In January, April and May of this year, our newsletters highlighted the ongoing controversy with the vaginal mesh implants both in the USA and here in the UK. These devices continue to cause misery and pain to many women and senior doctors have now called for a public enquiry into the use of vaginal mesh surgery in the UK. The concern is the scandal could parallel the thalidomide crises.
Earlier on this year, it was revealed that over 800 women were suing the NHS and device manufacturers, following surgery for vaginal mesh implants to treat problems caused by childbirth which left hundreds of women in agony.
Experts suspect the actual number of victims is much higher than officially reported citing the hospital readmission rates for one type of mesh surgery as high as 19%.
Labour MP for Pontypridd Owen Smith along with campaign group Sling the Mesh organised a meeting at the Houses of Parliament recently, calling for a ban on the procedure.
A separate meeting was held at the University of Oxford where Professor Carl Heneghan, an expert in evidence-based medicine quoted “With thalidomide you could see the visual representation, (with mesh) you can’t see it”, and has called for a public enquiry. Professor Heneghan and Dr Sohier Elneil, a consultant urogynaecologist at University College Hospital, told the meeting that complication rates for some types of the surgery were unacceptably ‘high’. Using the NHS’s Hosptial Episode Statistics, Dr Elneil and her team have researched this issue and the unpublished data shows the surgery has a readmission rate of 8.9%, with most of these patients requiring some form of subsequent procedure. These statistics and the warning by Professor Heneghan and Dr Sohier raise concerns whether the surgery is being performed appropriately.
However, the MHRA has countered concerns by publishing a report suggesting the rate of pain or ‘erosion’ for mesh procedures is just 1%-2%.
Professor Heneghan has hit back with statistics from a study published in the Lancet, which demonstrated the readmission rate for one form of the surgery was 19%.
The controversy is ongoing, and the MHRA has stated “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients.”
The MHRA continues to encourage patients to report any side effects via the Yellow Card scheme.
The vaginal meshes are implanted to treat incontinence after childbirth and pelvic organ prolapse.
The side effects
Many side effects have been reported with this device, particularly severe discomfort due to internal cuts to the vagina caused by the mesh. One sufferer was almost driven to suicide due to the pain. Other patients have reported they are unable to walk, work or have sex due to the pain. Between April 2007 and March 2015, 92,000 women had vaginal mesh implants fitted in England and according to NHS data, one in 11 have experienced problems with the device.