Sydney: Australia Thursday banned the use of pelvic mesh implants citing potential risks to patients, months after a major class action was launched against global healthcare giant Johnson & Johnson over alleged side effects.
The mesh, implanted through surgery to fix pelvic floor damage and treat urinary incontinence and prolapse, is the subject of a parliamentary inquiry into potential complications and side effects. It followed local media reports of women claiming the devices left them with severe and chronic pain.
The Therapeutic Goods Administration (TGA) said it had examined clinical evidence on the implants supplied in Australia and reviewed the latest published international studies.
“The TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,” the government agency said in a statement.
It said there was also a “lack of adequate scientific evidence” that there were more benefits than risks to using them to treat urinary incontinence.
The products will be removed from the Australian Register of Therapeutic Goods from January 4 next year.
One procedure that uses the implants to treat incontinence, mid-urethral slings, was not banned.
One of the lead claimants in the Australian class action, Gai Thompson, welcomed the ban, telling public broadcaster ABC that women like her had been told there was “nothing wrong with us”.
“I don’t think people understand (there’s not) one day from the time it’s been put in that we haven’t had pain — not one day,” she said.
The announcement came with British health watchdog NICE set to recommend the implants used to treat prolapse should be banned in England for routine operations, according to draft guidelines cited in media reports this week.
The Australian Johnson & Johnson lawsuit is on behalf of more than 700 women, with the legal firm representing them claiming up to 8,000 women in the country were believed to be impacted.
Johnson & Johnson has defended the mesh products, saying they were developed in consultation with surgeons and backed by clinical research.
The company faces 54,300 plaintiffs in pelvic mesh cases in the United States, the firm said in a report filed to the American Securities and Exchange Commission earlier this month.
The report added that there were class actions, personal injury cases or claims in various other countries including Britain, the Netherlands, Belgium, Israel and Canada....