A study of women who have been implanted with the permanent contraceptive implant Essure has concerning results, according to The New York Times. Over 52,000 women received sterilization procedures in hospitals and ambulatory surgery centers between 2005 and 2013. Out of those women, over 8,000 were implanted with Essure, while the remaining 44,000 had tubal ligation.
An alarming 2.4 percent of women with Essure implants needed surgery within a year of implantation. In contrast, only 0.2 percent of women who had more traditional sterilization procedures needed additional surgery. Complications of the device or device failure necessitated these surgeries. Often, the surgery needed was a hysterectomy or a fallopian tube removal.
The device is essentially a small metal coil that is placed in the fallopian tube. The idea is that scar tissue will form around it, blocking off sperm’s access to the egg. This procedure is supposed to be significantly less invasive than a tubal ligation, which involves laparoscopic surgery. Advertised as a quick ten-minute procedure in a doctor’s office, Essure is implanted vaginally, allegedly requiring no anesthesia and requiring no incisions. However, more than half of patients who received the implant received general anesthesia. Additionally, Essure implantation costs an average of nearly $3,000 more than traditional sterilization procedures.
In some particularly dangerous instances, the device improperly pierced the fallopian tubes and lodged itself in organs. The device has caused several other serious side effects in many women, including painful and prolonged menstruation, painful intercourse, intense back and pelvic pain, chronic fatigue, and even autoimmune diseases.
The FDA held a meeting about Essure last month, where it reamed Bayer out for the dangers of its product and criticized it for its failure to collect sufficient data. Thousands of women hurt by the thirteen-year-old product are urging the FDA to take Essure off the market. As of now, the FDA has not taken any action.