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ethicon 21/6
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J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Jun 20, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh. -
Surgical Revision Rate 4% for Mesh-Based Prolapse Surgery
Jun 20, 2016 | Renal & Urology News
or women undergoing mesh-based prolapse surgery, the reoperation rate is 4% at a median of 1.17 years, with reduced risk for patients of surgeons with very high volume, according to a study published in the July issue of Obstetrics and Gynecology. -
Incontinence makes you feel 'isolated and imprisoned': Survey reveals 6 million people in the UK have the condition - but many of them suffer in silence
Jun 20, 2016 | Daily Mail
By Madlen Davies
It's an embarrassing problem that stops some people from leaving the house or having a relationship. Yet millions suffer urinary incontinence in silence as they are too embarrassed to see their doctor about their symptoms. -
Issues Urologists Can Help Women With
Jun 21, 2016 | BoldSky
You might think that urologists are specialized to treat only the diseases related to the male reproductive organs. This is not true. -
Interrogating research to protect public health
Jun 20, 2016 | UK Medicines & Healthcare products Regulatory Agency
Part of the work of the medicines and medical device regulator involves looking at existing research to help reach conclusions about potential and emerging issues with devices. -
Soft Tissue Repair Market : Growth, Development, and Outlook 2015 to 2021
Jun 20, 2016 | MedGadget
North America dominates the global market for soft tissue repair due to the growing geriatric population and obesity rate and rising demand for tissue regeneration and soft tissue repair procedures in the region.
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J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Jun 20, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh.
In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.
West Somerville, N.J.-based Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but hasn’t been able to pin down a cause.
“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to the letter. “Ethicon will not return theEthicon Physiomesh composite mesh product to the market worldwide.”
Patients already implanted with the product should be followed as usual, the company said. The recall does not involve any other Ethicon meshes, including the Physiomesh Open flexible composite mesh, it said.
“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the companywrote. A list of the affected product codes can be found here.
http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/
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Surgical Revision Rate 4% for Mesh-Based Prolapse Surgery
Jun 20, 2016 | Renal & Urology News
HealthDay News — For women undergoing mesh-based prolapse surgery, the reoperation rate is 4% at a median of 1.17 years, with reduced risk for patients of surgeons with very high volume, according to a study published in the July issue of Obstetrics and Gynecology.
Erin C. Kelly, MD, from the University of Western Ontario in London, Canada, and colleagues conducted a retrospective, population-based cohort study involving all women who underwent mesh-based prolapse procedures between 2002 and 2013. The authors examined the proportion of women who underwent surgical revision of the mesh, with the primary exposure of surgeon volume. Data were included for 5,488 women who underwent mesh implantation by one of 368 unique surgeons; median follow-up was 5.4 years.
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The researchers found that at a median of 1.17 years after implantation, 4% percent of women underwent mesh reoperation. Patients of very high-volume surgeons had a lower risk of reoperation for complications (3% versus 4.8% percent; adjusted hazard ratio, 0.59). Younger age, concomitant hysterectomy, blood transfusion, and increased medical comorbidity correlated with vaginal mesh reoperation in multivariable modeling.
"Approximately 5% of women who underwent mesh-based prolapse surgery required reoperation for a mesh complication within 10 years," the authors write. "The risk of reoperation was lowest for surgeons performing 14 or more procedures per year."
One author disclosed financial ties to Astellas Canada.
http://www.renalandurologynews.com/overactive-bladder-oab/surgical-revision-rate-4-for-mesh-based-prolapse-surgery/article/503269/
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Jun 20, 2016 | Daily Mail
By Madlen Davies
Millions suffer urinary incontinence in silence as they are so embarrassed
Condition, where urine is unintentionally passed, has huge impact on lives
Doctor: 'Many people with it feel completely isolated and imprisoned'
It's an embarrassing problem that stops some people from leaving the house or having a relationship.
Yet millions suffer urinary incontinence in silence as they are too embarrassed to see their doctor about their symptoms.
With an ageing population and rising levels of obesity - the main risk factors for the problem - the £1.8 billion the NHS spends on the condition each year is set to soar.
Tamsin Greenwell, a urological surgeon at University College London, says the condition - where urine is unintentionally passed - has a huge impact on people's lives.
'I think lots of people feel completely isolated and imprisoned. This is desperately sad because it doesn't have to be this way.'
Ms Greenwell said: 'Incontinence affects people of any age and often has a huge impact on the lives of the patients I see.
'It affects their self-worth, their personal relationships, intimacy, their finances and it has a significant impact on their employment.
'It's almost impossible to teach or be a policeman or policewoman on the beat if you have to run to the toilet every hour.'
Some patients are running themselves into debt as they need so many incontinence pads a day - and the private market for incontinence pads is worth £750m a year.
Ms Greenwell said: 'It is hard to for many patients to fund containment products like pads while the NHS struggles to deal with this Cinderella condition.
'The cost of incontinence pads is huge – one patient of mine went virtually bankrupt because she had to buy so many pads since the NHS only pays for a patient to have two to four a day,
'I remember seeing another patient whose whole life had fallen apart – her relationship had crumbled, she couldn't work and she said if I didn't operate on her, she didn't want to live.'
There are an estimated six million people who suffer from incontinence in the UK.
However, Ms Greenwell believes the real figure is almost double this amount as many more remain undiagnosed because they're too embarrassed to see a doctor.
'It is very important people access help early on – pelvic floor exercises and muscle-training get good results in between 60 and 65 per cent of people urinary incontinence,' Ms Greenwell said.
'But incontinence is not sexy and most people don't want to admit to having it. It is interesting that people are happy to talk about their sex lives but not about being incontinent, even to their GP.'
She continued: 'This is a travesty because there are a lot of treatments available, such as behavioural training, pelvic floor physiotherapy, and both minor and more major surgical treatments which can be highly effective and get a lot of women and men sorted out.
'Treatments range from simple to complex and vary depending on the patient's preferences and what treatments they have had before.'
Indeed, a survey by the charity The Urology Foundation found 60 per cent of people admitted they would be embarrassed to talk about urinary incontinence – more so than weight, family, money and relationship troubles.
The condition is associated with obesity, as extra weight puts more pleasure on the bladder and this may lead to overloading of the pelvic muscles that keep urine from leaking out.
Yet of the 1,000 respondents to the charity's survey, only one per cent associated the condition with being overweight.
'We assess obesity in terms of body mass index or BMI. A normal BMI is between 20-25,' Ms Greenwell said.
'The odds of developing urinary incontinence in a 5-10 year period increase by 30-60 per cent for each 5 unit increase in BMI above normal.'
Reducing weight to within normal BMI levels improves stress incontinence - a type of urine incontinence where people pass fluid when they cough or laugh - in 40 per cent of people.
For those with urge incontinence -when urine leaks after people feel a sudden, intense urge to go to the toilet - weight loss reduced the symptoms in 30 per cent of people.
In fact, surgeons cannot operate to unless people lose weight, Ms Greenwell said.
Ms Greenwell said: 'The risk of complications from surgery such as wound infection, chest infection and blood clots are much higher in those with high BMIs.'
Louise de Winter, chief executive of the Urology Foundation, said: 'Incontinence costs the NHS nearly £2 billion every year, and the emotional and social costs are equally high.
'We need to do much more to make people realise that they can take control of their continence issues and that help is at hand.
'Breaking down taboos plays an important part of this, enabling people to acknowledge there is a problem and seek help to deal with it.
'Thousands of people are suffering in silence and it simply doesn't have to be this way.'
John Tiner, a father-of-three, from Devon, became incontinent eight years ago following surgery for prostate cancer.
Now chairman of The Urology Foundation, he urges people with the problem to see a doctor - as it is a condition that can be managed.
'Frankly speaking, I can't understand why anybody who is incontinent would want to bottle this up,' said Mr Tiner.
'It is a condition that impacts your quality of life – where you can go, what you can do, who you can see, what sports you can be involved with, what rows you sit in in theatre (always get an aisle seat), and just a whole bunch of practical things.
'I have moments of complete acute anxiety where I know I've probably got 20 seconds to get somewhere.
'When you get this anxiety moment, then you can't think of anything else, your brain is occupied with the need to deal with this and this is why people think that they can't go out into the open world and face that situation.'
Mr Tiner first became incontinent following treatment for prostate cancer at the age of 48.
At first he found it hard to manage, but his doctor who helped him turn a corner with constructive and helpful advice.
He said: 'As soon as you think that you've got an issue, you should see your doctor, and in the privacy of your conversation you can talk about whatever you want.
'I would encourage everybody to just take control of a situation, because it just doesn't have to be a threat to your quality of life.'
Mr Tiner added: 'The new public information campaign by The Urology Foundation is so important, because incontinence is a silent, Cinderella problem, that one no one wants to talk about, and yet absolutely everything can be done to make your life as normal as it would be without it.
'I think people are embarrassed to talk about incontinence because it's a dignity question, and people feel that somehow talking about issues related to going to the toilet, is somehow degrading.
'And yet, it's really nothing, it's just another part of the body. If you had a broken shoulder, you'd go to the doctor and try and get it sorted. It's no different to that.
The advice he would give to anyone suffering from incontinence is to firstly recognise it, he said.
'Secondly, accept that you're not unusual, so there's no stigma that comes with it,' he continued.
'Thirdly go see your doctor, and talk about how you can remedy this and finally just think about your day and about where you can go to the toilet in among all that.
'My experience is that you can live a completely happy and untainted life with this condition.'
http://www.dailymail.co.uk/health/article-3647140/The-embarrassing-problem-affects-millions-wrecks-relationships-people-suffer-silence.html
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Issues Urologists Can Help Women With
Jun 21, 2016 | BoldSky
You might think that urologists are specialized to treat only the diseases related to the male reproductive organs. This is not true. A number of urologists are devoted to the study of issues and problems related to women. Here are some of the areas in which urologists can help women: If there is a pain in the general pelvic region, and it is a non-gynaecologic issue, urologists can be of help. Urologists find the cause for these symptoms. They can be due to chronic constipation, irritable bowel syndrome, ulcerative colitis or even colon cancer.
Urologists can help you with diagnosing whether the conditions that you have are due to urinary tract infections or sexually transmitted diseases. Emergency departments often misdiagnose these symptoms and end up providing wrong medications. Urologists can help you with finding out the actual reason behind sexual dysfunction: whether it is depression, stress, certain medications, or low levels of oestrogen and testosterone and offer treatment accordingly in the form of medications or therapy. Urinary continence may be caused by menopause, obesity, hysterectomy, late pregnancy, urinary tract infections, constipation, chronic cough, etc. Urologists can help women treat urinary incontinence with various types of nerve stimulation, medications and pelvic floor physical therapy. Many women have an overactive bladder. For treating this issue, urologists can help you with collagen implants, electrical stimulation therapy, minimally invasive surgery and medication. Urologists can also help you with the detection and treatment of kidney stones. They advise people with kidney stones to stay hydrated and be physically active. When you have difficulty in peeing or pooping, irritated vaginal tissues, or pain during conjugation, it can be due to pelvic organ prolapse - common in women after pregnancy or menopause. Urologists can help you in the treatment with either surgery, a vaginal pessary or pelvic floor therapy. After menopause, due to the declining levels of oestrogen, issues related to the vagina, pelvic floor, bladder, etc. crop up. Urologists can help treat these symptoms with vaginal replacement oestrogen, lactobacillus, antibiotics and cranberry extract supplements.
http://www.boldsky.com/health/wellness/2016/issues-urologist-can-help-women-with-102612.html -
Interrogating research to protect public health
Jun 20, 2016 | UK Medicines & Healthcare products Regulatory Agency
Part of the work of the medicines and medical device regulator involves looking at existing research to help reach conclusions about potential and emerging issues with devices.
Monitoring new and emerging safety issues with medicines and medical devices is a major part of the work the Medicines and Healthcare products Regulatory Agency (MHRA) undertakes to protect public health.
In addition to monitoring reports from our Yellow Card Scheme, teams of experts across the agency review published information to assist in understanding areas where concerns have been raised regarding medical devices. In this instance, concerns were raised about the safety of implanting polypropylene into patients. Our review resulted in the publication of a paper in an internationally respected, peer reviewed journal.
This work has never before been undertaken in such a thorough and systematic way and has served to gather all of the relevant data together in one place for the first time.
The International Urogynecology Journal has recently published a paper by Michelle Kelly, Katherine Macdougall, Oluwafisayo Olabisi and Neil McGuire of the MHRA device division titled In vivo response to polypropylene following implantation in animal models: a review of biocompatibility.
Polypropylene is a material commonly used to treat pelvic floor conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is the material used in the majority of mesh medical devices.
All relevant abstracts from original articles investigating the host response of mesh ‘in vivo’ were reviewed. Papers were obtained and categorised into various mesh material types and the results from the studies were carefully interrogated and evaluated.
Ultimately, the review of the evidence shows that polypropylene evokes a less inflammatory response compared to other materials which are or can be used in mesh devices in humans. It was also indicated that a lightweight, large pore mesh provides the most satisfactory outcomes.
While some promising outcomes have been observed with the use of biologically derived and fully reabsorbable meshes, both these types of material currently lack the mechanical strength required for long-lasting repair.
What was seen, and continues to be seen through research evaluated as part of this paper, is that the greater proportion of the clinical community agree the use of these devices in the UK is a valuable treatment option for the distressing conditions of stress urinary incontinence and pelvic organ prolapse. However it is clear longer term studies need to be completed in patients. As with all implanted medical devices, to date, it is recognised they all produce some degree of inflammatory reaction so the search for even better alternatives must continue, even though this is in part, how they produce their strengthening action.
We are committed to helping to address the serious concerns that have been raised by some patients and continuously assess findings of studies undertaken by the clinical community over many years, as well as considering feedback from all sources. MHRA sympathises greatly with women who have suffered complications after surgery.
https://www.gov.uk/government/news/interrogating-research-to-protect-public-health
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Soft Tissue Repair Market : Growth, Development, and Outlook 2015 to 2021
Jun 20, 2016 | MedGadget
Soft tissues in the body include tendons, ligaments, fascia, skin, fibrous tissue, skeletal muscle, and synovial membrane. Soft tissue injury is caused due to traumatic injury, fall, sudden twist, and repetitive motion of body. A person recovers from a soft tissue injury on the time of injury and the healing process. Once soft tissues (fascia, tendons or muscles) are injured, the pain and inflammation may eventually resolve and the healing process continues long after. Acute (protective phase), sub-acute (repair phase), late stage (remodeling phase), and chronic phase are the various phases of soft tissue injuries. Acute stage is the initial phase of the injury and is relatively a short phase, wherein the person experiences severe pain, bleeding, and swelling being experienced by the concerned patient. Sub acute stage is an essential component of the tissue repair process wherein repairing of the injured tissue takes place, and it lasts for approximately six weeks after the injury. During the repair phase, new blood vessels grow in the injured area, thus, maximizing the transport within the tissue. In the late stage, healing is continuum, and collagen maturation and remodeling is being initiated. In this process, collagen is realigned along the line of stress. Strains, sprain, contusion, bursitis, tendonitis, and stress injuries are some of the common soft tissue injuries. Soft tissue repair products are used to repair and reconstruct soft tissue injuries. Soft tissue repair matrix is a collagen matrix used for the repair and replacement of soft tissue. Hernia repair, breast reconstruction repair, skin repair, dural repair, vaginal sling procedures, dental and orthopedic are some of the applications of the soft tissue repair.
North America dominates the global market for soft tissue repair due to the growing geriatric population and obesity rate and rising demand for tissue regeneration and soft tissue repair procedures in the region. Asia is expected to grow at a high rate in the next five years in the global soft tissue repair market, with China and India being the fastest-growing markets in the Asia Pacific region. The key driving forces for the soft tissue repair market in developing countries are the large pool of patients, increasing health care awareness, rise in aging population, growing health care expenditure, increase in medical tourism, and rising demand for tissue regeneration and orthopedic soft tissue repair procedures in the region.
Increasing health care expenditure, rise in incidences of soft tissue injuries, increasing number of sports participants, growing geriatric population, increasing awareness about soft tissue injury, rise in minimal invasive procedure, increasing obesity rate, advancements in orthopedic surgical products, and geographic expansion by leading players in developing countries are some of the key factors driving the growth of the global soft tissue repair market. However, lack of awareness, increasing cost of surgical procedure, and limited reimbursement for soft tissue injury surgeries act as major restraints for the growth of the global soft tissue repair market.
Shift from conventional synthetic mesh toward biological mesh for soft tissue repair is the current trend being witnessed in the global soft tissue repair market. The major companies operating in the global soft tissue repair market are Smith & Nephew plc, C. R. Bard, Inc., Lifecell Corporation, Wright Medical Group, Inc., Johnson & Johnson Limited, LifeNet Health, Inc., Arthrex, Inc., Covidien PLC, American Medical Systems, Inc., Stryker Corporation, and Integra Lifesciences Corporation.
Key geographies evaluated in this report are:
North America
U.S
Canada
Europe
France, Germany, Italy, Spain, and the UK
Eastern Europe
CIS
APAC
China
India
Japan
Australia
Others
Latin America
Argentina
Brazil
Others
Key features of this reportDrivers, restraints, and challenges shaping the Soft Tissue Repair market dynamicsLatest innovations and key events in the industryAnalysis of business strategies of the top playersSoft Tissue Repair market estimates and forecasts(2015 -2021)
http://www.medgadget.com/2016/06/soft-tissue-repair-market-growth-development-and-outlook-2015-to-2021.html
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