Johnson & Johnson faces Australian class action over vaginal mesh implants

A class action lawsuit involving more than 700 women in Australia was filed on Tuesday against Johnson & Johnson over complications allegedly caused by the company's vaginal mesh implants. Rebecca Jancauskas, who filed the case on behalf of the plaintiffs in the Federal Court in Sydney, claimed "the complications that women are suffering include the mesh or tape eroding through, and into, surrounding tissue and organs, as well as incontinence, infection and chronic pain." She added that as many as 8000 women in the country may be affected by such complications after having the implant surgery. 

According to the lawsuit, Johnson & Johnson was negligent for not properly warning doctors and patients about the risks associated with the devices. Plaintiffs also allege the implants were not fit for the purposes for which they were designed, and that testing done prior to the devices being sold was inadequate. Tony Bannon, one of the plaintiffs' lawyers, alleged Johnson & Johnson did not investigate correct clinical trials on the possible complications of the mesh. He also accused the company of having launched an aggressive marketing campaign that suggested implanting the device would be a "quick and easy operation," adding that none of the plaintiff's would have taken on the risks if they had been properly advised. 

While Johnson & Johnson said it has sold over 100 000 mesh products in Australia, the lawsuit is focused on nine separate devices, five of which the company has removed from the market, although none were recalled by Australian regulators. During an Australian Senate inquiry earlier this year, Johnson & Johnson argued that the use of implantable mesh was supported by clinical research and that it was frequently the preferred option to treat pelvic conditions. However, the company did not provide details of the total number of such implants, nor did it specify how many women reported adverse effects or how many in Australia or elsewhere have attempted to have the device removed.

In response to the class action lawsuit, Johnson & Johnson said "these pelvic mesh products have been developed in close consultation with specialist surgeons and are backed by years of clinical research." The company added "we have always complied fully with local regulatory requirements when providing the products in Australia, and have acted ethically and responsibly in the research, development and supply of the products."

According to the plaintiffs' lawyers, the trial is expected to run for at least six months, with Johnson & Johnson's lawyers presenting their opening submissions next week.

Patients in the US, the UK and Canada have filed tens of thousands of lawsuits against Johnson & Johnson and other pelvic mesh manufacturers over the devices. In the UK, more than 800 women are preparing to sue the NHS and vaginal mesh implant manufacturers, including Johnson & Johnson, due to pain and injury related to the products. In May last year, Johnson & Johnson was sued by the US states of Washington and California over claims that the company misrepresented the risks of vaginal mesh implants it sold to repair pelvic organ collapse (POP). At the time, Johnson & Johnson's Ethicon unit, which marketed the mesh, called the lawsuits unjustified.

In January 2016, the FDA issued two final orders to strengthen the "data requirements for surgical mesh to repair POP transvaginally, or through the vagina." One order reclassified the medical devices from class II to class III, while the other required a premarket approval application to be submitted by manufacturers to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

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