Uterine Curettes

Question

? During estimates, TGA discussed notifications of adverse impacts from uterine curettes. Please confirm how many notifications have been received since January 2025, and how many were received from ? Medical practitioners ? Device manufacturers ? Affected women ? AHPRA ? Others ? Where an adverse impact was reported by a patient, how many reported a history of having a device used to remove pregnancy tissue (even if they could not identify the exact device)? ? What follow up action was taken in response to each of the adverse impact reports received by the TGA? ? Does the TGA have any record of how many adverse incident reports were made in relation to transvaginal mesh before action was taken to address those harms? ? TGA advised that they have requested sponsors of uterine curettes to include warnings about Asherman's syndrome in device packaging ? Does this request apply to both sharp and suction curettes? ? What monitoring is done to confirm that all packaging includes the requested warnings? ? Does the warning include other serious adverse outcomes, including haemorrhage and uterine perforation, or only Asherman's Syndrome? If limited to Asherman's syndrome, why? ? Do you know how many reports of adverse incidents were made in relation to transvaginal mesh before action was taken to address those harms?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002805.pdf (opens in a new tab)