Fears that sterilization procedure is unsafe
http://www.medicalnewstoday.com/articles/300921.php
Patients undergoing hysteroscopic sterilization have a far higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization, according to research published in The BMJ.
The benefits and risks of both procedures should be discussed with patients to help them decide on the best option, conclude the team from Cornell University in Ithaca, NY.
Female sterilization is one of the most commonly used methods of contraception globally, and is used by over 10 million women of reproductive age in the US.
Laparoscopic sterilization has been the primary method of sterilization for decades. It is a surgical procedure that clips, stitches or burns the fallopian tubes to prevent pregnancy, and requires general anesthetic.
Hysteroscopic sterilization was developed more recently as a less invasive alternative; it involves implanting the "Essure" device to block the fallopian tubes. It does not require general anesthetic or surgery.
Approved, but is it safe?
The Essure device received approval in Europe in 2001 and was approved by the US Food and Drug Administration (FDA) in 2002. Its safety has been considered to be similar or superior to that of laparoscopic sterilization.
It is used in North America, Europe, Australia, New Zealand, Central and South America and the Middle East.
However, a number of problems have been reported following the hysteroscopic approach.
The procedure has a 3-month post-procedure waiting period before sterilization becomes effective. Reports have also associated it with a higher risk of unintended pregnancy.
Other reported complications related to the device have included pelvic pain, hemorrhage and device migration or incompatibility, necessitating reoperation.
After thousands of concerns were received by the FDA, the device failure became a subject of litigation in 2014.
No randomized controlled trial or large comparative cohort study had been conducted to compare the efficacy and safety of hysteroscopic and laparoscopic sterilization.
The researchers therefore carried out the study to compare the performance, safety and other outcomes of the two procedures. They also conducted sub-group analyses by age and important risk factors.
Using statewide and all-inclusive population data, they analyzed information on 8,048 women who underwent hysteroscopic sterilization and 44,278 who underwent laparoscopic sterilization in outpatient settings between 2005 and 2013 in the New York State.
Increased risk of reoperation and complications
They looked at complications within 30 days of the initial sterilization procedure and investigated unintended pregnancies and reoperation up to 3 years after the initial sterilization procedure.
They found that both methods have a similar risk of unintended pregnancy, but the risk of reoperation associated with hysteroscopic sterilization is more than 10 times higher - the equivalent to around 21 additional reoperations per 1,000 patients undergoing surgery. The authors warn that this is a "serious safety concern."
The likelihood of reoperation was eight times higher at 2 years after the initial operation and six times higher after 3 years.
Women who underwent hysteroscopic sterilization were more likely to be over 40 years old and have a history of pelvic inflammatory disease and cesarean section. Nevertheless, the higher risk of reoperation persisted in the various age groups and women with history of pelvic inflammatory disease.
The overall risk of unintended pregnancy for both groups was comparable; with the Essure device it was approximately 1 in 100, which is higher than reported in previous studies.
The authors also found that as the laparoscopic procedure has declined in popularity, the hysteroscopic procedure has become more common.
The use of laparoscopic sterilization decreased from 7,852 cases in 2005 to 3517 cases in 2013, while the use of hysteroscopic sterilization significantly increased from 45 cases in 2005 to 1,231 cases in 2013.
The authors comment:
Quote:
|
"With an estimated 600,000 sterilization procedures performed in the US every year, the device-based hysteroscopic sterilization has a major public health impact."
|
Limitations of the study include the fact that, being an observational study, some unmeasured factors may have influenced the relationship between use of the Essure device and the increased risk of reoperation.