Concerns over female sterilisation device
A study published in the BMJ has highlighted concerns over implant based female sterilisation using the Essure device which blocks the fallopian tubes. Women who undergo the hysteropic sterilisation procedure have a significantly heightened risk of reoperation following complications, which the study’s authors have highlighted as a serious safety concern.
"With an estimated 600,000 sterilisation procedures performed in the US every year, the device based hysteroscopic sterilisation has a major public health impact," write the authors. They conclude that the "benefits and risks of both procedures should be discussed with patients for informed decisions making.”
Researchers compared the performance, safety and other outcomes of the two leading forms of sterilisation, hysteropic sterilisation and laparascopic sterilisation in 52,326 US women between 2005 and 2013 and found:
-Hysteroscopic sterilisation was associated with over 10-fold higher risk of reoperation;
-Women who underwent hysteroscopic sterilisation were more likely to be older (more than 40 years), have a history of pelvic inflammatory disease and caesarean section
-The risk of unintended pregnancy was comparable in the “Essure’ and laparoscopic sterilisation groups, however the overall chance of unintended pregnancy was found to be approximately one in 100 after use of the “Essure” device. This is higher than reported in previous studies.
The authors also found that the use of laparoscopic sterilisation decreased from 7,852 cases in 2005 to 3517 cases in 2013. Meanwhile, the use of hysteroscopic sterilisation significantly increased from 45 cases in 2005 to 1,231 cases in 2013.
The “Essure” device received approval in Europe in 2001 and was approved by the US Food and Drug Administration (FDA) in 2002. Since its approval, thousands of concerns have been received by the FDA, and device failure became a subject of litigation in 2014.
This was an observational study which means that some unmeasured factors may have influenced the relationship between use of the "Essure" device and the increased risk of reoperation.
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