Bayer HealthCare is facing a slew of lawsuits from numerous women who allegedly suffered complications from the Essure birth control device.

The Essure coils, which make up the device, reportedly caused a number of serious side effects for women, including allergic reactions and ectopic pregnancies that resulted from device failure.

The Essure coils are currently the only non-surgical form of female sterilization in the country, and have been prescribed to numerous women who no longer want children. The Essure device provides a quick and convenient alternative to traditional tubal ligation, being much less invasive and with a much quicker recovery time.

The Essure coils are implanted into each of the woman’s fallopian tubes, which cause the tissues to swell. These coils are made out of a nickel alloy, which is partially what spurs the swelling and ultimately prevents sperm to egg fertilization.

However this treatment mechanism has allegedly caused numerous women to suffer allergic reaction, with their having severe bodily reactions to the device such as painful cramping, unpredictable periods, bloating, and rashes.

Other complications reported in conjunction with the Essure coils are more serious, like organ perforation, pelvic pain, miscarriage, unexpected pregnancies, and ectopic pregnancies. Ectopic pregnancy occurs when the baby forms outside of the uterus, and is one of the most serious risks associated with the Essure coils.

Miscarriages have also been reported by women who the Essure coils implanted, alleging the effects of the permanent contraceptive not only failed to prevent pregnancy but had also caused the miscarriage to happen.

Overview of Essure

Numerous women have alleged that Bayer HealthCare failed to warn them against potential Essure complications, and claim that the contraceptive was unreasonably dangerous.

The Essure contraceptive was approved by the FDA in 2002, and was originally manufactured by Conceptus Inc. Bayer HealthCare later obtained the rights to the Essure coils, which has earned the company millions from its popularity.

When the Essure contraceptive was approved, it was thought to be a revolutionary breakthrough in the medical community. As the only non surgical method of female sterilization, the FDA had granted the product fast track approval and thought the Essure option would be a positive addition to women’s health.

However a growing number of women have alleged that the Essure birth control method was not properly evaluated before gaining FDA approval, and that the Essure coils were unreasonably dangerous to patients.

Consumer advocate Erin Brockovich is one of the main leaders in a campaign to recall the Essure contraceptive from the market, along with thousands of other women alleging the contraceptive should never have been released. Brockovich and other activitists are lobbying for the FDA to remove the device from the market, which the FDA has currently declined to do.

However the FDA has ordered additional cautions to doctors regarding the Essure coils, including discussing the potential device complications and evaluating each patient to determine if the permanent contraceptive is a good choice for them.

Since its release, there have been over 5,000 injury reports submitted to the FDA regarding the Essure coils.