In 2002, Bayer Pharmaceutical invented a relatively non-invasive form of permanent birth control, known as Essure. The Essure procedure can be done in several minutes by a gynecologist, has a recovery time of approximately two days, and does not require an anesthetic, unlike tubal litigation (colloquially known as “getting your tubes tied”). Essure is a nickel and titanium covered coil that is inserted into each of a women’s fallopian tubes. The women must take another form of birth control three months after the procedure. During this time, scare tissue forms around the two coils, blocking the tubes and making it impossible for sperm to fertilize any eggs. After the three months pass, the women can be completely dependent on Essure. This means that they will not experience the hormone imbalances caused by traditional forms of birth control, and they will experience mensural cycles and menopause as normal.
While this may sound like an attractive alternative to tubal litigation, the Essure coils have been the cause of serious health issues for thousands of women over the past fourteen years. Many have ensued due to the coils being improperly inserted or breaking apart inside the fallopian tubes. The pieces or the whole coil then essentially get lost in the women’s reproductive system or abdomen. This has led to organ perforation, additional surgeries, including total hysterectomies, and nickel poisoning, among other problems. Troubles were not exclusive to women that had the coils migrate from their fallopian tubes, however. Many of the harmful side-effect persisted over long periods of time after the procedure was seemingly a success. Women reported weight gain, extreme pelvic and back pain, and cramps that continued to hinder their daily lives after they had the Essure Permanent Birth Control procedure. Furthermore, a study published in the British Medical Journal proves that complications that require surgery increase tenfold in patients who undergo Essure’s method of permanent birth control relative to those who undergo traditional permanent sterilization.
As many as 10,000 cases of Essure malfunctions have been reported to the FDA. This prompted them to launch an investigation into the safety of the product in mid-2015. As of February 2016, the FDA has stated that health problems associated with Essure are significant enough that a recall could be issued in the near future. They will force Bayer to conduct a long-term study on the safety of its product and the health of the patients. They additionally required Bayer to add a “black box” warning to the product’s label, which would point out the potentially life-threatening side-effects the Essure coils have caused. Potential Essure users and their doctors must now sign a “patient decision checklist” proving that the two have discussed the risks and benefits of the device and procedure.
See more here at the FDA website.