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:
"Essure is a highly effective birth control option with a positive benefit-risk profile for women who have completed their families and want permanent contraception with a non-surgical procedure. Over a decade of research and development and a decade of real world experience supports the safety and efficacy of Essure. The findings of the BMJ article published on Oct. 13, 2015, further support the established high efficacy rate of Essure. However, this observational study has a number of limitations and makes several assumptions that require clarification to prevent misunderstanding among patients and healthcare professionals."
"It is important to note that this study is based on a single database of one U.S. state and it is unclear if the data includes patients who underwent Essure in office settings. Further, the authors use the term "reoperation" ambiguously, and acknowledge that unmeasured factors may have influenced the relationship between use of Essure and reoperation."
"As the authors note, the rate of reoperation after Essure in this study may be related to "detection bias." A required Essure confirmation test is administered three months after the procedure to determine whether or not a woman's fallopian tubes are blocked and she can rely on Essure for birth control. This follow-up test may detect unsatisfactory device placement, resulting in the need for "reoperation" to remove the device and/or complete a tubal ligation if sterilization is still desired. Because there is no confirmation test that could identify potential failure of a laparoscopic tubal ligation procedure, it stands to reason that the comparative reoperation rate would be lower."
"Bayer is fully committed to helping provide physicians the tools they need to appropriately counsel women when they are considering Essure and to reinforce the importance of the three-month confirmation test and use of an alternate form of birth control until a satisfactory confirmation test is documented critical steps that can impact safe and effective use of Essure."
"No form of birth control is without risk and should be considered appropriate for every woman. It is imperative that women consult with their healthcare providers before making any contraceptive choice, to fully understand both the benefits and risks and determine the best option to meet their needs. It is also important for women to continue that dialogue anytime they have any concerns or questions about a product or procedure."