After 3 months, your doctor will perform an Essure Confirmation Test, a special type of x-ray to confirm that your tubes are completely blocked and you can rely on the Essure micro-inserts for birth control.

Unlike birth control pills, patches, rings, and some forms of IUDs, Essure does not contain hormones to interfere with your natural menstrual cycle. Your periods should more or less continue in their natural state.


BENEFITS and RISKS

Benefits of the Essure procedure

Effective
The Essure procedure is 99.80% effective based on 4 years of follow-up. Essure is the first and only FDA approved method of female sterilization. There were zero pregnancies in the clinical trials.

No incisions or burning
The Essure micro-inserts are passed through the body’s natural pathways and inserted into the fallopian tubes. Unlike other forms of tubal sterilization, there is no cutting into the body, burning, or destruction of the fallopian tubes.

Quick recovery
The Essure procedure takes very little time out of women’s busy lives and most women return to their normal activities within one day.

No general anesthesia required
There are risks and side effects associated with general anesthesia. Although some physicians may offer general anesthesia, this is not a requirement of the procedure. You should discuss your anesthesia options with your Essure physician.

Short procedure time
The Essure procedure only takes about 35 minutes for an Essure trained physician to perform. Most women are on their way in an average of 45 minutes.

No hormones or silicone
Unlike many temporary methods of birth control such as birth control pills, the patch, the ring or some IUDs, the Essure micro-inserts do not contain silicone or release hormones and are made with the same kind of safe materials that have been used in other medical devices (such as heart stents and valves) for many years. 

Can be performed in a doctor's office
Because there is no cutting or general anesthesia required the Essure procedure can be performed safely and comfortably in a doctor's office.

Covered by insurance 
The Essure procedure is covered by most health insurance plans. Check with your health insurance company to see if the Essure procedure is covered for you.

Risks of the Essure procedure

• Perforation, expulsion, or other unsatisfactory location of the micro-insert
• Pregnancy & theoretical increased risk of ectopic pregnancy
• Risks associated with anesthesia
• Pain, cramping, vaginal bleeding, menstrual pattern changes
• Nausea/vomiting, or fainting

As with all procedures, there are risks associated with the Essure procedure. Learn more about key risks and considerations.


CLINICAL TESTING

Conceptus has conducted research and clinical testing of its micro-insert technology since 1997 in several separate clinical trials. These trials were conducted under strict guidelines in the United States, Europe, Australia, and Mexico:

• Phase 1A - placement of micro-inserts
• Phase 1B - placement and comfort of micro-inserts
• Phase II Study - preliminary safety and effectiveness
• Pivotal Trial - safety and effectiveness

Clinical testing has shown that the Essure procedure:

• Is 99.80% effective in preventing pregnancy based on four years of follow-up
• Can be performed in about 35 minutes without incisions or general anesthesia
• Provides for a rapid recovery and return to all things important to women
• Has a high patient satisfaction rating

Phase 1A - Placement feasibility of micro-inserts
In this early clinical trial, micro-inserts were placed in patients immediately before a planned hysterectomy, which was previously planned for medical purposes. These patients never relied on the micro-inserts for birth control, but evidence was obtained that micro-inserts could be safely placed in the fallopian tubes.

Phase 1B - Placement feasibility and comfort of micro-inserts
In this second clinical trial, patients had micro-inserts placed up to 30 weeks before planned hysterectomies, so they never relied on the micro-inserts for birth control. After the hysterectomy, the tubes containing micro-inserts were examined under a microscope by an independent specialist. The specialist found that the tissue response to the micro-inserts caused sterilization. Additionally, this clinical trial provided evidence that micro-inserts could be safely placed in awake patients, and women were comfortable with micro-inserts in their fallopian tubes.

Phase II Study - Preliminary safety and effectiveness
The Phase 1A and 1B clinical trials, discussed above, provided evidence that micro-inserts could be safely placed into fallopian tubes and were well tolerated by women. The Phase II Study was conducted to obtain evidence about the effectiveness and long-term use of the Essure system. The study involved about 200 women seeking permanent birth control from the United States, Europe, and Australia. From this study we obtained evidence that the Essure procedure was effective and well tolerated by women. This data supported testing in a larger group of women. Follow-up of all Phase II patients is continuing.

Pivotal Trial - Safety and effectiveness
Based on the positive results obtained from earlier clinical trials, a Pivotal Trial of the Essure procedure was conducted in about 450 women from the United States, Europe, and Australia. Follow-up of all Pivotal Trial patients is continuing.

Results from the Phase II and the Pivotal trials showed:

• Essure is 99.80% effective based on four years of follow-up
• Almost all women employed outside the home returned to work 24 hours or less after the day of the procedure
• Almost all women rated their comfort as “good” to “excellent” within one week of the procedure
• Almost all women rated their satisfaction with the Essure procedure as “somewhat satisfied” to “very satisfied” after the one-week visit

Here are some Frequently Asked Questions about the Essure Procedure:
(Just click on the question to get the answer)