Important Safety Information


WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device. Continue reading below

Identifying Patients Who May Be Counseled on Essure

Click below for examples of patient types who may be appropriate for the discussion about Essure:

OB PATIENT who does not intend to have additional children

The American College of Obstetricians and Gynecology (ACOG) recommends counseling pregnant patients regarding their postpartum contraceptive options during the second trimester.1

And the Centers for Disease Control and Prevention (CDC) now encourages healthcare providers to have their patients clarify decisions about their reproductive life plans.2

Essure is contraindicated in pregnant women and for patients who have delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure.

Example of OB Patient Why Essure May Be Right For Her
24 weeks pregnant and has decided this will be her last pregnancy With >99% efficacy at preventing pregnancy based on clinical study data, Essure is the only permanent birth control with a nonincisional procedure that may be performed in an office setting

Patient must remain on alternative contraception until a satisfactory Essure Confirmation Test is documented
Is seeking permanent contraception (at least 6 weeks postpartum) and is interested in a nonhormonal option Essure is a permanent, nonhormonal birth control procedure that uses the body’s natural processes to create a barrier against pregnancy
Does not want to worry about getting pregnant again Three months after the procedure, the Essure Confirmation Test is done to confirm that your patient can rely on Essure for birth control

IMPORTANT : For some women, it may take longer than 3 months for Essure to completely block the fallopian tubes, requiring a repeat confirmation test at 6 months

References: 1. American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 7th ed. Washington, DC: American Academy of Pediatrics and the American College of Obstetricians and Gynecologists; 2012. 2. Gavin L, Moskosky S, Carter M, et al; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: recommendation of the CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014;63(4):1-54.

GYN PATIENT who knows her family is complete

The American College of Obstetricians and Gynecology (ACOG) recommends discussing contraceptive options for prevention of unwanted pregnancy during the well-woman visit.1

And the Centers for Disease Control and Prevention (CDC) now encourages healthcare providers to have their patients clarify decisions about their reproductive life plans.2

Essure is contraindicated for patients who have delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure.

Example of GYN Patient Why Essure May Be Right for Her
Has 3 children and is in for her annual exam visit With >99% efficacy at preventing pregnancy based on clinical study data, Essure is the only permanent birth control with a nonincisional procedure that may be performed in an office setting.

Patient must remain on alternative contraception until a satisfactory Essure Confirmation Test is documented
Is currently using the pill for contraception and would like to learn more about permanent options Essure is a permanent, nonhormonal birth control procedure that uses the body’s natural processes to create a barrier against pregnancy
Doesn’t want to worry about becoming pregnant Three months after the procedure, the Essure Confirmation Test is done to confirm that your patient can rely on Essure for birth control

IMPORTANT : For some women, it may take longer than 3 months for Essure to completely block the fallopian tubes, requiring a repeat confirmation test at 6 months
Is unaware of all her permanent birth control options Essure has been FDA approved for over 10 years and remains among the most effective contraceptive options you can offer your patients who are seeking a permanent birth control option

References: 1. American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 7th ed. Washington, DC: American Academy of Pediatrics and the American College of Obstetricians and Gynecologists; 2012. 2. Gavin L, Moskosky S, Carter M, et al; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: recommendation of the CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014;63(4):1-54.

HORMONE-AVERSE PATIENT whose family is complete

The American College of Obstetricians and Gynecology (ACOG) recommends discussing contraceptive options for prevention of unwanted pregnancy during the well-woman visit.1

And the Centers for Disease Control and Prevention (CDC) now encourages healthcare providers to have their patients clarify decisions about their reproductive life plans.2

Patient must remain on alternative contraception until a satisfactory Essure Conformation Test is documented.

Example of Hormone-Averse Patient Why Essure May be Right for Her
Is uncomfortable using hormonal contraception, or is contraindicated to hormone-based birth control Essure is a permanent, nonhormonal birth control procedure that uses the body’s natural processes to create a barrier against pregnancy
Is currently using condoms and worried about getting pregnant With >99% efficacy at preventing pregnancy based on clinical study data, Essure is the only permanent birth control with a nonincisional procedure that may be performed in an office setting

Patient must remain on alternative contraception until a satisfactory Essure Confirmation Test is documented
Knows her family is complete and is interested in exploring permanent birth control options The CDC, in collaboration with the WHO, recommends HCPs help patients find nonhormonal contraceptive options when patients have certain medical conditions that put them at increased risk for adverse health events resulting from unintended pregnancy3

References: 1. American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 7th ed. Washington, DC: American Academy of Pediatrics and the American College of Obstetricians and Gynecologists; 2012. 2. Gavin L, Moskosky S, Carter M, et al; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: recommendation of the CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014;63(4):1-54. 3. Centers for Disease Control and Prevention. U.S. medical eligibility criteria for contraceptive use, 2010. Adapted from the World Health Organization medical eligibility criteria for contraceptive use, 4th ed. MMWR 2010;59(No. RR-4):1-88.

Women undergoing sterilization at a younger age are at greater risk of regretting their decision. If there is any chance that the patient may want to have children in the future, she should choose a reversible method of birth control.2

Essure is contraindicated in patients who have delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure.

Contraindications

Essure is contraindicated for patients who:

  • Are uncertain about ending fertility
  • Can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus)
  • Have a known abnormal uterine cavity that makes visualization of the tubal ostia impossible and/or abnormal tubal anatomy or previous tubal ligation (including failed ligation)
  • Are pregnant or suspect pregnancy
  • Have delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure
  • Have an active upper or lower genital tract infection
  • Have unexplained vaginal bleeding
  • Have a gynecological malignancy (suspected or known)
  • Have a known allergy to contrast media (a modified HSG may be required for the Essure Confirmation Test)

Additional Patient Considerations

  • Patients on active immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) may experience delay or failure of the necessary tissue in-growth needed for tubal occlusion. For these patients, physicians must use the modified HSG as the Essure Confirmation Test. TVU should not be utilized for confirmation, as this test cannot confirm tubal occlusion in these patients. Clinical trials were not conducted with patients undergoing immunosuppressive therapy
  • Unusual uterine anatomy may make it difficult to place Essure inserts
  • Patients with known hypersensitivity to nickel, titanium, platinum, stainless steel, and PET (polyethylene terephthalate) fiber or any of the components of the Essure system may experience an allergic reaction to the insert. This includes both patients with or without a history of metal allergies. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Typical allergic symptoms reported for this device include hives, urticaria, rash, angioedema, facial edema and pruritis. Prior to the Essure procedure all patients should be counseled on the materials contained in the insert, as well as potential for allergy/hypersensitivity to these materials. Currently, there is no test that reliably predicts who may develop a hypersensitivity reaction to the materials contained in the insert

Next: Learn about Counseling Your Patients

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INDICATION

Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

Important Safety Information

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.

Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases.

Contraindications

Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have a known abnormal uterine cavity that makes visualization of the tubal ostia impossible, and/or abnormal tubal anatomy or previous tubal ligation (including failed ligation), are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active upper or lower genital tract infection, have unexplained vaginal bleeding, have a gynecological malignancy, or have a known allergy to contrast media.

General Warnings

Pregnancy Risk

Procedure Warnings

MRI Information

The Essure insert was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05.

Adverse Events

The most common (≥10%) adverse events resulting from the placement procedure were cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first year of reliance were back pain, abdominal pain, and dyspareunia.

This product does not protect against HIV infection or other sexually transmitted diseases.

Prescription Only

Report any adverse events or product technical complaints involving Essure® immediately by calling 888-84-BAYER (888-842-2937).

You are also encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.