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Ethicon Media Monitoring 7/17/2018
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Dr Zak: 'Don't suffer in silence if sneezing makes you wee'
Jul 17, 2018 | The Northern Echo
By Hannah Chapman
Within the last week the government has accepted the recommendations of an independent review, looking into the use of plastic mesh for the management of stress urinary incontinence in women, and as a result has ordered this treatment to be halted for the present time. -
Carlow mum of two affected by vaginal mesh scandal call on Government to ban the devices
Jul 17, 2018 | The Irish Sun
By Aoife Finneran
WOMEN affected by the vaginal mesh scandal are calling on the Government to follow Britain’s lead and BAN the devices. -
Campaigners call for suspension of mesh operations in Scotland
Jul 15, 2018 | The Sunday Post
By Marion Scott
Last week, NHS England announced the suspension of mesh tape implants to treat incontinence, going further than the measures put in place in Scotland four years ago. -
UK bans transvaginal mesh: here’s 5 reasons why
Jul 13, 2018 | British Medical Journal
By Carl Heneghan
This week the UK put a temporary ban on surgical mesh for stress urinary incontinence. Julia Cumberlege, who chaired the review, said: “I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.
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Dr Zak: 'Don't suffer in silence if sneezing makes you wee'
Jul 17, 2018 | The Northern Echo
By Hannah Chapman
WITHIN the last week the government has accepted the recommendations of an independent review, looking into the use of plastic mesh for the management of stress urinary incontinence in women, and as a result has ordered this treatment to be halted for the present time.
Initially seen as a godsend when it first came out, the simple procedure involves inserting the mesh through the vagina to support the bladder and other organs which have prolapsed, for example after childbirth.
However, after reports of the mesh slicing through other organs and complications ranging from chronic pain through to even death in one case, some have labelled it “the biggest health scandal since thalidomide”.
Urinary incontinence is a serious and disabling issue, conservatively estimated to affect three and a half millions individuals in the UK.
Although much more common in women, it does affect the male population too.
Broadly speaking, there are two types, stress and urge incontinence, with mixed being a combination of both.
If you imagine the bladder as an upturned hot water bottle, urge incontinence is due to the bladder being over irritable and the muscle at its neck not being strong enough to control it until a socially appropriate moment.
Stress incontinence is due to weakness of the muscles of the pelvic floor, which support the bladder.
Damage to these may happen after childbirth, or abdominal or gynaecological surgery.
Sufferers leak urine when they cough, sneeze, or exercise.
I would urge anyone with urinary incontinence to seek the help and support of their GP rather than suffer in silence.
Basic measures involve addressing alcohol and caffeine consumption, as both these worsen symptoms. Weight loss reduces pressure on the bladder and stopping smoking should have you coughing less.
FIRST line treatment for urge incontinence is bladder retraining, which involves slowly increasing the time between each trip to the toilet.
If this is unsuccessful, medications called anticholinergics may be used, which reduce the irritability of the bladder, lessening the spasms which cause urine to leak.
Managing stress incontinence starts with pelvic floor exercises with the aim of strengthening weakened muscles.
Although there are several devices you can buy over the counter, it may be sometimes difficult to actually isolate the right muscles and hence there are specialist services available where you can be taught the correct technique.
The exercises should form a regular part of your schedule.
If pelvic floor exercises do not provide the desired result, the next step would be a referral to a dedicated pelvic floor surgeon, to assess your case. The surgical management of both types of incontinence is a specialist area.
Treatments for urge symptoms including injecting Botox into the bladder muscle to help it relax, nerve stimulators which control the nerves supplying the bladder, and techniques to enlarge the capacity of the bladder itself.
For stress incontinence there are now dedicated pelvic floor surgeons, and thankfully there are options other than mesh slings to help patients whose cases require this level of input.
http://www.thenorthernecho.co.uk/news/16357381.dr-zak-dont-suffer-in-silence-if-sneezing-makes-you-wee/
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Carlow mum of two affected by vaginal mesh scandal call on Government to ban the devices
Jul 17, 2018 | The Irish Sun
By Aoife Finneran
WOMEN affected by the vaginal mesh scandal are calling on the Government to follow Britain’s lead and BAN the devices.
Yet while the suspension could save some patients from excruciating side-effects, it’s already too late for many women who have suffered irreversible damage.
The net-like fabric is used as a treatment for stress urinary incontinence or prolapse and acts as a hammock, keeping the bladder in place.
However, some patients have been left with “life-changing” injuries as a result of the mesh eroding through the vaginal tissue.
In the UK, the NHS last week accepted a recommendation to immediately suspend mesh implant procedures, with the review group’s chairwoman Julia Cumberlege insisting there was no evidence the benefits of mesh outweigh the “severity of human suffering caused by mesh complications”.
Now the HSE is under increased pressure to follow suit by halting the use of the devices here.
Mesh implants have only been used in Ireland for the last ten or 15 years, and little is known about the long-term impact and resulting complications.
Women injured by the device have reported severe pain, constant bleeding, inability to have sex and difficulty in walking or moving.
Last week, they met with Health Minister Simon Harris to outline their concerns.
As a result, the HSE has ordered doctors to inform all patients of the possible severe complications before they undergo the procedure.
In addition, campaigners have met with the Health Products Regulatory Authority which is set to investigate the issue.
However, survivors say it’s not enough, and that the report expected by the end of the year is “far too late for Irish women”.
Among these is Carlow’s Lesley-Anne Stephens, who has been bravely campaigning for an immediate halt to the mesh procedures until a full review and audit has been completed by experts.
The mum of two, who previously spoke out about her experience in the Irish Sun, admitted: “The damage the mesh has done to me is irreversible, so I have to try and live with the chronic pain and nerve damage.”
Lesley-Anne underwent two operations here to have the mesh partially removed after it grew around her internal tissue.
She was then forced to seek a further procedure in the UK, paid for by herself, in order to remove what remained of the device.
https://www.thesun.ie/news/2860001/carlow-mum-of-two-affected-by-vaginal-mesh-scandal-call-on-government-to-ban-the-devices/
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Campaigners call for suspension of mesh operations in Scotland
Jul 15, 2018 | The Sunday Post
By Marion Scott
Last week, NHS England announced the suspension of mesh tape implants to treat incontinence, going further than the measures put in place in Scotland four years ago.
Former health secretary Alex Neil has condemned pro-mesh surgeons in Glasgow and Edinburgh for continuing to operate on at least 500 more women because he “requested” rather than ordered a suspension in 2014.
He said: “I was appalled some health boards continued using mesh, and hold them responsible for the women who have been badly injured as a result.
“We must now introduce a full suspension, and I call on our new health secretary to do that.
“It’s clear from what we’re seeing in Australia, New Zealand and now in England, that mesh should be banned.”
Elaine Holmes, of Scottish Mesh Survivors, said: “Alex Neil believed he was going to get full suspension.
“Now, we want our rules tightened to do what was originally intended.
“The evidence is clear.
“Surgeons must accept what everyone else can see.”
NHS England say the most used mesh tape implants, to treat stress incontinence, will not be used until next March.
https://www.sundaypost.com/fp/campaigners-call-for-stricter-rules-surrounding-mesh-operations/
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UK bans transvaginal mesh: here’s 5 reasons why
Jul 13, 2018 | British Medical Journal
By Carl Heneghan
This week the UK put a temporary ban on surgical mesh for stress urinary incontinence. Julia Cumberlege, who chaired the review, said: “I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. This ban follows the NICE recommendation in December 2017, to restrict the use of mesh in prolapse to research only. The reasons for this ban, though, are long-standing and here’s five of those reasons that have contributed:
Reason 1:
It’s been 13 years since NICE stressed the need to inform women of the lack of long-term outcomes, and `Cochrane recommended the need for studies with longer term follow up. Little has changed over time and there is still a lack of high-quality long-term data to inform the use of mesh. When long-term data is produced it is often poor quality (riddled with bias) lacks a control group, has substantial losses to follow-up and has ridiculously small sample sizes. This type of evidence, therefore, has added little to the safety debate.
Reason 2:
Ten years ago, the FDA first alerted practitioners of the medical complications associated with transvaginal mesh. In 2008 the FDA released a review identifying serious safety concerns and adverse events. This review corrected former 2008 statement that side effects are not rare. “The most common mesh-related complication experienced by patients undergoing transvaginal POP repair with mesh is vaginal mesh erosion.”…..”More than half of the women who experienced erosion from nonabsorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries.
Reason 3:
A significant number of mesh devices have been removed from the market (likely more than 80%). For example, in 2012 announced it would no longer sell Gynecare Prolift, Gynecare Prolift+ M, Gynecare TVT Secur and Gynecare Prosima surgical meshes. The company-maintained safety concerns did not play a role in the decision. However, it is incompatible with patient safety to have so many devices on the market at any one time, to then remove them at will, and subsequently replace them with mesh devices that do not provide new evidence to inform their use and somehow hope women will remain safe.
Reason 4:
Over the last 20 years. transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence – this is an understatement as often it’s no evidence – and they have inherited approval status using equivalence from just a few products. This regulatory lax approach to the approval of devices is inexcusable and made it inevitable that problems would occur and women would be exposed to avoidable harms
Reason 5:
One woman saying there is a problem might be seen as an outlier. But when you have groups in England, Wales, Ireland, Sweden, when you have over 6000 women in the Sling the Mesh Facebook support group, when over 100,000 women are in US litigation then you must accept there is one humongous problem.
Yet, health professionals continual denial and dismissal of the problems with mesh, the use of poor quality evidence to shore up their arguments (a little bit of EBM training wouldn’t go amiss) and defensive statements that often ignore patients and pretends everything is OK remains a significant problem to progress, and it has ensured the problems with mesh have been perpetuated and gone on far too long.
https://blogs.bmj.com/bmjebmspotlight/2018/07/13/uk-bans-transvaginal-mesh-heres-5-reasons-why/?utm_campaign=shareaholic&utm_medium=twitter&utm_source=socialnetwork
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