Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

Inclusion Criteria:

- Subjects who are at least 21 years of age;

- Subjects of all weights will be included;

- Subjects who are scheduled to undergo an Essure insert placement procedure for
permanent birth control or laparoscopic tubal sterilization. Decision for either
treatment based upon clinical practice and physician/patient counseling.

- For the Essure group only:

• Subjects selecting hysteroscopic sterilization who are not contraindicated for the
Essure procedure according to the most current approved version of the Essure IFU;

- For the laparoscopic tubal sterilization group only:

- Subjects selecting laparoscopic sterilization who are not contraindicated for
laparoscopic tubal sterilization according to common clinical practice standard
of care.

Exclusion Criteria:

- Subjects who are post-menopausal;

- Subjects suspected of being or confirmed pregnant;

- Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled
procedure;

- Subjects uncertain about ending fertility;

- Subjects with an active upper or lower genital tract infection;

- Subjects with gynecologic malignancy (suspected or known);

- Subjects who have had an attempted prior sterilization procedure (either laparoscopic
or hysteroscopic);

- Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at
the time of insert placement (intrauterine device removal is not considered a
concomitant procedure) or laparoscopic sterilization;

- Subjects with unexplained vaginal bleeding.