As part of our ongoing monitoring, we urge you to report any adverse events associated with urogynaecological surgical meshes.
The TGA believes that adverse events involving these devices are most likely under-reported. Patients may not realise their symptoms are related to an adverse event.
Urogynaecological surgical mesh is a netlike device. It is placed in and attached to the pelvis.
They are also known as transvaginal or pelvic mesh, 'sling', 'tape', 'ribbon' and 'hammock'.
The mesh is mostly used to treat two conditions:
- pelvic organ prolapse
- stress urinary incontinence.
We have been monitoring surgical meshes since 2008. Pain and erosion were the most common adverse events.
Reporting adverse events provide important information. We can use it to build a picture of a product's on-going safety profile and monitor its continuing safety.
Adverse events
Urogynaecological meshes can cause these adverse outcomes:
- punctures or lacerations of vessels, nerves, structures, or organs, including the bladder, urethra, or bowel (these may need 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
- seroma
- 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
- abscess
- swelling around the wound site
- recurrent prolapse
- contracture
- scarring
- excessive contraction or shrinkage of the tissue surrounding the mesh
- vaginal scarring, tightening and/or shortening
- constipation/defecation dysfunction
- granulation tissue formation.
Reporting problems
We encourage consumers and health professionals to report any problems with medical devices. Anyone can make a report.
For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.