Regulation of pelvic mesh
What is pelvic mesh?
Pelvic mesh (also known as transvaginal mesh) is a manufactured, plastic, net-like product that has previously been used for the treatment of pelvic organ prolapse and stress urinary incontinence. It is permanently placed surgically via the vagina and is designed to provide extra support to weakened tissues.
Mesh products can also be known as a sling, tape, ribbon or hammock.
Some women who have had mesh procedures have experienced serious complications including infection, mesh extrusion or erosion, chronic pain, problems sitting and walking, urinary conditions; painful sexual intercourse and further incontinence issues.
Who regulates medical devices?
The Commonwealth Government’s TGA is responsible for the regulation of medical devices such as transvaginal mesh in Australia and has taken action. On January 4 2018, transvaginal mesh products designed solely for the treatment of pelvic organ prolapse and single incision mini-slings used for the treatment of stress urinary incontinence were removed from the Australian Register of Therapeutic Goods (ARTG) and are now unavailable for legal supply in Australia. The TGA took this regulatory action after a review found there was insufficient scientific evidence to show that the risks to patients outweighed the benefits.
It should be noted that mini-slings are different devices to mid-urethral slings, which have not been removed from the ARTG.
Senate inquiry and the Australia-wide response
A senate inquiry was conducted in 2017 into the number of women in Australia who had transvaginal mesh implants and related matters. The Senate Affairs Reference Committee’s report was released on 28 March 2018. The Senate report contains findings and thirteen recommendations (PDF 40KB) to improve regulatory processes and care pathways such that they are robust, evidence based, clinically sound and focused on good patient outcomes.
To assist clinicians and consumers, the TGA has a dedicated transvaginal mesh website which also provides information on mesh.
Regulation of pelvic mesh products
To assist in monitoring the safety of medical devices the TGA mesh hub provides information for patients and clinicians to register if a medical device has caused an adverse event (death, serious injury or serious deterioration). The TGA assesses each report submitted. Note: This website will require information about the device i.e. brand name, manufacturers details.
For more information on reporting adverse events from a medical device please read the TGA guide to the medical device incident reporting & investigation scheme (IRIS).