Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Condition: Sterility, Female; Contraception; Contraceptive Device; Complications
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      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.

      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 healthcare, 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 2 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)? 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.
    

Detailed description: 
      Study Aims:

      Aim 1. To compare the real world effectiveness of hysteroscopic sterilization, laparoscopic
      sterilization and intrauterine devices (IUDs) by calculating:

        1. Pregnancy rates at 3, 6, 12, 24, 36, 48, and 60 months post-procedure, indicating
           sterilization failure.

        2. Patient's ability to rely on sterilization after hysteroscopic sterilization (blocked
           tubes on hysterosalpingogram) compared to laparoscopic sterilization and IUDs at 3, 6,
           12, 24, 36, 48, and 60 months post-procedure, indicating concern of sterilization
           failure.

      Aim 2. To compare safety and complications after hysteroscopic sterilization laparoscopic
      sterilization, and IUD placement by:

        1. Evaluating rates of reoperation to achieve sterilization or reinsertion to achieve IUD
           placement at 3, 6, 12, 24, 36, 48, and 60 months post-procedure.

        2. Evaluating other outcomes suggested by patient partners, including additional surgeries
           due to complications, chronic pain, and/or depression, by measuring claims for narcotic
           prescriptions, and antidepressants at 3, 6, 12, 24, 36, 48, 60 months post-procedure
           (hysteroscopic sterilization, laparoscopic sterilization, or IUD placement).

        3. Identify sociodemographic and pre-sterilization clinical variables which may predict
           complications following hysteroscopic sterilization compared to laparoscopic
           sterilization and to IUDs.
    

Intervention name(s): Essure; Laparoscopic sterilization; Intrauterine Device (IUD)
Intervention type(s): Device; Procedure; Device
Intervention description(s): Essure hysteroscopic sterilization; Laparoscopic sterilization via electrocautery, ring, or clip.; Intrauterine Device (IUD)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We will use linked data from Centers for Medicare and Medicaid Services (CMS) Research Data
        Assistance Center (ResDAC) including research identifiable files (RIF) containing Medicaid
        records, known as the Medicaid Analytic Extract (MAX) files to identify women who have
        undergone hysteroscopic or laparoscopic sterilization procedures or IUD placement. The MAX
        files contain claims, encounters, and eligibility information on recipients of California's
        Medicaid program (Medi-Cal).