Medsafe Implements Surgical Mesh Restrictions

On the 12th of December 2017 Medsafe made a public announcement regarding the concerns that they have about the use of surgical mesh in both Pelvic Organ Prolapse and Stress Urinary Incontinence. Using powers under the Medicines Act (under section 38) they took significant regulatory action to limit the use of some surgical mesh products that are used in urogynaecological procedures. This action removed supply from four large mesh manufacturers and enabled Medsafe to limit the use of these surgical mesh devices.

The reason identified for this decision, was because there was enough “cause for Medsafe to question the safety of certain devices”. The Australian TGA (Therapeutic Goods Administration) review into surgical mesh complications resulted in a similar decision, where regulatory action was taken to remove all pelvic mesh devices for POP from the market along with single incision mini slings.