Women beat med giants in pelvic mesh case

Luke Costin
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PELVIC MESH CLASS ACTION

Julie Davis (third from right) says mesh implant victims were treated like guinea pigs

A band of Australian women "treated like guinea pigs" have won their seven-year-long case against three medical giants whose defective vaginal implants left hundreds in debilitating pain.

The Federal Court on Thursday found the nine implants were defective and that two foreign manufacturers and their Australian supplier misled customers and were liable for the injuries caused.

The companies - all from multinational Johnson & Johnson Group - marketed the plastic implants as safe ways to reinforce the pelvic floor and address stress urinary incontinence or pelvic organ prolapse.

But in reality, hundreds of the synthetic implants eroded, extruded or caused infection without warning.

Women were left with chronic pain, acute pain during sex, damage to surrounding organs and other symptoms.

Julie Davis, one of 1350 woman to have registered with the class action, said the judgment was incredibly pleasing.

"The corporates have a lot to answer for because they've treated women essentially like guinea pigs," she said outside court.

Victorian woman Diane Dawson, who turned to the plastic implant in 2009 years after having traditional surgery repair, experienced excruciating pain months after surgery.

Some of the mesh was removed in late 2009 before further surgery in 2013 tried to get the rest of what was left.

Despite those and three other surgeries, Ms Dawson was still beset by chronic pain, Justice Anna Katzmann said.

"She is understandably angry, frustrated and distressed by her plight," the judge said.

"She does not see herself as the woman she once was."

Justice Katzmann was scathing of companies for concealing the true extent of complications and taking to market the nine mesh products without rigorous clinical trials.

Some of the devices had no clinical trials while others had sponsored trials with small groups. No trials compared them to other treatments let alone did so in a randomised, controlled manner.

Ethicon's post-market surveillance was also deficient on multiple fronts, Justice Katzmann said.

Essentially passive, the surveillance was conducted primarily for marketing purposes, lacked genuine risk analysis, didn't comply with regulatory requirements and, in some cases, ignored altogether the complaints of patients and surgeons.

Some clinical evaluation reports included text copied and pasted from other reports without regard for the new context.

"For the most part, these reports could scarcely be described as evaluations at all, let alone critical analyses," Justice Katzmann said.

Australia's medical device regulator, the Therapeutic Goods Administration, didn't escape criticism either for its role in endorsing the products for sale.

Eight of the nine devices were accepted by the TGA without any independent assessment of safety or efficacy or a requirement for the manufacturer to demonstrate it had done so itself, the judge said.

All the implants needed was proof of the European "CE" certification mark.

But none of the Ethicon devices ever met all the requirements for CE marking, the judge found.

After Canada took action in 2015, the TGA called on Ethicon to amend the instructions it was giving patients.

Fully aware its instructions were false, Ethicon had been telling patients the mesh elicited a minimal to a slight inflammatory reaction that was "transient" or "transitory".

"I found the amended versions still provided inadequate and, in some respects, misleading accounts of the effects of implantation and the risks of the pleaded complications," Justice Katzmann said.

The ruling followed an eight-month trial, 48 witnesses and more than 164,000 pages of written evidence.

Lawyer Rebecca Jancauskas said some 8000 women were believed to have been affected by the implants nationwide.

She believes there could be more, while affected women can still sign up to the class action.

Damages will be awarded in early 2020.