Mesh Medical Device News Desk, July 10, 2018 ~ SUI Mesh use will be suspended in England after regulators listened to stories of horror from mesh-implanted women. A full review should be concluded next March to determine if the suspension becomes permanent.
The use of mesh for incontinence has been suspended in Great Britain ending a review by the government. The procedure will be halted until five strict conditions, campaigners insisted on, have been met.
Kath Sansom, founder of campaign group Sling the Mesh, which represents those affected by mesh implants, said the announcement came “out of the blue” today.
“This is incredible news. It is a testament to people power. Our members have written, emailed, attended Parliament and lobbied to get this result and I am delighted.”
There are 6,100 members of Sling the Mesh group that campaigns to have mesh taken off the market until its safety can be assured.
Sansom brought campaigners to Parliament and led to an internal investigation by the National Health Services and debates in the House of Commons, making the public aware of the complications of surgical mesh Last February, the government announced a review of surgical mesh meeting face-to-face with citizens around the UK. See the schedule here.
In February, a review of mesh implants was announced by Health and Social Care Secretary Jeremy Hunt. The final recommendation should be publicized next March.
Baroness Julia Cumberlege, who led the review was so moved by what she encountered, she suggested a pause without delay in the use of surgical mesh for stress urinary incontinence (SUI). She also wants to add rectopexy mesh used to treat rectal prolapse to the suspension.
The Daily Mail quotes her:
‘We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications. I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.”
‘We had to act now. My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.’ ~ Baroness Julia Cumberlege
CONDITIONS MUST BE MET
A ban will not be enacted at this time, but a halt to procedures until five conditions are met.
* The conditions are that surgeons only undertake a SUI operation if they receive appropriate training and perform surgeries regularly.
* Surgeons must report every procedure to a national database.
* A registry of surgeries will be maintained to note the type of procedure and the woman involved.
* Complication reports to the MRHA must be linked to the register.
* Specialized centers must be identified and accredited that deal with complications and removals.
Like the U.S., mesh proponents said only prolapse surgeries should be banned, but health regulators acknowledge that three-quarters of pelvic mesh surgeries are done to treat SUI and they account for most of the stories.
In the UK, an estimated 130,000 patients have had a SUI or POP procedure in the past decade. Complication rates have been found up to 42% with 30% reporting a lost or reduced sex life and urinary infections reported at 22% with bladder perforation in 31 percent of cases.
This is part of a global push back on mesh, Scotland has also addressed government directly and got a suspension on the SUI mesh in 2014 after a consistent verbal campaign and extensive media coverage by reporter, Marion Scott.
New Zealand and Australia have also suspended the use of mesh for prolapse but New Zealand expanded the suspension to include incontinence mesh. Hundreds of women are currently locked in litigation against Ethicon in Australia over its controversial mesh implants. A judge is expected to issue her conclusion sometime this year.
SLING THE MESH REACTS
Sansom says the announcement today to suspend the use of mesh for incontinence was surprising.
“We were not expecting this at all because they just started their review. They’ve only had one formal meeting with women in London and have had a teleconference with campaigners, with only one formal meeting the stories they’ve heard are so horrific with lives damaged beyond repair that they’re calling a halt to these implants until March 2019.”
At that time a final report should be issued. It is unclear at this time whether a ban will become permanent.
Sansom, a reporter for CambsTimes says, “I think the really positive thing about the suspense is the government is finally listening to us and realizing just how awful it is when these mesh implants go wrong.”
Sansom says that is the positive. On the not so positive side, they are not suspending the use of mesh for rectal prolapse which shows similar complications. Sansom says they would like to see those suspended as well. The same plastic is used for hernia repairs and they are starting to get the same complications, pain loss of sex life, autoimmune conditions.
Hopefully this review will be the spring board to put in place a permanent suspension of mesh used for hernia repair since all are made of polypropylene, she says. ###
**Late Add here:
The British Society of Urogynaecology (BSUG) strongly disagrees with the decision to suspend the use of surgical mesh for stress urinary incontinence recommended by the All Party Parliamentary Group (APPG). See statement here.
The decision is not based on any scientific logic or thinking, members say. The statement is signed by Professor Jonathan Duckett chairman of the BSUG. ##
**Later Add here*
1. Majority of trials are mesh vs mesh. That means most trials are not randomised = bias & it is considered lower quality evidence2. Most trials are short term. Average is two years. Average mesh problem time to cut in is 3 to 4.3. Very small cohorts. One is 90 women which drops to 58 after 17 yrs, a drop of 22%. Even a drop of 5% is considered to add significant bias to a study4. They use poor quality of life studies that only look at if it fixes the problem. It doesn’t look any new onset of chronic pain, nerve damage, Urinary infections, loss sex life etc5. Most QoL questionnaires base themselves on the pad test for SUI. It is as basic as it sounds eg how many Tena pads do you wear now? oh none! Then you’re fixed madam.6. Many trials authors have conflicts of interest eg the trial I speak of in Point 3, the two trial authors are paid by Ethicon, who make the mesh slings they are testing. Talk about marking your own exam papers!7. In many trials they come up with some pretty damning stats eg there is one by Brubaker et al that says it has 42% risk but in the abstract / conclusion it brushes it off as saying they are only short term and mesh is an effective treatment option! Busy medics dont have time to read through every report so believe the hype. https://www.ncbi.nlm.
Independent Medicines and Medical Devices Safety Review Update, July 10, 2018 (here).
British Society of Urogynaecology statement (here)
BAUS – British Association of Urological Surgeons supports establishing centers (here)
BMJ on Evidence Against Mesh (here)