- Mesh Report does not look into mesh safety.
- At least one in 11 women have complications.
- Hundreds more suffer in silence as six in ten surgeons don’t log problems.
- Women who go to doctors or outpatients are not logged in mesh risk statistics.
- More than 126,000 mesh tape implants used in England alone in last decade.
- More than 4,800 mesh tape implants have been removed and 1,200 adverse events logged in England in the past decade but because of under-reporting, the real figure will be much higher.
- Pelvic mesh been used in NHS for 20 years.
- Patient reps and leading mesh removal surgeon not invited to mesh report meetings for 18 months.
Women are outraged after realising the NHS never intended to investigate mesh implant safety despite undertaking a three-year mesh review costing thousands of pounds.
A long-awaited report was never given funding to look at the mesh product itself. The review began in 2014 and involved experts and patient representatives. It only commissioned to look at patient leaflets, under-reporting and how to deal with women who suffer mesh complications.
Labour MP Owen Smith, who has set up an All Party Parliamentary Group into mesh, said: “Mesh-injured women will be deeply disappointed by the outcomes of the final NHS England review, which seems to have made little progress since its interim report came out over a year ago.
“This was an opportunity for the NHS to take a lead and recommend a pause in the use of mesh until we know precisely how many women have been adversely affected by the product. Instead, they appear content to allow mesh to be widely used despite growing, international concerns about its potential ill effects.
“The only people pleased with this report will be the medical device companies who marketed mesh so diligently and who now fear mass litigation. Many companies have already taken their mesh products off the market, that alone should tell us something is not right with these devices.”
Surgeon Wael Agur said: “If we cannot obtain accurate figures on the true risks in real life, we cannot continue offering these procedures in the future. The UK mesh group did not plan to comment on safety of mesh procedures in comparison to the alternatives. Recording these procedures on a national database and reporting adverse events to watchdogs must be made mandatory.”
Kath Sansom, of campaign group Sling The Mesh, said: “They might as well park an ambulance at the bottom of a cliff and wait for women to fall in. They should have looked at product safety, not at ways to fix women once things have gone wrong.
“How can a major study of mesh not look at mesh safety. It is a whitewash. The NHS paid lip service to patient reps. Mesh implants are the only operation done blind, using large hooks to put in plastic that can then shrink, twist or degrade inside the body. But nobody has explored that.
“We want a full investigation and audit into how many women are suffering from mesh implants. While that takes place, we want a mesh suspension. We want a national register and NICE to urgently bring its SUI guidelines forward from 2019.”
David Golten, partner and head of litigation at City law firm Wedlake Bell, leading the group legal action for Sling The Mesh, said: “The suffering of women affected by surgical mesh implants is immense. They live not only with life-changing pain, but they also have to accept they will never again be the people they once were. The emotional impact of that for them and their families is appalling, and all for an operation that was supposed to improve their quality of life.
“We are putting together a team of leading legal experts from around the globe to represent these women to make sure they receive the redress they deserve.”
Surgeon Suzy Elneil, of UCLH, said: “The complexity of mesh surgery, no matter where it is placed, is not in the putting it in-situ, but in the preparation of the patient. This includes taking a proper history, investigating appropriately, instituting non-invasive measures such as physiotherapy, and offering the patient options of all available therapies. All of this requires informed consent, including the pros and cons of every procedure being discussed at length.
“In addition, should complications arise, there should be a defined pathway of care. But, above all the patient must be listened to and supported by us in the profession. To do otherwise would be harmful at all levels.”
Retired surgeon John Osborne said: “Undoubtedly many women have been helped by the TVT operation, but the complication rate seems to have been under-reported. My feeling is too many women have had this procedure as a quick fix when the symptoms did not justify the risk.”
Jemima Williams of Welsh Mesh Survivors said: “Wales has been ignored for years. This is the tip of a huge global iceberg that needs to be addressed now. Mesh should be suspended until an investigation is made into the adverse effects. No other life should be destroyed.”
Jackie Harvey of Northern Irish mesh support group, said: “Over 200 mesh-injured women in Northern Ireland have joined the local support group within the past four weeks. Heartbreaking stories of going to seek help with pain and infection only for many of them to be fobbed off or told they are the only one. The realisation is now dawning that they are unlikely to get the treatment they need in Northern Ireland, so are increasingly turning to England and choosing to pay for private treatment by mesh complication experts there.”
Scottish Mesh Survivors said: “Patients should not have had to campaign for years to highlight the suffering mesh implants have caused and to get basic safety measures in place. It is no longer acceptable for surgeons to assume that if a device has made it onto an NHS shelf it is safe.
“We have been let down badly by pro-mesh health professionals who cannot fix us when serious complications occur, and we have been let down by the MHRA who regurgitates the claim that the ‘benefit [of mesh] outweighs the risk’ without having necessary data to back up this up.
“We need the Government to step up to the mark and take responsibility for what is arguably the biggest health scandal ever and stop these procedures now!”
‘Key areas of action’
A spokesman for NHS England said the interim report “recognised three key areas of action and made recommendations on what should be done to tackle them”.
It said: “These focused on improving clinical quality and practice to achieve good outcomes consistently, better data and information, and informed consent. It has not been NHS England’s role to set the direction of the work: the expertise and experience in this field lie with the clinicians and patients.
“The working group’s role has been to identify issues causing concern in the treatment of SUI and POP, particularly surrounding use of mesh devices, and make recommendations to the health system to address them.”
For the mesh report, the NHS commissioned and provided funds to look at:
- Encouraging surgeons to report problems. Six in 10 don’t.
- New patient information leaflets.
- How to deal with women suffering. Within that 16 hospitals in England and Scotland have become specialist mesh problem centres. There are none in Wales or Northern Ireland. Surgeons at some centres have no comprehensive mesh removal experience and many are known to have told women they are mystery mesh patients.
The NHS relies on NICE guidelines into mesh. However, the last major review of incontinence mesh was 2013. It was revised in 2015. The next major review is 2019. For prolapse mesh, a study, called PROSPECT, shows there are no benefits to using mesh and carries risk for at least one in ten women.
Watchdog body the MHRA said the mesh causes serious complications for a minority of women, but it remains an effective treatment option. It said the benefits of vaginal mesh implants outweigh the risks.
Some of the English group patient reps resigned due to not being listened to. They were made oversight members 18 months ago and have not been invited to any meetings in that time.
The Guardian reported the MHRA tried to limit media attention on mesh.
Members of Sling the Mesh held a packed meeting with Mr Smith on July 18 in Parliament where women and their families wept as they gave harrowing accounts of traumatic complications suffered from mesh implants.
At the meeting Carl Heneghan, professor of evidence-based medicine at Oxford University, said mesh was like the thalidomide scandal – except with that you could see the injuries. With mesh, problems are hidden.
Politicians in Scotland called for a suspension of mesh use in 2014; however the material is still widely used in England, Wales and Northern Ireland.
- Read the English group working party report into mesh. Commissioning details can be viewed on page 14.