HEALTH:

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.

The Saturday Paper - - The Week Contents - Lindy Alexan­der

Mesh im­plants.

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.

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