Lawsuits filed over Essure birth control side effects allege that the permanent birth control implant causes serious injuries and complications, and that Bayer knew of these risks but failed to disclose that information to the public.

Essure is marketed as a permanent form of birth control, manufactured by Bayer HealthCare. It’s implanted during a short, non-surgical procedure. It is promoted as a breakthrough contraceptive device as an alternative to tubal ligation, or having one’s “tubes tied.”

However, although Bayer has long maintained that Essure is a safe and effective method for permanent birth control, many women have complained of serious injuries and complications from the Essure implant. Reported Essure birth control side effects have included allergic reactions, miscarriage, ectopic pregnancy and bloating.

The U.S. Food and Drug Administration (FDA) has recently issued a “black box” warning due to Essure birth control side effects. According to the FDA, a “black box” warning appears on a device or prescription drug label to “call attention to serious or life-threatening risks.”

Essure Birth Control

Essure, a small, flexible coil composed of titanium alloy and nickel, was approved by the FDA in 2002. It was originally manufactured by Conceptus before being bought by Bayer.

During the non-surgical procedure, coils are placed into each fallopian tube. Throughout a three-month period, a barrier forms preventing contraception as scar tissue develops around the coils.

After the three-month period, a woman returns to a radiologist to confirm that the fallopian tubes are completely blocked by the coils. To do this, a radiologist injects dye into a woman’s cervix, and an X-ray is then taken to confirm that no leakage occurred with the dye passing through passed the coils.

Essure Birth Control Side Effects

Since the product’s approval by the FDA in 2002, nearly 15,000 adverse event reports of Essure and deaths from the Essure device were reported to the FDA.

In fact, according to the Daily Hornet, the “FDA received 5,016 medical device reports involving Essure in 2016, plus another 6,176 reports in 2015, and 30 reports of deaths.”

The deaths included 18 pregnancy losses, four adult women, a stillborn baby, and two infants that died after birth.

Essure birth control side effects reported to the FDA include headaches, pain/abdominal pain, fatigue, weight changes, pregnancy, migration of Essure, broken Essure, and heavier menstrual bleeding or irregularities.

The FDA added the “black box” warning to the Essure birth control system in Nov. 2016. The warning is reserved to the most severe potential side effects of medical devices and drugs.

After receiving several complaints of serious injuries with Essure, the FDA set up a meeting of its Obstetrics and Gynecology Devices Panel, one year prior in 2015. The panel released recommendations advising women to not use Essure under certain circumstances.

The recommendations with Essure advised women, particularly those with hypersensitivity to nickel, autoimmune disorders, prior uterine surgery, and allergies, to not use the permanent contraceptive device.

The Obstetrics and Gynecology Devices Panel held Bayer accountable for failing to collect data that may have assisted women and predicted Essure birth control side effects.