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Urogynaecological Surgical Mesh Complications

2 August 2016

The Therapeutic Goods Administration has added an alert to their website as part of its ongoing monitoring of the safety of urogynaecological surgical meshes.

If you have been implanted with one of these devices for stress incontinence and/or prolapse (otherwise known as a tvt, tvto, sling, hammock, prolapse mesh, tape, ribbon) you may be suffering from complications without realising that your symptoms are associated with an adverse event.

Adverse events that may be associated with urogynaecological 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

•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.

 

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

Report Your Complications Here

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