A Study to Evaluate the Effectiveness of Essure Post-NovaSure Radiofrequency Endometrial Ablation Procedure Following a Successful Essure Confirmation Test

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc.,
Bayer is now the sponsor of the trial.

Inclusion Criteria:

- All inclusion criteria from the Essure Permanent Birth Control System Instructions for
Use and/or the NovaSure Impedance Controlled Endometrial Ablation (EA) System
Instructions for Use and Controller Operator's Manual will apply.

- Women experiencing menorrhagia due to benign causes

- Women who are relying on the Essure micro-inserts for permanent contraception
following a successful Essure Confirmation Test (as applicable to the Post Approval
Study)

- Women willing to accept the risk of pregnancy while relying on the Essure
micro-inserts for prevention of pregnancy following a NovaSure ablation procedure for
menorrhagia

Exclusion Criteria:

- All exclusion criteria from the Essure Permanent Birth Control System Instructions for
Use and/or the NovaSure Impedance Controlled Endometrial Ablation System Instructions
for Use and Controller Operator's Manual will apply.

- Women who previously underwent a fallopian tube sterilization procedure (other than
Essure placement)

- Women who present with any other medical complaints, conditions or symptoms unrelated
to the Essure System and/or subsequent NovaSure EA including, but not limited to:

- Gynecological co-morbidities (e.g., pelvic infection, cervicitis, undiagnosed
vaginal bleeding, endometrial cancer, myomas, and polyps)

- Reproductive tract anatomical variants and/or pathology which could make the
subject unsuitable for the Essure and/or NovaSure transcervical procedures

- Women currently wearing an intrauterine device and unwilling to have it removed before
NovaSure