Preview Newsletter
Ethicon Media Monitoring 4/19/2018
-
NHS releases figures on controversial vaginal mesh procedures in Suffolk and north Essex
| East Anglian Daily Times
By Gemma Mitchell
Twelve women have undergone surgery in Suffolk and north Essex to remove vaginal mesh or tape, new figures reveal. -
Though most prolapse surgeries regress over time, symptoms remain improved
| Medical Xpress
By Duke University Medical Center
An estimated one in three women in the U.S. has a pelvic floor disorder, a condition that often develops after bearing children and getting older. -
NHS report shows scale of mesh scandal
| Medical Plastics News
A report by NHS Digital has revealed the scale of the vaginal mesh scandal that has affected thousands of women across the UK. -
Vaginal mesh op failures 'costing NHS millions' says analysis
| Sky News
Vaginal mesh operations are failing and costing the NHS millions of pounds, according to new analysis. -
FDA releases plan for improving medical device safety
| Health Exec
By John Gregory
The Food and Drug Administration (FDA) has released its “Medical Device Safety Action Plan,” a series of ideas and proposals on more quickly enforcing new safety requirements, encouraging manufacturers to make safer products and improving cybersecurity of devices. -
Mesh scandal costing NHS millions, analysis shows
|
Online Sources
-
NHS releases figures on controversial vaginal mesh procedures in Suffolk and north Essex
| East Anglian Daily Times
By Gemma Mitchell
Twelve women have undergone surgery in Suffolk and north Essex to remove vaginal mesh or tape, new figures reveal. The experimental NHS Digital data shows Ipswich Hospital and Colchester General Hospital have carried out six removal surgeries each since 2008/09.The implants are used to treat vaginal prolapse or stress urinary incontinence.
Their use has been thrown into the spotlight in recent months as women up and down the country say they have suffered horrendous complications. A campaign called Sling The Mesh has been launched.
The statistics also reveal how many patients were fitted with vaginal mesh or tape between 2008/09 and 2016/17.
Ipswich Hospital has performed 1,790 implants; Colchester General Hospital has done 864; and West Suffolk Hospital has carried out 565.
In February, this newspaper revealed Woodbridge woman Jo Coghill had won a legal case against Ipswich Hospital after being fitted with a mesh by the trust in July 2013.
Ms Coghill said she was left “traumatised” and endured almost two years of severe pain following the procedure for stress incontinence.
She had the mesh removed by doctors at a private clinic who found it was eroding through her vaginal wall. Sarah Wealleans, the medical negligence lawyer at Irwin Mitchell who acted for Ms Coghill, said: “In our work we have seen first-hand the devastating impact that problems with these implants can have on women.
“It’s important that appropriate steps are now taken by the NHS to ensure those who are negatively impacted by their mesh implant are fully supported and treated to ensure the impact on their life is as limited as it can be.”
Health Minister Lord O’Shaughnessy said the figures had been requested to establish a “clearer national picture” on mesh and tape use.
Kath Sansom, founder of Sling The Mesh, said “thousands of women” were missing from the data as it failed to capture private procedures and treatment for pain, as well as the “devastating social and psychological impact”.
Health Secretary Jeremy Hunt has launched a review into how the NHS responds to safety concerns raised by patients about medical devices, including vaginal mesh implants.
-
Though most prolapse surgeries regress over time, symptoms remain improved
| Medical Xpress
By Duke University Medical Center
An estimated one in three women in the U.S. has a pelvic floor disorder, a condition that often develops after bearing children and getting older. These disorders can lead to incontinence, painful intercourse and even the bulging or prolapse of pelvic organs into the vaginal canal.
Surgeons have been performing procedures to improve these symptoms for decades, but few studies have tracked how patients fared beyond the first couple of years after surgery. A Duke-led study publishing April 17 in the Journal of the American Medical Association followed women for five years after two common prolapse surgeries and found failure rates for both procedures were equally high, at over 60 percent.
However, surveys of the nearly 300 women in the study found that even for patients whose surgical adjustments regressed or caused new or worsening symptoms, more than half still reported that their quality of life five years later was much better than before surgery, and relatively few women sought retreatment.
"This was surprising to us," said lead author J. Eric Jelovsek, M.D., director of Data Science for Women's Health in Obstetrics and Gynecology at Duke. "That failure rate was higher than we expected. But that does not necessarily align with how patients feel, and we don't know why that is. It is possible the definitions we set for failure in this case were too stringent. We need to do some more research to understand what is the most optimal way to define success or failure, and how that factors in women's quality of life and desire to seek retreatment."
The randomized clinical trial, known by the acronym OPTIMAL, began in 2010 as an initiative of the National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. The mission was to compare two common treatments for prolapse—sacrospinous ligament fixation (SSLF), resulting in a 70.3 percent failure at 5 years, and ligament vaginal vault suspension (ULS), resulting in a 61.5 percent failure at 5 years. Participants' median age was 57 years.
For both operations, surgeons access the affected area through the vagina, bringing points of the tissue upward to connect with ligaments on the pelvis. The goal is to reattach the woman's own tissue to support pelvic organsand reduce incontinence. No synthetic mesh is used in either procedure.
If after five years, the repaired tissue descended past the upper third of the vaginal canal, researchers considered the surgery a failure. The procedure was also considered failed if the patient felt a bothersome bulge or sensation of prolapse, or were treated again with surgery or a removable pessary to relieve their symptoms. About 12 percent of ULS patients and 8 percent of SSLF patients were treated again with one of these options.
The trial also evaluated whether several weeks of behavioral therapy and pelvic muscle floor training could improve success rates for either procedure, but there was no significant difference in outcomes.
The results suggest that neither procedure might work as well in the long-term as surgeons once thought, Jelovsek said.
"We may be at the point where we need to think of treating prolapse as treating a chronic disease that's likely to return over time" Jelovsek said. "It's like getting a hip or knee replaced. Will your quality of life improve? Yes. Is it worth it? Absolutely, but down the road this will likely be something we'll have to revisit."
However, he said, "These are still very reasonable surgical options to regain quality of life. The surgical improvements to the anatomy might gradually regress, but the relief is significant enough that after five years, more than half of the women report their symptoms were still improved."
-
NHS report shows scale of mesh scandal
| Medical Plastics News
A report by NHS Digital has revealed the scale of the vaginal mesh scandal that has affected thousands of women across the UK.An audit published by NHS Digital on 17 April reveals data for mesh implants in England between 2007 and 2017.Mesh devices, made from polypropylene, were introduced to treat stress urinary incontinence (SUI) and prolapse for women following childbirth. Over the past few years, women have campaigned against the devices, claiming they have caused complications such as chronic pain, psychological damage and the erosion of organs are the mesh had eroded.
Since 2008, at least 500 removal operations have been carried out by the NHS every year, the audit shows. Out of 101,538 women treated for SUI with mesh devices, there have been 5,374 removal operations by the NHS.
In December last year, UK health watchdog NICE recommended that vaginal mesh products be banned from treating prolapse due to safety concerns. Figures within the NHS report show that almost half (46%) of women treated for prolapse with a mesh device have attended an appointment with a trauma and orthopaedic surgeon.
Almost the same number (44%) of women treated for SUI with a mesh device attended an outpatient appointment with a trauma and orthopaedic surgeon, increasing from 34% in 2009.
The government has previously claimed that complication rates caused by mesh devices were as low as 1.5% and that no regulatory action was needed for the devices.
The report was undertaken after the All Party Parliamentary Group for Surgical Mesh demanded it to establish a clearer picture of the scandal.
Owen Smith MP and chairman of the group said: “These data show that the campaign against mesh has been totally justified in our claim that large numbers of women have been damaged by mesh. Government has previously, repeatedly claimed that mesh was ‘safe’ and that just 1-3% of women suffer serious complications after surgery.”
“The data also shows that the number of operations using mesh has almost halved over the last decade, illustrating that doctors and patients have themselves decided to stop using mesh. This is precisely the opposite effect that you would expect to see with a new innovative and effective treatment, the use of which would normally rise as its value was proved in clinical usage”
“Mesh is proving itself unsafe and ineffective in many women and the doctors are therefore stopping using it. That, in itself, shows that the government, NICE and the MHRA have been wrong to repeatedly defend the use of mesh. NICE should now fast-rack its review of the mesh – still, inexplicably, not due until 2019 – while the NHS should suspend use of mesh until the results of that review are known.” Smith concluded.
The report has drawn criticism from campaign group, Sling the Mesh, who state that ‘the government have selectively used figures in a bid to make mesh risk look low,’ according to Kath Sansom, founder of the group.
Sansom says the report “has not included private patients or women going to GPs for pain medication or antibiotics to treat painful urinary infections so there are thousands not included in this data.”
“The report shows even 8 years after mesh insertion it is still causing problems. This audit has no information on the devastating social and psychological impact on women - we ran a survey that shows 1/3 women in our group of 6,000 have had to stop work and 1/5 reduce their hours due to disability or pain. The impact on women and their use of health service is missing. Our survey showed 54% of women suffer persistent and chronic urinary infections – none of that information is in this audit. 8% in our group are subsequently developing antibiotic resistance due to multiple courses of antibiotics – this is not in the audit. More importantly we would expect to see - as standard - the impact on quality of life: This audit looks at overnight stays, removals and under reported outpatient visits. This is an obscure measure of if a mesh operation is a problem or not.” Sansom said.
-
Vaginal mesh op failures 'costing NHS millions' says analysis
| Sky News
Vaginal mesh operations are failing and costing the NHS millions of pounds, according to new analysis.
Government figures show that about 500 of every 13,000 women implanted with the mesh to treat urinary incontinence and prolapse are re-operated on within a decade to have it removed.
The surgery, which usually takes less than half an hour, involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel.
Analysis by Carl Heneghan, professor of evidence based medicine at Oxford University and a clinical adviser, revealed that the 100,516 women who have undergone mesh surgery in England since 208/9 have needed 993,035 outpatient appointments costing the NHS £119,164,200. Professor Heneghan said: "These are the sort of outpatient treatment numbers one would expect to see among a cohort of patients with multiple co-morbidities, not that you'd see among the relatively young women who have usually been operated on with surgical mesh for urinary incontinence."
The Government has previously claimed that the normal rate of serious complications - such as pain over a long period, sexual dysfunction or erosion and intrusion of the mesh - only occurs in 1-3% of patients.
The new statistics show that over a nine-year period following surgery, 4% are at some point having operations to have the mesh removed, suffering serious side-effects which force them back to hospital for treatment. Commenting, Owen Smith MP, chairman of the All Party Parliamentary Group (APPG) on surgical mesh, said: "These statistics show that the scale and complexity of the problems associated with mesh is far greater than has previously been accepted. It cannot be right that so many women are having to return repeatedly to hospital to deal with the side-effects caused by mesh, and it cannot be cost-effective for the NHS either."
Mr Smith added: "They now need to suspend the use of mesh until the results of these twin investigations are known."
The Government has now called in Dame Sally Davies, the Chief Medical Officer, and Baroness Julia Cumberledge to investigate.
Emma Hardy MP, vice chairman of the APPG, who will open a debate in Parliament on Thursday, said: "Despite some recent successes in the mesh campaign, there is still more work to be done both to help the victims of the current scandal and to make sure that nothing like this ever happens again. "I believe the Government now needs to fully suspend mesh operations and to bring forward the NICE guidance which is still not expected until 2019.
I also believe the Government should urgently review the financial consequences of dealing with failed mesh procedures and should consider introducing post-natal pelvic floor physiotherapy for all new mothers on the NHS."
-
FDA releases plan for improving medical device safety
| Health Exec
By John Gregory
-
Mesh scandal costing NHS millions, analysis shows
|
Online Sources
Add recipients
Suggested