Medical mesh: Australia’s largest class action lawsuit brewing over medical horror
It’s a medical horror affecting tens of thousands. Now there’s a major parliamentary and legal push to win justice for victims of medical mesh.
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More than 40,000 Australians implanted with a plastic mesh that can cause serious lifelong injuries will be urged to join one of the nation’s largest-ever class actions.
The revelation comes as a South Australian parliamentary committee will next week begin to hear evidence from men and women suffering complications, including disability and chronic pain, from medical mesh.
The medical mesh is used in up to 50 different procedures in SA hospitals, including abdominal, rectal and orthopaedic surgeries.
The inquiry wants to find out how many South Australians are adversely affected by medical mesh, which has been used to treat pelvic organ prolapse and urinary stress incontinence in Australia for the past two decades.
The Sunday Mail can also reveal an SA Health audit of pelvic mesh implants across seven public hospitals found 37 per cent of female patients were likely to return to hospital with post-surgery complications. Complication rates overseas range from seven to 23 per cent.
The number of Australian women implanted with these mesh devices, made of polypropylene, remains unknown as there is no official register.
Lawyers have told the Sunday Mail that health insurers and hospitals will send out letters to more than 40,000 women in the next two weeks, informing them that they have been implanted with one of nine pelvic mesh devices deemed unsafe last year by the Federal Court.
The letters will ask women suffering complications to register for a class action run by Brisbane-based Shine Lawyers against medical giant Johnson & Johnson and its subsidiary company, Ethicon.
The Federal Court in November found Johnson & Johnson was negligent and had engaged in misleading or deceptive conduct in the supply and promotion of nine pelvic mesh devices it supplied in Australia from 1999.
Since 2013, 49 pelvic mesh devices have been removed from the Therapeutic Goods Administration’s approved product register. At least three companies continue to supply 20 approved pelvic mesh devices to Australian medical practitioners.
In 2018, the TGA ruled pelvic mesh devices treating prolapse must be implanted abdominally rather than through vaginal incision.
Shine Lawyers has applied for a court injunction for the urgent updating of product warnings for five of the nine Johnson & Johnson pelvic mesh products still available in Australia.
“Now is the time for Australian women affected by pelvic mesh to have the opportunity to participate in the class action,” Shine Lawyers senior associate Bridget Cook said.
“Their individual experiences and their life-altering complications must be taken into account.”
A Johnson & Johnson spokeswoman said Ethicon empathised with women who had experienced complications after pelvic mesh procedures, but noted that the mesh had improved the quality of life of millions of women worldwide.
She said Ethicon was reviewing the Federal Court decision and believed it had acted ethically and responsibly in the research, development and supply of the pelvic mesh products.
In SA, the audit report – conducted for an SA Health committee and obtained by the Sunday Mail – estimates almost 3774 women across the seven public hospitals were implanted with unspecified pelvic mesh devices from 2003 to 2018.
The public hospitals involved in the audit were the Lyell McEwin Hospital, Modbury Hospital, Noarlunga Hospital and hospitals in Port Pirie, Murray Bridge, Mt Gambier and the Riverland. The audit identified these hospitals as having ordered a large number of pelvic mesh devices.
Port Pirie paramedic and mother of three Kim Blieschke wants medical mesh for surgical use in Australia banned, or at least suspended pending more rigorous safety checks.
“Mesh is not fit for implant in the human body,” said Ms Blieschke, a long-time advocate for those affected by mesh implants.
“It can shrink and degrade when implanted; it cuts into tissue and nerves and it erodes through organs.”
Ms Blieschke will give evidence at the Surgical Implantation of Medical Mesh in SA inquiry, initiated by state Labor MP Dana Wortley. Health Minister Stephen Wade, in a letter submitted to the inquiry, says medical mesh may have been used in more than 2700 procedures in 2018-19, the bulk of them to treat hernia.
Royal Adelaide Hospital established a pelvic mesh clinic last July to help women with complications. A total of 55 have so far visited the clinic.
The federal Health Department, in its submission, says all new surgical mesh devices have been reclassified to a higher risk since December 2018, requiring pelvic mesh suppliers to provide implant detail cards for patients and information of associated risks.
The Royal Australian and New Zealand College of Obstetrics and Gynaecologists is recommending gynaecologists only use currently available pelvic mesh devices for prolapse in specified circumstances where alternative surgical treatment is deemed riskier.
More traditional native tissue repair surgery is an alternative to mesh. Physiotherapy and use of a support pessary are non-invasive options available for mild prolapse.