Essure Sterilization Failure Risk Higher Than Having “Tubes Tied”

French researchers indicate that the findings of a new study suggest that the controversial Essure birth control procedure carries a higher risk of gynecological complications than laparoscopic sterilization, commonly referred to as having “tubes tied”, but that the risk of Essure complications do not result in an actual increase in medical problems. 

The study was published last week in the Journal of the American Medical Association (JAMA), indicating that the Essure implant carried a seven times higher risk of sterilization failure, and more than three times the risk for an additional operation. However, the report found no significant risk of medical outcomes when compared to laparoscopic sterilization.

Essure is designed to provide permanent sterilization, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, thousands of women have experienced painful and debilitating injuries when the coils migrated, perforated the uterus or fallopian tubes, caused allergic reactions, infections or other complications.

Researchers used the French national hospital discharge database to look at data on more than 100,000 women ages 30 to 54 who underwent a first Essure procedure, known as hysteroscopic sterilization, or laparoscopic sterilization procedure, from 2010 to 2014.

According to the findings, nearly five percent of women implanted with the Essure coils suffered sterilization failure; compared to 0.69% of women who had their tubes tied. The study also found that 5.65% of women who received the Essure required gynecological reoperation, compared to just 1.76% of women who had laparoscopic sterilization.

The findings also found that Essure procedures resulted in fewer surgical complications during the implantation procedure itself, carried a lower risk of pregnancy within the first year, but not across three years, and that the risk of medical outcomes were not significantly increased when compared to laparoscopic sterilization.

Medical outcomes, as defined by the study, included allergies, autoimmune diseases, thyroid disorder, the use of additional medications, sickness, suicide attempts and death, at the one year and three year marks.

“Among women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years,” the researchers concluded. “These findings do not support increased medical risks associated with hysteroscopic sterilization.”

Essure Injury Lawsuit

The study comes several months after Bayer announced it was halting sales of the Essure implant all over the world, except in the United States. The company claimed that the decision to stop selling Essure was a marketing decision and not related to the numerous complaints of adverse events.

In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.

The agency also required that women be provided with a checklist to make sure they are aware of the risks before undergoing an Essure coils procedure, and many medical experts suggest that no woman should elect to undergo the sterilization.

Bayer now faces a hundreds of  Essure lawsuits filed by women nationwide, each raising similar allegations that the manufacturer has known about the serious risks and failed to adequately warn women and the medical community.

Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.

The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.