Adverse Events Spur FDA Reconsideration of Essure Birth ControlJul 20, 2015
The Food and Drug Administration (FDA) is reconsidering Essure, the only nonsurgical permanent birth control option currently approved by the agency after numerous complaints from women who have the device.
Essure, a permanent form of birth control that is implanted in the fallopian tubes, was approved by the FDA in 2002, National Public Radio (NPR) reports. In an office procedure, a doctor inserts the flexible metal springs made from a nickel-titanium alloy into each fallopian tube. Scar tissue grows around the spring, blocking the tube and preventing eggs from becoming fertilized or making their way to the uterus. Three months after the procedure, the woman has a follow-up X-ray using dye to confirm that the tubes are fully blocked. Once the blockage is confirmed, the method is considered 99.83 percent effective.
Andrea Dykeman, who had Essure implanted in September 2010, experienced a range of symptoms: chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression and severe bloating that she feel she looked pregnant, NPR reports. Dykeman learned through a Facebook group of more than 18,000 women who had experienced similar symptoms they attributed to Essure. Though Essure is designed to be permanent, Dykeman and many other women have had it removed, according to NPR. The women are frustrated that doctors, the FDA, and Bayer, the manufacturer, dismissed their concerns for years.
Bayer said Essure passed a detailed FDA process before the company could sell it. "Essure was reviewed through the premarket approval process for Class III medical devices, the most stringent type of device marketing application, according to the FDA," according to Tara DiFlumeri, a spokeswoman for Bayer. Based on clinical trial data, known effects immediately after the procedure include cramping, vaginal bleeding, nausea, vomiting, fainting and pelvic or back pain for several days. In rare cases, the body can expel a coil. Long-term risks include chronic pelvic pain; allergic reactions to the nickel; a coil perforating the fallopian tube or uterus; or the coil migrating through the tube, requiring surgery. Women with Essure also have a higher risk of ectopic pregnancies, NPR reports.
Based on many complaints, the FDA is now reconsidering Essure, and has updated the list of risks and adverse events reported on its web site. The agency has also scheduled a public advisory meeting of its Obstetrics and Gynecology Devices Panel on September 24 that will bring together experts, physicians, patients, and industry advocates to review the data and hear public comments from Essure recipients. The committee could consider whether Bayer needs to amend labeling or conduct additional studies, said FDA spokesman Eric Pahon.
A major question is whether Essure is the cause of the problems many women have reported and how common the problems are. According to Dr. Elizabeth Micks, an OB-GYN and contraception specialist at the University of Washington Medical Center in Seattle, women may attribute health concerns to their method of birth control, even if their method cannot feasibly cause some of those complaints, according to NPR. But, Micks said she thinks "it is very clear that some women have been harmed by the Essure device." Micks said she would like to see more data on long-term complications. The longest study currently available is a 10-year retrospective study focused primarily on pregnancies and the method's effectiveness.