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Ethicon Media Monitoring 2/28/2018
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'Plastic shrapnel' procedure subject of government health review
Feb 28, 2018 | Daily Echo
By Faith Eckersall
A GOVERNMENT review into TVT operations - which have left women crippled by 'plastic shrapnel' - has been welcomed by a Poole solicitor who is representing women fighting for compensation. -
Government to review failures in responding to patient concerns over valproate
Feb 28, 2018 | The Pharmaceutical Journal
By Emma Wilkinson
Government will investigate whether patient reports of adverse effects from sodium valproate, the use of vaginal mesh and the hormone pregnancy test Primidos were acted on appropriately. -
TVT Safe, Effective, Durable for Female SUI
Feb 28, 2018 | Medpage Today
By Diana Swift
Using both subjective and objective outcomes, a Swiss/Italian study has confirmed earlier findings that synthetic retropubic tension free vaginal tape (rTVT) is a safe and effective long-term therapy for women with stress urinary incontinence (SUI). -
Urinary incontinence: ‘Many a field I went into and many a stinging I got’
Feb 28, 2018 | The Irish Times
By Michelle McDonagh
Helen had tried a number of electrotherapy devices, some of which she found very invasive, before she started treatment on the PelviPower chair -
Urinary incontinence: The embarrassing loss of control few want to discuss
Feb 27, 2018 | The Irish Times
By Michelle McDonagh
Patients advised to try more conservative therapies before rushing into surgery for incontinence and prolapse -
Researchers Suggest New Transvaginal Mesh Material Could Reduce Complications
Feb 28, 2018 | RX Injury Help
By Laurie Villanueva
A group of British researchers have suggested that an alternative material could help prevent the types of life-changing complications that have driven thousands of women to file transvaginal mesh lawsuitsagainst Ethicon, Inc. and other device makers.
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'Plastic shrapnel' procedure subject of government health review
Feb 28, 2018 | Daily Echo
By Faith Eckersall
A GOVERNMENT review into TVT operations - which have left women crippled by 'plastic shrapnel' - has been welcomed by a Poole solicitor who is representing women fighting for compensation.
Medical negligence specialist Lydia Barnett said the government’s review into Tension-Free Vaginal Tape (TVT) surgery - intended to help women suffering from urinary stress incontinence after childbirth - was 'long overdue'.
“We want to see a complete ban on TVT mesh because surgery can cause life-changing injuries,” she said. “It’s like plastic shrapnel. The mesh is made from the same material as plastic bottles and a lot of the ladies are experiencing severe neurological pain."
She said some women were having difficulty walking, others are now in wheelchairs and she has seen 'dozens of new cases' in the last few months as news of the 'national scandal' spreads.
"Failed TVT surgery is difficult to treat," she said. "Repair procedures may not work because surgeons cannot always remove all the broken shards of mesh."
Lydia, who is a partner at the Coles Miller practice, encountered her first case back in 2012 before TVT hit the headlines. As more women contacted her and she realised that a major national scandal was about to break.
One of her clients, a mother from Kent, agreed to a compensation settlement of £60,000, although damages in cases which involve loss of earnings can run to £100,000.
Health Secretary Jeremy Hunt announced this week that Baroness Julia Cumberlege will lead a review into patient concerns about vaginal mesh, as well as hormone pregnancy test drug Primodos.
The review will investigate how the NHS responds to safety concerns raised by patients about medicines or medical devices. It will also consider whether any further action is required, including whether a full investigation or a public inquiry is necessary.
http://www.bournemouthecho.co.uk/news/districts/bournemouth/16053849.__39_Plastic_shrapnel__39__procedure_subject_of_government_health_review/
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Government to review failures in responding to patient concerns over valproate
Feb 28, 2018 | The Pharmaceutical Journal
By Emma Wilkinson
Government will investigate whether patient reports of adverse effects from sodium valproate, the use of vaginal mesh and the hormone pregnancy test Primidos were acted on appropriately.
Health and social care secretary Jeremy Hunt has announced a review into the way the NHS and medicines regulators respond to reports from patients about side effects after high-profile campaigns over sodium valproate, the use of vaginal mesh and the hormone pregnancy test Primidos.
Hunt said the response patients received over concerns about adverse effects from these treatments was “not good enough”.
The issue of increased risk of birth defects associated with the anti-epileptic drug sodium valproate were highlighted by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2015, which said that if the drug was the only treatment option, women of childbearing age should be given effective contraception.
Despite valproate being associated with a 10% increase in physical abnormalities and a 40% risk of autism, low IQ and learning disabilities for children exposed to the drug in the womb, charities say many women were never told of the dangers.
The European Medicines Agency has recently issued tighter safety regulations governing the use of valproate including the implementation of a pregnancy prevention programme.
Baroness Julia Cumberlege, who will lead the government review, will consider if any further action is needed relating to complaints involving the three treatments, the processes the NHS and regulators follow in response to complaints, and improving communication.
“From Primodos to the mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many,” said Hunt.
“I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”
Sandra Gidley, chair of the Royal Pharmaceutical Society’s English Pharmacy Board, said: “Action is being taken, but for a lot of people it is too late and we have to find ways of flagging up these things at an earlier stage.
“If this review of the three products highlights systems failures it will have done the public a great service.”
https://www.pharmaceutical-journal.com/news-and-analysis/news/government-to-review-failures-in-responding-to-patient-concerns-over-valproate/20204472.article
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TVT Safe, Effective, Durable for Female SUI
Feb 28, 2018 | Medpage Today
By Diana Swift
Using both subjective and objective outcomes, a Swiss/Italian study has confirmed earlier findings that synthetic retropubic tension free vaginal tape (rTVT) is a safe and effective long-term therapy for women with stress urinary incontinence (SUI).
In the prospective study, published online in BJU International, Andrea Braga, MD, of the Beata Vergine Hospital in Mendrisio, Switzerland, and colleagues assessed 52 consecutive patients undergoing rTVT for urodynamically proven pure SUI, excluding those with mixed incontinence and/or anatomical evidence of pelvic organ prolapse.
At baseline, the median age of the patients was 60 (range of 51-72), and their median body mass index was 25.9 (25-28), with obesity occurring in 11.5%. A total of 77% of participants were still sexually active, 82.3% were postmenopausal, and 32.7% were taking hormone-replacement therapy.
Over 17 years of follow-up, the investigators collected data on subjective outcomes using the International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores. Documented objective cure rates were determined based on stress tests as well as adverse events.
Of the 46 patients evaluable at 17 years, 41 (89.1%) reported themselves cured (P=0.98), and 42 (91.4%) were objectively cured, with no significant deterioration in cure rates over the follow-up period (P for trend=0.50). There was a slight trend to less patient satisfaction toward the end of the study period, the researchers reported.
Asked for her opinion, Kathleen C. Kobashi, MD, of Virginia Mason Medical Center in Seattle, who was not involved with the study, told MedPage Today: "The findings support that this is still the gold-standard, go-to procedure for treating this condition, and worldwide it is the most used technique and has not changed much since it was introduced in the late 1990s. But using the patient's own tissue for the sling has grown in popularity."
Kobashi added, however, that the results were surprisingly strong: "I don't think anyone could duplicate the 90% results reported here. Usually we tell our patients to expect 70% to 80% success as the norm."
The high success rate might have been due to the small sample or to a loose definition of success, she speculated. "[The researchers] never really defined what objective cure meant. In reality, 95% of patients will not be 100% dry." Her group is currently evaluating sling patients just coming up to the 15-year mark.
The current findings are in line with those of earlier studies: In 2013, Nilsson and colleagues also reported positive subjective and objective outcomes with rTVT after 17 years, finding only one minimal symptom-free tape extrusion. In addition, good results at the 13-year follow-up were reported in 2017 by Song and colleagues and by Serati et al.
In 2015, MedPage Today wrote about a systematic Cochrane review that found an approximately 70% cure rate at 5 years with both rTVT and transobturator sling procedure, although the latter method had fewer adverse events.
As for adverse events in the Braga et al study, two women with Clavien grade I had persistent voiding dysfunction and two had recurrent urinary tract infections, treated with antibacterial prophylaxis or therapy. No specific risk factors correlated with recurrent SUI. Fifteen women (32.6%) reported de novo onset of overactive bladder (OAB) in the late postoperative period and were treated with antimuscarinic β agonists.
"This observation could reflect the aging of the patients rather than being a direct consequence of surgery," the researchers wrote.
Kobashi noted that some sling patients develop urgency immediately after sling surgery, but since these cases were of late development, they were likely due to the natural increase in risk with age. "Those who develop OAB earlier on may have a tendency to OAB before the surgery, which just unmasked it," she said.
"Regardless," wrote Braga and co-authors, " the onset of OAB syndrome in women who received MUS [midurethral sling] is a very relevant problem." An earlier study by his group noted that antimuscarinic treatment has significantly lower efficacy in women with de novo OAB after MUS placement. "These data are relevant for the provision of adequate preoperative counseling," the team concluded.
The Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction has a position statement on the procedure for incontinence. In 2011 the U.S. Food and Drug Administration had raised concerns about the safety of mesh slings for pelvic organ prolapse.
A limitation of the current study was its small sample size, and the authors noted the need for more data on long-term outcomes after rTVT.
https://www.medpagetoday.com/obgyn/urinaryincontinence/71398
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Urinary incontinence: ‘Many a field I went into and many a stinging I got’
Feb 28, 2018 | The Irish Times
By Michelle McDonagh
Helen had tried a number of electrotherapy devices, some of which she found very invasive, before she started treatment on the PelviPower chair
Urinary incontinence had reduced Helen Devaney’s quality of life to the point where she no longer wanted to leave the house and her confidence had hit rock bottom. The 65-year-old Mayo woman, who had suffered from incontinence since giving birth to her children, knew every toilet in her local town – in shops, restaurants, train and bus stations and even the library.
“The urge to go to the toilet would come on very suddenly and I couldn’t hold it so I would wet myself. Of course there are always queues in the ladies toilets. I had to bring a face cloth, towel and change of underwear and trousers everywhere I went. Even though I was clean, I felt smelly. You develop a real hang-up about it,” she says.
Car journeys were a nightmare for Helen with constant toilet stops along the way. She was fortunate to have a patient and understanding husband, but says “many a field I went into and many a stinging I got”. She suffered constantly urinary infections and sensitive skin from wearing pads.
“I didn’t talk about it to anybody apart from my sisters. I was embarrassed to even discuss it with a male doctor and was very thankful my GP had a practice nurse who was really helpful. Once, I leaked on the table during an MRI in front of two male technicians, I was so ashamed.”
Helen’s symptoms deteriorated considerably when she hit the years of menopause and she ended up with stress and urge incontinence, pelvic organ prolapse, diverticular disease and chronic constipation. She was “in a bad way” by the time she was referred to a colorectal consultant at the Bon Secours Consultants Clinic in 2013 who in turn referred her to clinical physiotherapist, Aoife Ni Eochaidh.
“That was the first time I got real help. Aoife’s first words were “you’re not the best I’ve seen, but you’re not the worst. I can help you”. To hear those words mean so much to a person who is desperate. I’m not fully out of the woods yet but I’m a hell of a lot better than I was. I can walk for 2k now without needing the toilet and the other day we drove from Tipperary to Galway and I didn’t have to ask my husband to stop once.”
Helen had to be taught how to sit on a toilet properly and how to empty her bladder fully. She had to make a number of lifestyle changes which included switching to decaf tea and coffee, losing weight, walking and getting a good night’s sleep. She also has to incorporate her pelvic floor training exercises into her daily routine.
She had tried a number of electrotherapy devices, some of which she found very invasive, before she started treatment on the PelviPower chair.
“I basically sit back, close my eyes and let the chair do the work for me. I have definitely seen great improvements since I started the treatment. My confidence has improved so much overall. Now if anybody asks me to go on a journey, I’m in the car before they can change their mind,” she laughs.
Helen is appealing to local authorities to think twice before removing public loos as people suffering from incontinence rely heavily on them and most would be happy to pay for the use of the facilities. She points out that many shops, bars and restaurants prominently display signs stating their toilets are for customer use only and she herself has been refused on more than one occasion when she was really desperate to go.
“Can I just say to anyone out there who is going through what I went through for so many years, there is help, there is a fix. Don’t be afraid to talk to your doctor or practice nurse, it has given me a new lease of life and it can for you too.’Prevention
Urinary incontinence isn’t always preventable. However, there are some ways to help decrease your risk:
Pelvic floor exercises
Doing pelvic floor exercises, daily, can be really effective at reducing leakage.Smoking
If you smoke, you put yourself at risk of incontinence. Coughing puts strain on your pelvic floor muscles.Lifting
Heavy lifting puts strain on your pelvic floor muscles.Weight
Being overweight can weaken your pelvic floor muscles and can cause incontinence.Coffee
Caffeine irritates the bladder and can make incontinence worse. Remember, fizzy and energy drinks, tea and hot chocolate also all contain caffeine.Alcohol
Alcohol is a diuretic, which makes you urinate more often.Water
Many with urinary incontinence avoid drinking fluids. However, you need to drink to avoid reducing your bladder’s capacity.https://www.irishtimes.com/life-and-style/health-family/urinary-incontinence-many-a-field-i-went-into-and-many-a-stinging-i-got-1.3399217
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Urinary incontinence: The embarrassing loss of control few want to discuss
Feb 27, 2018 | The Irish Times
By Michelle McDonagh
Patients advised to try more conservative therapies before rushing into surgery for incontinence and prolapse
It’s a condition that most people are too embarrassed to talk about, yet one that affects one in three women and one in nine men, and costs the HSE €100 million every year.
Urinary Incontinence (UI) can have a hugely negative impact on a person’s quality of life, mood and confidence with some sufferers becoming virtual prisoners in their own homes.
Research has shown that UI symptoms are under-reported in primary care, due in part to a perception that it is an inevitable consequence of aging.
While one in seven older adults in Ireland experience UI, the condition does not discriminate where age is concerned and the number of younger people suffering is increasing.
Weakness of the pelvic floor muscles has long been identified as a cause of urinary incontinence. Pelvic floor muscle weakness is common after childbirth, and is also associated with age.
The treatment of incontinence and other pelvic disorders is based on strengthening the pelvic muscles in addition to lifestyle changes such as cutting out tea and coffee, losing weight and taking exercise. Some patients also require medication.
Traditional methods of strengthening the pelvic floor muscles have involved active participation by the patient in contracting muscles and often involve techniques that are intrusive and uncomfortable.
New research and advances in treatment have greatly improved treatment outcomes for bladder and bowel incontinence, prolapse and sexual dysfunction.
One new technology with a high success rate in treating UI and erectile dysfunction is currently being rolled out around Ireland. The PelviPower chair has already been introduced to facilities in Donegal, Galway and Limerick, and is being rolled out to Dublin, Cork, Kilkenny and Kildare this year.
Clinical physiotherapist at the Bon Secours Consultants Clinic in Galway, Aoife Ni Eochaidh, says that “continence and pelvic problems are very common and are awful, but treatment results are great. New research and advances in treatment and medical devices such as the PelviPower Chair have greatly improved treatment outcomes. Persevere with your treatment, results may be slow but normal function is achievable with a 75 per cent or greater cure rate.
“The patient sits on the chair in their normal clothes and the machine does all the muscle stimulating work. Treatment takes 15 minutes once a week for five weeks which is much faster than other therapies which usually have to be done on a daily basis five days a week.”
Physios have been using electrotherapy since the 1950s to train very weak pelvic floor muscles, explains Ni Eochaidh. However some of these therapies can be quite invasive and uncomfortable for patients involving needle electrodes placed in the body or indwelling probes in the back passage.
Ni Eochaigh points out that the PelviPower therapy is not suitable for everybody, eg patients with metal hip replacements or pacemakers as it uses electromagnetic stimulation.
The therapy is not cheap with physiotherapy varying from €80 to €100 per session and treatment required once a week for five weeks, and a number of follow-up sessions. Some of the cost is covered by health insurance.
Electrotherapy is used in conjunction with pelvic floor muscle training programmes, explains Ni Eochaidh, which she stresses is not a quick fix.
“The European and Nice guidelines state it takes three to six months to fully train the pelvic floor muscles and this should be supervised by a specialist for six to 12 weeks. We work very closely with the consultant urologist and nurse specialist. Gone are the days when you gave the patient a sheet of exercises and sent them off. It’s like running a marathon, you need to train the muscles, making the exercises harder as you progress.”
Many of her patients have a combination of stress incontinence – leaking of urine when they cough, sneeze, exercise or lift something heavy – and urge incontinence – a sudden intense urge to urinate followed by involuntary loss of urine.
“Unfortunately the statistics show that people leave it until they are really bad before they come for help. People don’t like to admit they have incontinence, it’s taboo. And health professionals are not good at asking. They need to ask their patients about any bowel or bladder dysfunction and give them time to tell. It’s never too late, a 100-year-old muscle can be trained. I see patients from the age of four to 100, age is not a barrier to treatment.”
Ni Eochaidh, who is the Pelvic Obstetric and Gynaecological Physiotherapy rep for Ireland, advises patients to try more conservative therapies before rushing into surgery for incontinence and prolapse amid calls in the UK to ban controversial vaginal mesh operations as a routine treatment.Types of urinary incontinence
The loss of bladder control ranges in severity from occasional leaking (particularly when sneezing or coughing) to not having reasonable time to get to a toilet in time.
Stress incontinence
Urine leaks when you exert extra sudden pressure on your bladder, eg by coughing, sneezing, laughing or exercising. The amount of urine passed is usually small.Urge incontinence
You have a sudden and intense urge to urinate and you are unable to prevent the immediate loss of urine. Often occurs as part of group of symptoms called overactive bladder syndrome. Sometimes also means you need to get up several times during the night to urinate.Overflow incontinence
Also called chronic urinary retention, occurs when the bladder cannot completely empty when you pass urine. You experience frequent or constant dribbling of urine.Functional incontinence
A physical or mental impairment keeps you from making it to the toilet in time.Total incontinence
Urinary incontinence that’s severe and continuous.Mixed incontinence
You experience more than one type of urinary incontinence.https://www.irishtimes.com/life-and-style/health-family/urinary-incontinence-the-embarrassing-loss-of-control-few-want-to-discuss-1.3399179
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Researchers Suggest New Transvaginal Mesh Material Could Reduce Complications
Feb 28, 2018 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
A group of British researchers have suggested that an alternative material could help prevent the types of life-changing complications that have driven thousands of women to file transvaginal mesh lawsuitsagainst Ethicon, Inc. and other device makers.
“Unacceptable” Rate of Complications with Polypropylene Mesh
Transvaginal mesh – indicated for use in women who suffer from pelvic organ prolapse and stress urinary incontinence – is generally made from polypropylene, a plastic material also used to manufacture food containers, outdoor carpets, and other household items.
“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 announcing her team’s findings.
“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 continued.
MacNeil and her fellow researchers have proposed using polyurethane instead, asserting that it is stronger and has more elasticity than polypropylene.
As part of their study, the scientists also inserted estrogen into the polyurethane mesh to help speed up the healing process. The addition of estrogen did not reduce strength and elasticity of the mesh.
“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,” MacNeil said. “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.”
Transvaginal Mesh Complications
Since 2009, the U.S. Food & Drug Administration (FDA) has issued two warnings regarding the serious complications associated with transvaginal mesh. In 2016, the agency reclassified mesh implants indicated for prolapse repair as Class III (high risk) medical devices, subjecting the implants to stricter regulatory scrutiny.
Transvaginal mesh complications reported to the FDA include:
· Mesh erosion
· Mesh perforation
· Chronic pain
· Pain during sexual intercourse
· Infections around the mesh
· Urinary tract problems
· Bleeding from the area round the mesh
· Damage to nearby organs
· Scarring and adhesions
· Mesh contraction (shrinkage)
Transvaginal Mesh Litigation
Tens of thousands of women throughout the United States have filed transvaginal mesh lawsuits since the FDA issued its first warning in 2008. Plaintiffs claim that Ethicon and other device manufacturers failed to conduct proper testing to ensure the safety and efficacy of their implants. They further allege that the defendants concealed the dangers associated with the devices and failed to provide doctors and patients with adequate warnings of their risks.
31 transvaginal mesh trials have been convened over the past several years. Plaintiffs have been awarded multi-million verdicts in 23 cases. A significant percentage of transvaginal mesh lawsuits have also been settled, though thousands remain pending in federal and state courts throughout the country.
https://www.rxinjuryhelp.com/news/2018/02/27/researchers-suggest-new-transvaginal-mesh-material-could-reduce-complications/
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