What's the issue with mesh implants?
- 6 October 2015
- From the section Scotland
An independent review into mesh implant surgery was ordered after women who had been left suffering from painful complications took their case to Holyrood. But what is the procedure, and why has it caused a problem for some patients?
What are transvaginal mesh implants?
The implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Some women with incontinence receive treatment using tension free vaginal tape, although adverse side effects are not thought to be as common. Mr Neil has also requested that these operations be suspended.
The mesh, usually made from synthetic polypropylene, is supposed to repair damaged or weakened tissue.
The implants are widely used throughout the UK, Europe and North America.
What are the possible complications?
BBC Scotland's health correspondent Eleanor Bradford said mesh implants had been used successfully in many other parts of the body, but appeared to react differently when inserted in the abdomen, leading to some women being "cut".
A report by US regulatory body the Food and Drug Administration said once the mesh was implanted, it was very difficult, sometimes impossible, to remove.
Some women have reported severe and constant abdominal and vaginal pain following the surgery, and some have been told that they can no longer have sexual intercourse.
Other women have experienced infections and bleeding, while many have said their original incontinence symptoms have not been improved by the surgery.
Some women who experienced problems said they were not aware the implants were permanent.
How many women have the implant surgery?
About 1,850 women have the surgery each year in Scotland, although it is unclear how many experience problems. So far, 12 have reported cases to the UK-wide Medicines and Healthcare Products Regulatory Agency (MHRA), while it is believed more than 300 women have undergone repeated operations in an attempt to resolve the problems.
Around 1-3% of women having the procedure for stress urinary incontinence and 2-6% who receive an implant for pelvic organ prolapse suffer complications, according to the MHRA.
Some studies have suggested about 15% of patients having mesh implants suffer side effects, though the figures can be difficult to interpret because many of the women involved experienced problems before the surgery.
In the summer of last year, the then health secretary Alex Neil requested health boards to suspend both procedures - mesh implants and tape - pending further investigation into their safety.
The current health secretary, Shona Robison, said the suspension would remain in place.
What has the review said?
An independent review was ordered last year and is being chaired by Lesley Wilkie.
Her full report is awaiting the outcome of additional studies and should be published early next year.
However, the interim report made a number of conclusions, including;
- establishing clear clinical rules around the decision to use mesh surgery
- the reporting of adverse outcomes should be catalogued
- patients should be fully informed before they make a decision on mesh surgery
- and allowing extended long term follow up, including information on quality of life and activities of daily living
Is this surgery the only option?
Non-surgical treatments, including physiotherapy, are routinely offered to women suffering from a prolapsed bladder and/or incontinence. However, in more serious cases traditional surgery - which doesn't use implants - can be necessary.
However, such surgery has a 20-30% failure rate, which is why many women were offered the mesh implants as an alternative.