Vaginal mesh procedures need compulsory register, says royal collegeBMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k586 (Published 06 February 2018) Cite this as: BMJ 2018;360:k586
A mandatory register to record outcomes in all women treated with vaginal mesh is essential to properly monitor the adverse effects of these implants, the Royal College of Obstetricians and Gynaecologists (RCOG) has said.
The college was responding to government plans announced last month1 for an audit of problems caused by vaginal mesh. The audit, which aims to better understand complications related to mesh implants used for incontinence and prolapse, is expected to be completed by April.
Tim Hillard, RCOG clinical lead for patient safety, said that, while he supported the audit, he would like to see more done. “We are concerned that a retrospective audit is going to be of limited value and might be over-interpreted,” he said. “Retrospective audits in general are incomplete and open to bias.”
Hillard said that, although the details were not yet known, the audit was likely to be based on hospital episode statistics data on patient readmission, which could be of limited value in understanding the nature of the problems women experienced.
“What we would really like to see is a mandatory prospective registry of all of these procedures,” he said. “We have been calling for that through the British Society of Urogynaecology and the Royal College for many years.”
The society has its own database for all urogynaecology procedures including mesh, which has been running for over 10 years. However, it is a voluntary database for society members and is unlikely to record more than half of all procedures carried out.
Hillard said that a mandated database would ensure that data on procedures and their outcomes were all collected so that doctors and patients could better understand how patients were affected.
It was difficult to get a clear picture of how many women had sustained adverse reactions from mesh implants, he said, but clinical trials had found that this could be as high as 10% after prolapse procedures, although lower when mesh is used for incontinence. “However, longer term problems seem to be emerging in some women,” he said.
He added that the scale of the problem as portrayed to the public did not reflect what most doctors were seeing, “and it’s difficult to rationalise that without hard data.”
“Our priority,” he concluded, “is to ensure that women are provided with the most effective and safest treatment options for what are common and often distressing conditions. A prospective audit would allow us to collect the information and start to build a better picture of the situation.”
Kath Sansom, founder of the Sling the Mesh campaign group, said that the retrospective audit would give a better idea of the scale of the problems caused by mesh implants.
She added, however, that it was too little too late. “We would like every single woman who has ever received a mesh implant to be contacted individually so that she may give a clear idea of her outcome on a national recall basis,” she said. “A prospective register is 20 years too late.”