The Government has accepted a recommendation from the Independent Medicines and Medical Devices Safety Review to temporarily ban the use of surgical mesh to treat stress urinary incontinence. This comes following serious safety concerns highlighted by the review, chaired by Baroness Julia Cumberlege who said that it found no evidence that the benefits for treating urinary incontinence would outweigh ‘the severity of human suffering caused by mesh complications’.
On 10 July 2018, NHS Improvement and NHS England wrote to all acute NHS trusts, advising them of the findings of the review and the implementation of the restriction on such procedures. The Royal College of Obstetrics and Gynaecology has also issued a safety alert advising surgeons that vaginal mesh surgery should not be undertaken until a number of safety conditions are met.
Last year Penningtons Manches commented on the report published by NHS England which examined vaginal mesh implants used to treat both stress urinary incontinence and pelvic organ prolapse. The conclusion of the report that mesh was a safe option for use in incontinence procedures caused outcry with campaigners who believed that there was a failure to consider all the relevant data.
Emma Beeson and Elise Bevan, both clinical negligence solicitors at Penningtons Manches who have dealt with a large number of claims for those who have suffered serious and often life-changing injuries as a result of the mesh, were amongst those campaigners. They are pleased, and relieved, to see that the Government has accepted the use of vaginal mesh to treat urinary stress incontinence should be stopped immediately pending further investigations and consultations to minimise the risks relating to these implants.
Stress incontinence is the involuntary loss of urine from the bladder when it comes under stress. It happens because the pelvic floor muscles which support the bladder become weak. The mesh is inserted through the vagina to support the bladder like a sling. Whilst the implant has been a success for many patients, it has also caused devastating complications for many others.
Emma Beeson and Elise Bevan first reported on the significant risks of vaginal mesh over three years ago. These include erosion of the mesh, causing recurrent infections and damage to surrounding organs and tissues. Many of the women Emma and Elise have acted for have required multiple revision operations in attempts to remove the mesh. Some have been left in chronic pain, with a stoma, unable to work and probably most significantly of all, unable to have sex.
At this stage, the review has not recommended a total ban given that the procedure can work well for some patients. However, the use of the mesh has been suspended whilst further enquiries are made into the safety of the implant. The ban will only be lifted if certain checks and measures are met by March 2019. These include keeping a register of every procedure and any complications.
Elise Bevan, who is a senior associate in Penningtons Manches’ clinical negligence team, comments: “This has been a long time coming but it represents a very positive step and we are reassured that finally it has been recognised that the mesh can cause serious harm. Over the last few years we have been humbled to see how many brave women have come forward to talk about what they have been through and it is by raising this awareness that action has now been taken. We hope that those who have been too afraid to talk before may now seek the help they need.”