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Trust admits that patients should not have had pelvic floor mesh surgery
May 1, 2019 | British Medical Journal
By Clare Dyer
More than 50 patients who had controversial pelvic floor surgery involving artificial mesh should not have been operated on, an NHS trust has admitted. -
Mother who spent £13K to remove a vaginal mesh implant that made sex with her husband impossible accuses the NHS of STILL failing women 'mutilated' by the surgery
May 1, 2019 | Daily Mail
By Hayley Richardson
A mother-of-three who was left in constant agony and unable to have sex with her husband by a vaginal mesh implant has spent £13,000 on having it removed. -
Devon hospital probe demanded by suffering women who received vaginal mesh surgery
May 1, 2019 | DevonLive
By Anita Meritt
A group of injured women from Devon will be hand delivering a letter today to Torbay and South Devon NHS Foundation Trust which lists the names of woman who severely suffered after being fitted with the controversial vaginal mesh implants at the hospital. -
As Lawsuits Take Flight, Boeing Facing Burgeoning Legal Bills. Plus: Lit Funders Gain Ground in NFL Concussion Deal
May 1, 2019 | Law.com
By Amanda Bronstad
Mesh Milestone: Johnson & Johnson got hit with a $120 million pelvic mesh verdict in Philadelphia last week. The award includes $20 million in compensatory damages and $100 million in punitive damages to Susan McFarland, a 68-year-old woman who ended up with chronic urinary tract infections after having a pelvic mesh device made by Johnson & Johnson’s Ethicon surgically implanted to treat incontinence. -
'No reason in logic' why Ethicon pelvic mash class should not be expanded, judge says
May 2, 2019 | Lawyerly
By Cat Fredenburgh
A judge has signed off on the lead applicants' bid to expand the current group definition in a class action against Johnson & Johnson unit...
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Trust admits that patients should not have had pelvic floor mesh surgery
May 1, 2019 | British Medical Journal
By Clare Dyer
More than 50 patients who had controversial pelvic floor surgery involving artificial mesh should not have been operated on, an NHS trust has admitted.
North Bristol NHS Trust has told 57 women and men who had the procedure at Southmead Hospital in Bristol that they should have been offered alternative treatment first. The review follows an independent investigation into laparoscopic ventral mesh rectopexy (LVMR) cases between 2007 and 2017.
Surgeon Tony Dixon, a pioneer in the use of the technique, was suspended in 2017 after concerns were raised. He has also had his practising privileges withdrawn by the private …
Access to full text unavailable – subscription required.
Story can be found here: https://www.bmj.com/content/365/bmj.l1503
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May 1, 2019 | Daily Mail
By Hayley Richardson
A mother-of-three who was left in constant agony and unable to have sex with her husband by a vaginal mesh implant has spent £13,000 on having it removed.
Ceri Baker, 43, of Dartmoor, Devon, underwent the initial 45-minute operation at Torbay Hospital in March 2017 to treat stress urinary incontinence which she was plagued with after having children.
But afterwards, the formerly fit and healthy mum was left in constant pain by the trans-obturator tape (TOT), making it difficult to sit comfortably or do the physical hobbies she loved with her family.
She was also unable to have sex with her husband-of-20-years Peter, and said her vagina felt 'mutilated'.
Having gone back and forth to her GP and surgeon and undergone two steroid injections under general anaesthesia, in January she suffered a severe nerve reaction and hasn't been able to walk for more than 30 minutes or sit comfortably since.
It got so bad that Ceri, a special educational needs coordinator, was considering a hysterectomy when she eventually decided to go private and have the mesh removed, rather than face a year-long wait for the procedure on the NHS.
Ceri is now taking legal action against Torbay and South Devon NHS Foundation Trust for the suffering she has endured and the impact on her life.
She is calling on the hospital to carry out an investigation and urging the trust to gather information from all patients who have suffered since having the implant and offer them support and appropriate care to aid their 'mental and physical health and well-being'.
Ceri, who documents her experiences on her YouTube channel Vaginal Mesh Story Time, explained: 'I paid to have the mesh removed privately in order to save myself, as if I waited a year it is very likely I would have been unable to work or lead anywhere near a normal life.
'I was already struggling to do so, having to spend many days lying on the sofa working from home as I couldn't sit on a chair for more than 20 minutes comfortably.
'I will need three to six months off work now to recover and have been told it will be up to two years for full nerve and muscle recovery.'
Speaking about her reasons for having the TOT mesh, she said she was 'leaking daily' which was 'annoying and embarrassing', especially when she was out running, shopping or dancing on a night out. The controversial devices that have been compared to thalidomide...
WHAT ARE VAGINAL MESH IMPLANTS?
Vaginal mesh implants are devices used by surgeons to treat pelvic organ prolapse and urinary incontinence in women.
Usually made from synthetic polypropylene, a type of plastic, the implants are intended to repair damaged or weakened tissue in the vagina wall.
Other fabrics include polyester, human tissue and absorbable synthetic materials.
Some women report severe and constant abdominal and vaginal pain after the surgery. In some, the pain is so severe they are unable to have sex.
Infections, bleeding and even organ erosion has also been reported.
WHAT ARE THE DIFFERENT TYPES OF MESH?
Mini-sling: This implant is embedded with a metallic inserter. It sits close to the mid-section of a woman's urethra. The use of an inserter is thought to lower the risk of cutting during the procedure.
TVT sling: Such a sling is held in place by the patient's body. It is inserted with a plastic tape by cutting the vagina and making two incisions in the abdomen. The mesh sits beneath the urethra.
TVTO sling: Inserted through the groin and sits under the urethra. This sling was intended to prevent bladder perforation.
TOT sling: Involves forming a 'hammock' of fibrous tissue in the urethra. Surgeons often claim this form of implant gives them the most control during implantation.
Ventral mesh rectopexy: Releases the rectum from the back of the vagina or bladder. A mesh is then fitted to the back of the rectum to prevent prolapse.
HOW MANY WOMEN SUFFER?
According to the NHS and MHRA, the risk of vaginal mesh pain after an implant is between one and three per cent.
But a study by Case Western Reserve University found that up to 42 per cent of patients experience complications.
Of which, 77 per cent report severe pain and 30 per cent claim to have a lost or reduced sex life.
Urinary infections have been reported in around 22 per cent of cases, while bladder perforation occurs in up to 31 per cent of incidences.
Critics of the implants say trials confirming their supposed safety have been small or conducted in animals, who are unable to describe pain or a loss of sex life.
Kath Samson, founder of the Sling The Mesh campaign, said surgeons often refuse to accept vaginal mesh implants are causing pain.
She warned that they are not obligated to report such complications anyway, and as a result, less than 40 per cent of surgeons do.
She told Devon Live: 'I was so bad I stopped having fun, but it caused no pain at all and I could in fact lead a perfectly "normal" life, so long as I planned ahead.'
Having been told by her surgeon that the implant would 'change her life', she said it did just that - dramatically for the worse.
'The nerve pain was so severe that I needed to take strong nerve blocking medication to function in any normal capacity,' she said.
I felt I had reached breaking point as I couldn't sit at my desk to work and I felt constantly exhausted, and like I was being gradually poisoned.'
Ceri claims she was never made aware of the risks by her surgeon and was shocked to see a letter two years later which claimed she had been informed of the success rate and reoperation risks, together with the risk of pelvic organ damage, chronic pain, dyspareunia (difficult or painful sexual intercourse), mesh erosion and rejection.
Since having her mesh implant removed, at a personal cost of £13,000, Ceri said she is completely exhausted and struggles to maintain good mental health.
She added: 'My main sadness as a mother is that I am losing precious time with my children again that I can never get back or ever be compensated for.'
Ceri and a number of other women who claim to have suffered seriously since having the implants at Torbay Hospital have formed The Action for Mesh Injured Patients campaign group.
Today they presented a petition to officials at the hospital to mark International Mesh Awareness Day.
Ceri explained: 'Our petition is calling on the hospital trust to look into the care and health of patients who have suffered injury following vaginal mesh implant surgery. A clear picture needs to be identified and communicated.
'Through our social support and campaign groups, it has come to our attention that there are many women who have suffered injury after surgery at Torbay Hospital and their injuries simply have not been addressed or recognised.
'Many of the injured women, like myself, are being forced to seek private treatment – at the cost of thousands of pounds – or are having to go to other hospital trusts out of the area to receive appropriate care in order to save their physical and mental health and well-being. This is not acceptable.
'We are calling for a full investigation to ensure the true health outcomes for all women who underwent mesh surgery at Torbay Hospital since its introduction is understood.
'This should cover details including exactly what information given to patients when seeking their consent to carry out this life-changing procedure. This investigation needs to be carried out with urgency.'
Vaginal mesh implants, which have caused worldwide controversy, are designed to be permanent and during the first weeks after surgery become embedded in the surrounding tissue to provide better pelvic support.
This means surgeons and doctors have to weigh up the risk of damage to nerves and nearby organs, including the bladder and bowel, before agreeing to their removal.
Torbay and South Devon NHS Foundation Trust stopped using the meshes indefinitely in October 2017, seven months after Ceri's operation.
Last July, the Department of Health and Social Care and NHS England agreed to immediately suspend their use after a Medical Devices Safety Review, led by Baroness Cumberlege, heard from many women about the 'life-changing' and 'life-threatening injuries' they had suffered.
However, the National Institute of Health and Care Excellence (NICE) last month issued new guidelines paving the way for the implants to be used again, with the review still to be completed.
Ceri said: 'I hope women don't see the new guidance and think all concerns have been dismissed.
'I have joined many support groups online and seen that thousands of women are campaigning from all over the world for their voices to be heard and for vaginal mesh to be banned.
'The NHS still isn't responding quickly to the plight of these desperately ill women or coming forward to find them and give them a clear plan of intervention with real care and time plans for removal, and further corrective surgery.
Instead, desperately ill women all over the UK are being left to fight this whole battle for themselves. It is entirely wrong.'
A Torbay and South Devon NHS Foundation Trust spokesperson said: 'We are unable to comment about specific cases; however, we are committed to listening to our patients and the public to ensure that we're continually providing the highest quality of care possible.
'Due to public concerns about this type of surgery, as well as some updated NICE recommendations, we voluntarily stopped using the meshes in October 2017. Before we removed the meshes as a surgical option for our patients, we had been significantly reducing the number of procedures being carried out using these meshes, well before the NICE recommendations were made.
'As a trust, we have decided to stop using the meshes indefinitely and we are currently offering our patients the more traditional surgery options. However, we are closely monitoring the evidence and development of alternatives so that we can ensure that we are at the forefront of any future surgical developments.'A U-TURN ON THE PROLAPSE MESH BAN
Last month health chiefs announced a dramatic U-turn on the proposed ban on 'barbaric' vaginal mesh implants, prompting fury among campaigners.
The National Institute for Health and Care Excellence declared two years ago the implants should be outlawed for prolapse – a common childbirth issue that causes the organs to fall out of place.
However, the Government body has backtracked on its decision, despite having no new scientific evidence to prove the procedure is safe.
Furious victims of the procedure have slammed the announcement by NICE, which advises the NHS.
Kath Sansom, founder of campaign group Sling The Mesh (STM), described the guidelines as being an 'institutional betrayal of women'.
Currently there are restrictions on the controversial procedure, which is used for stress urinary incontinence as well as pelvic organ prolapse.
NICE said these will remain in place until all operations and complications are registered on a national database.
After that, only expert surgeons based at specialist centres will carry out operations for the common disorders – usually stemming from natural childbirths.
https://www.dailymail.co.uk/femail/article-6981375/Mother-three-spent-13K-vaginal-mesh-implant-removal-sex-husband-impossible.html
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Devon hospital probe demanded by suffering women who received vaginal mesh surgery
May 1, 2019 | DevonLive
By Anita Meritt
A group of injured women from Devon will be hand delivering a letter today to Torbay and South Devon NHS Foundation Trust which lists the names of woman who severely suffered after being fitted with the controversial vaginal mesh implants at the hospital.
The move coincides with International Mesh Awareness Day.
The campaigners are calling for the hospital to carry out a full and open investigation and for the trust to reveal how it is going to offer physical and mental health care for those women who have had their lives changed devastatingly beyond recognition following the procedure.
Among those from The Action for Mesh Injured Patients group who will be at the hospital at noon, is mother-of-three Ceri Baker who was left at ‘breaking point’ following her mesh surgery.
The 43-year-old, of Dartmoor, has gone from being a fit and active woman with a zest for life to being in constant pain and discomfort after having the surgery in March 2017.
She cannot sit comfortably or do any of the physical activities and hobbies she always previously enjoyed with her children, and is unable to have sex with her husband of 20 years, Pete, without it being ‘extremely painful’.
After a nerve reaction in January of this year left her unable to walk for just half an hour, she decided to fund the removal of her mesh implant privately, which was carried out in March at a personal cost of £13,000. She would have waited over a year on the NHS for removal.
Ceri, who is a member Devon and Cornwall Mesh Awareness on Facebook, said: “We are currently a group of 10 women who are asking Torbay and South Devon Hospital Trust to hear and act on the following demands. We acknowledge that Torbay Hospital have stated, ‘as a trust we have decided to stop using the meshes indefinitely and we are currently offering our patients the more traditional surgery options’.
“It has come to our attention, via Facebook support pages, that many women have been injured from mesh surgery at Torbay Hospital and their historic injuries are not being addressed or heard effectively.
“Many of the injured women are being forced to go privately and to other hospital trusts to receive appropriate care in order to save their physical and mental health and well-being.
“We demand that a full investigation regarding the informed consent and real health outcomes for all women who have received mesh surgery at Torbay Hospital, since its introduction, is carried out as a matter of urgency.
“We demand that every woman who presents with injury and illness following mesh surgery is given information about how Torbay hospital will proceed in acknowledging their injury and support them.”
The vaginal mesh implants which have caused worldwide controversy were designed to be permanent and during the first weeks after surgery become embedded in the surrounding tissue to provide better pelvic support.
This means surgeons and doctors have to weigh up the risk of damage to nerves and nearby organs, including the bladder and bowel, before agreeing to their removal.
Ceri is currently taking legal action against Torbay and South Devon NHS Foundation Trust for the suffering she has endured and the impact on her life. She is being represented by medical negligence specialists Hudgell Solicitors, and claims she was never made aware of the risks by her surgeon.
Last July, the Department of Health and Social Care and NHS England agreed to immediately suspend their use after a Medical Devices Safety Review, led by Baroness Cumberlege, heard from many women about the ‘life-changing’ and ‘life-threatening injuries’ they had suffered.#
However, the National Institute of Health and Care Excellence (NICE) last month issued new guidelines paving the way for the implants to be used again, with the review still to be completed.
Joining Ceri at Torbay hospital tomorrow will be fellow mesh campaigner Susan Morgan. The mum-of-two has relentlessly campaigned to stop the use of vaginal mesh implants after being left a virtual recluse due to the pain following surgery.
At the age of 51, Susan, of Brixham, was advised a urinary incontinence procedure would achieve her wish of being able to enjoy ballroom dancing.
Instead she has no control over her bladder and remains in constant pain from the vaginal mesh trans vaginal tape (TVT), which she says feels like a chemical burn and cheese wire inside her body.
Susan said: “Today is International Mesh Awareness Day where women from all walks of life and all over the world have been catastrophically injured, some have lost their lives or were unable to cope with the hideous pain.
https://www.devonlive.com/news/devon-news/devon-hospital-probe-demanded-suffering-2818013
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May 1, 2019 | Law.com
By Amanda Bronstad
......Here’s what else you need to know:
Mesh Milestone: Johnson & Johnson got hit with a $120 million pelvic mesh verdict in Philadelphia last week. The award includes $20 million in compensatory damages and $100 million in punitive damages to Susan McFarland, a 68-year-old woman who ended up with chronic urinary tract infections after having a pelvic mesh device made by Johnson & Johnson’s Ethicon surgically implanted to treat incontinence. It’s the seventh jury verdict in the Philadelphia Court of Common Pleas against Ethicon over its pelvic mesh devices, but the first over $100 million. Tracie Palmer and Braden Lepisto (Kline & Specter) represented McFarland, and Ethicon’s lawyers were Kate Skagerberg (Beck Redden), Adam Spicer (Butler Snow) and D. Alicia Hickok (Drinker Biddle).https://www.law.com/2019/05/01/as-lawsuits-take-flight-boeing-facing-burgeoning-legal-bills-plus-lit-funders-gain-ground-in-nfl-concussion-deal/
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'No reason in logic' why Ethicon pelvic mash class should not be expanded, judge says
May 2, 2019 | Lawyerly
By Cat Fredenburgh
A judge has signed off on the lead applicants' bid to expand the current group definition in a class action against Johnson & Johnson unit...
Access to full text unavailable – subscription required.
Story can be found here: https://www.lawyerly.com.au/no-reason-in-logic-why-ethicon-pelvic-mesh-class-should-not-be-expanded-judge-says/
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