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Women who undergo a procedure to implant Essure birth control may be ten times more likely to need additional surgery due to complications than women who undergo tubal ligation, an alternate form of sterilization.
In a study published in the medical journal the BMJ on October 13, researchers from the university’s Weill Medical College compared rates of unintended pregnancies and reoperations, as well as any safety events that occurred after women received the Essure device or tubal ligation, which is commonly referred to as having one’s “tubes tied.”
The research comes less than a month after an FDA advisory committee held a hearing on Essure risks following a large number of adverse events reported by women throughout the U.S.
Essure is an implant offered as an outpatient procedure by many medical facilities to provide long-term birth control. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
There have been growing concerns over the safety of Bayer’s Essure implant. The FDA reports that it has received at least 5,093 adverse event reports involving the device between it’s approval in November 2002 and May 31, 2015. Most of those reports were voluntary from women who received the implants and later suffered Essure complications.
According to FDA adverse event reports, there have been at least 3,353 incidents involving abdominal pain from Essure, 1,408 involving menstrual irregularities, 1383 involving headaches, 966 were reports of fatigue, 936 were reports of weight fluctuation, and there were four reported deaths.
In this latest study, researchers looked at data on more than 50,000 women undergoing either tubal ligation or an Essure sterilization procedure, known as hysteroscopic sterilization. The study looked for safety issues in the first thirty days, and then need of reoperation or unintended pregnancy over the next year.
Researchers found that women who were likely to get the Essure were older than those getting tubal ligation on average, and more likely to have a history of pelvic inflammatory disease, major abdominal surgery and cesarean section.
While neither technique showed significant rates of unintended pregnancy, those who were implanted with the Essure were 10 times more likely to have to undergo additional surgery due to complications compared to those who had tubal ligation. A history of pelvic inflammatory disease accounted for some of the increased risk, according to the researchers, which may have only been a factor in a fraction of the incidents.
According to the researchers, the reoperation risk with the Essure translated to 21 additional surgeries per 1,000 women who received the implant.
“A more than 10-fold higher occurrence of reoperation during the first year following Essure based surgery is a serious safety concern,” the researchers warned. “While reoperation following sterilization procedure can be related to unintended pregnancy, the similar risk of unintended pregnancy for both procedures in our study indicated that additional surgeries were performed to alleviate complications such as device migration or incompatibility after surgery.”
At the advisory committee meeting in September, a line of women testified about just such complications, urging the committee to recommend an Essure recall to the FDA.
However, the advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. They also said Bayer should provide women with more detailed information about the risks of Essure before it is implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure.