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Campaigners delighted about a report that shows mesh, used by surgeons in hospitals across Cambridgeshire, degrades while inside the body
Sep 10, 2015 | Wisbech Standard
By Kath Sansom
Campaigners raising awareness about an operation that uses a plastic mesh sling to support weakened pelvic floor muscles have welcomed a new report proving the plastic degrades inside the body. -
JAMA: Women face increased risk for second vaginal mesh surgery 10 years after implant
Sep 10, 2015 | Fierce Medical Device
By Emily Wasserman
Amid a raft of litigation over vaginal mesh implants, a new study shows that women outfitted with the device often need another operation 10 years after getting the slings for urinary incontinence. -
Transvaginal Mesh Complications Lower In High Volume Surgical Practices
Sep 10, 2015 | Medical Research
Dr. Welk: Stress incontinence is a common problem among women. The most frequently used surgical treatment is a mesh-based midurethral sling.
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Sep 10, 2015 | Wisbech Standard
By Kath Sansom
Three leading researchers, who offer expert opinions in medical legal cases, are calling for mesh to be properly examined saying they have evidence to show it degrades causing chronic pain for patients.
The trio studied 164 explanted meshes and found that a foreign body reaction continues until it is removed.
The report, published last month, has been welcomed by journalist Kath Sansom, who launched Facebook campaign Sling The Mesh after suffering painful complications following a TVT operation for stress incontinence suffered after natural childbirth.
Kath said: “Women in the campaign are delighted that for the first time a report by respected authors shows mesh can cause problems.”
The report said: “Polypropylene meshes, originally introduced for hernia repair, are used in several sites and several million are implanted worldwide. Up to 10 per cent will be excised to treat complications.
“In many cases, mesh-related complications develop several years after implantation. The degraded layer becomes thicker over time while its cracking indicated brittleness and loss of flexibility.
“Explants from patients are the primary source of information, however the material has been largely under utilised,” and has been “overlooked for decades.”
The report says the thickness of degraded material grows while the mesh is in the body and increases the longer it is inside.
It creates potential for bacterial colonisation of the fissures within the degraded material.
“The scar around mesh fibres undergoes a continuous remodelling,” the report said.
“An important finding was the detection of inflammatory cells partially migrated and trapped within the fissures.
“Molecules released from mesh may play a role in inflamed tissue damage with subsequent repair.
“Polypropylene degrades while in the body,” said authors Canadian researcher Vladimir Lakovlev, American professor Scott Guelcher and Canadian hernia surgeon Dr Robert Bendavid.
The average mesh studied by them was inside a patient for four and a half years.
The report is great news for campaigners but it is unlikely to be included in the Cochrane Review, an independent panel that reports on mesh every five years.
A spokesman said: “Research included in Cochrane reports typically include randomised control trials, so this is unlikely to feature in a systematic review.”
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JAMA: Women face increased risk for second vaginal mesh surgery 10 years after implant
Sep 10, 2015 | Fierce Medical Device
By Emily Wasserman
Amid a raft of litigation over vaginal mesh implants, a new study shows that women outfitted with the device often need another operation 10 years after getting the slings for urinary incontinence.
Researchers at Ontario, Canada's Western University looked at data on 59,887 women who had mesh slings implanted by about 1,000 different surgeons between 2002 and 2012, and found that after 5 years, 2.2% of women required reoperation. And when women were followed for 10 years, that figure shot up to 3.3%, creating a one in 30 chance that a woman with a mesh implant will have to undergo revision surgery or reoperation, Reuters reports. The team published their findings in a recent issue of JAMA Surgery.
Who performed the original mesh surgery could make a difference, researchers noted in the JAMA Surgery study. A surgeon's specialty, such as whether they were gynecologists or urologists, did not affect results. But surgeons who performed more cases were associated with better outcomes for patients, with the top 25% of surgeons by case volume outperforming the rest. And patients of lower-volume surgeons have a 37% greater chance of a complication further down the line.
Still, researchers acknowledged that there were some holes in the data. The team did not look at the severity of a patient's incontinence presurgery, or their smoking history or type of mesh used in the procedures. The study was also limited to complications serious enough to require repeat surgeries, Reutersnotes.
But the findings raise important questions about who is performing the surgery. Women should make sure they know about their surgeon's past experience, lead researcher Dr. Blayne Welk of Western University said in an email toReuters.Dr. Quoc-Dien Trinh
The study also underscores the importance of finding surgeons who have done high volumes of the procedure, which might be difficult for patients in less populated areas, Dr. Quoc-Dien Trinh of Brigham and Women's Hospital, told the news outlet.
"This paper shows that there is merit in asking that question specifically in the context of mesh surgeries, and it has been shown to be a generally reliable metric of surgical quality care," Trinh said, as quoted by Reuters. "Ultimately, patients need to strike a balance between convenience and quality."
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Transvaginal Mesh Complications Lower In High Volume Surgical Practices
Sep 10, 2015 | Medical Research
Blayne Welk MD
Assistant Professor in the Division of Urology
The University of Western OntarioMedical Research: What is the background for this study? What are the main findings?
Dr. Welk: Stress incontinence is a common problem among women. The most frequently used surgical treatment is a mesh-based midurethral sling. This procedure is commonly called a transvaginal sling, and is usually an outpatient procedure that takes about an hour in the operating room. However, there has been significant concern about some of the complications of this procedure, which include chronic pain, and mesh erosions into the urinary tract. This prompted the FDA and Health Canada to issue warnings regarding the use of transvaginal mesh, and numerous lawsuits have been launched against manufactures of transvaginal mesh products.This study by Dr Welk and colleagues identifies the long term rate of surgical treated complications among a group of almost 60,000 women who had mesh based incontinence procedures between 2002-2012. The rate of surgically treated complications at 1 year is 1.2%, however this increased to 3.3% after 10 years of followup. The FDA and Health Canada recommend that surgeons obtain training and experience in their chosen type of midurethral sling, and we demonstrated that patients of high volume surgeons (who frequently performed mesh based incontinence procedures) were 27% less likely to have one of these complications.
Medical Research: What should clinicians and patients take away from your report?
Dr. Welk: Up to 1/30 women may have complications from their midurethral mesh sling that will require a surgical procedure to remove or revise the mesh. Our results substantiate some of the regulatory recommendations around the use of transvaginal mesh: namely that complications are not infrequent, and that surgeons should obtain experience in the procedure. Patients should make sure they discuss the risks and benefits of this procedure with their surgeon, and ensure that their surgeon is comfortable managing the potential complications of this procedure.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Welk: Further research should attempt to identify women at risk for specific complications. We were unable to identify specific sling types with our study, and future observational studies should try and characterize this variable in order to assess the safety of specific products and techniques.
Citation:Welk B, Al-Hothi H, Winick-Ng J. Removal or Revision of Vaginal Mesh Used for the Treatment of Stress Urinary Incontinence.JAMA Surg. Published online September 09, 2015. doi:10.1001/jamasurg.2015.2590.
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