Developed in the 1990's vaginal tape and mesh implants were introduced to permanently fix pelvic organ prolapse (POP) and to treat women suffering from stress urinary incontinence.
According to recent figures issued by the Department of Health (DOH), around 13,000 vaginal tape implants are used every year to treat women suffering from urinary incontinence and 1,500 mesh implants for women suffering from POP.
Although the majority of these procedures are carried out to an acceptable standard and can provide an improvement to their quality of life, some women have suffered adverse side effects from the procedure including pain and sexual dysfunction.
On the 22 November 2012 the DOH issued a press statement entitled 'Better guidance and support for NHS surgeons on vaginal tape and mesh implants'.
The Medicines and Healthcare products Regulatory Agency, the DOH, and other clinical groups are working together to ensure that surgeons have the necessary information to carry out these operations as safely as possible and ensure that patients are counselled prior to the surgery and women feel reassured before deciding to undergo the procedure. As well as the above there are proposals for a national register to record the procedures that are undertaken.
In the US, in July 2011 a report issued by the Food and Drug Administration (FDA) stated that between 2008 and 2010, vaginal mesh prolapse repairs caused thousands of injuries and resulted in seven deaths. The report went on to say that there was not any conclusive evidence vaginal mesh implants improved prolapse surgery outcomes.
In September 2011, the FDA's Obstetrics & Gynecology Devices Advisory Committee reviewed the dangers of mesh and the associated health risks. The committee declined to remove vaginal mesh from the market. However, the committee did call for more stringent testing of new mesh devices and also supported reclassifying the device. This would require premarket approval to ensure the safety and effectiveness of any future devices.
In January 2012, the FDA sent letters to dozens of vaginal mesh manufacturers, requiring three-year studies to be performed on their products. The goal is to study the device's side effects and the women's overall quality of life.