AUSTRALIA’S peak medical device regulator has banned all transvaginal pelvic mesh devices to treat prolapse in women but the move is “too little, too late”, say women who have complained for years about devastating complications following mesh surgery.
“Why has it taken so long?” said Gai Thompson, of Sydney, after the Therapeutic Goods Administration announced it was removing the last mesh devices on the market to treat prolapse in women after childbirth, implanted via the vagina, because of little or no evidence backing their safe use.
The TGA said it was also cancelling single incision mini-slings to treat stress urinary incontinence after evidence the risks to women outweighed the benefits.
The move follows years of complaints by women leading to several high-profile class actions involving at least 1300 Australian women, an unknown number of confidential settlements with doctors, and an on-going Senate inquiry launched after Victorian Senator Derryn Hinch described pelvic mesh as “the greatest medical scandal” against Australian women.
In its statement on Wednesday, after sustained public criticism of the regulator by women dealing with the consequences of mesh surgery, the TGA said the move came after it reviewed the latest published international studies of transvaginal mesh devices – implanted via the vagina rather than abdomen – of each device supplied in Australia.
“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 TGA said.
While the ban includes single incision mini-slings it does not extend to mid-urethral slings regarded as the “gold standard” for treating stress urinary incontinence. Despite evidence supporting the benefits of the mid-urethral slings, a significant number of women are registered in a legal class action against Johnson & Johnson alleging serious complications from the use of one of its most popular mid-urethral slings.
The TGA announcement comes just weeks after the regulator announced it was moving to shift all transvaginal mesh devices in Australia, to treat prolapse and stress urinary incontinence, to a high risk classification.
The TGA issued cancellation notices, and notices to impose conditions, on a number of manufacturers on Wednesday, with the ban coming into effect from January 4. The devices can be used until then, and manufacturers have 90 days to appeal.
The TGA said it had overseen the removal of 45 transvaginal mesh devices since it launched a review in 2013 following global controversy about the devices.
Mrs Thompson, who was implanted with a Johnson & Johnson Prolift device in 2008 leading to catastrophic injuries, complained to the TGA in 2011 but said her complaint was simply filed and not taken seriously.
“The TGA treated us with complete disdain. A group of us met with them in May last year and they were so dismissive, just like the doctors have been dismissive. For years we’ve been saying these devices have destroyed women’s lives, and no-one was listening,” Mrs Thompson said.
“The only reason this is happening now is because of the publicity. They have been so condescending. How many women have had their lives destroyed because these people didn’t act when they should? Why were these devices ever let on the market when clearly there was no evidence they could be safely used?”