Bayer Healthcare Pharmaceutical's immensely popular intrauterine device (IUD), Mirena, is now subject to mass litigation throughout the country and abroad. Lesser attention is being paid to its other IUD, Essure, despite its equally damaging health effects. IUD injury attorneys at Pintas & Mullins highlight this other contraceptive device so women are better informed of their options.
IUDs are implanted by trained healthcare professionals, typically an OB/GYN, to prevent pregnancies long-term. Unlike the Mirena, Essure does not release hormones to prevent egg fertilization for up to five years; rather, the Essure is a more permanent solution, with coil devices implanted in the fallopian tubes. Physicians insert the flexible inserts internally (through the uterus) using a catheter, leaving the tip of the device outside for visual placement confirmation.
After the initial procedure, it takes about three months for the body to grow tissue and form the natural barrier to prevent pregnancy. An Essure Confirmation Test is then conducted to confirm full tube blockage. Conversely, the Mirena device is implanted into the uterus and releases a hormone, progestin, to prevent pregnancy.
Although the two IUDs work differently, the serious health risks associated with them are very similar, and both are relatively new to the market. Many experts believe, in hindsight, that Bayer's IUDs were rushed onto the market through inadequate and exaggerated clinical trials. Among their complications, both the Mirena and Essure can spontaneously migrate outside the uterus and fallopian tubes, which can cause painful perforation, adhesions, scarring, and permanent infertility.
Some of the most serious health effects associated with IUDs are ectopic pregnancies and required hysterectomies. An ectopic pregnancy occurs when the fertilized egg is unable to pass through the fallopian tube into the uterus, which can cause devastating and life-threatening effects. Forced hysterectomies usually result from extensive perforation, embedment, or severe allergic reactions.
Essure is held in place by inner stainless steel coils and an outer nickel titanium alloy coil. Surprisingly, physicians are not required to test patients for nickel allergies before implantation. One woman suffered from debilitating pain after Essure implantation, ultimately being admitted to a hospital where the surgeon had to perform an emergency hysterectomy to remove her fallopian tubes and uterus. She was only 25 years old at the time.
There are thousands of other women in the U.S. with similar Essure stories. According to the FDA, the most frequent adverse event reported by Essure patients are device migration (where the Essure falls out of travels to the end of the tube), incompatability, malposition, and breakage. Women severely injured by this device are urging patients to report their adverse events to the FDA's MedWatch program, so the device can be more closely monitored and possibly even recalled.