The Essure sterilization process provided an alternative to the invasive procedure known as tubal ligation when the medical device was first approved in 2002 by the U.S. Food and Drug Administration (FDA).

The Essure twin coils—made of a nickel-titanium combination and polyester—were made to be implanted in a woman’s fallopian tubes. The process which was supposed to be so much more convenient because it could be done inside of a normal doctor’s visit rather than in an operating theater under general anesthesia.

The process of achieving Essure sterilization was, of course, more complicated than the mere implantation time. The coils were meant to occlude the fallopian tubes and thus prevent the union of ripened ova and active sperm that would normally initiate the formation of embryonic life. The full blockage of the tubes takes up to three months during which a woman is advised to use a backup birth control method with her sexual partner.

Essure sterilization is verified by a hysterosalpingogram—a diagnostic test that investigates the internal shape and function of the uterus and fallopian tubes by injecting a radio-opaque substance through the cervix into the internal cavity of the womb.

The test uses a series of X-rays to follow the substance and determine whether it travels through the tubes or is stopped by the resultant scar tissue which should have developed around the coils. This same test is used to verify Fallopian tube rupture in cases of tubal pregnancy.

The Complaints Mount

Women’s experiences of the Essure sterilization process were not even as purportedly convenient as this real-time outline of implantation and subsequent testing would indicate. Complaints from recipients painted a picture of alleged device failure that could be experienced in many ways. Among the adverse event reports were stories of:

• Uncontrolled bleeding
• Unwanted pregnancy
• Organ perforation by the device
• Severe pain and inflammation
• Bodily expulsion of birth control coils and breakage
• Hair loss
• Allergic reactions to the metal in the coils

According to an article by Mogul, in response to this growing body of complaints, the FDA warned and cited the Bayer Co. on multiple occasions as early as 2008.

The warnings were given for using unapproved materials in the device’s manufacturing and the drug oversight agency made more than one request for additional post-market clinical safety trials.

To date, 16,000 Essure sterilization individual lawsuits have been filed against Bayer. No class action lawsuit has been initiated by any of the plaintiffs involved. Complainants are choosing to hold Bayer liable for manufacturing and advertising the device on the basis of its alleged convenience while keeping silent on its risks and potential side effects.

Litigants claim that the pharmaceutical giant withheld information when seeking FDA approval for coils. It is this approval which is keeping Bayer somewhat legally protected for the time being.

Women that have been implanted with Essure coils and had some of these negative experiences are encouraged to keep precise records of all related medical interventions and to speak with an expert product liability attorney regarding their experiences now rather than later.

Filing a legal claim may help to secure funds in the future that could pay retroactively for all medical and hospital care as well as pain and suffering.