Essure: The Controversy Behind this Female Sterilization Device
In 2002, Bayer released a permanent contraception device called Essure. The device presented women with the option of having two “soft, flexible inserts” implanted through the vagina and cervix into the fallopian tubes in a “gentle, non-surgical” procedure. Bayer promoted this approach as a drastically simpler alternative to the incision and anesthesia necessary for a tubal ligation surgery. The Essure coil-like inserts were designed to generate scar tissue to block the fallopian tubes, without releasing any disruptive hormones into the body. The women’s health community praised the device for its 99.7% accuracy and relatively simple implantation method. However, Bayer failed to adequately warn users and doctors of the dangerous side effects of the Essure birth control implant.
Since its release 15 years ago, the Food and Drug Administration (FDA) has received over 17,000 adverse-event reports regarding Essure. Women cited serious complications resulting from the device, including unusually heavy menstrual periods, extreme fatigue, hair loss, and tooth decay. Some women reported that the Essure device migrated out of the fallopian tubes and became embedded in the uterus or punctured other organs. Others who decided to have the device removed ended up needing the hysterectomy they had tried to avoid by using Essure in the first place. Several women even became pregnant despite the device being described as “the most effective form of birth control available.”
A major cause of these adverse side effects resulted from Bayer neglecting to properly study and report on the effects of a main material in the implant’s design: nickel. In fact, very little data exists on the reaction of this device in women who have a nickel allergy. This is especially dangerous considering that Essure is 55% nickel, and is being distributed to a female population in which about 20% are known to be allergic to nickel. Several experts have expressed a concern that the nickel in Essure could be activating an autoimmune reaction in women with a nickel allergy which causes the immune system to go haywire and begin to attack healthy cells.
In 2016, the FDA issued a “boxed warning” to the public on the potential dangers resulting from the use of Essure. The warning informs women and doctors of possible side effects of the device, including persistent pain, allergic reactions, and perforation of the uterus. While this represents a victory for anti-Essure activists, many see the black box warning as too little, too late. This is especially true because the device is still available to the public, and many in the United States Medical Community continue to endorse the use of Essure.
By keeping these alarming adverse events under wraps, Bayer misled thousands of women. Our experienced lawyers fight for individuals who have been harmed by defective products. If you or someone you know has suffered an injury because of Essure or became pregnant while using the device, the attorneys at the Yost Legal Group will investigate your potential claim and possible lawsuit. For a free consultation, please call us at 1-800-YOSTLAW.