| Reason for the Action |
Intrauterine surgical procedures, particularly those involving mechanical trauma to the endometrium, may be associated with the formation of intrauterine adhesions. In clinically significant cases, these adhesions may result in Asherman Syndrome. The risk may be influenced by the clinical circumstances, including the underlying condition, the extent of endometrial trauma, repeated intrauterine procedures and other patient- or procedure-related factors.
The IFU is being updated to include information regarding intrauterine adhesions and Asherman Syndrome, together with relevant warnings. |