Chamber and committees

Sling The Mesh submission of 26 January 2022

PE1865/YYY - Suspend all surgical mesh and fixation devices

Sling The Mesh has more than 9,300 members with vaginal, abdominal, pelvic, rectal, hernia and mesh following mastectomy.

Our latest survey shows 1 in 4 have considered taking their life owing to life changing, irreversible pain and 6 in 10 suffer depression. A third have been forced to give up work and 1 in 5 reduce their hours in order to cope. There are 1 in 4 who now need a stick to walk and almost 1 in 14 who need a mobility scooter or wheelchair.

Six in 10 suffer recurring urinary tract infections and 1 in 14 are becoming antibiotic resistant so are at risk of sepsis.

These complications are unacceptable.

Background

Incontinence mesh was suspended in Scotland in 2014 and the rest of the UK in 2018.

There is a confusing situation surrounding prolapse mesh. Vaginally inserted prolapse mesh was banned in the UK, America, Australia and New Zealand in 2019 due to unacceptably high rates of complications, but the same prolapse mesh material, supporting the same organs, but inserted ABDOMINALLY, is still freely used across the UK.

Our group shows women with abdominal prolapse mesh suffer the same severe complications as women who had vaginally inserted prolapse mesh.

Rectopexy (rectal) mesh is generally hernia mesh cut to size. I consider this to be off-lable use (this is a product that is being used for something different to what it was originally intended for). The complications are devastating and also supremely embarrassing to people. Many members of the group with rectopexy mesh now have stoma bags.

We are beginning to see women join who had mesh following breast cancer and mastectomy. This is after surgery, taking out stomach muscle to recreate a new breast. Mesh may be used to replace the stomach muscle.

We are aware of a male mesh sling, for men who suffer urinary incontinence following prostate cancer and prostatectomy.

For group members experiencing hernia mesh complications, we see the same theme that happened with women's pelvic mesh – told they are a mystery patient, to manage their pain with medication or their mesh is not the mesh that’s written about in the media.

Many are given scans which won’t reveal if hernia mesh is a problem as it won’t show if it’s cutting or pressing on nerves, won’t show degradation of polypropylene causing systemic illnesses nor if the material has gone brittle like an internal knife.

Hernia mesh background

In the UK hernia mesh is seen as first line option and surgeons say recurrence is lower than native tissue repairs, however, many papers only follow patients for six weeks to a year.

Robert Bendaiv and Vladimir Iakovlev have shown follow up needs to be at least 10 years, as many complications take years to manifest.

Bendavid says: “Synthetic meshes have become the mainstay of hernia surgery, thanks to an industry that fostered conferences, societies and free courses, but also flagrant and undaunted marketing. Copious publications are firming up statistics on postoperative complications of mesh: 11% of patients will have a history of severe chronic postoperative inguinodynia severe enough to be detrimental to their quality of life. Another (3%–4%) will suffer irreversible dysejaculation, which only 20 years ago, without mesh, had an incidence of 1 in 2,500 cases and was reversible! A hundred-fold (or 10 000%) increase.

A study by The University of Toronto reviewed 235,192 patients over a 14-year period. Data came from the government’s database and registry. The study compared the risk for a recurrence at the Shouldice Hospital (65,127 patients) with those of the general hospitals in Ontario (170,065 patients). The results revealed that the risk for recurrence for a Shouldice Hospital patient was 1.15% compared with 4.79%, 4.90%, 5.21% and 5.63% at all the other hospitals.

During that period, the frequency of mesh use for groin hernia surgery at the Shouldice Hospital was just 1.46%.

https://www.generalsurgerynews.com/The-Great-Debates/Article/01-18/To-Mesh-or-Not-to-Mesh-That-Is-the-Question/46624

To summarise

The true number of people suffering mesh complications is unknown as there are no databases to log complications.

There’s institutional denial that mesh is to blame, so a surgeon is unlikely to log it with the MHRA Yellow Card. Also, it’s not mandatory for clinicians to report to the Yellow Card, so many adverse events go under the radar.

Patient Reported Outcome Measures (PROMS) focus on if an operation has worked, not new complications = adverse events are lost in a black hole.

If a person requests a traditional, non–mesh repair, there are decreasing numbers of surgeons with the skills to do so.

Hernia surgeons look to guidelines from the World Hernia Society and the European Hernia Society, both of which are heavily funded by industry. There are no up to date, nor indeed a complete set of hernia mesh NICE guidelines. This is unacceptable.

There urgently needs to be a full data review of hernia mesh, looking at PROMS used and checking potential for bias, when reviewing the evidence.

Finally, a high number of Sling The Mesh members suffer autoimmune conditions and allergies, caused by the polypropylene plastic mesh material. We’re told there is no scientific evidence to support this. But that’s only because nobody has carried out large scale studies YET.

https://www.cambstimes.co.uk/news/leading-canadian-professor-talks-on-links-between-surgical-mesh-and-4897512

Jan Willem Cohen Tervaert, director of rheumatology at the University of Alberta, Canada, reports a study in 40 patients with mesh that developed symptoms like chronic fatigue, cognitive impairment “brain fog”, muscle and joint pain “fibromyalgia”, feverish temperature, and dry eyes and dry mouth. In addition, 45 per cent of the patients developed an autoimmune disease.