 2016 | News-Medical.net
Two controversial methods of surgical repair of prolapse in women have been found to be no more effective than the existing standard repair technique, up to two years after surgery.
Widespread concerns about the use of mesh and graft in prolapse surgery have been raised in public, with some patients reporting serious complications. Consequently, the use of mesh was banned in Scotland (with the exception of clinical trials) in June 2014 until further evidence was found regarding its suitability.
Researchers at the University of Aberdeen led a national collaborative research project comparing the outcome of pelvic organ prolapse repairs reinforced by either non-absorbable synthetic mesh or biological grafts against standard native tissue repairs in 1348 women.
They found the mesh, inserted through the vagina, resulted in a number of complications but did not offer any clear benefits, concluding that its use for these procedures could be considered an “unnecessary risk”, until further research was conducted.
The study was the largest randomised trial of the use of mesh or graft in transvaginal prolapse surgery and the results have been published today in the world’s leading medical journal The Lancet.
Pelvic organ prolapse occurs when one or more of the pelvic organs bulges into the vagina, which can affect around 40% of women. It is associated with childbirth and increasing age. Symptoms can include vaginal discomfort and urinary, bowel and sexual problems.
Up to one in 20 women with prolapse symptoms will need surgery to correct it and of those women, around three in ten will eventually need more prolapse surgery. On average, this happens about 12 years after the first operation.
Previous studies suggested non-absorbable mesh was more successful than standard native tissue to repair prolapse but there was not enough reliable evidence about other symptoms or quality of life. Studies comparing biological grafts with standard repair were inconclusive. There was not enough information about adverse effects to enable women and their doctors to judge which operation was safest.
The PROSPECT study was funded by an NHS research grant from the National Institute for Health Research (NIHR) Health Technology Assessment programme in 2007 to find that necessary reliable evidence. It consisted of two parallel randomised controlled trials, involving 1348 women having surgery for pelvic organ prolapse. The study was carried out in women attending 35 different hospitals across the UK, in conjunction with over 100 doctors and researchers between January 2010 and August 2013.
Participating women used a self-assessment questionnaire (Pelvic Organ Prolapse Symptom Score or POP-SS) to record their prolapse symptoms. Other symptoms and side-effects were also measured.
The Lancet paper published today reports the results for women having their first vaginal prolapse operation.
The results revealed that there was no significant clinical or statistical difference between those who had the mesh or graft surgery, compared to the standard native tissue repair, at one or two years after the surgery.
The study also revealed that more than one in ten women who had synthetic (non-absorbable) mesh had a mesh complication – though most were asymptomatic. However, there were no similar risks with biological grafts.
Researchers stressed that this study has only recorded the outcomes during the first two years after the operation. Because half the prolapse surgeries that fail, do so within 12 years, they are following up the same women at regular intervals up to at least 12 years. This is vital to determine whether mesh or graft repairs might prove more durable in the longer term.
The researchers concluded that using mesh, inserted through the vagina, could pose an unnecessary risk because some women who had been treated with mesh required extra surgical procedures in theatre for mesh complications. They suggested that in the future, synthetic mesh should only be used in clinical trials aimed at identifying better materials, improving insertion techniques or for use in a defined category of high risk women.
Professor Cathryn Glazener, who led the study said:
"This study showed in the first two years after surgery, there was no benefit to women having their first prolapse repair from the use of transvaginal synthetic mesh or biological graft to reinforce a standard anterior or posterior repair, either in terms of prolapse symptoms or in short term anatomical cure.
This contrasts with the conclusions of the most recent Cochrane review which reported that fewer women were aware of prolapse symptoms with synthetic mesh and fewer had anatomical recurrence, compared with women who did not have mesh.
Our findings provide robust evidence on which to base counselling for surgical decision making. However, these findings are confined to the first two years after surgery and only to women having their first repair. Longer-term follow up is required to truly assess any potential benefits or adverse effects of transvaginal mesh or graft.
Because mesh did result in a number of complications, with no clear benefits, we conclude its use for these procedures could be considered an unnecessary risk. Therefore we consider that mesh should only be used in the future in high quality clinical trials aimed at improving the results of vaginal prolapse surgery.
The study was carried out in collaboration with Glasgow Caledonian University, NHS Grampian, Plymouth Hospitals NHS Trust, Central Manchester University Hospitals and NHS Foundation Trust."
http://www.news-medical.net/news/20161222/Pelvic-prolapse-surgery-using-mesh-or-graft-not-more-effective-than-standard-technique-study-finds.aspx
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Study Supports Mesh Surgery for Incontinence But Not for Bowel or Bladder Prolapse
Dec 22, 2016 | MedicalResearch.com
MedicalResearch.com Interview with:
Dr Rachael Wood PhD
Consultant in Public Health Medicine – women and children’s health
NHS National Services Scotland
Information Services Division
EdinburghMedicalResearch.com: What is the background for this study?
Response: Mesh surgery for female stress urinary incontinence and pelvic organ prolapse is currently controversial.
Mesh surgery was introduced to overcome recognised limitations of traditional, non-mesh, surgery for these conditions, in particular extensive surgery and long hospital stays for incontinence and high failure/recurrence rates for prolapse. Mesh surgery may therefore offer additional benefits over traditional surgery. Mesh surgery may also carry additional risks however, with patient advocacy groups highlighting cases of severe, long term, mesh-related complications in some women who have undergone mesh surgery.
We therefore used routinely available, population based hospital discharge records from Scotland to identify women having mesh and non-mesh procedures for incontinence and prolapse. We then followed the women up for up to 5 years to assess how often they were readmitted for complications or further incontinence or prolapse surgery.
MedicalResearch.com: What are the main findings?
Response: Our findings for incontinence and prolapse are different.
Regarding surgery for prolapse of the bladder or bowel, we found that mesh surgery was less effective than non mesh surgery (higher rate of repeat prolapse surgery) and associated with substantially (x2-3) higher long term complication rates.
Regarding surgery for prolapse of the vaginal vault, we found no difference in repeat surgery or complication rates following non mesh surgery or surgery involving transvaginally- or abdominally-placed mesh.
Regarding surgery for incontinence, we found that mesh surgery was as effective as non mesh surgery (specifically open colposuspension) and long term complication rates were similar. Further, we found that mesh surgery carried a lower risk of immediate complications (at the time of the initial surgery) and a lower risk of inducing prolapse.
MedicalResearch.com: What should readers take away from your report?
Response: Mesh surgery should not be recommended as first line treatment for prolapse of the bladder or bowel.Current evidence supports the use of mesh surgery in incontinence.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Further research on long term complications following mesh and non –mesh incontinence surgery would be beneficial.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
https://medicalresearch.com/author-interviews/study-supports-mesh-surgery-for-incontinence-but-not-for-bowel-or-bladder-prolapse/30718/
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