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Ethicon Media Monitoring 2/15/2018
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New material suggested as better alternative for vaginal mesh
Feb 15, 2018 | Medical Plastics News
A new material has been suggested as an alternative to treat pelvic organ prolapse and stress urinary incontinence to the current mesh material, polypropylene. -
New vaginal mesh implant material could reduce complications, accelerate healing
Feb 14, 2018 | Plastics Today
By Norbert Sparrow
Vaginal mesh implants made of polypropylene have caused severe medical complications in millions of women across the world, and medical manufacturers from Johnson & Johnson to Bard, acquired by BD last year, have been mired in lawsuits as a result. -
New vaginal mesh material could help thousands of women affected by life changing complications
Feb 14, 2018 | Medical Xpress
Scientists from the University of Sheffield have developed a material that could be used as an alternative to the current vaginal mesh material, polypropylene, used to treat pelvic organ prolapse and stress urinary incontinence. -
New vaginal mesh material that could end pain and complications is developed by scientists
Feb 15, 2018 | Evening Standard
By Patrick Grafton Green
A new material has been developed by UK scientists which could mean an end to the painful side effects associated with older forms of vaginal mesh implants.
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New material suggested as better alternative for vaginal mesh
Feb 15, 2018 | Medical Plastics News
A new material has been suggested as an alternative to treat pelvic organ prolapse and stress urinary incontinence to the current mesh material, polypropylene.
Researchers from the University of Sheffield have proposed polyurethane as an alternative to polypropylene, which has led to thousands of women suffering adverse side effects after certain surgical procedures.
Scientists from the Department of Material Science and Engineering at the University of Sheffield state that polyurethane is softer, more elastic and is better suited for use in the pelvic floor. More so, the researchers believe that the introduction of oestrogen into the material could help form new blood vessels and speed up the healing process.
Due to the elastic material of polyurethane, the researchers believe that the material is better suited to support the pelvic organs.
Research showed that when used, the mesh retained its strength and the oestrogen did not compromise the material’s elasticity.
Professor Sheila MacNeil, professor of Tissue Engineering in the Department of Materials Science and Engineering at the University of Sheffield said: “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 to hand - polypropylene.
“In certain procedures, for example, when the polypropylene mesh is used as a thin strip to support the urethra and reduce the symptoms of stress incontinence, the results show it is beneficial to the patient and carries relatively little risk.
“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.
“Surgeons who are experts in this area have concluded that there is a need for a new synthetic material that is better suited for use in the pelvic floor. We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor.”
Last year the UK's health watchdog NICE recommended that polypropylene be banned from treating prolapse due to safety concerns and should only be used for research purposes.
Commenting on the announcement that University of Sheffield has developed a new polyurethane mesh, Chair of the APPG on Surgical Mesh Implants, Owen Smith MP said:
“Whilst I welcome new interventions to treat stress urinary incontinence and prolapse, I would urge great caution over the use of synthetic materials to treat these conditions. It is crucial that lessons are learnt from the use of polypropylene mesh and the life-changing complications women have experienced since undergoing surgery. This new material must undergo rigorous and strict clinical trials and should only be used if such complications can be ruled out.”
https://www.medicalplasticsnews.com/news/new-material-could-be/
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New vaginal mesh implant material could reduce complications, accelerate healing
Feb 14, 2018 | Plastics Today
By Norbert Sparrow
Vaginal mesh implants made of polypropylene have caused severe medical complications in millions of women across the world, and medical manufacturers from Johnson & Johnson to Bard, acquired by BD last year, have been mired in lawsuits as a result. Now, scientists at the University of Sheffield in the United Kingdom have developed an alternative polyurethane material to treat pelvic organ prolapse and incontinence that is better suited for use in the pelvic floor. Moreover, they have embedded the material with estrogen, which is released into the surrounding pelvic tissue to form new blood vessels and accelerate the healing process. The research is published in the Journal of Neurourology and Urodynamics.
Polypropylene mesh can be beneficial and carries little risk to the patient when it is used as a thin strip to support the urethra and reduce the symptoms of stress incontinence, said Professor Sheila MacNeil, Professor of Tissue Engineering at the university’s Department of Materials Science and Engineering. “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. Surgeons who are experts in this area have concluded that there is a need for a new synthetic material that is better suited for use in the pelvic floor. We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor,” said MacNeil in an article on the university website.
Polypropylene (left) is currently used to fabricate vaginal mesh implants. Scientists at the University of Sheffield have developed a polyurethane that would reduce complications caused by these devices.
Image courtesy University of Sheffield.The scientists spent seven years researching different materials for this application and ultimately settled on polyurethane because of its elasticity, which made the material a better fit than polypropylene for sustaining the pressure that pelvic organs exert on the pelvic floor.
Electrospinning is used to create a fine mesh, which is fabricated in layers to mimic the structure of human tissue, explained MacNeil. “We have shown through our research that it does not provoke inflammation and retains its strength and elasticity. The addition of estrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue,” she added.
Pelvic organ prolapse and stress urinary incontinence affect 50% of post-menopausal women worldwide, according to the University of Sheffield website. In addition to the physical symptoms and the inability to have a normal sex life, these disorders can lead to depression, anxiety and a reduction in the quality of social life.
The onerous lawsuits have caused some medical device manufacturers to stop marketing mesh for pelvic organ prolapse. However, they continue to market the same mesh for the treatment of stress urinary incontinence, where a strip of the material is used as a tape under the urethra. That treatment remains very beneficial for the majority of patients with a very low complication rate in experienced hands, according to the University of Sheffield.
The scientists expect the breakthrough research to have a hugely positive impact on millions of women across the globe, but first the polyurethane mesh will need to through clinical trials and the regulatory approval process, which will take a considerable amount of time.
https://www.plasticstoday.com/medical/new-vaginal-mesh-implant-material-could-reduce-complications-accelerate-healing/96428474158261
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New vaginal mesh material could help thousands of women affected by life changing complications
Feb 14, 2018 | Medical Xpress
Scientists from the University of Sheffield have developed a material that could be used as an alternative to the current vaginal mesh material, polypropylene, used to treat pelvic organ prolapse and stress urinary incontinence.
The use of these current meshes, in particular surgical procedures, has led to severe complications for millions of women across the world and is now banned in Australia.
The research conducted by the University of Sheffield, published today in the Journal of Neurourology and Urodynamics, provides evidence which supports the use of a softer and more elastic material better suited for use in the pelvic floor and one that releases oestrogen into the surrounding pelvic tissue to form new blood vessels and ultimately speed up the healing process.
Scientists from the Department of Material Science and Engineering at the University of Sheffield have recently concluded that a different material, polyurethane, would be a much better material to use as a vaginal mesh due to its flexibility and its likeness to human tissue.
Polyurethane possesses much more elasticity than polypropylene and is therefore better equipped to sustain the pelvic organs - the bladder, bowel and vagina - exerting pressure on the pelvic floor every day.
The research group at the University of Sheffield have also gone one step further in their research by introducing the female hormone, oestrogen into the polyurethane mesh. The research in the paper demonstrates that oestrogen stimulates cells to produce new tissue and form new blood vessels - regenerating the tissue and ultimately speeding up the healing process. In initial research, the mesh retained its strength and elasticity and was not compromised by incorporating the oestrogen into it.
Professor Sheila MacNeil, Professor of Tissue Engineering in the Department of Materials Science and Engineering at the University of Sheffield said: "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 to hand - polypropylene.
"In certain procedures, for example, when the polypropylene mesh is used as a thin strip to support the urethra and reduce the symptoms of stress incontinence, the results show it is beneficial to the patient and carries relatively little risk.
"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.
"Surgeons who are experts in this area have concluded that there is a need for a new synthetic material that is better suited for use in the pelvic floor. We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor."
She added: "Over the last seven years, we have investigated a range of materials and for the past few years, we have focused our efforts on polyurethane, using the method of electrospinning to create a fine mesh which we have fabricated in layers to mimic the structure of human tissue. We have shown through our research that it does not provoke inflammation and retains its strength and elasticity. The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue."
Pelvic organ prolapse and stress urinary incontinence affects 50 per cent of postmenopausal women worldwide. Many women view both conditions as embarrassing and in addition to the physical symptoms and inability to have a normal sex life, these disorders can lead to depression, anxiety and a reduction in the quality of social life.
In the UK, around 20 per cent of postmenopausal women suffer from pelvic organ prolapse, which occurs when a pelvic organ, such as the bladder, drops from its normal place in the lower abdomen and pushes against the walls of the vagina. This commonly affects women after childbirth but will often only become apparent years later once they go through the menopause and the lack of female hormones affect the pelvic tissue.
Many of these women choose to undergo major surgery, to insert the more rigid polypropylene mesh which acts as a scaffold to support the prolapsed pelvic organs.
The aim of the mesh is to give permanent support to the weakened organs. A number of meshes currently used have led to severe complications such as chronic inflammation, leading to pain and scar tissue formation around the implant.
Around 19 per cent of women who undergo this procedure have gone on to have a second procedure as a result of complications following the initial surgery.
The first lawsuits concerning polypropylene mesh went to trial in America in 2012 and 2013. Since then, several companies making these meshes have lost multimillion dollar lawsuits totalling billions of dollars. Many companies stopped marketing mesh for pelvic organ prolapse as a result. However, they continue to market the same mesh for the treatment of stress urinary incontinence as they use a strip of it as a tape under the urethra and it remains very beneficial for the majority of patients with a very low complication rate in experienced hands.
The material will need to go through rigorous clinical trials and only once it has been approved, scientists at the University of Sheffield hope this breakthrough research will have a hugely positive impact on millions of women across the globe.
https://medicalxpress.com/news/2018-02-vaginal-mesh-material-thousands-women.html
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New vaginal mesh material that could end pain and complications is developed by scientists
Feb 15, 2018 | Evening Standard
By Patrick Grafton Green
A new material has been developed by UK scientists which could mean an end to the painful side effects associated with older forms of vaginal mesh implants.
A huge number of women were left in severe pain due to the controversial implants, a small mesh support used to treat organ prolapse or urinary incontinence mainly after childbirth.
It has sparked controversy with risks linked to the implant including nerve damage, chronic pain and organ erosion and, in some cases, sepsis.
The treatment involves implanting the netted mesh made from polypropylene into the vaginal wall.
However scientists at the University of Sheffield have said they have now come up with a better material after seven years of research.
They believe the softer and more elastic material – polyurethane – will be better suited to the pelvic floor muscles.
Polyurethane is said to be more suitable because it is softer, has more elasticity and has a greater likeness to human tissue.
Professor Sheila MacNeil, of Sheffield University's Materials Science and Engineering department, said: "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 to hand – polypropylene.
"In certain procedures… the results show it is beneficial to the patient and carries relatively little risk.
"However, when much bigger areas of the same material are inserted… the complication rate is frankly unacceptable.
"We started our research because it was clear that the polypropylene mesh was not fit for use in the pelvic floor."
Over 10,000 women per year use the treatment in the UK.
https://www.standard.co.uk/news/health/scientists-develop-new-vaginal-mesh-that-could-avoid-serious-complications-a3766071.html
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