Bayer Healthcare is facing a new Essure lawsuit from a Connecticut woman alleging that the product caused her to suffer unexpected pain and suffering.

The woman claimed that she had experienced serious Essure complications that Bayer Healthcare had failed to protect her from.

Plaintiff April had the Essure birth control coils implanted into her on March 11, 2012, opting for permanent sterilization. At the time of her procedure, April and her physician relied on the product’s label to warn against any Essure side effects, according to the claim.

Essure is the first and only permanent, non-surgical form of birth control in the United States that is considered a breakthrough in contraceptive technology. Originally manufactured by Conceptus and purchased by Bayer, Essure was approved by the FDA in 2002.

Essure was approved through the FDA’s fast track review system, due to the company being the first to offer a non-surgical method for female sterilization. This device consists of two flexible metal and polyester coils which are implanted inside each fallopian tube.

When the tissue eventually swells around the metal coils, conception is completely blocked. Essure is often advertised as a safer and simpler alternative to tubal ligation and has soared in popularity since its release.

However a number of women have reported Essure side effects, allegedly due to the defective design and lack of safety information of the product.

Overview of Essure Side Effects

Less than a year later on Feb. 13, 2013, April underwent a hysterectomy to remove the Essure coils. She came to this decision after suffering unexpected Essure side effects of which she had no knowledge at the time.

The Essure complications listed in her lawsuit included: pelvic pain, weight gain, heavy bleeding, blood clot formation, painful intercourse, hair loss, and depression. These symptoms made keeping the Essure in place impossible, prompting April to remove the contraceptive as soon as possible.

According to her lawsuit, many women have reported similar and more serious Essure side effects including: organ perforation, allergic reactions, miscarriage, and ectopic pregnancies.

Each of these women allege that they were not warned of these Essure complications, and that they never would used used the contraceptive if they had known of the potential problems. Since its approval, over 4,500 Essure side effect reports have been submitted to the FDA.

April is included among these women with adverse reports, with her Essure lawsuit stating that she had no reasonable way of knowing the potential injuries she could sustain while using the device. There were no warnings or studies provided to her physician, nor had the defendant notified her physician of the dangers, the claim indicated.

For the company’s responsibility of manufacturing, selling, distributing, and marketing an allegedly dangerous product, April is suing Bayer Healthcare. The charges in April’s Essure lawsuit include: negligence, false advertising, concealing information, and misrepresenting a product.

The Essure Lawsuit is Case No. 3:2016cv00253, in the U.S. District Court for the District of Connecticut.