The Therapeutics Goods Association (TGA) is responsible for approving any medical devices that come into Australia. They are also responsible for monitoring whether the devices have caused any complications (or adverse events) and making the decision to remove them from the Australian Register of Therapeutic Goods (ARTG). They also classify the devices into risk categories.
Since the ‘Senate Enquiry into Transvaginal Mesh and Related Matters’ and following many reports of adverse events relating to particular pelvic meshes, many pelvic mesh implants have been removed from the ARTG.
However many of the reports have come from the injured women themselves and not from the health professionals. Unfortunately, at this time there is no Mandatory Reporting for Adverse Events by the medical profession. Many Pelvic Mesh groups across Australia are actively campaigning to get that changed and it was one of the Recommendations to come out of the Senate Enquiry.
At the time of writing, we cannot rely on the health fraternity to report the adverse events which will mean that pelvic mesh will remain on the ARTG and continue to be implanted into women. This is why we would ask that you report your own adverse events.
We realise that this may seem daunting but we will help you through it step by step.
Adverse events that may be associated with
urogynecological meshes include:
- punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel (these may require surgical repair)
- transitory local irritation at the wound site
- a ‘foreign body response’ (wound breakdown, extrusion, erosion, exposure, fistula formation and/or inflammation)
- mesh extrusion, exposure, or erosion into the vagina or other structures or organs
- as with all foreign bodies, mesh may potentiate an existing infection
- over-correction (too much tension applied to the tape) may cause temporary or permanent lower urinary tract obstruction
- acute and/or chronic pain
- voiding dysfunction
- pain during intercourse
- neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area
- recurrence of incontinence
- bleeding including haemorrhage, or haematoma
- urge incontinence
- urinary frequency
- urinary retention
- adhesion formation
- atypical vaginal discharge
- exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
- mesh migration
- allergic reaction
- swelling around the wound site
- recurrent prolapse
- excessive contraction or shrinkage of the tissue surrounding the mesh
- vaginal scarring, tightening and/or shortening
- constipation/defecation dysfunction
- granulation tissue formation
How to Report Your Complication
Step by step, we are here to help
- Call the hospital where you had your mesh implanted and speak to the records department or Privacy Officer to obtain a copy of your operation notes.
You will usually have to complete a Freedom of Information short form to get the records. When you get your records there should be a document called an ‘implant log’ that is usually one page and will have a barcode that will have the description of your mesh implant similar to the one in the picture. On occasions, hospitals refuse to send the notes and if you do not receive them in a reasonable time, please keep calling as you are entitled to them under the Freedom of Information Act.
- When you receive your notes you can then go to the TGA website and complete the medical device reporting form.
You can find the form by clicking on this link: https://www.tga.gov.au/hubs/transvaginal-mesh
- Select the Medical Device Reporting Form and complete the form. You only need to complete the boxes in red.
The information about your mesh is on the Implant log sticker. Do not worry about the manufacturer details as the TGA have those details but you must write the name of the mesh exactly as it is written on the sticker.
- Alternately you can download a copy of the word document or pdf and email or post it back to the TGA by clicking on this link.
- Medical Devices form example.
Please click here to download the sample form.
- You will receive a standard letter back from the TGA advising you that your report has been received.
Finally, we cannot stress how important it is that we get as many reports as possible completed.
If you are still struggling, please don’t hesitate to contact us by clicking the ‘send us an email’ button and we will assist you assist you as best we can.