Patient information
The Therapeutic Goods Administration (TGA) has compiled a list of potential complications and adverse events.
The National Health Service Scotland has developed patient information that identifies the approximate chance of having specific complications for surgical treatment of urinary incontinence.
Reporting complications to the TGA
If you are experiencing complications with pelvic mesh, we recommend talking to your GP about a referral to the Queensland Pelvic Mesh Service. It is also important to ensure that your complications are reported to the TGA. This ensures that accurate information on the safety of pelvic mesh is collected.
You can make a report yourself using the TGA online Medical Device Incident Report form or request assistance from your GP.
Read more about reporting adverse events from the TGA.
TGA actions on transvaginal mesh
On 4 January 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) by the TGA.
Due to the lack of scientific evidence that the benefits outweigh risks, the products are now unavailable for legal supply in Australia.
The TGA review was undertaken as a direct result of numerous reports by women of medical complications experienced because of pelvic mesh implants. It should be noted that mini-slings are different devices to mid-urethral slings which have not been removed from the ARTG.
The ARTG provides information on therapeutic goods that can be supplied in Australia. If a therapeutic good is not on the ARTG, it cannot be supplied in Australia. There are special circumstances where individuals can access unapproved therapeutic goods. Many mesh devices have been removed from the ARTG.
On 26 October 2017, the TGA released a statement that a new regulatory framework for surgical mesh devices and provision of information to the consumers for all implantable medical devices was approved by the Minister for Health.
From 1 December 2018, all new surgical mesh devices seeking approval from the TGA, will need to meet higher evidentiary requirements of a Class III medical device—this includes urogynaecological mesh devices. A transition period will apply for surgical mesh devices currently on the market.
It is now a requirement that women are provided with patient information leaflets (in the TGA approved format) and patient cards for urogynaecological mesh devices, which are classified as implantable medical devices.
Informed consent: pelvic mesh procedures
In response to the senate inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters, Queensland Health has revised and developed consent forms for pelvic mesh related procedures in partnership with consumers who have experienced complications due to transvaginal mesh.
The informed consent forms below have been revised to align with the ACSQHC consumer information resources:
- Abdominal Sacrocolpopexy with mesh
- Transobturator Route (TOR) Insertion of Mid-urethral Sling for Stress Urinary Incontinence and Cystoscopy Consent
- Retropubic Route (RPR) Insertion of Mid-urethral Sling for Stress Urinary Incontinence and Cystoscopy Consent
Subsidy schemes
You may be eligible for the following subsidy schemes.
Medical Aids Subsidy Scheme (MASS)
Subsidy funding for medical aids and equipment is available to eligible Queenslanders with permanent or stable conditions or disabilities under the Medical Aids Subsidy Scheme.
Aids and equipment are subsidy funded either on a permanent loan basis, private ownership or through the supply of consumables.
Find out if you are eligible for support in purchasing items such as continence pads, aids and bladder catheters through the scheme:
- Phone—(07) 3136 3665 or 1300 443 570
- Email—MASSContinenceAids@health.qld.gov.au
Continence Aids Payment Scheme (CAPS)
The Continence Aids Payment Scheme is an Australian Government scheme that helps eligible people who have permanent and severe incontinence to meet some of the costs of continence products and continence related products.
National Disability Insurance Scheme (NDIS)
The National Disability Insurance Scheme is a national scheme for people with a permanent and significant disability, providing funding directly to individuals for disability support.
If you need someone to support you or need special equipment because of a permanent and significant disability due to pelvic mesh complications, you may be eligible for the NDIS.