NICE guidance overlooks serious risks of mesh surgeryBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l1537 (Published 02 April 2019) Cite this as: BMJ 2019;365:l1537
New national guidance on urinary incontinence and pelvic organ prolapse in women neglects the serious risks associated with the use of mesh in surgery, MPs and campaigners have warned.
The final recommendations of the UK National Institute for Health and Care Excellence, published this week,1 acknowledge that use of mesh surgery to treat these conditions is subject to a period of “high vigilance restriction.” However, the All Party Parliamentary Group on Surgical Mesh Implants said in a press statement that the guidelines “disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects.”
The guidelines also seem to contradict NICE advice issued at the end of 2017 that mesh for vaginal prolapse should be restricted to research because of safety concerns.23 No such statement appears in the latest guidance.
Owen Smith MP, chair of the parliamentary group, said, “I cannot understand why NICE appears to have effectively lifted its ban on mesh for prolapse, and I have serious concerns that, as a result, women undergoing mesh surgery for prolapse may not be aware of the potential risks.”
Kath Sansom, from the campaigning group Sling the Mesh, said that the decision was a “bizarre U turn based on no new scientific evidence, and leaves women open to major harm.”
But a NICE spokesperson said that the latest guidance did not contradict the previous advice on prolapse because there was a new requirement for all mesh procedures and any related complications to be recorded in a national database.
The spokesperson added, “The committee are recommending mesh surgery only in a very specific, restricted clinical context. The committee agreed that mesh surgery … should be available to this small number of women, when the only alternative is to do nothing, and only following full discussion with the woman regarding the potential risks regarding mesh surgery.”
Paul Chrisp, director of NICE’s centre for guidelines, said that a series of patient decision aids, published alongside the NICE guideline, would ensure that women considering surgery had the best evidence available.
“Where surgical mesh/tape could be an option, there is almost always another intervention recommended in our guideline which does not involve surgical mesh/tape,” Chrisp said. “If a surgeon cannot provide a full range of choices to the woman, then she should be referred to one who can.”
Linda Millband, head of clinical negligence at Thompsons Solicitors, the firm acting for more than 280 mesh clients, said that patients would remain dependent on surgeons’ variable advice. “With those who are pro-mesh skirting around known problems and making a positive case for its use, and more cautious surgeons sitting on the fence, this puts inappropriate pressure on patients and surgeons,” she said.
Millband also questioned the timing of the guideline’s publication. “These revised guidelines come less than two months before Baroness Cumberlege is due to report the findings of her independent review into mesh—two months when those who have mesh inserted may suffer long term complications. This may be a straw in the wind of a consensus that mesh surgery is fine to continue.”
The period of “high vigilance restriction,” which effectively paused the use of vaginal mesh surgery, was imposed by the government in July 2018 after recommendations from Julia Cumberlege, who is chairing an independent review into pelvic mesh surgery.4
She set five conditions that would need to be met before the pause could be lifted, including that all operations and any complications must be registered on a national database and that surgery must be performed by specialist surgeons based at specialist centres.
“Those conditions have not yet been met, and it is clear to us that it will be some considerable time before they are,” Cumberlege told The BMJ.
She added, “We made the recommendation [to pause mesh] because we had already heard from many women, all of whom had suffered terribly following their mesh procedures. Since then we have met many hundreds more women across the country who face the same situation. The scale and intensity of this tragedy is truly shocking: lives have been ruined.”
Her review team expects to publish its report later this year.