It was recently announced that the Scottish Health Secretary Alex Neil requested a suspension of the use of mesh implants by the NHS in Scotland. He has asked that there be safety investigations into the vaginal mesh and was “deeply troubled” by what had been presented thus far.
The Scottish government is turning over adverse event reports to the Medicines and Healthcare Products Regulatory Agency (MHRA) which is responsible for decisions regarding the mesh implants in the UK. It has been reported that approximately 1,850 women have the procedure in Scotland every year. This is in stark contrast to the United States where in 2010, 300,000 women received vaginal mesh implants.
While the FDA on April 29, 2014 announced that it was reclassifying mesh products used for pelvic organ prolapse as high risk, the Scottish government is suspending the use of mesh for both pelvic organ prolapse and stress urinary incontinence.
At a committee hearing before Scottish Parliament, Mr. Neil stated “I’ve personally met with women who’ve been adversely affected, and I was deeply troubled to hear how women affected have suffered, and they have my full sympathy and support and we’ll certainly do everything we can to improve the situation. No one should have to experience the level of suffering that some of these women have had.”
This sentiment echoes what women all over the world have experienced as a result of the vaginal mesh. The complications with the vaginal mesh can have life-changing consequences, including the ability to engage in intercourse, pelvic pain, significant infections and inability to have the products removed.
In 2012, the MHRA conducted and independent analysis of the safety and effectiveness of the vaginal mesh products and found that while a small number of women experienced problems, the products were still effective. Mr. Neil has criticized the MHRA’s research calling it “completely flawed.”
While the FDA and Scottish Health Department are now recognizing the problems associated with vaginal mesh products, it is too little too late for many women. Problems were first reported in 2011 and it has taken more than 3 years for the products to be reclassified or suspended.