Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

Inclusion Criteria: * • Women aged 18 to 45 * Women who are seeking permanent contraception * Women who are at risk of becoming pregnant * Willing to risk becoming pregnant when relying on the Adiana device for contraception * Relatively normal uterine cavity, uterine wall thickness, and uterine size as demonstrated by pelvic sonography * Willing to keep a coital/menstrual log * Have at least one confirmed pregnancy and one living child * Monogamous relationship with a partner who has proven fertility * Sexually active (at least 4 acts of intercourse per month) * Willing to use alternate contraception (either a barrier method or oral contraceptive pills or other monthly, cyclic, hormonal birth control) during the three months following device placement prior to relying on the Adiana device for contraception * Willing and able to maintain in regular contact with the investigator * Women with regular, cyclical menses within 2 months prior to the device placement procedure * Able to provide informed consent Exclusion Criteria: * Women who are unsure of their desire to end their fertility * Presence of gross genital infection, including sepsis * Presence of chlamydia, gonorrhea or syphilis * Presence of genital cancer (note: CIN1 is acceptable) * Intra-uterine pathology which would prevent optimal access to the tubal ostium and intramural portion of the fallopian tube, such as large submucous fibroids or uterine adhesions * History of chronic pelvic pain (present within the previous year), prior ectopic pregnancy, or fallopian tube surgery, or currently diagnosed severe dysmenorrhea, severe dyspareunia, endometriosis, adenomyosis, or pelvic inflammatory disease * Women with unresolved tubal, ovarian or endometrial pathology * Uterine neoplasia or precursors to neoplasia * Dysfunctional uterine bleeding or intermenstrual bleeding within the prior three months * Women who have not had at least two normal periods after the following events: irregular periods treated with oral contraceptives (or other monthly, cyclic, hormonal birth control) which have since been discontinued, IUD removal, childbirth, or termination of pregnancy * Currently taking immunosuppressive medications including steroids * Pregnancy * Uterine perforation within the last 3 months * Contraindications for surgical methods of sterilization * Less than three months have passed since the last delivery or abortion