TVT or TVTO mesh surgery for stress urinary incontinence
The use of transvaginal tape (TVT or TVTO) for treatment of stress urinary incontinence was considered to be a simple, less invasive method of helping women with this troublesome and sometimes embarrassing condition.
However significant complications have been reported including bleeding, urethral or bladder injury, urethral or bladder mesh erosion, organ perforation, vaginal extrusion of mesh, urinary tract infection, chronic pain, urinary urgency and bladder outlet obstruction.
Women often did not receive sufficient information from their treating surgeons before undergoing mesh treatment.
Some women have been left with long term complications, unable to work, unable to enjoy social and leisure activities. They have been unable to have sexual intercourse and in very severe cases have been unable to walk. Studies suggest that as many as one in 10 women have suffered serious complications.
Amid safety concerns, the use of TVT and TVTO was halted across the UK in 2018.
However, many women have highlighted the fact that they were not advised about the alternative forms of treatment for their stress urinary incontinence, about the conservative methods of treatment and safer alternative surgical options. Women were not given the choice between TVT surgery which involves making two small incisions in the abdomen or the use of TVTO surgery which involved making two small incisions in the groin (this type of surgery carried an increased risk of chronic groin and leg pain).
TVM mesh surgery for pelvic organ prolapse
The use of transvaginal mesh (TVM) surgery to help repair pelvic organ prolapse (POP) became popular due to its simple, less invasive implantation technique. However, it appears that there are serious problems with TVM surgery which has resulted in further injury to many women. Complications include chronic pain, bleeding, nerve damage, infections, painful sexual intercourse, mesh erosion and organ perforation.
Since December 2017 the National Institute for Health and Care Excellence (NICE) recommends that mesh should only be used for the treatment of pelvic organ prolapse under research circumstances. This effectively imposes a ban on the use of transvaginal mesh.
Claims are being pursued against the NHS trusts who were responsible for the mesh treatment. The allegations are of clinical negligence in the trusts’ failure to provide sufficient information to enable women to give fully informed consent to mesh treatment. Had women been told about the potential risks associated with mesh, advised fully and been given a choice, they would have opted for a safer alternative treatment.
The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, published its report in 2020, titled “First Do No Harm”. The report made several recommendations to the government to provide redress for those who had suffered injury and for measures to prevent a repeat. One of her recommendations was to appoint a Patient Safety Commissioner. Dr Henrietta Hughes was appointed in this role in 2022. Her report “The Hughes Report” was published on 6 February 2024. The report has gone to the government recommending the creation of a redress scheme to help those affected. It is not yet known whether the government will accept any of the recommendations and if they do, how long it will take before victims receive any help or redress.