The Therapeutic Goods Administration (TGA) decided this week to remove transvaginal mesh for the sole purpose of pelvic prolapse and single incision mini-slings from the Australian Register of Therapeutic Goods (ARTG), deeming the devices too risky.
A TGA review of the latest international studies on their use found the risks outweigh the benefits.
The review was conducted following hundreds of complaints by women across Australia, saying the implants had left them with chronic, debilitating pain and unable to have sex.
They are used by surgeons to treat urinary incontinence.
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“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,” a TGA statement said.
“The TGA also considers that there is a lack of adequate scientific evidence before the TGA for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits.”
The changes to the registry take effect from January 4.
Senator Hinch, the leader of a Senate inquiry into the use of vaginal mesh in Australia, took to social media on Thursday to praise the decision of the TGA.
“Our campaign against transvaginal mesh, including public hearings before my Senate inquiry has paid off. Therapeutic Goods Administration yesterday banned mesh for pelvic organ prolapse. Thanks Sling the Mesh for your support,” Senator Hinch tweeted.
“Much credit for TGA mesh ban must go to the Australian Pelvic Mesh Support Group which has grown from 300 members to more than 1200 in a year.”
The mesh products were used to treat problems women commonly experience after giving birth or having a hysterectomy such as incontinence.
However, a growing body of evidence shows there is an extensive list of complications associated with urogynaecological meshes. These can include: bleeding, acute or chronic pain, pain during intercourse, abscess, vaginal scarring or tightening, constipation and urinary retention and/or frequency.
In August, a class action by more than 700 Australian women against manufacturer Johnson & Johnson was launched in the High Court.
Both the court’s ruling and the final findings of the vaginal mesh Senate inquiry are expected to be handed down in February next year.