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Baroness Julia Cumberlege, Chair of The Independent Medicines and Medical Devices Safety Review (the Review), advised the Department of Health and Social Care and NHS England that for the treatment of Stress Urinary Incontinence (SUI), mesh implants should not be used until certain conditions can be met. NHS England has therefore confirmed that the use of vaginal mesh implants will be immediately suspended.
By Ben Lees
Vaginal mesh or tape are plastic devices used to treat SUI or urogynaecological prolapse (UP). Mesh implants have been used across Europe and the United States of America, and have been favoured over the traditional open-surgery procedure.
The most common procedure, TVT implant, is performed using keyhole surgery which is less invasive and associated with quicker recovery times. However, thousands of women have reported concerns about the procedure and calls for the mesh implant to be banned have been ignored – until now.
There has been growing concern around the use of vaginal mesh implants due to reports that, after undergoing the procedure, women have been experiencing life-changing side effects. These range from chronic pain in the back, pelvis and legs to burning in the vagina.
Kath Sansom, founder of the campaign group Sling the Mesh, amongst others including MP Owen Smith, have been campaigning for a complete ban on the use of vaginal mesh implants due to concerns about life-changing side effects experienced by women.
In April 2018 NHS Digital published a review retrospectively investigating Surgery for Urogynaecological Prolapse and Stress Urinary Incontinence using Tape or Mesh.
The review found that between April 2008 and March 2017 194,107 patients had SUI or IP procedures. 27,106 patients had mesh implants for UP and 100,516 patients had tape implants for SUI. Of these procedures a high number of patients were having their implants removed.
Between 2008 and 2009 580 implants were removed, between 2012 and 2013 679 were removed, and between 2016 and 2017 502 were removed. The audit reveals that a high proportion of patients who underwent mesh and tape procedures had the implants removed within 30 days following treatment.
After meeting with women affected by vaginal mesh implants Baroness Julia Cumberlege stated that she was “appalled at the seriousness and scale of the tragic stories we have heard from women and their families”.
Baroness Cumberlege further stated:
“My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment”.
The review concluded that the following conditions must be met by March 2019 in order for the suspension to be lifted. The conditions are as follows:
For now, the suspension on vaginal mesh implants could save thousands of women from unnecessary pain. However, women in Wales and Northern Ireland still await news on whether the use of these implants will be suspended there, too.
It remains to be seen how quickly this will be implemented by surgeons in hospitals, and whether the conditions set by the review are met by March 2019. But the outcome of the review is certainly a step in the right direction.