12/23/2017 What does pelvic mesh do and why are women suing over it?

omen suing over it? – explainer | Society | The Guardian

What does pelvic mesh do and why are women suing

over it? – explainer
theguardian.com/society/2017/aug/31/vaginal-pelvic-mesh-explainer

Melissa Davey 8/31/2017

What is a transvaginal mesh implant?

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.
12/23/2017 What does pelvic mesh do and why are women suing over it? – explainer | Society | The Guardian

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How does it work?

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.

When were they introduced?

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.

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12/23/2017 What does pelvic mesh do and why are women suing over it? – explainer | Society | The Guardian

“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.

What is the current controversy surrounding vaginal mesh?

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.

What can go wrong?

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“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
12/23/2017 What does pelvic mesh do and why are women suing over it? – explainer | Society | The Guardian

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.

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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.

How many women have mesh implants?

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.

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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.
12/23/2017 What does pelvic mesh do and why are women suing over it? – explainer | Society | The Guardian

However, Australia’s Therapeutic Goods Administration believes there have been “many
thousands” of mesh devices implanted in Australian patients.

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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.

Is the surgery reversible?

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.

Should women be worried?

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.

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“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.