A new Essure study published by the Journal of the American Medical Association indicates the non-surgical sterilization method leaves women with an increased risk of gynecological complications.

The Essure permanent birth control system has been marketed as a quick and easy alternative that offers irreversible results with no down time.

Essure consists of small metal and fiber coils that are inserted into the fallopian tubes, which are reached through the vagina. The coils instigate scar tissue to grow around the coils, blocking the fallopian tubes to stop the eggs’ release.

The Essure study compared women who had undergone laparoscopic sterilization, or having their fallopian tubes tied, with those who opted for Essure permanent implants. Researchers found that women with Essure were more apt to see the sterilization fail, requiring a second sterilization procedure.

The study indicated that 4.83 percent of Essure patients experienced failure after 12 months. After three years, that percentage rose to 5.75 percent. In comparison, laparoscopic tube tying had failure rates of .69 percent and 1.29 percent respectively.

Researchers examined data of more than 105,000 women in France who underwent sterilization between January 2010 and December 2014.

Essure Study Still Needed in U.S.

According to Milwaukee’s FOX6 News, Dr. Sanket Dhruva is a postdoctoral research fellow at Yale University. He didn’t participate in France’s research, but he has experience writing about Essure. He feels a randomized Essure study that collects data on women for a minimum of five years is still needed in the U.S., where Essure has been available to women since 2002.

Doctors concerned about Essure complications have had issues with the FDA approval in 2002 that was based on clinical trials of only 745 patients for a maximum of two years. Long-term bodily responses and the ability of the devices to stay securely in place were unknown.

Essure’s original manufacturer was Conceptus, a company accused of falsifying patient records during clinical trials. Patients who reported severe pain say they saw the Conceptus representative record that they had no pain.

Conceptus also allegedly failed to meet federally regulated post-approval obligations for Essure. The company allegedly failed to report adverse events to the FDA, failed to monitor Essure patients after pre-market approval, and failed to report any ill effects or complaints to the FDA.

In 2013, Bayer bought Essure from Conceptus. Since then, Bayer has faced multiple lawsuits filed by patients who have reportedly suffered serious adverse health issues as a result of the coils.

Women have reported reactions to the metal coils because of a nickel allergy. The coils consist of a nickel alloy, which means women who are allergic to the metal could experience fatigue, rashes and joint inflammation and pain. According to the Centers for Disease Control and Prevention, up to 20 percent of the population suffers from a nickel allergy.

Some patients’ coils have migrated to other parts of their abdominal cavity. Other women have experienced perforation of the fallopian tubes, which causes intense pain and requires Essure to be surgically removed.

Yet other symptoms are believed to stem from the PET plastic used in the fibers that cover the metal coils. PET plastic degrades and leaches toxic substances when it’s in an environment that reaches 85 degrees. The human body at 98.6 degrees is more than adequate for the toxins to deploy from the coils, leading to chronic inflammation and possible autoimmune system responses.

If you have suffered from complications that have or have not been documented in an Essure study, you could be eligible for compensation through legal representation.