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Johnson & Johnson withdraws pelvic mesh device from Australian market
Jan 23, 2018 | The Guardian
By Melissa Davey
Pharmaceutical giant Johnson & Johnson has withdrawn from the Australian market its supply of the vaginal mesh device that is the subject of a class action before the federal court. -
Johnson & Johnson Has Withdrawn The Mesh Products It Is Being Sued Over
Jan 23, 2018 | BuzzFeed News
By Gina Rushton
The Therapeutic Goods Administration (TGA) requested last year that all manufacturers of transvaginal sling and mesh update product information on the devices by January 17 to include warnings about potential adverse side effects. -
Vaginal mesh implants blight Southampton women's lives
Jan 23, 2018 | Daily Echo
By Sally Churchward
They were told that it was a straightforward procedure that would end the difficulty of urinary incontinence. -
D-Mannose – A Simple Sugar To Treat UTIs
Jan 23, 2018 | Mesh Medical Device News Desk
D-Mannose is a simple sugar that has an ability to prevent bacterial infections in the urinary tract system in both men and women.
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Johnson & Johnson withdraws pelvic mesh device from Australian market
Jan 23, 2018 | The Guardian
By Melissa Davey
Pharmaceutical giant Johnson & Johnson has withdrawn from the Australian market its supply of the vaginal mesh device that is the subject of a class action before the federal court.
On Tuesday a spokeswoman for Australia’s medical devices regulator, the Therapeutic Goods Administration, confirmed to Guardian Australia that the mid-urethral vaginal sling devices, used to treat stress urinary incontinence in women, were no longer being imported.
The devices are produced by the Johnson & Johnson company Ethicon and no longer appear on the Australian Therapeutic Goods Register, which is a list of products that can be lawfully supplied in Australia. The TGA has not responded to questions about whether the removal of the products from the register also means that products already on hospital shelves cannot be used by surgeons.
The TGA asked all manufacturers of transvaginal sling and mesh devices to update the “instructions for use” on transvaginal mesh and tape products before 17 January to include information about possible adverse events such as severe chronic pain, groin pain and bladder perforation.
According to the TGA, Johnson & Johnson did not meet this deadline and withdrew the supply of their mid-urethral sling devices to enable them to consider their options. A list of pharmaceutical companies that have met the new requirements has been made public.
The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson, told Guardian Australia he had written to all members to alert them to the development. It was his understanding that Johnson & Johnson slings already on hospital shelves could still be used but new supplies could not be imported.
Robson said he did not have “exact figures”, but the Johnson & Johnson devices were probably the most widely used by surgeons to treat incontinence.
“What I have heard is once the stock on the shelf is gone that’s it, and many hospitals, if not most, are looking at other options including other brands of urethral tape, which are still available,” Robson said.
“The feedback is some places are exploring transition arrangements so women can be offered other similar products. What I also wrote to our members yesterday was that it is clear mid-urethral tapes are the most appropriate response to incontinence which has not responded to other clinical treatment. We recirculated a Cochrane review that shows that mid-urethral tapes are the most appropriate treatment when used appropriately, and are very safe.
“In fact, I think it’s regrettable it won’t be available for a while, but there are other similar products.”
The Johnson & Johnson/Ethicon implant became the subject of a class action run by Shine Lawyers in 2017, with 700 Australian women alleging that faulty pelvic mesh implants caused them debilitating pain.
Similar class actions involving thousands of women are also under way in the UK and US. More than 100,000 transvaginal mesh lawsuits have been filed in the US, the largest number against Johnson & Johnson, the manufacturer of the most commonly used meshes. Shine Lawyers alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients.
A Senate inquiry has examined whether any financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants; the lack of data available on how many procedures were performed; and the type and incidence of health problems woman have experienced.
The class action is due to return to the federal court in Sydney on Monday.
Johnson & Johnson has been contacted for comment.
https://www.theguardian.com/society/2018/jan/23/johnson-johnson-withdraws-pelvic-vaginal-mesh-device-from-australian-market
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Johnson & Johnson Has Withdrawn The Mesh Products It Is Being Sued Over
Jan 23, 2018 | BuzzFeed News
By Gina Rushton
The Therapeutic Goods Administration (TGA) requested last year that all manufacturers of transvaginal sling and mesh update product information on the devices by January 17 to include warnings about potential adverse side effects.
A spokesperson for the authority today confirmed to BuzzFeed News that Johnson & Johnson missed this deadline and had withdrawn the supply of its mid-urethral sling devices "to consider their options in response to TGA’s request to update the Instructions for Use of their products".
The devices will no longer be imported while the company weights up its options.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
The products, known as Gynecare TVT, are the subject of a class action involving 700 Australian women.
The women are currently in court fighting Ethicon, a subsidiary of Johnson & Johnson, in a class action brought by Shine Lawyers claiming vaginal medical devices left women "suffering painful and life-altering complications".
A Johnson & Johnson spokesperson said the products were placed "on hold" in Australia and New Zealand on January 17 due to the TGA's new warning rules.
"The company is assessing the new requirements and the global regulatory implications," the spokesperson said. "Importantly, this is not a product recall and no action is required by patients who have received TVT products. No new orders will be shipped to customers."
An estimated 100,000 Australian women have been implanted with Johnson & Johnson mesh devices since 2000.
Shine Lawyers estimates there could be upwards of 8,000 Australians who have been implanted with one of the nine devices in question.
Shine Lawyers would not talk to BuzzFeed News about the latest development, as the matter is still before the courts. The firm's lawyers will make closing submissions on the case next week.
Johnson & Johnson said the company's pelvic mesh products had been developed in "close consultation with specialist surgeons" and were "backed by years of clinical research".
Last month New Zealand's Ministry of Health told leading suppliers of transvaginal mesh products to prove the implants are safe or stop marketing them.
"The [New Zealand Medicines and Medical Devices Safety Authority] response is effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence," the authority said in a statement.
The decision came less than a fortnight after the some of the devices were banned by Australia's TGA after a review found "the benefits do not outweigh the risks these products pose to patients".
The TGA also cancelled single incision mini-slings to treat stress urinary incontinence due to evidence the risks to women outweighed the benefits.
An Australian Senate inquiry into transvaginal meshes is expected to report back next month.
In its submission to the Senate inquiry, Johnson & Johnson said the use of implantable mesh was supported by clinical research and was often the preferred option to treat pelvic conditions, including incontinence and pelvic organ prolapse.
The inquiry was established to find out exactly how many women have had transvaginal mesh implants and, of those, how many experienced adverse side effects.
Queensland associate professor of urogynaecology Christopher Maher has estimated more than 200,000 mesh implant surgeries have been performed in Australia to date.
More than 100 women have written to the inquiry — here are the most heartbreaking submissions.
A list of pharmaceutical companies that did update their product information, and will continue to import and sell mesh devices in Australia, can be found here.
https://www.buzzfeed.com/ginarushton/johnson-johnson-has-withdrawn-the-mesh-products-it-is-being?utm_term=.ctbYbm5nY#.mq2xnavmx
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Vaginal mesh implants blight Southampton women's lives
Jan 23, 2018 | Daily Echo
By Sally Churchward
THEY were told that it was a straightforward procedure that would end the difficulty of urinary incontinence.
But, instead, Eleanor May-Johnson and Suzie, both from Southampton, are among thousands of women in the UK whose lives have been blighted by vaginal mesh implants.
The implants are used to treat pelvic organ prolapse and incontinence in women,often following childbirth.
The mesh is usually made from synthetic polypropylene and is intended to repair damaged or weakened tissue.
The implants have been widely used throughout Europe, Australia and North America, since the early 2000s.
But NHS data indicates that one in 15 women who have had mesh implants have had to have them removed.
And mesh campaigners, as well as the Labour Party, are calling for use of mesh plants to be immediately halted and are urging the government to carry out a full public enquiry into the controversial procedure, which is causing some women severe pain and incontinence, while mesh campaigner Chrissy Brajcic died from sepsis.
Despite already having had two operations to remove mesh that had become loose, Eleanor, a midwife, is still in constant discomfort.
Meanwhile, Suzie has undergone five surgeries to remove mesh after it began to cause her severe pain, and is still in constant agony. At just 42 she has been medically retired and has gone from working in a high pressure job as an analyst for an insurance company, with an active lifestyle including ten hours of tae kwondo training a week, to having to alternate between sitting on the sofa or lying down, unable to find relief from her intense pain.
Eleanor, now 46, developed urinary incontinence following the birth of her three children, now aged 29, 24 and 21.
The condition worsened over time, and in December 2005, she had surgery to implant TVT (tension-free vaginal tape).
But within less than nine months, she had mesh exposure – a fragment had broken off and was visibly sticking out of her body. It was, of course, extremely painful.
She had surgery to remove the fragment, but five years later, the same problem happened again and further surgery was necessary.
"I was told that it was extremely rare and that my surgeon had never seen it happen five years later," she says.
"I thought I was just unlucky, but then a couple of years ago I began to see the stories about mesh implants in the media, and realised that it wasn't that rare after all, and a significant number of women have had problems that are much worse than mine.
"I still have more mesh inside me. I can feel a piece right by my urethra, and along one side of my vagina. I know it will be difficult to remove, because these are such sensitive structures and the mesh was designed to bond with the body's tissues."
Eighteen specialist mesh centres have been set up across the country for women experiencing problems related to mesh implants, but demand is high and waiting lists are long.
Eleanor was referred to University College London Hospitals (UCLH) in November, but the waiting list for a consultation is around eight months, with a similar wait for surgery after that.
"It feels like there is a ticking time bomb inside you," she says.
"I feel very let down my the manufacturers of this device. It wasn't communicated to women that there might be any complications. I was just told about the usual risks of having surgery."
Eleanor has become involved with pressure and awareness group Sling the Mesh, which is calling on the government to ban all mesh and tape implants in the UK, a move which has already happened in Scotland.
While a number of women are taking legal action regarding their implants, Eleanor is not sure whether she will do so.
"The NHS doesn't have any money and I don't want to sue the NHS. I would rather go after the manufacturer but I'm outside of the ten year limitation period. However, I wasn't aware of there being general issues with the device until two years ago.
"We're asking the government to change the law so that we can go after the manufacturer."
Eleanor adds that she wonders if the problem is being underestimated in part because women are being falsely perceived as being over dramatic about their symptoms.
"Women are often told that they are imagining their pain, that they're depressed or that they're mentally ill," she says.
"I feel very angry and let down."
Suzie developed urinary incontinence following the birth of her daughter, now 19. She had TVT surgery in 2012 and it was immediately apparent that something was not right.
"I never really recovered," says the 42-year-old from Southampton.
"At my post-operation check, my surgeon said that something wasn't right and thought that perhaps I was allergic to the material."
A couple of months after the implant, Suzie was back in surgery again, but unfortunately it wasn't all removed.
She has had a further four operations to remove the mesh but some still remains in her body.
Suzie was referred by her GP to specialists at UCLH in October, but found out last week that her referral had not been received so has had to start the process again.
In the meantime, she is left in what she describes as constant and horrendous pain.
"It is like someone is stabbing me in the groin and twisting the knife. When I try to walk, it feels like something is literally cutting into my urethra. It's excruciating. I also have a constant feeling like severe period pain.
"I also have main in my lower back and hips – it feels like my pelvis is twisted.
"The worst pain is trying to wee. I find myself screaming and crying. It's like trying to pass razorblades. It's easier when Im incontinent as at least it's not as painful as actually trying to wee. It's got to the stage where I don't think it can get anymore painful, but then it does."
Suzie's life now could hardly be more different to before her surgery. She had a well-paying full-time job, and often travelled with work. Having divorced her daughter's father, she was also busy as a single mum, and filled the rest of her time with lots of hobbies, including tae kwondo training – she has a black belt – walking, running, playing the piano and socialising.
Now, she can only get about using a mobility scooter or, on a good day, a walking aid, and is largely confined to the house, due to double incontinence, pain and lack of confidence.
"It has made my life unbearable," she says.
"I'm very depressed. I have shut myself off from my friends. I can't really go out. I used to be very fit and sociable. Now I'm just at home and I hardly speak to anybody.
"I can't express how horrible it is. I can't get any relief from the pain. I can't sleep. I can't do any of the things I used to enjoy doing. I can't even play piano because it's too painful to sit at it.
"I just alternate between short spells of either lying down or sitting on the sofa. There's nothing else I can do to relieve the pain.
"It has been bad for a couple off years, but it's got worse recently,and the last six weeks have been a living hell."
Suzzie would like to see the government suspend the use of all mesh implants while a full public enquiry is carried out and to give the NHS a cash injection, to provide mesh awareness training in the NHS so that women can be referred for the treatment they need and to bring down waiting times.
"It is incredibly expensive to see someone privately, and I just don't have that kind of money. I used to have a fantastic job where I made good money, and now I'm struggling to make ends meet, with no future prospects whatsoever.
"I feel very let down. We weren't warned that this could happen and now the NHS isn't in a position to offer us the treatment that we need to fix it. "
A survey of members of campaign group, Sling The Mesh, shows how previously healthy women must adjust to devastating new normals if they suffer complications after a quick fix operation for prolapse or incontinence.
The survey of 570 women comes before a Westminster mesh think tank meets on Tuesday, January 30.
It shows seven out of ten women lose their sex lives and six out of ten suffer depression, while one in seven lose their marriage/partners.
A third give up work completely, while one in five reduce their hours to cope.
More than half suffer constant urinary infections (UTI/cystitis), and one in 20 are becoming antibiotic resistant, a dangerous condition which puts them at risk of sepsis.
The survey shows that the majority (two thirds) had a mesh tape to fix incontinence – the type of mesh that surgeon society, RCOG says is an effective treatment for many women. Only a third had prolapse mesh – vaginal prolapse mesh was effectively banned at the end of last year.
Commenting on the survey, Chair of the APPG on Surgical Mesh Implants, Owen Smith MP said: “These results are truly heart-breaking and show the shocking extent of the suffering some women are facing following mesh implant surgery. Many of the issues detailed in the survey are life-changing and cannot be ignored. I am calling on the Government to urgently conduct a full audit of all patients who have been treated with mesh and a undertake a prospective registry of any new patients. Until we have a clear understanding of the long term risks and benefits of mesh, its use should be suspended.”
Kath Sansom of Sling The Mesh said: "The survey shows the personal devastation. We have women in the group who are suicidal, who don't want to carry on because the pain is so intense. Yet previously they led healthy lives.
"Surgeon societies know there are big problems as 18 specialist mesh centres have been set up across England. Also conferences are being held on how to deal with mesh litigation.
"Surgeons only monitor women for around three months after an operation so have no idea of the scale of suffering as some problems take months or years to cut in. There is little reliable audit to back up claims it is a long term solution because there is no National Register like there is for hip implants."
Of those surveyed, further results include: eight out of ten suffer pain when walking, seven out of ten lose their sex lives and six out of 10 suffer depression and anxiety.
http://www.dailyecho.co.uk/news/15890161.Vaginal_mesh_implants_blight_Southampton_women__39_s_lives/
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D-Mannose – A Simple Sugar To Treat UTIs
Jan 23, 2018 | Mesh Medical Device News Desk
D-Mannose is a simple sugar that has an ability to prevent bacterial infections in the urinary tract system in both men and women.
Many women with transvaginal mesh develop urinary track infections (UTIs) and in some, the condition becomes chronic.
Mesh News Desk has partnered with Superior Labs to offer you a discounted, high quality D-Mannose. See the link here.
UTIs and D-Mannose – A Simple Sugar Treatment for UTIs
Urinary tract infections (UTI) are responsible for 10 million doctor’s office visits a year, according to the National Kidney Foundation.
Symptoms include burning urination and a low output of urine. E. coli is the primary bacteria that causes 90 percent of infections.
The National Kidney and Urologic Diseases Information Clearinghouse says bladder infections are the most common type of UTI.
The bacteria comes from the bowel and the bladder, ureters, and urethra can all become infected. While most UTI’s stay in the bladder, if it is not treated promptly, the bacteria can travel to the kidneys causing pyelonephritis, an actual infection of the kidney. This is more serious and may appear as back pain and fever.
In men, an enlarged prostate that restricts normal urine flow can result in a bladder infection.
Preventing a UTI is better than treating one because it takes far less effort to treat says Dr. Joseph Mercola, an online alternative medicine MD. Drink plenty of water, says Dr. Mercola, so urine is a light color, unless you are taking some supplements that might leave your urine a deeper color.
To prevent UTIs, don’t hold your urine, use a bidet if possible, and wipe from front to back. Cleanse after intercourse.
Dr. Mercola says avoid antibiotic treatment because it kills good and bad bacteria. Fermented foods also help deliver good bacteria to the gut.
Superior Labs D-Mannose
D-Mannose – A Simple Sugar
D-Mannose is a simple sugar.It is related to glucose and is found naturally in foods such as peaches, oranges, apples, blueberries and cranberries. Even though it’s a sugar, D-Mannose does not reportedly interfere with blood sugar regulation so it does not present a problem for diabetics because very little of it is metabolized.
E. coli bacteria is the primary bacteria that causes 90 percent of infections.
Clinical trials from Europe show D-Mannose can be used to treat and prevent urinary tract infection as it appears to stop the E. coli bacteria from sticking to the bladder walls. Instead, it sticks to the sugar. Then the bacteria leaves the body through your urine.
D-Mannose can be used for a few days or long term use.
In one study of more than 300 women, D-Mannose worked as well as antibiotics to prevent recurring UTIs with fewer side effects.
The British Journal of Urology on the use of D-Mannose in recurrent urinary tract infections (UTIs) in women defines recurrent UTIs as at least two UTIs in every six months or three in one year. This clinical trial involved 308 women for up to 18 years. Women were divided into two groups, some treated with D-Mannose, some with antibiotics.
In one clinical trial the group treated with D-Mannose had a 15% recurrence of UTIs versus the group who did not receive it who had a 60% recurrence of UTIs.
D-Mannose is also used as a probiotic stimulating good bacteria in your digestive system.
https://www.meshmedicaldevicenewsdesk.com/d-mannose-simple-sugar-treat-utis/
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