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Are surgeons correctly trained? Leading Italian surgeon says mesh used in women’s operations has a high rate of complications
Apr 30, 2016 | Cambs Times
By Kath Sansom
A leading medic says surgeons do not have the correct certification to carry out certain women’s mesh operations which carry a high risk of complications and pain. Twelve years after publishing a report calling for plastic mesh to be stopped for pelvic organ prolapse repair, Italian surgeon Professor Stefano Salvatore, has again spoken out again against polypropylene material used in gynaecology surgery. -
Global Mesh Awareness Day Twitter Party, Sunday, May 1
Apr 29, 2016 | Mesh Medical Device News Desk
...So far the group has sent out about 1,500 tweets, every Friday night between 8 pm and 11 pm EST. Many of them are directed at J&J, the largest manufacturer of pelvic mesh. -
May is Global Mesh Awareness
May 2, 2016 | Mesh Medical Device News Desk
By Jane Akre
May 1 is Global Mesh Awareness Day and the month should be dedicated to putting a face on adverse events. The women speaking up are doing so out of frustration and a true desire to help others avoid their fate. They are courageous, beautiful and dedicated. -
Advanced maternal age associated with obstetric pelvic floor trauma
May 1, 2016 | 2 Minute Medicine
By Maren Shapiro and Leah Bressler MD, MPH
...Pelvic floor dysfunction, which can manifest as urinary/fecal incontinence or pelvic organ prolapse, is a major cause of morbidity, and affects roughly half of all women at some point in their life. In this study, researchers preformed a sub-analysis of a previous randomized controlled trial to investigate whether maternal age was linked to pelvic floor trauma in women having their first vaginal delivery.
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Apr 30, 2016 | Cambs Times
By Kath Sansom
A leading medic says surgeons do not have the correct certification to carry out certain women’s mesh operations which carry a high risk of complications and pain.
Twelve years after publishing a report calling for plastic mesh to be stopped for pelvic organ prolapse repair, Italian surgeon Professor Stefano Salvatore, has again spoken out again against polypropylene material used in gynaecology surgery.
His plea comes amid figures that show the risk of bladder slings for female incontinence in England is 8.56 per cent - not one to three per cent as quoted by Government watchdog body, the MHRA.
Following Professor Salvatore’s speech at an annual conference, a Sling The Mesh campaigner asked if UK surgeons complied with current certifications for mesh operations.
Within days of the request the British Society of Urogynaecology (BSUG) posted on its website asking surgeons to make sure they are up to date with training and urging them to report problems to the MHRA - until now it has not been mandatory for them to do.
Prof Salvatore, president of the European Association of Urogynaecology (EAU), said during its annual conference that: “Meshes can be helpful but we don’t yet have the ideal material and we currently have no certification for the surgeons who perform the procedure.
“We are trying to work together with EAU offices and sections to try to create a common training programme or initiative with the European Commission, improving treatment on a European level.”
He added that mesh: “brings a high rate of complications including pain, not just during sexual intercourse but also spontaneously.
“Also there is the case of infections, erosion, and exposure. Patients can experience shrinkage of mesh, worsening of the condition of women.
“Pain during sex can occur not just for women but for their partners as well. This has given rise to a new term dyspareunia,” he said, which has contributed to bringing a “huge reaction against meshes from the patients themselves.”
He said mesh procedures should be performed at centres with a high number of cases to minimize complications.
For the first time firm rules were being established for mesh use, which can only be a good thing for the safety of patients, especially as complications were not always immediately clear, he said.
New developments in pelvic organ prolapse treatment may replace mesh use altogether, he added, including regenerative medicine like stimulating tissue growth, remodelling with collagen or stem cells.
• Hospital Episode Statistics for England show that in 2014/5 a total of 5,256 women had a TVT implant. Of those 450 were either fully or partially removed because of problems = 8.56% complication rate.
• The MHRA were contacted for a comment on the 8.56 per cent complication rate but after 12 days they had not replied.
• In 2004 Professor Salvatore was among a group of medics who said plastic mesh should be abandoned for pelvic organ prolapse repair surgery.
The report into prolapse repair using prolene mesh showed that in some cases 63% of women suffered dyspareunia - painful sex.
• Within days of a mesh campaigner asking about the legality of mesh operations in the UK, the BSUG posted this statement on their website.
NHS Improvement (an amalgamation of Monitor & the NHS Trust Development Authority) have written to chief executives and medical directors informing them of the need for their clinicians to comply with appropriate training, adherence to clinical practice, reporting of complications to MHRA and compliance with national data requirements for all surgeons undertaking mesh procedures.
It is important that all procedures (especially tapes for incontinence and vaginal mesh for prolapse) are entered onto a national database. Together with BAUS we aim to collect all data on mesh implants for the current year (2016 to 2017).
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Global Mesh Awareness Day Twitter Party, Sunday, May 1
Apr 29, 2016 | Mesh Medical Device News Desk
The women behind the Facebook group, Mesh Awareness, will be Tweeting all day and night Sunday, May 1 and will be joined by mesh awareness groups across the globe.
That would include women in Scotland, the UK and The Netherlands, all of which have very active social media group surrounding the mesh complication issue.
The event will last all day.
Dora De Wilde of The Netherlands designed the poster. Global Mesh Awareness is growing in numbers and began loosely about two years ago. It is growing as mesh injuries are growing.
The hash tag is #MeshAwareness. Social media abounds with mesh-injured women and many find unity in talking and offering support to each other online. Many are relieved to find out they are not alone.
Hernia mesh is included among polypropylene mesh injuries. There are now more than 90,000 product liability cases concerning pelvic mesh filed in federal court in West Virginia as well as thousands filed in courts around the country. Internationally, mesh injury lawsuits have been filed in the UK, Scotland, The Netherlands, Israel, Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, and Venezuela seeking damages.
Major mesh manufacturers include Johnson & Johnson/Ethicon, C.R. Bard, Boston Scientific, American Medical Systems, Cook Medical, Covidien and Neomedic. Women report chronic infections, pain, mesh erosion, mesh shrinkage, and many are disabled and unable to leave their beds.
Janis Urban writes about Mesh Awareness Day, “Along with our Posts and Tweets to bring awareness to the Risks of Mesh. Let us Share Pictures, Memories both past and now. It’s not all bad… Good Things, Blessings that still remain in our Lives. I’m grateful for the love and support you all give to me and sharing your joys of family activities always lift me up! Let’s spend the day be grateful and happy! ““I have said we have the World at our Fingertips lets use it!“
Urban (@janurban12) is a lead participant along with Mesh Awareness Movement (@MeshAwareness) and Tammy Jackson (@TammyJa54001341). Thousands of women are online with Facebook pages including Mesh Problems, Links on Mesh, Deb Meshme not, Scottish Mesh Survivors, Meshed-Up, among others.
Urban says if you don’t know how to tweet, go into the pages of Mesh News Desk or find a mesh-related story and hit the little Twitter bird, that will send it to Twitter. You don’t even need an account but signing up is also very simple.
Friday Twitter Parties
So far the group has sent out about 1,500 tweets, every Friday night between 8 pm and 11 pm EST. Many of them are directed at J&J, the largest manufacturer of pelvic mesh.
The parties began on March 11 and the focus of the Tweets for two weeks was on J&J – #JNJHurtWomen, #JNJhurtsforprofit, @MeshAwareness, #FDA.
Jackson wrote directly to Johnson & Johnson at @JNJcares and #JNJNews.
Don’t think J&J didn’t notice, in fact, a tweet claiming to be The Johnson & Johnson Team even replied to the latest!
The reply was:
“Thanks for alerting us to these Tweets. We’ll continue to monitor the situation, and we appreciate you letting us know. Sincerely, The Johnson & Johnson Team.”
Twitter
Twitter allows you to talk directly to anyone crossing continents and oceans. The Twitter campaign of MAM includes support messages for support groups of people injured by pelvic mesh around the world including:
Sling the Mesh @MeshCampaign, #ScottishMeshSurvovirs, and groups in New Zealand, Australia. In the U.S. there’s been a growing population of the mesh injured community taking to social media including Mesh Me Not, Mesh Problems, MAM, Mesh News Desk, Peggy Day Writes. They may have websites, or blogs but they are unified by a common thread- injury from a polypropylene implant.
The participation among mesh injured has been good, says Janis, who plans to reach out to other support groups such as @EssureProblems and @PowerMorcellator, medical devices also allowed onto the market by the FDA that are injuring women.
How do you use Twitter?
It’s easy.
For those uninitiated to Twitter, a # is a Hashtag and it opens up a general topic of interest. Put in a # and pull up a general topic that follows the hashtag, also known as a number sign. For example #toxicmesh, or #FDA.
The @ sign is basically used to call out user names on Twitter. @JNJcares will send a Tweet directly to the company. Its also how you are identified @meshdevicenews, or @janurban
Remember you are limited to 140 characters, short and sweet!
Hashtags used to spread the mesh word have been: #Pain, #Autoimmune, #Toxic, #Untested, #Lives Matter #FDA, #Congress, #Media, #Regulations, #Doctors, #Polypropylene, #Justice, #PelvicMesh, #MeshInjury, #HerniaMesh, #LivesRuined, #MedicalDevice, #HealthcareReform, #HSM, (healthcare social media), #healthhacks, #healthfit, #ehr (electronic health records), #patient safety, #medical research, and the list goes on.
Mesh Art
Social media abounds with clever posters created by the mesh injured community. Check out Twitter and Facebook and visit the above sites.
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May 2, 2016 | Mesh Medical Device News Desk
By Jane Akre
May 1 is Global Mesh Awareness Day and the month should be dedicated to putting a face on adverse events. The women speaking up are doing so out of frustration and a true desire to help others avoid their fate. They are courageous, beautiful and dedicated.
There are many of you out there, some understand and some are new to the issues.
Every day women ask, “Could what’s happening to me be from my mesh?” Not that every ailment is related to pelvic or hernia mesh, but doctors have downplayed the links. The women here are not.
Communicating to each other, they are finding that many of the ailments are the same following a pelvic mesh implant – chronic pain, ongoing infection, UTI’s, pain in the back and shooting down the leg, mesh erosion, inability to walk and sit. Some autoimmune issues seems to be common following the implant such as Lupus, fibromyalgia, joint aches, pains, rashes, brain fog, teeth falling out.
If you are new to the mesh mess you have come to the right place.
There are about 100,000 lawsuits currently filed in the U.S. to address the injuries that come from pelvic mesh. More are filed every day, not just in the U.S. but globally. Despite the product liability litigation, mesh is still used every day. Women are told “It’s different mesh.” It isn’t.
See the story “Top 10 Myths Women are Told Today about Pelvic Mesh” here
Most mesh for surgery – both pelvic and hernia is made of polypropylene, a polymer from the petroleum industry. It is small pore and subject to shrinkage and, in some, inciting a systemic reaction. This in combination to the mechanics of a hard polymer permanently implanted in a soft, nerve-rich pelvic area during a blind procedure, often by under-trained professionals, and there is a huge potential for complications.
Hernia mesh is also made of the same polypropylene and anecdotal reports, as well as those gathered by scientists who deal with complications, show they too are having complications after their implant.
Please be sure to register your complaints with the Food and Drug Administration. Here’s how to here. The FDA has been slow to react, but the only way the world will know of collectively what’s happening is if you ALL register your adverse events, as they are called.
The FDA has issued two reports about pelvic mesh, the first, in 2008, after thousands of reports of complications came into the agency, said pelvic mesh complications were “rare.” By mid-2011 the FDA reversed that stance and said complications were “not rare.”
Please use the Search Bar to explore any topic mesh related. There are more than 700 stories posted over the last five years.
Mesh News Desk is not intended to substitute for information by lawyers and doctors. But the community is awesome! Many women find relief just knowing they are not alone!
Please refrain from using your actual name and posting any confidential information you receive from your law firm. It could negate the settlement agreement you may have signed.
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Advanced maternal age associated with obstetric pelvic floor trauma
May 1, 2016 | 2 Minute Medicine
By Maren Shapiro and Leah Bressler MD, MPH
1. Advanced maternal age at first birth was associated with an increased risk of major obstetric pelvic floor trauma with vaginal delivery.
2. Forceps delivery was associated with increased likelihood of any type of trauma while vacuum delivery was associated with increased probability of anal sphincter injuries.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Over the past four decades, the average age at first birth has increased in women living in major industrialized nations. Pregnancy at advanced maternal age, defined as over the age of 35 years old, is an established, independent risk factor pregnancy-associated morbidity and mortality. Risks of pregnancy-related complications such as miscarriage preeclampsia, and gestational diabetes are meaningfully higher in women over the age of 35. Some research suggests that older women are also more likely to have pelvic floor dysfunction possibly related to trauma during childbirth. However, these studies have been small, retrospective, and included mostly multiparous women, such that the main factors leading to pelvic floor injury remain unclear. Pelvic floor dysfunction, which can manifest as urinary/fecal incontinence or pelvic organ prolapse, is a major cause of morbidity, and affects roughly half of all women at some point in their life. In this study, researchers preformed a sub-analysis of a previous randomized controlled trial to investigate whether maternal age was linked to pelvic floor trauma in women having their first vaginal delivery.
Maternal age at first birth was associated with an increased risk of major obstetric pelvic floor trauma during vaginal delivery. Findings confirmed results of prior investigations whereby the highest likelihood of any type of pelvic floor trauma occurred with forceps delivery. This is the first study to look at the relationship between maternal age at first birth and obstetric trauma. The primary outcome was pelvic trauma at the time of birth, but what proportion of these women will go on to develop clinical pelvic floor disorders remains unclear. Further limitations include a predominantly (80%) Caucasian cohort. Future studies might prospectively recruit a more diverse study population and follow them longitudinally, assessing a more long-term clinically relevant outcome like fecal or flatal incontinence or advanced (> stage II) pelvic organ prolapse.
In-Depth [prospective cohort]: In a sub-analysis of a previous trial of a perinatal intervention, researchers examined the association between maternal age and obstetric trauma. All primiparous women with term, singleton vaginal deliveries at two tertiary hospitals received 3D/4D pelvic floor ultrasounds both antepartum and postpartum (n = 375). Major pelvic trauma assessed included levator ani muscle avulsion, hiatal over-distention to ≥25 cm2, and anal sphincter injuries. Multiple confounders, including forceps and vacuum-assisted vaginal delivery, were evaluated in multivariate logistic regression models.
The plurality (46%) of women experienced at least one form of major pelvic trauma. In multivariate models, advanced maternal age at first delivery was associated with increased risk of pelvic floor trauma whereby each year over the age of 18 was associated with an incrememental 6% increased odds of pelvic floor trauma (OR: 1.064 per year, p < 0.01). Forceps delivery was associated with an increased probability of all types of pelvic floor trauma while vacuum delivery was associated with greater odds of anal sphincter injuries. The trial intervention was not associated with pelvic floor trauma and was neither an effect modifier nor confounder of the relationship between age and pelvic floor trauma.
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