Australia investigates implants that left some women with ‘rotting pelvises’

Like more than 100,000 Australian women, Linda Schulz had a pelvic mesh implant to treat complications from childbirth that resulted in her bowel and bladder prolapsing.

The mesh was meant to be a quick fix, but the aftermath was worse.

Her right leg went numb almost immediately after the procedure, and after a few weeks the mesh was like a knife constantly cutting her up from the inside.

“The mesh cut through my vagina wall and came through my skin,” Schulz said. “Any movement, whether I moved my legs or not, felt like a serrated-edge knife was cutting me.”

In the last year, Schulz, 48, along with hundreds of women experiencing similar complications, petitioned the Australian Senate to investigate their use, hoping for an outright ban and recourse for past procedures.

After a yearlong inquiry, the Senate released a report Wednesday, recommending that the implant be a “last resort” and raised concern that medical practitioners had not adequately informed their patients and “overused” the procedure “without considering alternative treatment options.”

The report went on to outline vital recommendations for improved treatment guidelines and medical training, prevention of financial inducements for practitioners, a registry of high-risk implantable devices and an audit of past procedures. It also outlined concern that it is not possible to identify accurately the number of women who have received transvaginal mesh implants in the country.

“Women that have had those implants, who have those outcomes … have been failed in a monumental way by the system and by certain people in the medical profession who they trusted,” said Sen. Rachel Siewert when she introduced the report Wednesday to the Senate. “I hope that we never have to have another inquiry where we see such suffering from the witnesses.”

Senate involvement all started when Sen. Derryn Hinch heard stories such as Schulz’s, and was moved to start an inquiry in February 2017.

“I hope our report convinces them they have been listened to and more importantly they have been believed,” Hinch said at the Senate meeting introducing the report.

Hearings were held across Australia in 2017, interviewing both patients and mesh manufacturers. Hundreds wrote in to the Senate, sharing a range of stories about living with pain after the operation – from not being able to walk, sit or drive to puncturing their partner during intercourse with a splinter that broke off the implant.

Schulz said she hopes the report will go past recommendations into action, and she hopes no woman has to go through what she did: “It changes your whole life. You don’t feel like a woman anymore. They just take everything in one fell swoop.”

‘Horror stories’ in consumer group’s survey

Clocking in at 20 minutes, the mesh implant is a quick fix aimed at repairing common complications from childbirth and menopause.

The mesh is implanted to support weakened or damaged tissue to treat poor bladder control and organ prolapse. But the procedure can be risky because of the methods and materials used. According to various studies, complications can include organ perforation, infection, hemorrhage and sexual dysfunction.

About half of women between 50 and 79 may have prolapse, according to the American Urogynecologic Society. When muscles and ligaments in the pelvic floor get too stretched, for reasons such as childbirth, they fail to hold up the pelvic organs: the bladder, rectum and uterus. The organs can drop into the cavity, making urination and sex painful.

One in five women has incontinence, or poor bladder control, from childbirth, according to the Journal of Prenatal Medicine.

Part of the problem in the past, Schulz said, is that there were no hard statistics and records of how many procedures are done and their effects.

In April 2017, the Health Issues Centre – an Australian consumer advocacy group – conducted its own survey. After asking on Facebook for stories, it heard from 2,500 women in six weeks.

“We heard horror stories, lives that were completely destroyed,” said Danny Vadasz, head of Health Issues Centre, who also wrote to the Senate, asking for reform. “We were shocked and barely believed something like this could happen in what we considered the world-class health system of Australia.”

The Australian health care system offers universal health care insurance, paid through taxes, as well as private insurance.

Based on his survey, Vadasz estimates that in the past two decades, there have been 120,000 to 150,000 mesh implants in Australia, and around 70% of the stories his group heard involved a lack of fully informed consent. Many women, he said, were not even told that a mesh would be implanted into their bodies.

‘Mine was badly fitted’

“As these devices were to be permanent, we are meant to live with rotting pelvises forever,” said Justine Watson, a Sydney resident who submitted her mesh photos to the Senate as part of the inquiry and joined more than 700 Australian women last year in a suit against Johnson & Johnson over claims of flaws in its mesh devices.

In January, the pharmaceutical giant withdrew its mesh products from the Australian market. That same month, Australia’s medical devices regulator, the Therapeutic Goods Administration, removed mesh products for prolapse.

Watson’s pain was so severe that she tried to take her own life after being hospitalized multiple times. Doctors didn’t believe her, she said, referring her to psychiatrists instead.

“Mine was badly fitted,” said Watson, who spent her life savings to travel in October from Australia to the United States to remove the mesh that was first implanted in 2010. “It broke into the wall of my bladder and skewered my urethra.”

After giving birth to two boys, both weighing more than 8 pounds, Watson struggled with incontinence.

But within three months of the procedure, Watson was incontinent again and after suffering multiple medical problems, such as fibromyalgia, chronic pain and fatigue, she had the mesh removed. At 47, the procedure left her with the body of an 80-year-old: unwell, overweight and unable to walk more than 100 meters.

The need for more action

Both Watson and Schulz said they felt that Wednesday’s Senate report was full of guidelines rather than concrete rules.

“This (report) feels somewhat ambiguous and can be interpreted several different ways. … It’s very unlikely that it’ll make any difference,” Watson said.

And eight Australian pelvic mesh implant support groups agreed, saying in a joint statement: “There are a few glimmers of hope for mesh-injured women in the report - but the wording used in the recommendations are so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual. We are disappointed that the recommendations are not stronger, mandating a change in treatment, monitoring and care - especially considering that the report found that: Women are not having their mesh complications identified, or believed, by primary or specialist doctors.”

Now Schulz, along with others who have been affected, are now looking into a Royal Commission, an official investigation that they hope can fully ban the practice and even offer financial restitution.

Schulz wants more recognition of the problem. She represents more than 1,600 women in the Australian Pelvic Mesh Support Group, an advocacy organization that warns women about the risks of the procedure.

In response to the Senate study, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) said, “more needs to be done to protect the safety of women.”

“It was very clear in the report that women who have experienced adverse complications as a result of a mesh implant have endured long-term pain and reduced quality of life,” said President Professor Steve Robson from RANZCOG, which trains and accredits doctors in Australia and New Zealand.

Along with agreeing with the recommendation for a registry for high-risk medical devices, he added in his statement: “We support our members by offering clinical guidance and ensure that our College communications and information hubs reflect current national standards.”

A 2016 study, which compared the results of women across 35 UK hospitals who had surgery with and without mesh, concluded that there was “no benefit to women having their first prolapse repair from the use of transvaginal synthetic mesh.”

More than 1 in 10 in their study suffered complications, with 3 in 10 needing another operation, leading the study authors to recommend the more standard approach, without mesh, where organs are repositioned to their original areas and the supportive tissue surrounding them is repaired and stitched. The Mayo Clinic consistently uses this method.

There are also less invasive treatments, recommended by some researchers, such as pelvic floor muscle training to strengthen the weakened tissue.

But for many women, such as Schulz, no other option is given.

A global issue

The surgical mesh procedure is controversial and has led to many class-action suits across the United States, UK and Australia.

In the UK, the National Health Service estimates that over the past two decades, more than 100,000 women have had surgery involving a mesh implant and 3% to 5% have had complications. But a recent study suggested higher figures, estimating that 1 in 15 women had to have her implant surgically removed in the UK.

Edward Morris, vice president for clinical quality for the Royal College of Obstetricians and Gynaecologists, highlights that based on current evidence, the mesh may be effective to treat incontinence but is not advised for organ prolapse.

There is still a small subset of women for whom it might be beneficial, he added, given the “appropriate information and counseling about the risks and benefits.”

The college has a mesh webpage dedicated to information and advice on mesh implants to help women be informed about the procedure.

In December, the National Institute for Health and Care Excellence – the UK’s health watchdog – withdrew its recommendation for the procedure to treat pelvic organ prolapse, and the Department of Health and Social Care is auditing cases dating to 2005.

In January, New Zealand banned all vaginal mesh procedures to treat organ prolapse.

In the United States, the Food and Drug Administration has not taken steps to ban vaginal mesh. However, in 2016, it reclassified the device from class II (moderate risk) to class III (high risk), providing the agency with more oversight over the manufacturing of mesh products.

The FDA estimated that there are 75,000 procedures involving pelvic mesh implants each year in the United States. A 2011 report by the FDA also reported 2,874 cases of injury, death or malfunction related to the use of vaginal mesh between 2008 and 2010, including three deaths: two from bowel perforations and one from hemorrhage.