Health

Pelvic mesh devices to be banned in Australia

Nov 30, 2017

Thousands of women have been impacted by the mesh implant.

Following a wave of controversy, the medical watchdog has announced that some pelvic mesh devices will be banned in Australia.

The news comes after an investigation found a large number of women were in agony after they were fitted with the devices.

The Therapeutic Goods Administration (TGA) confirmed the ban earlier this week.

“The TGA has today decided to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG),” a statement read.

“This follows a review by the TGA of the latest published international studies and an examination of the clinical evidence for each product included in the ARTG and supplied in Australia.

“Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, 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.”

In most cases, the mesh was fitted in women who faced an array of problems after hysterectomies, birth and pregnancies.

The TGA added that there wasn’t enough scientific evidence to give grounds to the health risks of the mesh products.

It is believed that the changes will come into effect from January 4, 2018.

Having said that, the TGA said the ban did not cover all the current devices and explained: “It should be noted that mini-slings are different devices to mid-urethral slings, which are not being removed from the ARTG.”

The news comes after thousands of women sued Johnson and Johnson over the pain that their mesh devices caused them.

Back in July, 700 women in Sydney claimed that the pharmaceutical giant’s vaginal mesh implant ruined their lives.

The device was designed to help with incontinence and prolapse, but instead left the women with severe long-term pain.

Johnson and Johnson claimed that the device was supported by research, despite the 8,000 Australian women who ended up being affected by the mesh and tape implants.

In some cases, women were unable to have intercourse because of the debilitating pain.

The TGA said they issued a range of cancellation notices and noted that 45 devices have been removed from urogynaecological use since the review commenced in 2013.

While the news will be welcome to people who have been affected by the implant, Health Issues Centre CEO Danny Vadasz was disappointed that it didn’t cover all of the devices.

“We think there are ample reasons for a total ban,” he told the Sydney Morning Herald.

“We can’t imagine which surgeon would still want to use mesh in the absence of evidence and with so many injured women.”