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Real-world effectiveness and safety of hysteroscopic (Essure[R]) compared to laparoscopic sterilization
Investigator (PI): Gariepy, Aileen M
Performing Organization (PO): (Current): Yale University, Yale School of Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences / (203) 785-4002
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2017
Final Year: 2021
Record Source/Award ID: PCORI/APDTO-1609-36359 ; PCORI/CER-1609-36359
Funding: Total Award Amount: $1,411,873
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: The problem: More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking women's Fallopian tubes but neither are 100% effective. Both can have complications, but not enough is known to help women make an informed choice between the two. Essure is popular because it can be performed without anesthesia in a doctor's office and women can return to work the next day. However, patients have reported that the Essure procedure was unexpectedly painful. Also, women need to use other contraceptives for 3 months and then return for testing, to make sure their tubes are blocked and will prevent pregnancy. Not all women return for this test and some may get pregnant before realizing their Essure didn't work. Essure was approved by the Food and Drug Administration (FDA) in 2002, but no studies ever compared it to tubal ligation. By 2015, over 9,000 women reported serious complications to the FDA. Women who were unhappy with Essure found each other online and created a Facebook "Essure Problems" support group that now has over 31,000 members. After an FDA Advisory Board expressed concerns about Essure's risks, in 2016 the FDA required stronger warnings about complications and announced that "more rigorous research" was needed, demanding Essure's maker conduct a new study comparing the benefits and risks of Essure to tubal ligation. Unfortunately, that study will not be finished before September 2023. The solution: To provide answers as rapidly as possible for women considering sterilization, we will analyze data from the medical records of thousands of women with sterilization procedures funded by California's Medicaid. As poor women and women of color have different experiences with health care, and they more often choose sterilization, comparing these women's experiences with Essure and tubal ligation is very important. We will compare the safety and effectiveness of the two sterilization procedures to answer: How many women got pregnant afterwards? How many operations did each woman need to become infertile? Which complications did women have (i.e., chronic pain, depression, allergic symptoms)? We will also check whether certain women (such as certain age groups or those with diabetes) were most likely to have problems after either procedure. Patient engagement: Patients were involved in this study before we applied to PCORI. The "Essure Problems" Facebook group shared their experiences with our co-investigators and helped one of them survey 1,104 group members. This helped identify potential sterilization complications that need more attention. "Essure Problems" group members and women with better sterilization experiences will comprise half our advisory board and the entire Patient Perspectives Committee, to make sure the study is patient centered from start to finish.
MeSH Terms:
  • Anesthesia
  • California
  • Comparative Effectiveness Research
  • Contraceptive Agents /therapeutic use
  • Fallopian Tubes /surgery
  • Female
  • Humans
  • Hysteroscopy /*methods
  • Laparoscopy /*methods
  • Medicaid
  • Patient Safety
  • Patient-Centered Care /organization & administration
  • Pregnancy
  • Social Media
  • Sterilization, Reproductive /*methods
  • Sterilization, Tubal /*methods
  • United States
  • United States Food and Drug Administration
Country: United States
State: Connecticut
Zip Code: 06520
UI: 20181384
Project Status: Ongoing
Record History: ('2018: Project extended to 2021.',)