MHRA response to the final report of the Mesh Oversight Group
NHS England set up the Mesh Working Group to address the concerns of a number of patients and clinicians.
John Wilkinson, Director of Devices at MHRA, said:
Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.
We are committed to helping address the serious concerns raised by some patients. We have undertaken work to assess the findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.
What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances. This is supported by the greater proportion of the clinical community and patients.
In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.
We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card Scheme.
The final report of the NHS England-led Mesh Working Group can be found on the NHS England website.
In 2014 MHRA also produced a summary report of the evidence on the benefits and risks of vaginal mesh implants as part of ongoing research.
Published: 26 July 2017