Medsafe has clarified its surgical mesh ban statement from last year allaying fears of a ban on mid-urethral slings used to treat stress urinary incontinence.
In a press release on 11 December, Medsafe listed 29 mesh products used in urogynaecological surgery for which it was taking regulatory action to effectively remove them from supply and limit their use.
The Medsafe statement explained its response to an Australian review of the safety of mesh would be “effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence rather than a limit on use of surgical mesh for other types of surgery”.
Urological and gynaecological surgeons widely interpreted this as including a ban on the use of mid urethral slings for stress urinary incontinence, as well as transvaginal mesh for pelvic organ prolapse.
However, in a statement released 31 January, Medsafe clarified that its regulatory action had only resulted in 16 transvaginal mesh products used solely for pelvic organ prolapse and one single incision mini-urethral sling for stress incontinence being removed from the market.
Medsafe group manager Chris James says of the 12 remaining products, those with dual pelvic prolapse and stress urinary incontinence use had or would have their instructions amended to stipulate they can no longer be used for pelvic organ prolapse; others will or already have changed their safety information to add risk warnings and emphasise the need for informed consent.
Medsafe will continue to monitor the use of mesh, Mr James says.
"Work on a registry of all mesh implants is continuing, including a cost benefit analysis which is continuing to be progressed following the regulatory action."