Urogynaecological mesh is used to treat stress incontinence and pelvic organ prolapse – and it has triggered class actions in the US, UK and Australia

Urogynaecological meshes (sometimes known as transvaginal meshes) are used to treat stress incontinence, a condition that can lead to women leaking from their bladder when doing impact activities such as running and jumping, or when sneezing or coughing. The condition is very common in women after childbirth and at the menopause – around 20% of women are affected sufficiently for it to be a problem in their daily lives. Mesh surgery has a low complication rate for incontinence.

The meshes are also sometimes offered as a treatment for women suffering from pelvic organ prolapse. Pelvic organ prolapse affects up to half of women who have had children, and occurs when a pelvic organ – such as the bladder, rectum or uterus – “sags” and moves out of place. This can happen when the pelvic floor muscles, ligaments and tissue that hold the organs in place are weak or damaged.

Childbirth is a main source of trauma to the muscles and ligaments, and hormonal changes during the menopause also lead to muscles weakening and becoming less elastic. Heavy lifting can also cause damage to the pelvic organs and lead to prolapse. The condition also tends to run in families and is more common in women who are overweight.

While some women have no symptoms, pelvic organ prolapse can be debilitating and make it hard to go to the toilet, can cause painful or heavy sensations in the vagina, and can make sex difficult, all of which require treatment. It can also cause a loss of sensation and make it harder to “push”, for example when urinating. For women with these symptoms reconstructive surgery using vaginal mesh is sometimes recommended.

The mesh is a net-like implant. It comes in a number of forms including a “sling”, “tape”, “ribbon”, “mesh” and “hammock”. There are different brands and manufacturers.

The aim of the mesh is to give permanent support to the weakened organs and to repair damaged tissue.

Surgery can be done through the abdomen (transabdominal) or through the vagina (transvaginal). A small incision is made in the vaginal or abdominal wall, and the surgical mesh is implanted and held in place by sutures or tissue fixation devices. The idea is that tissue will grow into the pores of the mesh to create a wall of support.

The most common form of implant, called a transvaginal tape (or TVT), has been widely used to treat stress incontinence across Europe, the US and Australia since the early 2000s.

Early clinical trials suggested excellent efficacy and many surgeons saw advantages over traditional open-surgery procedures, which took longer to perform, involved a longer recovery for patients and were associated with their own range of complications. By contrast, a TVT procedure typically takes 3o minutes, is performed using keyhole surgery and patients often go home the same day.

Meanwhile, the traditional treatments for pelvic organ prolapse, which included suturing to reconstruct and repair the affected organs and surrounding tissue, were proving less successful, with reports of up to 29% of women suffering another prolapse after treatment. Hysterectomy is another treatment option, which some women wish to avoid.

“Because outcomes of using the mesh for incontinence and hernia were so good people were enthusiastic and confident it would also be good for prolapse,” said Christopher Maher, a urogynaecologist and associate professor at the University of Queensland. “That’s what the mindset was when it was introduced for prolapse around 2002.”

But he said regulators around the world should have demanded more testing to ensure the mesh was as effective for treating prolapse as it was for other conditions.

There have also been reports that pharmaceutical companies who make the meshes began heavily promoting them to doctors for treating pelvic organ prolapse. By 2010, transvaginal mesh operations accounted for nearly 25% of prolapse interventions in some countries.

Most short-term clinical trials have found high efficacy and low complication rates for the most common mesh implants (TVT) used for incontinence, but there is a growing body of evidence that efficacy is lower and complication rates are higher for pelvic organ prolapse.

There is also little robust information on the success of the procedures in the long term and when carried out in the wider population. However, there are indications that complication rates could be significantly higher than those typically reported in trials – in the UK, NHS data suggests that one in 15 women later has to have their implant surgically removed.

In a survey of 2,220 women who had undergone pelvic mesh implants to treat stress urinary incontinence and pelvic organ prolapse, 59% said the procedure did not resolve their original issue, and 58% said they were left experiencing pain during intercourse. However, this was a consumer survey, carried out by the consumer advocacy group, the Health Issues Centre, rather than being a scientific study.

As the mesh became more widely used, women came forward suffering complications and class actions have been brought against manufacturers around the world. In 2012 the United States Food and Drug Administration reclassified transvaginal mesh as a high-risk device.

“In most cases, the complications are relatively minor,” said Peta Higgs, a Royal Australian and New Zealand College of Obstetricians and Gynaecologists spokeswoman and a urogynaecologist. “However, in a small number of cases the complications have been very serious.”

These include mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. And although serious complications appear to be rare, given the thousands of women who have had the implants, the numbers of women suffering adverse reactions is high.

Three Johnson & Johnson group companies are now fighting a major class action from 700 Australian women, who allege faulty pelvic mesh implants caused them debilitating pain. Similar class actions involving thousands of women are also under way in the UK and US. More than 100,000 transvaginal mesh lawsuits have been filed in the US, with the manufacturer of the most commonly used meshes, Johnson & Johnson, facing the most lawsuits.

In many of the cases, issues have been raised around informed consent. Shine Lawyers is leading the Australian class action and alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients.

The Australian government is also holding a Senate inquiry into the use of transvaginal mesh examining any financial or other incentives provided to medical practitioners to use or promote transvaginal mesh implants, the lack of data available on how many procedures were performed, and the type and incidence of health problems women have experienced. The next round of public hearings will be held in Sydney on 18 September.

In the UK, a 2014 government report estimated the procedure was performed on about about 17,000 women per year suffering stress incontinence and that these numbers had remained stable for a few years. The number of vaginal mesh implants used for prolapse peaked around 2009 with 3,200 implants sold to hospitals, but had dropped gradually to about 2,000 per year, the report found.

In the US, the Food and Drug Administration [FDA] issued safety warnings to doctors and consumers in 2011 about an increase in adverse event reports related to mesh. The latest available FDA figures show approximately 300,000 women in the US undergo surgical procedures for prolapse each year and approximately 260,000 underwent surgical procedures to repair stress incontinence. According to industry estimates, approximately one out of three prolapse surgeries used mesh, and of the incontinence surgeries, over 80% were done transvaginally with mesh.

There is no accurate data available to track the number of women who have had a mesh implant for the treatment of prolapse or incontinence in Australia, Higgs says.

According to Maher, this is because surgeries for prolapse have been recorded under “vaginal repair”, which can involve numerous procedures that do not involve mesh. It also makes it hard to determine complication rates related to mesh unless women are signed up to clinical trials. However, Australia’s Therapeutic Goods Administration believes there have been “many thousands” of mesh devices implanted in Australian patients.

Brands of mesh have been pulled from the market around the world by manufacturers, and brands and types that have been studied have been replaced by newer versions that doctors have less evidence about. This makes it difficult to understand if some have higher complication rates or are more effective than others.

The mesh implants are designed to be permanent and during the first weeks after surgery become embedded in the surrounding tissue to provide better pelvic support. If the implant becomes exposed in the vagina, doctors normally cut away the mesh and put in some stitches, which can sometimes be done under local anaesthetic. However, if the patient is suffering from more permanent complications, such as pain, full removal can require hours of surgery and doctors have to also weigh up the risk of damage to nerves and nearby organs, including the bladder and bowel.

Higgs said women who had undergone a mesh procedure in the past and who are well are unlikely to suffer any adverse effects or complications.

“However, some women might experience a late vaginal mesh exposure or erosion,” she said. “If women are concerned, or experience any abnormal vaginal bleeding or pain, we encourage you to see your doctor.”

The complications seem to be much more common in women who had the surgery to treat prolapse.

While new treatments are sometimes trialled on patients when other options have proven ineffective, patients should always be informed that the treatment is new and that little data exists for its efficacy, so that they can give informed consent. Women should feel comfortable asking their specialist about complication rates, the evidence that the surgery will work, and about surgeon training.