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Ethicon Media Monitoring 2/23/2018
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U.K. orders review of ‘systemic failures’ in vaginal mesh safety procedures
Feb 22, 2018 | Fierce Biotech
By Nick Paul Taylor
The United Kingdom has ordered a review into whether “systemic failures” led the regulatory system to respond too slowly to patient concerns about the safety of vaginal mesh implants. -
New Material Could Make Vaginal Mesh Surgery Safer
Feb 22, 2018 | Healthline
By Ann Pietrangelo
Researchers say polyurethane is more elastic and could cause fewer complications than the material currently used in vaginal mesh. -
Vaginal mesh review announced
Feb 22, 2018 | WebMD
By Dr Farah Ahmed
The government has announced a 9-month review into how the authorities handled 3 medical treatments, including vaginal mesh implants. -
Government Review of Vaginal Mesh 'Does Not Go Far Enough To Protect Women'
Feb 22, 2018 | HuffPost
By Rachel Moss
Campaigners say Health Secretary Jeremy Hunt must also 'revisit the science'. -
Woodbridge woman wins settlement from Ipswich Hospital after ‘traumatising’ mesh implant case
Feb 22, 2018 | East Anglian Daily Times
By Katy Sandalls
A woman from Woodbridge has says she was left traumatised following a procedure to fit a vaginal mesh at Ipswich Hospital.
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U.K. orders review of ‘systemic failures’ in vaginal mesh safety procedures
Feb 22, 2018 | Fierce Biotech
By Nick Paul Taylor
The United Kingdom has ordered a review into whether “systemic failures” led the regulatory system to respond too slowly to patient concerns about the safety of vaginal mesh implants. Mesh will stay on the market in the U.K. while the government implements near- and long-term changes to protect patient safety.
Officials already know some of the near-term actions. Announcing the medical device safety review, U.K. health secretary Jeremy Hunt said the government is initiating a retrospective audit of patient data and investing $1.5 million in a database designed to improve clinical practice and spot issues. Those actions are intended to ensure mesh remains available to patients who need it while reducing the risk of harm.
In the longer term, the government hopes to learn from the vaginal mesh case to ensure regulators listen to patients and respond “in a rapid, open and compassionate way.” Hunt thinks the system fell short of this ideal in the vaginal mesh case.
“The truth is that we have a system that has not treated patients’ concerns with the seriousness that it should have done,” the health secretary said during a parliamentary debate.
Hunt has tasked Baroness Julia Cumberlege with reviewing where the regulatory system went wrong. Cumberlege will look at the speed, coordination and patient engagement shown by U.K. regulators and other healthcare officials when reports of adverse events tied to mesh implants started to come to light. Hunt wants Cumberlege to assess whether a “fuller, or even statutory, public inquiry” needs to take place when reports of adverse events arise in the future.
Cumberlege has freedom to propose how this will work in practice, but Hunt has provided her with some guideposts. The health secretary is encouraging Cumberlege to consider how best to support patients who have suffered harm despite overall evidence suggesting there isn’t a legitimate concern with the safety of the device in question.
https://www.fiercebiotech.com/medtech/u-k-orders-review-systemic-failures-vaginal-mesh-safety-procedures
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New Material Could Make Vaginal Mesh Surgery Safer
Feb 22, 2018 | Healthline
By Ann Pietrangelo
Researchers say polyurethane is more elastic and could cause fewer complications than the material currently used in vaginal mesh.
Is a better mesh on the way for women who suffer from pelvic organ prolapse and stress urinary incontinence?
Scientists at the University of Sheffield in England are on a mission to find a more suitable material for the vaginal mesh that is surgically implanted in women who live with these conditions.
They say polyurethane, a material used in insulation, mattresses, and other household items, may be that better option.
Currently, most vaginal mesh is made with polypropylene, a material used to make food containers, outdoor carpets, and other household items.
The Sheffield scientists say polyurethane mesh has more elasticity than polypropylene.In addition, the researchers inserted estrogen into the mesh to help speed up the healing process.
In their research, the scientists said they found that the estrogen did not compromise the strength and elasticity of the mesh.
The researchers believe that polyurethane mesh with estrogen could help women avoid life-altering complications.
Pelvic organ prolapse and stress urinary incontinence are conditions that affect many women, including half of those who’ve reached menopause.
Treatment often involves surgery and use of transvaginal mesh.
The mesh is intended to provide support for pelvic organs.
But for some women, it ends up causing debilitating complications. These include persistent pain, inability to have sex, and organ perforation.
Severe complications occur more often when mesh is used for pelvic organ prolapse than for stress urinary incontinence.
“For many years now, surgeons have been treating the problems of urinary stress incontinence and pelvic organ prolapse using the only synthetic material they had on hand — polypropylene,” Sheila MacNeil, PhD, professor of tissue engineering in the department of materials science and engineering at the University of Sheffield, said in a press release.
“However, when much bigger areas of the same material are inserted through the vagina to relieve pelvic organ prolapse, the complication rate is frankly unacceptable,” she said.
n the United States, several makers of polypropylene meshes have faced lawsuits over complications.
As a result, they no longer market mesh for pelvic organ prolapse. The mesh is still marketed to treat stress urinary incontinence. When used for this purpose, the complication rate is low.
The new mesh still needs to undergo clinical trials in the United Kingdom.
Experts told Healthline that clinical trials in the United States are complicated and could take many years.
They note that the estrogen component adds an additional level of scrutiny. This is due to the risks of hormone use and potential risk of breast cancer, uterine cancer, stroke, heart attack, and blood clots.Why surgeons use transvaginal mesh
“For many women, having children is a joy. But for those same women, years later, the effect of delivering babies, particularly if they are large babies, exerts a toll on the supporting structures of the female pelvis,” said Dr. Kecia Gaither, a double board-certified physician in OB-GYN and maternal fetal medicine and director of perinatal services at NYC Health and Hospitals System in New York.
Gaither told Healthline that menopause and hysterectomy can also be contributing factors.
“The vagina, bladder, or rectum may begin to sag, or prolapse through the weakened pelvic musculature,” she said.
Women experience such symptoms as sexual problems, urinary incontinence, and problems with defecation.
One remedy is surgery with the transvaginal mesh consisting of polypropylene.
“It is non-absorbable and most of the mesh made are of this type. There are meshes made of absorbable synthetic materials, whereby it’s absorbed within the body, and tissue grows over the mesh. There are others made of natural products derived from animals like the cow and pig. Lastly, there exist mesh made of a composite of non-absorbable synthetic plus absorbable synthetic or biologically derived,” explained Gaither.
“It’s used to essentially provide a supportive bridge to the sagging, weakened pelvic musculature,” she said.Side effects and complications
“Some of the more common side effects of the surgical placement of this mesh include infection, erosion of the vaginal tissues, organ perforation, bleeding, neuromuscular dysfunction, and pain, particularly with intercourse,” said Gaither.
Treatment for complications could include vaginal estrogen therapy or revision surgery.
Dr. Michael Ingber is board certified in urology and female pelvic medicine and reconstructive surgery at The Center for Specialized Women’s Health, a division of Garden State Urology in New Jersey.
Ingber told Healthline that he does this type of surgery every week. He notes that there are different mesh procedures that have different complication rates.
“For example, suburethral slings have a very low complication rate and have been around since the 1980s. They are considered our gold standard therapy to treat stress urinary incontinence. The latest type of sling I tend to use is our mini-sling (Altis, Coloplast Corp). This sling has a 3 percent risk of a mesh exposure — where the incision doesn’t completely heal — over the sling mesh,” explained Ingber.
When that happens, a topical estrogen can be used to promote healing.
“However, in some cases, patients require the exposed mesh to be trimmed or removed. Because the sling is only 11 millimeters (mm) wide, this therapy is easy and can often be done even in the office setting,” he continued.
“One of the first mesh-related complications I saw was a 45-year-old woman who had her polypropylene mesh placed so tense by another surgeon that she had immediate pain right after the surgery. She hadn’t been able to have sexual relations with her husband for several years. After I removed the mesh and released some of the tension, in conjunction with intensive pelvic floor physical therapy, she was able to resume normal relations,” Ingber recalled.
“I currently use the Restorelle mesh from Coloplast. This mesh is one of the lighter-weight meshes on the market and is involved in the FDA postmarket surveillance studies. I have done several hundred vaginal mesh implants and the vast majority have done well. I have only two ‘failures’ so far with the vaginal mesh implants, where the mesh didn’t hold up well. The patients needed additional surgery to fix their prolapse,” said Ingber.FDA advisories
Australia and New Zealand have banned mesh products to treat organ prolapse. There are efforts to do the same in Canada and Britain.
In the United States, the Food and Drug Administration (FDA) changed the classification of mesh for transvaginal repair of pelvic organ prolapse from moderate risk to high risk. This does not apply when the mesh is used to treat stress urinary incontinence.
Ingber is an investigator with Coloplast’s DirectFix mesh product.
“The FDA now requires any mesh manufacturers to undergo rigorous testing, and several studies are under way to evaluate women who have chosen this mesh product for prolapse, as opposed to a native tissue repair, or using dissolvable sutures to lift the bladder/uterus/rectum,” he said.
“The first thing we learned is that these products may not be appropriate for young, sexually active women with vaginal prolapse. These women tend to be at higher risk for pelvic pain and dyspareunia (painful sex). For women with a mild prolapse, a native tissue repair may be more appropriate. We learned that putting in these meshes requires expert technique and training so it isn’t placed too superficial in the tissue,” explained Ingber.
Ingber tells patients that his exposure rate is about 5 to 10 percent in vaginal mesh cases.
“However, it is important to note that even in these cases, because I typically choose nonsexually active, older women for these procedures, most of them are asymptomatic,” he said.Potential of the new mesh material
“Women will have an exciting new option that confers less of a risk of complications, theoretically, than mesh made of polypropylene,” said Gaither.
She believes the addition of estrogen, particularly in postmenopausal women, is logical.
One drawback she sees is knowing what dose would be beneficial. She also notes the need to learn if this treatment would be inadvisable for women who have had estrogen-dependent cancers.
Ingber says doctors are always learning.
“We know now that polypropylene mesh has to be macroporous, or have large pores to allow collagen and tissue ingrowth. We also learned that lighter weight meshes, although out of the body seem weaker, are in fact stronger than heavier meshes once placed into the body,” he said.
According to Ingber, the gold standard repair for apical vaginal prolapse is sacral colpopexy (a surgical procedure). It can be performed with robotic-assisted, minimally invasive technology. The polypropylene “Y-mesh” is inserted abdominally.
“This carries a significantly lower risk than the transvaginally placed meshes, specifically related to exposure of the mesh, painful sex, and pelvic pain. We use this as a standard in younger, sexually active women with prolapse. I am not sure if we would get better results with a polyurethane Y-mesh,” said Ingber.
“With suburethral slings, a more elastic sling (which is what polyurethane appears to be) may be less desirable, as the more rigid support from polypropylene may provide the better hammock of support when women have stress urinary incontinence (leakage with coughing/sneezing),” he explained.
“I’ve read the studies on polyurethane slings. The ability of this sling to retain its nature is appealing. The more elasticity shown in vivo after implantation is appealing if we have to implant a large sheet of the mesh for prolapse repairs,” said Ingber.
Gaither advises women to consult with their doctors about their health history and potential side effects of all treatment choices.
https://www.healthline.com/health-news/new-material-could-make-vaginal-mesh-surgery-safer#8
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Feb 22, 2018 | WebMD
By Dr Farah Ahmed
22nd February 2018 – The government has announced a 9-month review into how the authorities handled 3 medical treatments, including vaginal mesh implants.
Jeremy Hunt, the secretary of state for health and social care, acknowledged deficiencies in how the government and health authorities had responded.
The treatments in question are:Primodos – a hormone based pregnancy test which is claimed led to miscarriages and birth defects during the 1960s and 70sSodium valproate – an anti-epilepsy drug which has been linked to autism andlearning disabilities in children when taken during pregnancyVaginal mesh implants – used in surgery to repair vaginal wall prolapse after childbirthPatients 'not listened to'
Speaking in the Commons, Mr Hunt said: "We must acknowledge that the response to these issues from those in positions of authority has not always been good enough.
"Sometimes the reaction has felt too focused on defending the status quo, rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse."
The review will be led by the former Conservative health minister Baroness Julia Cumberlege who has been asked to assess whether appropriate processes were followed by regulators and NHS bodies when safety concerns were raised.
She will also consider whether any future cases of widespread harm resulting from medical treatments should result in wider, or even public, inquiries.
Vaginal mesh implantsLast month, the government announced a national audit to investigate problems caused by vaginal mesh implants.
However, Mr Hunt has ruled out a total ban on the implants on the advice of the chief medical officer that, when used appropriately, women can gain benefit from the surgical intervention.
Vaginal mesh implants are used for a variety of conditions, including urinary incontinence and pelvic organ prolapse after childbirth.
Made from a plastic called polypropylene, they have been used to support organs such as the vagina, womb, bladder, or urethra which may have been weakened while giving birth.
Permanent painLast year, it was reported that more than 800 women in the UK were taking legal action against the NHS and the makers of vaginal mesh implants.
It came after some women said the devices have perforated the lining of the vagina, leaving them in permanent pain, unable to walk or have sex.
In April 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) released figures showing there were 733 adverse incidents in the UK for stress urinary incontinence and 346 for pelvic organ prolapse between 2012 and 2016.
In December, the National Institute for Health and Care Excellence (NICE) said the future use of meshes should not normally be offered as routine treatment in England and only carried out as part of a research study.
A review last year in Scotland concluded that vaginal meshes should not be routinely offered to women with stress urinary incontinence or pelvic organ prolapse.
Kath Sansom, founder of the campaign group Sling the Mesh, welcomed the review but commented: "It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering. Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence.
"Every woman affected by Primodos, Valproate or mesh implants have suffered personal tragedies that can never be compensated for."
https://www.webmd.boots.com/women/news/20180222/vaginal-mesh-operations-restrictions
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Government Review of Vaginal Mesh 'Does Not Go Far Enough To Protect Women'
Feb 22, 2018 | HuffPost
By Rachel Moss
Campaigners say Health Secretary Jeremy Hunt must also 'revisit the science'.
A governmental review of vaginal mesh does “not go far enough” to ensure the longterm safety of women, a leading campaign group has told HuffPostUK.
Thousands of women worldwide have reported life-changing side effects after having vaginal mesh surgery, often after childbirth, including debilitating pain leaving some unable to walk, work or have sex.
The Government has committed to investigating issues with vaginal mesh through a full retrospective audit of hospital records to confirm how many women underwent subsequent hospital treatment and consultations after experiencing complications.
On Wednesday Health Secretary Jeremy Hunt also announced a review of how authorities have handled medical complaints and feedback from patients.
However, speaking about reviewing the approval of vaginal mesh for market in the first place, Hunt confirmed: “We are not proposing to revisit the science”.
Kath Sansom, founder of campaign group Sling the Mesh, told HuffPost UK: “The government’s reviews do not go far enough because Jeremy Hunt said they would not revisit the science – yet this is where the problem lies.”
Many of the preliminary trials for mesh were carried out on animals, she said, adding “[they] can’t tell you about chronic pain in your legs, pelvis or back, or burning in the vagina making it impossible to have sex”.
Later trials on humans gave participants limited medical questionnaires to answer, Sansom argues, and were not conducted over long periods of time. “A lot of so-called existing ‘science research’ is based on short term trials, with a research team funded by industry, so it is like marking your own exam papers,” she said.
The Government’s audit into the risks of vaginal mesh, announced in January, is expected to be completed by April.
More than 100,000 women in the UK have had a mesh fitted, and the audit involves linking data on patients’ conditions and mesh surgery to subsequent NHS hospital treatment and consultations.
Once the data has been gathered and analysed, it will be published by the Department of Health.
But Sling The Mesh argues that the Government should write to all women who have had vaginal mesh surgery – whether they received treatment for complications or not – because a true picture of risks can not be gathered from data on hospital visits alone.
Sling the Mesh and other campaign groups have called for a full ban on vaginal mesh implants.
The National Institute for Health and Care Excellence (NICE) previously recommended the use mesh for vaginal wall prolapse should be suspended and only used in the “context of research” while the audit is carried out.
As part of his address, Hunt said he’d asked the Chief Medical Officer for advice. “Clinical experts here and abroad agree that, when used appropriately, many women gain benefits from this intervention, hence a full ban is not the right answer in the light of the current evidence available,” he said.
Sansom questions this due to the short term nature of some human trials. “If a woman has had a good outcome it is only ‘for now’. Any woman who has had mesh is a ticking time bomb as the product can shrink or twist years down the line,” she said.
MP Owen Smith, Chair of the All Party Parliamentary Group (APPG) on Surgical Mesh Implants, also expressed his disappointment, saying: “It is a shame...that NICE is still unable or unwilling to bring forward its review into the safety and efficacy of mesh and that the Government will not suspend mesh until the reviews have been undertaken, as has happened in New Zealand.”
http://www.huffingtonpost.co.uk/entry/vaginal-mesh-campaigners-say-government-review-does-not-go-far-enough-to-protect-women_uk_5a8e956ce4b077f5bfeb78a2
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Woodbridge woman wins settlement from Ipswich Hospital after ‘traumatising’ mesh implant case
Feb 22, 2018 | East Anglian Daily Times
By Katy Sandalls
A woman from Woodbridge has says she was left traumatised following a procedure to fit a vaginal mesh at Ipswich Hospital.
A woman from Woodbridge has says she was left traumatised following a procedure to fit a vaginal mesh at Ipswich Hospital.
Jo Coghill, 54, received the procedure after being diagnosed with stress incontinence following the birth of her third child.
Ms Coghill, who is a legal assistant underwent the procedure almost five years ago.
“Following tests it was decided I should go ahead with the procedure for the mesh to be fitted, and I had an operation in July 2013,” said Ms Coghill.
For a year after the procedure Ms Coghill experienced serious pain and was told to give the surgery time to heal.
She continued to experience pain and had trouble visiting the toilet.
Ms Coghill then sought a second opinion and found a surgeon who was able to remove the mesh.
It was discovered that the mesh had started erode, causing her pain.
“The whole experience left me completely traumatised and I felt at times that if I sought help I would not be taken seriously,” said Ms Coghill.
“It was also difficult for me to go to a GP or hospital as going to such places left me really anxious after what I had been through.
“I have since found out information through the legal investigation that was never discussed with me.”
Having found out what had happened Ms Coghill turned to solicitors to investigate the care she had received at Ipswich Hospital NHS Trust.
A spokesperson for Ipswich Hospital said: “We appreciate it has been a difficult time for Ms Coghill and hope the settlement will help improve her quality of life.
“The Trust treats all claims as an opportunity to learn and to improve further the safety and quality of care of our patients.
“The claim was settled out of court on confidential terms without any admissions of liability.”
Ms Coghill has now undergone a second, successful surgery.
“While it was so pleasing to be able to have the issue corrected, all of these problems have caused me a huge amount of distress,” said Ms Coghill.
“I still get very emotional talking about everything I’ve been through.
“I am now determined to raise awareness of the complications of mesh implants in women contemplating this surgery.”
Vaginal mesh is just one of several medical devices that the government announced a review into today.
The hormone pregnancy test drug Primodos and epilepsy drug sodium valproate will also be looked at following patient concerns.
The Secretary of State for Health and Social Care, Jeremy Hunt said the response to the issues “has not always been good enough”.
Mr Hunt said the review will also consider the processes followed by the NHS and regulatory bodies after patients report their concerns - including how they communicate with patients.
He also announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.
Speaking about all the drugs and devices concerned Mr Hunt said:“I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”
http://www.eadt.co.uk/news/woodbridge-woman-wins-settlement-from-ipswich-hospital-after-traumatising-mesh-implant-case-1-5404556
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