Documentation of new treatment methods
When new treatment methods are planned to be introduced into clinical practice, we believe two important questions should be asked: 1) Is the method effective and better than the standard method? and 2) Is the method safe, i.e., does not cause more complications than the standard method?
Randomised, controlled trials should be conducted to determine whether a new treatment method is better (more effective) than (a) previously used method(s). These trials can be carried out with stringent inclusion and exclusion criteria or as pragmatic trials (8). The first type of trial has a well-defined population and examines the efficacy under ideal conditions. The second type permits broader inclusion criteria and fewer exclusion criteria so that a larger segment of the relevant population is included (8). This provides information about the effectiveness that more accurately reflects typical clinical practice. No randomised, controlled trials were conducted on the Essure implant.
When new treatment methods are planned to be introduced into clinical practice, we believe two important questions should be asked: 1) Is the method effective and better than the standard method? and 2) Is the method safe?
Ideally, a pragmatic trial should have been carried out before the Essure implant was introduced. This would have hardly been possible in Norway, however, when the method was introduced in the early 2000s. At the time, limited capacity in Norwegian hospitals made it difficult to get a tubal ligation. The procedure was only prioritised in those few cases where there were medical grounds for sterilisation or the woman was undergoing surgery for other reasons.
Moreover, complications associated with a new treatment method are not always exposed in randomised, controlled trials. It is often the case that too few patients are included in the trials and the follow-up period is too short. This means it is even more important to establish registries in which all those using the new method can register their experiences on an ongoing basis.
In the case presented here, the trials conducted prior to market launch were small and of poor quality, and no registry was established either internationally or nationally (1, 3, 7). As a result, the complication rate, which was high and often serious, was discovered many years too late.
More than one million Essure implants have been sold internationally (9). A total of 15 % of the devices in the US and 16 % of those outside the US have been removed by laparoscopy/laparotomy because they could not be removed hysteroscopically (10). Exact information about the number of women with Essure implants in Norway is difficult to obtain, but the figure is likely to be several hundred (personal communication, Norwegian Patient Registry). There may be several thousand, but the codes used in the registry are unclear.