Though the Essure contraceptive device was hailed as a breakthrough for women when it came on the market, a citizens group is calling on the FDA to take the device off the market and newly published data may bolster their claims.
Essure, a permanent birth control method, is a non-surgical sterilization procedure that can be performed in a doctor’s office in about ten minutes with minimal anesthesia. But thousands of women have reported serious injuries from the implant, the New York Times reports. A number of patients have sued Bayer HealthCare Pharmaceuticals, the device’s manufacturer, and patient groups will meet with Bayer officials this week to discuss their concerns.
Troubling long-term data on Essure was published last week after an eight-year delay, the Times reports. The FDA has received more than 4,000 reports of serious complications associated with Essure; these include severe back and pelvic pain, heavy prolonged menstrual periods, painful intercourse, and coils that perforated the fallopian tubes and lodged in other organs. A citizens’ group, assisted by famed consumer activist Erin Brockovich, filed a petition with the FDA calling for Essure to be removed from the market. The petition claims 16,047 complaints were made to Essure’s original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired the company, according to the Times.
Essure is a small metal and polyester coil inserted into a woman’s fallopian tubes. It works by causing scar tissue to form, blocking the fallopian tubes and preventing sperm from reaching an ovum. The scarring process can take three months, and the woman must use other contraceptives until testing confirms the tubes are blocked, according to the Times.
Among representative cases of women who report injuries from Essure is a 42-year-old woman from Tannersville, N.Y. For two years after she had Essure inserted in 2009, she experienced severe pain and nonstop bleeding. The coils had lodged in her uterus and had broken apart. The woman needed several surgeries, including a hysterectomy, to remove the device fragments, according to the Times. Another woman, who participated in an early trial of Essure when she was 28, developed a sharp pain in her right hip that did not go away. She also experienced painful menstrual periods, fatigue, migraines and joint pain serious enough to make it difficult for her to work.
Because there is no device comparable to Essure on the market, and because Bayer will not say how many American women have it, experts find it difficult to judge whether the risks are disproportionate for such a device, according to the Times. In a safety trial with 269 women, ages 23 to 45, nine women had a coil perforate the fallopian tube, or a coil was expelled or lodged elsewhere in the woman’s body, according to a 2003 report in Human Reproduction. In a later trial with 518 women, only 449 of the women were able to rely on the device to prevent pregnancy. In 21 instances, the implant perforated the fallopian tubes, was expelled, or ended up elsewhere in the body. At least eight women had surgery to be sterilized or to remove a coil that had migrated.