MHRA Pelvic Mesh Group Finds Risk Information is Key Issue

The UK’s Medicines and Healthcare products Regulatory Agency released final recommendations from the Mesh Oversight Group, which concluded hospitals need to improve their processes for tracking data and patients need to be better informed about potential risks of pelvic mesh devices.

The Mesh Oversight Group released an interim report in December 2015 that addressed concerns over the use of mesh devices implanted in the pelvic region to treat stress urinary incontinence and pelvic organ prolapse. The interim report suggested action was needed to better inform women about potential risks following surgery.

Following the publication of that report, the Mesh Oversight Group was formed to advance recommendations and make sure responsible bodies were held accountable. The group worked with MHRA, NICE, the British Society of Urogynecology, the Royal College of Obstetricians and Gynecologists and the British Association of Urological Surgeons to finalize its recommendations.

The report highlights some positive changes. Hospitals have changed the way they record data, which has allowed them to collect more data on the complications women experienced. Some of the improvements in information flow resulted in an increase in the number of women reporting complications. The report concluded that this was due to the increased awareness rather than an increasing number of complications.

A registries subgroup continues to work to develop better ways of tracking implanted mesh devices to capture more accurate data. The subgroup will report its findings and make recommendations by November 2017.

NICE anticipates it will also publish a new guideline in 2019 for clinicians, clinical directors, hospital trusts and commissioners.

Read the final report here: www.fdanews.com/08-01-17-MHRAmesh.pdf. — Tamra Sami