Bayer HealthCare is facing a new Essure injury lawsuit, which was filed by a woman from South Carolina alleging the permanent contraceptive caused her serious injuries.

The Essure injury lawsuit alleges Bayer HealthCare either knew or should have known about the severe device complications, but failed to disclose this information to the general public.

Plaintiff Quanisha M. filed this Essure injury lawsuit, after discovering other women suffered similar events that had compromised their gynecological health. The Essure birth control device is the only non surgical alternative to tubal ligation, making it a minimally invasive female sterilization method.

Essure birth control consists of two metal coils which are implanted into each of the fallopian tubes. The surrounding tissue eventually swells around the coils and permanently prevents sperm-to-egg fertilization.

The Essure birth control was instantly popular when it was released in 2002 because it was seen as a more convenient and minimally invasive alternative to tubal ligation. Essure was approved through the FDA’s fast track review system, and was considered a revolutionary breakthrough for women’s health.

However, a number of women have alleged the Essure coils are unreasonably dangerous to patients, compromising the health of numerous women. This was allegedly the case with Quanisha, who alleges the coils caused severe and permanent injuries.

Overview of Essure Injury Lawsuit

According to the Essure injury lawsuit, Quanisha had the Essure coils implanted on May 29, 2009 after discussing the decision with her physician. However, not long after the device was implanted, Quanisha reportedly developed a number of serious complications that left permanent injuries.

Quanisha opted to file this Essure injury lawsuit after learning of the FDA’s recent Feb. 29, 2016 anncouncement. On this date, the FDA ordered healthcare professionals to go over a checklist with patients and require their signature to ensure that they understood the risks associated with the product.

The point of this checklist is to ensure that patients considering the Essure birth control device understand all the risks and benefits the contraceptive offers, before having the device implanted. The FDA further ordered that a detailed black box warning be added to the Essure warning label, to warn against potential Essure complications including:

• Allergic eactions
• Bloating
• Organ perforation
• Pelvic pain
• Unexpected pregnancy
• Miscarriage
• Ectopic pregnancy

Bayer HealthCare allegedly knew of these complications, but had withheld this vital product safety information for years. This caused Quanisha and numerous other women to suffer Essure complications, with some of these women leading a campaign to recall the Essure birth control device from the market.

At this point in time, over 4,500 injury reports have been submitted to the FDA regarding Essure complications. Quanisha states she would not have agreed to have the Essure birth control implanted if she had known about the potential device complications.

At all times relevant, Quanisha relied on all the marketing materials and product information provided by Bayer and had no way of discovering the dangerous nature of the Essure birth control until the FDA’s announcement.

Quanisha is filing this Essure injury lawsuit seeking multiple damages, including counts of negligence and failure to warn.

This Essure Injury Lawsuit is Case No. 2:18-cv-02678-MMB, in the U.S. District Court of Eastern Pennsylvania.