The Department of Health, the NHS Commissioning Board, NHS surgeons (urologists and gynaecologists), and the Medicines and Healthcare products Regulatory Agency (MHRA) are taking action to help reduce the side effects after surgery using vaginal tape for stress incontinence and vaginal meshes for pelvic organ prolapse.
Available literature on adverse event rates associated with these devices
Press notice from the Department of Health:
The independent report commissioned by the MHRA from York University Health Economics Consortium:
This information is available on the MHRA’s website:
Professor Keith Willett, National Clinical Director for Acute Episodes of Care at the NHS Commissioning Board, said:
“For the vast majority of women, mesh and tape implants are a safe and effective operation, but as with all surgery, there is an element of risk.
“Some women have experienced some distressing side effects and we are working closely with surgeons and the MHRA to make sure that improvements are made and patients are well informed about the benefits and potential risks with these procedures. The Medical Director of the NHS, Sir Bruce Keogh, and I have jointly written to all surgeons to make sure women who are offered a tape or mesh implant meet the criteria set out by NICE. We are also developing additional guidance to surgeons, including proposals for a single registry of outcomes data, so they can maximise the success rate of the procedure.
“Any women considering having the procedure or experiencing problems with an implant should speak to their GP or surgeon. If you have an implant or mesh and are not experiencing any discomfort, there is no cause for concern.”
Dr Susanne Ludgate, Clinical Director for Medical Devices at the MHRA, said:
“We listened to and understand the concerns that many women have about vaginal tapes and meshes. That is why we commissioned research to review the available literature on the safety and adverse effects associated with these products. Whilst a small number of women have experienced distressing effects, the current evidence shows that when these products are used correctly they can help with the very distressing symptoms of these conditions and as such the benefits still outweigh the risks.”