One in six women suffer pelvic mesh complications, according to the most up to date figures – despite governments globally insisting for years that the risk was as low as one in 100.

That’s one woman in every average friendship group suffering compared to one woman on every small housing estate.

The shocking figures of irreversible harm were highlighted when Scottish surgeon Wael Agur gave evidence to New Zealand Parliament.

Campaigners enlisted Dr Agur’s help in their plea for incontinence mesh to be suspended in New Zealand like it was in Scotland in 2014 and the rest of the UK in 2018.

Dr Agur told New Zealand politicians that: “The perception of the balance between [mesh] benefits and risks… and a subsequent decision whether or not to suspend such procedures, largely depends on the thickness of the safety goggles of those in authority.”

Three other key issues highlighted during his speech, which are relevant to mesh campaigners globally, include:

• Better training of surgeons will NOT lower mesh risk. The problem is the mesh itself.
• TVTO mesh for incontinence should be banned as the resulting obturator nerve injuries can leave women in wheelchairs or struggling to walk.
• Low rates of reported mesh complications in the data and scientific literature is due to, among other things, slow reaction to mesh complications, poor hospital coding and short term follow up of women.

“Chronic pain, one of the most serious and life-reducing mesh-related complication, has consistently increased over the last two decades,” Dr Agur said. “Early studies reported around 1% risk of chronic pain, which subsequently increased to around 5% and, most recently, reported as18% in 2021. I suspect such increase over time is contributed to by our improved knowledge, better ability to attribute chronic pain to the mesh device and the longer-term follow-up.”

He continued: “In my view, the risk of chronic pain and most other long-term complications are due to the mesh device itself, rather than surgical skill.

“According to the scientific evidence, and my own clinical and medico-legal experience, the most common risk that can be reduced by surgical experience and skill is the intraoperative organ damage – which is already known to cause no or little long-term consequences.”

Dr Agur said that mesh suspensions were introduced across the UK when Parliaments “witnessed the harm to people and urged Government to engage the precautionary principle.”

Politicians had no option but to step in because: “pelvic mesh implantation is an area of medicine that suffered a significant lack of self-regulation by us, clinicians.”

“Subsequent scientific evidence and several other unfolding events confirmed, and continue to confirm, that the original decision to suspend all mesh procedures was the right course of action,” he said.

Other points raised during Dr Agur’s presentation include:

• The concept that long-term problems are due to mesh rather than poor surgical skill, was acknowledged by the The Federal Court of Australia in 2019 which found the pelvic mesh devices from the main manufacturer were “not fit for purpose” and of “unmerchantable quality”.
• Use of a mesh device adds new mesh-related complications over and above non-mesh options.
• A 2011 Food and Drug Administration (FDA) warning stated that “among the 2,874 reports (injury, death and malfunction) 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs”.
• The FDA changed its description of mesh-related complications from ‘rare’ in 2008 to ‘not rare’ in 2011. Currently, mesh-related complications following mesh slings for incontinence are ‘very common’.
• There has been over 2,000 publications on mesh for stress urinary incontinence. However, over 90% are low-level evidence. More reliable evidence from randomised controlled trials (RCTs), and systematic reviews, contributed around 100 of the 2,000 publications (5%). None of the RCTs adequately reported on mesh safety.
• Only a few studies followed women up for 5 years or more. The lack of long-term follow up to detect safety issues is a serious drawback affecting even higher quality studies.
• Hospital coding globally did not catch up with the rapid development of mesh devices, their implantation, the complications and the required corrective procedures. The significant under reporting of mesh-related complications has been acknowledged by most medical device regulators.
• Both obturator mesh slings and mid urethral mesh slings lead to a risk of chronic pain regardless of how it is implanted.

Read Dr Agur’s written statement to the New Zealand Parliament:

Surgical alternatives to mesh

The Burch colposuspension was the gold standard continence procedure before mesh slings. Moving to a less invasive keyhole was the natural progression two decades ago. Unfortunately, such evolution was halted by the introduction of mesh.

The mesh suspension means an increasing number of surgeons are leading the development of keyhole colposuspension, which is back on track to return to the gold standard status.

• The incidence of chronic pain with colposuspension is rare. Chronic pain following mesh slings is very common due to mesh-induced scarring from chronic inflammation, secondary to foreign body reaction.

• If chronic pain develops following colposuspension, the condition is curable/treatable by removing the offending stitch(es), which is relatively easy. Mesh removal surgery is technically more difficult and of uncertain outcome, with only 50% reported success in improving chronic pain.

• Colposuspension is the first surgical treatment in the recommendation by the UK National Institute for Health and Care Excellence (NICE) for treatment of stress urinary incontinence in women.

Will some women be disadvantaged if mesh procedures are suspended?

• The number of mesh slings inserted in the UK had already dropped by almost half (48%) in the years preceding the pause in July 2018. Mesh suspension has allowed the development and evolution of the time-honoured non mesh native tissue surgery and restored the trust of many women in the surgical treatment of SUI.

• Urinary leakage is not a life-threatening condition. In the presence of equally successful and safer alternatives, it is difficult to imagine why a well-informed woman would accept the risk of chronic pain and request mesh for a quicker recovery.