Essure is one of the birth control methods that is implanted and a new study shows these women are about ten times more likely to need surgeries due to complications than women who choose alternate forms of sterilization including tubal ligation surgery.
The study published October 13 in the BMJ medical journal conducted by researchers from Weill Medical Collage details how researchers compared the rates of unintended pregnancies and re-operations. They also included any safety events occurring to the women who had the Essure device implanted or tubal ligation surgery.
The Essure birth control device is an implant, which is done as an outpatient procedure in medical facilities as a method of long term birth control. The surgery consists of the insertion of bendable coils into the fallopian tubes. This is done by going through the vagina, cervix and uterus and over the period of several months can cause scar tissue that cause the tubes to be blocked and prevents unintended insemination.
The findings of the study were published only a few weeks after the FDA advisory committee held a hearing on the risks of Essure after numerous complaints were made by women nationwide. Researchers found that while Essure implantation or tubal ligation did not have significant rates of unintended pregnancy, but did find increased rates of additional surgery with Essure birth control devices.
The study showed out of the more than 50,000 women undergoing either tubal ligation or Essure implantation, the Essure patient was generally older than the women with tubal ligation. The study looked at safety issues during the first thirty days, need of reoperation or unintended pregnancies over the first year.
The women with Essure birth control devices were older and often more likely to have a history of pelvic inflammatory disease, major abdominal surgery or at the time of pregnancy a cesarean section was necessary. The rate of undergoing additional surgery for the implantation device was found to be ten times higher for these women over those who chose tubal ligation. A history of pelvic inflammatory disease accounted for some increased risk, but researchers felt it only played a factor in a fraction of the additional surgeries, which researchers found to be 21 additional surgeries per 1,000 women having had the implanted device.
Researchers also found that some additional surgeries were preformed to deal with complications, including incompatibility after surgery and device migration. According to the FDA there have been at least 3,353 incidences involving abdominal pain and another 1,408 involving menstrual irregularities reported. They have received 1,383 complaints involving headaches, 966 complaints involving fatigue and 936 complaints involving weight fluctuation. There have also been four deaths reported to the federal agency involving the birth control implant.
Concerns about the safety of the birth control implant manufactured by Bayer have been increasing since its FDA approval in November 2002 and until May 31, 2015 there have been approximately 5,039 complaints of which were mostly voluntary about Essure complications. The advisory committee suggested obtaining more accurate safety data including the patient registry and new clinical studies on safety and the effectiveness of the device. The FDA suggested that Bayer should provide the women with more detailed information associated with the risks of the Essure implantation device and possible complications including a check list for the patient prior to surgery.