Long-term Data Raises Concerns about Essure Contraceptive DeviceMay 6, 2015
The Essure contraceptive device was considered a breakthrough for women when it came on the market more than ten years ago: it provided a non-surgical sterilization procedure that could be performed in a doctor's office in about ten minutes and promised a quick recovery. But thousands of women have reported serious injuries they blame on the implant and they are urging the Food and Drug Administration to take Essure off the market.
Troubling long-term data on women using Essure was published last week after an eight-year delay, 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.
Essure is a small metal and polyester coil inserted into a woman's fallopian tubes to make her permanently sterile. The coils cause scar tissue to form and block the fallopian tubes, 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.
The FDA has received more than 4,000 reports of serious complications related to Essure, including 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' petition filed with the FDA reports 16,047 complaints made to the original manufacturer, Conceptus, between 2011 and 2013, when Bayer acquired the company, the Times reports. Famed consumer activist Erin Brockovich assisted the group in collecting signatures for the petition.
Among the women who report injuries from Essure is a 42-year-old woman from Tannersville, N.Y. She experienced severe pain and nonstop bleeding for two years after receiving the implant in 2009. Doctors discovered that the coils had lodged in her uterus and had broken apart. She needed several surgeries, including a hysterectomy, to remove the device fragments, according to the Times. In another case, a 28-year-old woman, who participated in an early trial of Essure, said she developed a sharp pain in her right hip that did not go away. She experienced other symptoms including painful menstrual periods, fatigue, migraines and joint pain that interfered with her ability to work.
Because there is no other device like 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, the Times explains. In nine patients in a safety trial with 269 women, ages 23 to 45, a coil perforated the fallopian tube, or was expelled or lodged elsewhere in the woman's body, according to a 2003 report in the journal Human Reproduction. In a subsequent trial with 518 women, only 449 of them were able to rely on the device to prevent pregnancy. In 21 instances, the implant perforated the fallopian tubes, was expelled, or ended up in the wrong place in the body. At least eight women had surgery to be sterilized or to remove a misplaced coil.