Pharmaceutical

Transvaginal mesh complications reach ‘across the pond’

2012 TVM serious complications Transvaginal mesh complications reach across the pondTransvaginal mesh (TVM) complications are not just an American epidemic. Wisbech Standard recently reported about international professionals speaking out against mesh complications and calling for change in the United Kingdom when it comes to mesh procedures.

At the annual conference of the European Association of Urogynaecology (EAU), the association president, Italian surgeon Professor Stefano Salvatore, spoke out against the high rate of complications. Among these are mesh listing infections, erosion, exposure, shrinkage of mesh, worsening of the condition of the women, spontaneous pain, and pain during intercourse for both partners.

Slavatore said, “Meshes can be helpful but we don’t yet have the ideal material and we currently have no certification for the surgeons who perform the procedure. We are trying to work together with EAU offices and sections to try to create a common training programme or initiative with the European Commission, improving treatment on a European level.”

Twelve years ago Salvatore was among a group of professionals who called for a stop in the use of plastic mesh for pelvic organ prolapse repair.

Wisbech Standard reported that after Salvatore’s speech a campaigner from Sling the Mesh, a consumer group that wants to see pelvic mesh procedures stopped, spoke up, asking if surgeons in the UK complied with current certifications for mesh operations. The Standard reported that within days of this question the British Society of Urogynaecology (BSUG) posted on its website about mesh complications “asking surgeons to make sure they are up to date with training and urging them to report problems to the MHRA [Medicines & Healthcare products Regulatory Agency] – until now it has not been mandatory for them to do.”

BSUG said: “NHS Improvement (an amalgamation of Monitor & the NHS Trust Development Authority) have written to chief executives and Medical directors informing them of the need for their clinicians to comply with appropriate training, adherence to clinical practice, reporting of complications to MHRA and compliance with national data requirements for all surgeons undertaking mesh procedures. Thus it is important that all procedures (especially tapes for incontinence and vaginal mesh for prolapse) are entered onto a national database. Together with BAUS we aim to collect all data on mesh implants for the current year (2016 to 2017).”

In the same web post, BSUG addressed another issue: “Patient support groups have raised concern regards where they can access care regarding mesh complications. There is the impression that there are only 2 to 3 clinicians that offer this in the UK.”

Wisbech Standard introduced a new statistic for the UK, saying that the MHRA has quoted a 1  to 3 percent risk of complication rate, but that the Hospital Episode Statistics for England showed that in 2014-2015 a total of 5,256 women had a TVT implant. Of those, 450 were either fully or partially removed because of problems. This equals an 8.56 percent complication rate. Why the discrepancy?

“The MHRA were contacted for a comment on the 8.56 per cent complication rate but after 12 days they had not replied,” the Wisbech Standard article read.

Sources:
Wisbech Standard
British Society of Urogynaecology
Sling the Mesh