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One in four women experience bladder weakness at some point in their lives. It’s estimated that two out of five middle-aged women suffer from a type of weak bladder known as Stress Urinary Incontinence (SUI), which involves involuntary leakage of urine following physical effort.
To treat this condition over 13,000 women are having vaginal mesh implants each year in the UK. While the operations are mainly successful, a 1-3% adverse rate means there are still potentially more than 400 women a year suffering from the life altering side effects.
Vaginal mesh implants are also used to treat Pelvic Organ Prolapse (POP), this surgery is carried out on around 1,500 women annually in the UK. However, at around 15%, the adverse rates are much higher.
Concerns over the procedures were raised in the US in 2011 when they saw a fivefold increase in reports of complications from the previous year. And earlier this year women in Scotland launched legal cases following problems with their implants. Symptoms of something having gone wrong with the implants include; pain in the abdomen and pelvis, urinary problems, vaginal scarring, mesh erosion and painful sexual intercourse.
With around 65,000 vaginal mesh implants and trans-vaginal tape (TVT) operations estimated to have been carried out in the UK in the last 5 years, it’s feared the number of women affected could end up exceeding those affecting by the PIP implant scandal.
In February 2013 a US court awarded nurse Linda Gross almost $11million after finding makers Johnson & Johnson and subsidiary Ethicon failed to warn her of side effects which left her needing 18 further operations. After her initial surgery in 2006 she suffered mesh erosion, scar tissue and internal damage.
Dr Tom Margolis, who is one of America’s top specialists and has removed more than 150 mesh implants from women, said:
“There’s no doubt in my mind mesh implants procedures have serious complications. I’ve seen obstructions of the bowel and urethra, really nasty infections and major damage to tissue in the vagina, bowel and bladder. Because the procedures are carried out through the vagina, which cannot be a sterile environment, surgeons are immediately going against everything they’ve been trained to do."
He continues, “the use of mesh products to correct bladder and prolapse problems carries a far higher risk of complications than traditional surgical methods.”
Victims Comments
A re-occurring concern raise by the women suffering the horrific adverse effects following surgery is that they were not warned of the potential side effects or given alternatives. Many of the women involved in the legal cases in Scotland have had to have multiple surgeries, some have been told they will never be able to have sex again and several have had to give up work due to the constant and excruciating pain.
“My doctor told me the procedure was quick and easy and I trusted him that it was the right thing to do.”
“Whenever my husband and I were intimate, the mesh cut into him.”
“Nobody told me what the risks were or I never would have gone ahead.”
“I’ve now been told that all the mesh cannot be removed because of the damage to other organs such as my bladder and bowel.”
“Sometimes the pain is so bad, I have to use all my strength to stop screaming.”
“I’ve been forced to spend such a long time off work, I’ve had to give up.”
“I used to play badminton and walk. Now I’m registered disabled and use a wheelchair and walking stick. My life is destroyed.”
“I was never told what could go wrong or given alternatives.”
What’s Being Done?
The Department of Health, the NHS Commissioning Board, NHS surgeons and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to ensure surgeons have all the necessary guidance and support to carry out these operations as safely and effectively as possible. They’re also focusing on helping women to feel more informed and reassured prior to making decisions about their surgery.
Professor Keith Willett, National Clinical Director for Acute Episodes of Care at the NHS Commissioning Board said “some women have experienced distressing side-effects and we are working to make sure improvements are made and patients are well informed about the risks with these procedures.”
Earlier this month Health Secretary Alex Neil wrote to the MHRA, following the American FDA reclassifying the procedures as "high risk". He has asked them and the European Commission to consider whether the reclassification should also apply in the UK.
Mr Neil said: "In light of the proposals from the US Food and Drug Administration (FDA) to reclassify mesh as high risk, I have asked the MHRA and the European Commission to urgently consider whether this reclassification should be applied here."
The Scottish Government have set up an expert group earlier in the year to look at the issue of transvaginal mesh implants. They’ll develop an information leaflet and consent form to be given to women prior to surgery to ensure they are fully informed. This leaflet and consent form are expected to be in use from June this year.
What Next?
If you are due to have a procedure involing a vaginal mesh implant or trans-vaginal tape (TVT) then please see here for questions to ask your doctor or surgeon before proceeding. For a large proportion of women the surgery is successful, but it’s important to be aware of the potential side effects and other options before making your decision.
We Can Help
If you, or a friend or family member, have suffered side effects or complications from a vaginal mesh implant then you may be entitled to medical negligence compensation. The failure of a vaginal mesh device can have a huge impact on quality of life and compensation can help towards medical treatment, support and any debts incurred should you need to take time off work as a result of your symptoms.
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