Kirsten Oswald – 2015 Parliamentary Question to the Department of Health

The below Parliamentary question was asked by Kirsten Oswald on 2015-10-27.

To ask the Secretary of State for Health, with reference to the Answer of 6 May 2014 to Question 196742, what progress his Department has made on assessing the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants; and if he will make a statement.

George Freeman

The working group on vaginal tapes and mesh is now finalising its interim recommendations which NHS England expects to publish in November 2015, subject to its internal governance processes.

However in the meantime the Medicines and Healthcare products Regulatory Agency (MHRA) has unified and simplified reporting under the Yellowcard reporting brand- All reporting under one page, promoted Yellow card reporting at conferences to increase awareness e.g. RCN Congress, NICE Annual Conference; created the role of Medical Device Safety Officers in conjunction with NHS England to promote local reporting and learning.

As a result we have seen an increase in Member of Public reports relating to transvaginal mesh of 350% over 2014 so far (Table 2).

The data below is taken from the Adverse Incident Tracking System

Table 1: Adverse events reported to MHRA by health professionals concerning vaginal tape and mesh implants are as follows:

Table 2: Adverse events reported to MHRA by patients/members of the public concerning vaginal tape and mesh implants are as follows:

“