Objective To study the nature and incidence of complications, and the ease of use associated with a uterine thermal balloon system.
Design An anonymous postal questionnaire with no follow up for non‐responders.
Setting European survey throughout the UK, France, Switzerland and the Netherlands.
Sample All users of the ThermaChoice uterine thermal balloon system in the countries stated.
Main outcome measures These were the number of procedures performed by respondents throughout Europe; the nature and incidence of intraoperative and postoperative complications, and the perceived ease of use and safety of the thermal balloon system.
Results 446 questionnaires were mailed, and there were 149 responses (33.4%). From the returned questionnaires it is possible to report on an estimated 5859 procedures performed throughout Europe. In this series, there were 14 reported intraoperative complications (0.24%), two emergency procedures, and a total of 230 postoperative complications (3.92%). This gives an overall complication rate of 4.16%.
Conclusions This survey found that the ThermaChoice system is widely used throughout Europe. Although the methodology of this retrospective study has limitations, it has shown that the system has an excellent safety record, and notably that the complication rate appears to be lower than that observed for traditional ablation techniques as reported in the MISTLETOE study. Clinicians employing this system perceive it to be very safe and easy to use compared with traditional transcervical resection of endometrium. For the future, it is important to prospectively collect this data in order to gain the same information for the second‐generation devices, as is available for the ‘gold standard’ techniques for endometrial ablation.