The âEssureâ contraceptive is under scrutiny from the U.S. Food and Drug Administration (FDA) over complaints about its safety and effectiveness. A newly released analysis has not done the device any favors.
The study shows that women who were implanted with Essure were ten times more likely, compared with those who had their âtubes tied,â to need surgery within the first year due to complications. Specifically, the Essure return-surgery rate was 2.4% while the return rate for traditional sterilizations was only 0.2%. The analysis also noted that the actual effectiveness of the two procedures in preventing pregnancy were about equal.
Essure, manufactured by the German company Bayer HealthCare, is touted as the only permanent, non-surgical form of birth control on the market. The device is a small nickel-titanium coil that is inserted into the fallopian tubes. When in place, Essure aggravates the surrounding tissue and creates scarring that blocks the passage of sperm. Most of the return surgeries needed by Essure patients observed in the study were related to either complications from the device, the outright removal of the Essure coil, or the removal of the fallopian tubes themselves.
Bayer has accused the studyâs authors of drawing a false comparison by trying to contrast Essure with traditional sterilization methods. Officials noted many of the studyâs limitationsâit was based on a single stateâs database, did not include women who were implanted at a private doctorâs office, and a precise breakdown of the follow-up operations was not provided. They also criticized the overall intention of comparing Essure to traditional sterilization, likening it to an apples-to-oranges situation.
Doctors who have more involvement with Essure note that the study would not be able to capture all of the deviceâs possible complications as well. The FDA has received over 5,000 complaints about Essure since it entered the market in 2001. Many of the reported complications involve bleeding, chronic pain, or other longer-term conditions that would not fall within the study’s purview. The most serious side effects were due to the Essure coils shifting after implantation or becoming embedded in the uterus, fallopian tube, or other nearby tissue.
The authors of the study acknowledge some of the limitations of their research, but maintain that their findings show clear âreal worldâ effects of Essure that are not visible in clinical trials. In advocating for more understanding of potential side effects, they advise a larger study that explores a longer follow-up period to properly capture the extent of what are, so far, largely anecdotal reports.
Roughly 600,000 female sterilization procedures are performed in the U.S. each year. Device-based sterilizations, like those using Essure, are becoming increasingly popular as they are seen as generally less invasive options.
Sources for Todayâs Article:
Mao, J., âSafety and Efficacy of Hysteroscopic Sterilization Compared with Laparoscopic Sterilization: An Observational Cohort Study,â British Medical Journal, 2015; doi: http://dx.doi.org/10.1136/bmj.h5162.
Rabin, R.C., âWomen With Essure Contraceptive Implant Needed More Surgeries, Study Finds,â The New York Times web site, October 13, 2015; http://well.blogs.nytimes.com/2015/10/13/women-with-essure-contraceptive-implant-needed-more-surgeries-study-finds/?ref=health.