The frequency of horrific complications arising from transvaginal mesh implants, typically used to treat pelvic organ prolapse, has led to a class action, writes Lindy Alexander.
In the hospital’s recovery room Kim Blieschke knew something was wrong. After developing a severe uterine, bladder and bowel prolapse following the birth of her three children, Blieschke, a paramedic and registered nurse, had surgery to implant surgical mesh to reinforce her weakened pelvic organs. “I woke in excruciating pain,” she recalls. “I had pain like I have never experienced in my life and the staff couldn’t get it under control. From that moment I knew something wasn’t right.”
Blieschke’s surgeon had advised there were no known complications or side effects to the transvaginal mesh implant, commonly used to treat pelvic organ prolapse and urinary incontinence. That was in 2006 and Blieschke, now 50 years old, says the size of the implant – as big as her hand – was never explained to her, nor was the method of insertion or that the device was permanent. “I knew they went in via my vagina, but I didn’t know that to get the mesh ‘arms’ in place they use trocars [stainless steel needles] that they then pushed out blind through my buttocks,” she says. “After the surgery I had bruising from my groin down to my knees, with big puncture wounds in my buttocks.”
Despite being told she would need six weeks of rest, Blieschke required three months off work due to pain and bleeding. Within three months the mesh had started extruding through the wall of her vagina. “I went back to my GP and after an internal examination he could see parts of the blue mesh,” she says. “He would snip the parts that were eroding into my vagina. Despite the fact I had four major surgeries for mesh erosion, everyone assured me this was very rare.” Believing their assurances, Blieschke thought the debilitating pain, tiredness and anxiety she was experiencing was not related to the mesh.
Mesh implants have been used since the late 1990s. In 2003, Australia’s Therapeutic Goods Administration (TGA) approved a variety of transvaginal mesh kits to be used for pelvic organ prolapse. It is not known how many Australian women have been implanted, but estimates range between 30,000 and 100,000. Since the introduction of the mesh, complaints have been raised of chronic pain and persistent bleeding.
Following reports of these complications, the US Food and Drug Administration stated in 2008 and 2011 that the mesh carried serious risks. The complications with surgical mesh are not confined to one particular brand, and in 2013 the TGA launched an extensive review of about 100 devices used in Australia. Seventy-seven were delisted between August 2014 and November 2015. In a 2016 alert about surgical mesh complications, the TGA said, “adverse events involving these devices are most likely underreported and some patients may not realise that their symptoms are associated with an adverse event”.
Many women are not aware mesh has been used, as it is commonly referred to as a “sling”, “tape”, “ribbon” and “hammock”. An Australian study that analysed evidence from 37 randomised trials involving 4032 women found one in 12 experienced negative symptoms from mesh complications.
“The complication rate of the mesh appears to be between 10 to 15 per cent, which is really too high,” says Elizabeth Howard, an osteopath with the Women’s Health and Research Institute of Australia (WHRIA). Howard and the team of gynaecologists and pain medicine specialists at WHRIA have more than 50 women on their books who either have been seen or are waiting to be seen due to complaints about transvaginal mesh. “More women call for help each week,” she says. “WHRIA conducted an online survey of 124 women with mesh implants and the impact on their life is devastating.”
While transvaginal mesh surgery has benefits, international research has found up to 36 per cent of women experienced side effects after having mesh implanted for prolapse. A Health Issues Centre survey this year found 65 per cent of the 1431 respondents who had undergone a vaginal mesh implant in Australia described their ongoing pain as severe, debilitating or unendurable. Women have also reported organ perforation, recurrent prolapse, vaginal scarring, infection, urinary problems and painful intercourse as a result of the mesh. Removal of the mesh does not automatically eliminate the problems, and few Australian doctors are qualified to undertake the task.
“Many women are suffering from post-traumatic stress disorder as they have experienced ongoing emotional stress as a result of not being listened to or believed that their pain is real, nor offered any solutions to their pain or symptoms,” Howard says.
When Louise King, 65, went to see her doctor after experiencing severe pain after surgery for a vaginal mesh, she was told nothing was wrong. “My doctor examined me and told me it was all in my mind,” King says. “I was totally demoralised. My husband and I had tried to have sex and the pain was so excruciating that I couldn’t. We’d never had a problem before.”
King had mesh implants inserted in two operations after having a complete prolapse. Like Blieschke, King says she was never told about potential side effects or risks. She is incredulous that the risks were not widely known within the medical profession. “People were having trouble with mesh in 2002, but my operations were in 2006 and 2007,” she says. “They must have known something if they’d had problems with it in 2002.”
King believed her discomfort was psychosomatic and never attributed her chronic nerve pain, arthritis or fibromyalgia to the mesh until she read a newspaper article about a woman with similar experiences. “Up until then I thought it was just bad genes – that it was just me,” she says. “I rang Shine Lawyers who were mentioned in the article and they told me I wasn’t the only one. I was stunned. I walked around numb for a couple of days. There were thousands of women like me.”
In 2012, Shine Lawyers started to be contacted by women like King who had suffered “devastating, irreparable complications” as a result of vaginal mesh implants. The number of women coming forward meant that a class action was viable.
Early last month a trial against Johnson &
Johnson for its vaginal mesh implants began in Sydney. Shine Lawyers are acting on behalf of thousands of Australian women who have been left with life-altering complications after receiving mesh implants. It is alleged the pharmaceutical company put profit ahead of duty of care by downplaying the risks of the mesh and not conducting randomised controlled trials on the device’s safety and efficacy. The company is defending the case.
Both King and Blieschke are part of the class action, and Blieschke was one of the women who travelled to Melbourne from rural South Australia to lobby Senator Derryn Hinch last October. A senate inquiry was launched after Hinch’s speech to parliament in November, when he likened the use of mesh products to the promotion and use of Thalidomide in the 1960s, which caused spontaneous abortions and left more than 10,000 children with significant physical disabilities. “This is one of the greatest medical scandals and abuses of mothers in Australia’s history,” Hinch said.
For Blieschke, the trial and the senate inquiry – due to report on November 30 – offer a long overdue opportunity for affected women to have their voices heard. “I’m not going to hold my breath because class actions can go on for years,” she says. “Lots of people are saying it’s about the money, but it’s not. It’s about seeing justice and getting recognition that this mesh has affected us.”
Despite knowing there were other women who had experienced problems with mesh, King felt terribly isolated. “There was no one to talk to about it,” she says. While she confided in her husband, their relationship had shifted. After the operations, King and her husband never had sex again. “My husband passed away in 2014, and up until then he was afraid to touch me because everything hurt,” she says. “Eventually he was so afraid of hurting me that he didn’t touch me at all. We were soulmates and had a wonderful marriage, but it takes away all the little things like him putting his arms around me or walking along holding hands. All those things disappear and you end up very lonely.”
King lives with chronic pain and says she feels stranded. “I feel like the medical profession has let me down,” she says. “It’s been devastating. But I have to speak out now. I understand what it’s like to get to the edge and not know where to go. I don’t have the life I
• used to, but I don’t have any choice.”
The Australian Pelvic Mesh Support Group: facebook.com/groups/465698156902021
A leaflet explaining transvaginal mesh implants.
LINDY ALEXANDER is a freelance writer and researcher.