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Ethicon Media Monitoring 11/1/2018
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Call for comments on new mesh-use guideline
Oct 30, 2018 | Women’s Views on News
Recommendations offer a range of options for treatment that don’t involve the use of surgical mesh/tape. -
Mother claims her uterus was pierced by her contraceptive implant which has ruined her life and ‘even gave her breast cancer’
Oct 31, 2018 | Mail Online
By Stephen Matthews
...He added: 'As we saw with transvaginal mesh, there is no central register of women who have had Essure devices, so it is very hard to provide an exact estimate of the number of women who might have had a long-term adverse outcome.
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Call for comments on new mesh-use guideline
Oct 30, 2018 | Women’s Views on News
Recommendations offer a range of options for treatment that don’t involve the use of surgical mesh/tape.
After all the horror stories about surgical mesh/tape and months of awareness-raising campaigning, the National Institute for Health and Care Excellence (NICE) has now come up with a draft guideline regarding the future management of urinary incontinence and pelvic organ prolapse in women.
A full range of non-surgical options should be offered to women for stress urinary incontinence or pelvic organ prolapse before any operations, NICE has said, adding that there are a number of non-surgical options for both urinary incontinence and pelvic organ prolapse, and which should be considered before surgery.
The non-surgical options for urinary incontinence include lifestyle interventions, physical therapies, behavioural therapies, and medicines, while the non-surgical options for pelvic organ prolapse include lifestyle modification, topical oestrogen, pelvic floor muscle training and pessary management
New draft guidelines from NICE recommend that where surgery is offered, if a woman’s chosen intervention is not available from the consulting surgeon, she should be referred to an alternative surgeon.
And that surgical interventions using surgical mesh/tape should only be considered when other non-surgical options have failed or are not possible.
A national database should be set up to record all procedures involving the use of surgical mesh/tape in operations for stress urinary incontinence or pelvic organ prolapse to help with future decision making.
And in the cases where it is agreed to use surgical mesh/tape, women must be fully informed of the risks.
In July a national ‘pause’ was announced by the government on the use by the NHS of surgical mesh/tape to treat stress urinary incontinence and for urogynaecological prolapse where the mesh is inserted through the vaginal wall.
This ‘pause’ takes the form of a high vigilance restriction period during which certain conditions apply.
And this will remain in place until a number of conditions are met including registering all operations and any complications on a national database and surgery being performed by specialist surgeons based at specialist centres.
A follow up appointment should be offered within six months to all women who have had urinary incontinence or prolapse surgery.
The draft guideline also recommends how complications associated with surgical mesh/tape surgery should be assessed and managed.
It says that consultants at centres specialising in the diagnosis and management of surgical mesh/tape-related complications should develop an individualised investigation plan for each woman with suspected or confirmed mesh-related complications.
Complications related to the device should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) and details of the complications should be collected in a national registry.
There are also a number of recommendations included in the guideline for surgical mesh/tape-related complications.
These include:
Referring women who suffer a suspected surgical mesh/tape-related complication to a urogynaecologist, urologist or colorectal surgeon for specialist assessment.
Referring women with a confirmed surgical mesh/tape-related complication, or unexplained symptoms after a surgical mesh/tape procedure, to a consultant at a regional centre specialising in the diagnosis and management of surgical mesh/tape-related complications.
And the development of an individualised investigation plan for each woman with suspected or confirmed surgical mesh/tape-related complications.
Registered stakeholder organisations can now submit comments on these proposed recommendations. They have until 19 November 2018.
MumsNet is one registered stakeholder and has set up a thread so that if you want to you can share your thoughts on the proposed guidance on this thread, and MumsNet can then collate the themes and use your comments to compose their organisational response.
You can also submit responses as an individual, but NICE encourages people to do it via registered stakeholders wherever possible.
You can see more about the proposed guidance here and you can read the draft guideline itself here,
Sir Andrew Dillon, chief executive of NICE, said: “Our independent advisory committee looked at a range of evidence for interventions for urinary incontinence and pelvic organ prolapse in women and made a series of detailed recommendations, using the best evidence currently available.
“It is important that every woman is supported to make decisions that are right for her, consents to a procedure, and fully understands the benefits and risks of the procedure being offered before consenting to it.
“Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline, which does not involve surgical mesh/tape. If a surgeon cannot provide a full range of choices to the patient, then she should be referred to one who can.
“Surgeons must also record any intervention using surgical mesh/tape in a national database.
“The guideline committee was asked to look at a range of interventions and examine the evidence for them.
“Importantly, our recommendations offer women a range of options for treatment that don’t involve the use of surgical mesh/tape.”
There is though, another problem.
Kath Sansom, director of campaign group Sling the Mesh, told The Independent that a Scottish audit had also identified a higher risk of complications than the NHS England review.
But, she pointed out, these could still be under-reported.
“Nobody knows the true risk of mesh,” she said, “unless there is a national recall as thousands will be suffering having not made the connection mesh is causing their pain, some are treated in private hospitals where there is no data capture, others just go back and forth to GPs for pain meds or antibiotics for infection so won’t be picked up.”
http://www.womensviewsonnews.org/2018/10/call-for-comments-on-new-mesh-use-guideline/
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Oct 31, 2018 | Mail Online
By Stephen Matthews
A mother claims her uterus was pierced by the controversial contraceptive Essure and has even accused the implant of giving her breast cancer.
Julie Watts, 50, had the sterilisation device implanted into her fallopian tubes in 2009 after looking for a reliable and permanent birth control.
The mother-of-one, from Canberra, Australia, claims her life then became a 'living hell' with the device making her feel 'poisoned' every day.
After being 'healthy as a horse', Ms Watts endured more than a decade-long health battle, which included severe bleeding, chronic pelvic and back pain, excruciating cramps, fatigue, depression and anxiety.
These complications set her back at work, which Ms Watts claims ruined her career as a project manager and even caused the break down of her marriage.
In a desperate attempt to rid herself of her agonising symptoms, Ms Watts had a total hysterectomy last week to remove the implant and claims she instantly felt better.
'I feel like a new woman. I'm rejuvenated and have my mojo back,' she said.
'I wanted a permanent birth control solution, and the Essure implant sounded perfect to me at the time, as the recovery period was far shorter than a tubal ligation,' Ms Watts said.
The Essure implant is a permanent contraceptive device comprised of a metal nickel coil that is inserted into the fallopian tubes.
This generates scar tissue, which blocks sperm from reaching the egg.
Tubal ligation, known as having one's 'tubes tied', involves clamping, blocking and sealing the oviducts to prevent eggs reaching the uterus.
'I kept asking whether it was safe, but my doctor at the time assured me it was FDA and TGA [Therapeutic Goods Association] approved,' Ms Watts said.
'I had faith that everything would be fine, otherwise why would they use it.'
After enduring symptoms for more than 10 years, Ms Watts only made the connection between her implant and her ill health while watching the 2018 documentary The Bleeding Edge.
'I totally forgot I even had it until a month ago, when I saw this documentary that details all the horrific side effects of Essure,' she said.
'I recognised the name straight away and my jaw dropped to the floor.
'I went to my gynecologist with this new information.'
While visiting the medic, Ms Watts was told the implant had migrated from her fallopian tubes and pierced both sides of her uterus.
'We were both horrified. He explained that my uterus would have been trying to expel the toxic implant by contracting, which explains my cramps,' she said.
'But in turn, this caused the device to pierce through.
'I was lucky it was discovered before it perforated my bowel. That could have been disastrous.'
Now aware of the risks associated with the Essure implant, Ms Watts claims the onset of her symptoms has become much clearer.
'Looking back, it explains so many things. I'd always been healthy as a horse, but after getting the Essure implant, my health rapidly declined,' she said.
'I felt sick all the time and it was like I had been poisoned. I couldn't understand it.'
Ms Watts even believes the implant caused her to develop breast cancer in 2011, which resulted in her undergoing a mastectomy on her left breast.
Speaking of her diagnosis, she said: 'It didn't make sense to me, because nobody on either side of my family had ever had it.
'There was absolutely no history and my genes tested negative for the breast cancer gene.
'Then I discovered there are PET [polyethylene terephthalate] fibres in the implant that cause inflammation in the body and raise oestrogen levels.
'My breast cancer was oestrogen-positive, meaning high levels likely caused it.
'Although no doctors can confirm it, I look at the timeline and my lack of family history and I can see a link.'
Since having the device removed last week in a total hysterectomy, Ms Watts claims she feels 'healthier and more alive' than she has in years.
'The Essure implant has stolen my career, it destroyed my health and my marriage and ruined my life,' she said.
'I felt so hopeless and had no joy. I was fatigued all the time and was just always sick.
'But I felt a difference straight away after it was removed from my body.
'This never should have happened with a device that was given to women everywhere under the pretence that is safe and won't do any harm.'
Ms Watts' gynecologist Dr Stephen Robson claims he had never seen a contraceptive device pierce through the uterus before.
Her ordeal has added to his increasing concerns about the dangers of Essure.
'When I was training as a specialist back in the 1990s in Adelaide, I worked with the inventor of the Essure device, Professor John Kerin,' Dr Robson said.
'I was his assistant when he was developing the devices. However, I never really used them because of concerns I had.
'I placed a few sets of Essures back in the very early 2000s but have not used them since.
'I have to say now I have increasing concerns about longer-term adverse effects of the devices, including pain.
He added: 'As we saw with transvaginal mesh, there is no central register of women who have had Essure devices, so it is very hard to provide an exact estimate of the number of women who might have had a long-term adverse outcome.
'I now have seen a number of women with possible adverse outcomes, so I certainly believe more detailed research needs to be undertaken as a priority.'
The Essure implant has come under fire in recent months after the Australian law firm Slater and Gordon announced a proposed class action against the device's manufacturer Bayer in August - which would follow similar lawsuits in the US, Canada and Scotland.
Slater and Gordon claimed the action comes following an onslaught of complaints from hundreds of Australian women who allege to have experienced adverse side effects from the implant.
A spokesperson for Bayer said: 'At Bayer we take our social and corporate responsibilities very seriously and we make the health and wellbeing of our patients, and the integrity of all of our products, an absolute priority.
'Patient safety is of the utmost importance to Bayer, and we are always saddened to hear of anyone experiencing an adverse event with any medical device.
'Essure was developed by Conceptus Inc. and placed on the Australian market in compliance with the Therapeutic Goods Administration (TGA) requirements.
'While it was on the market Essure was maintained and updated in accordance with all Health Authority requirements to ensure the label reflected all current safety information and that information was distributed to healthcare professionals in a timely manner.
'Essure is supported by an extensive body of research, including more than 40 published studies involving more than 200,000 patients worldwide over the past 20 years.
'Women who currently have Essure in place may continue to use the device, and Bayer will continue to support healthcare providers in their management of these patients.'
https://www.dailymail.co.uk/health/article-6337143/Mother-claims-uterus-PIERCED-contraceptive-implant.html
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