By the thousands, women who have suffered injuries caused by Essure are filing claims against Bayer, the product’s manufacturer. They accuse the company of knowing about these complications but failing to provide adequate warnings.

Essure is manufactured by Bayer Healthcare and is marketed as being a non-surgical and permanent form of birth control. It is marketed as a safe and effective alternative to tubal ligation, or having one’s tubes tied. It was seen as a contraceptive breakthrough for women who wanted to be permanently sterile.

However, women who have been implanted with the device state they have suffered serious injuries caused by Essure and that the device severely worsened their health. Women allege they suffered from a multitude of serious complications including allergic reactions, organ perforation, excessive bleeding, bloating, rashes, pelvic pain, ectopic pregnancy, and miscarriage.

How Essure Works

Essure was originally manufactured by a company called Conceptus and later purchased by Bayer on June 5, 2013. It was approved by the U.S. Food and Drug Administration (FDA) in 2002.

The Essure permanent birth control implant is a small, flexible coil comprised of titanium alloy and nickel. The two flexible Essure coils are placed inside each fallopian tube after being inserted through the vagina and uterus. Over a three-month period, tissue begins to form covering the metal coils, thereby blocking contraception.

A woman then returns to her physician who confirms that the tubes are blocked by the coils, and sees a radiologist who injects dye into the woman’s cervix to confirm no leakage occurs allowing for the dye to pass through the coils. An x-ray image is taken to confirm that no leakage occurred.

Although approved by the FDA, Essure received its approval through the agency’s fast-track review system due to Essure allowing for a faster recovery time and allowing advantages to surgical sterilization.

However, there are increasing concerns of serious injuries and complications caused by Essure, as women allege the implant of being prematurely approved before all risks and concerns of the device were properly investigated.

Injuries Caused by Essure

Nearly 15,000 Essure-related adverse event reports and 30 related Essure deaths were reported to the FDA since the implants’ approval in 2002.

According to the Daily Hornet, there were 5,016 FDA medical reports filed in 2016, and 6,176 reports filed in 2015. The reports of 30 deaths included 18 losses during pregnancy, two infant deaths following birth, and deaths of four adult women.

The most commonly-reported injuries caused by Essure included abdominal pain; menstrual irregularities; bleeding; headache; fatigue; weight fluctuation; device incompatibility; device migration or breakage; allergic reaction to nickel; malposition of the device; unintended pregnancies; and perforation of the fallopian tube, colon, and uterus.

According to an article in Reuters, the FDA may have underestimated the number of fetal deaths reported in women who became pregnant despite being implanted with Esssure.

According to the article, analysis by a private firm of thousands of adverse event reports from the FDA’s website shows that 303 fetal deaths may have been associated with the permanent birth control implant.