HOUSTON – A new study confirms the Essure device is linked to 10 times as many problems as simply have tubes tied. Essure, a permanent, non-surgical form of birth control, sterilizes women by plugging the fallopian tubes. It consists of metallic coils inserted into the fallopian tubes.
An estimated 750,000 women have had the Essure sterilization device implanted since it was approved in 2002. Many opted for the implant to avoid major surgery involved in other permanent birth control procedures.
But the new research finds many women who had Essure ended up having to have surgery anyway.
Last month, the Food and Drug Administration held a public hearing on Essure. It came after thousands of women nationwide said they developed a variety of symptoms after Essure, including severe pain, nickel allergies, bleeding and fatigue.
As KPRC 2 News' Haley Hernandez reported earlier this year, some Houston women have complained of bleeding, pain and even got pregnant after the Essure device was inserted. Some women ultimately needed a hysterectomy.
Researchers from Weill Cornell Medical College analyzed data on more than 50,000 women in New York who had different kinds of sterilization procedures. Those who had Essure were 10 times more likely to later undergo surgery than if they'd had sterilization surgery in the first place.
"In some instances, it might be extensive surgery, a major surgery, to correct the problems if the device perforated, perforated another organ, or if it perforated the uterus," said Dr. Art Sedrakyan, with Weill Cornell Medical College. "I think there are more complicated events that can happen and a lot that require a major surgery."
Steven Immergut, the head of communications and pharmaceuticals at Bayer Corp, the maker of Essure, supplied the following statement: