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

Counseling and Patient Education

Identifying Patient Types

The Centers for Disease Control and Prevention (CDC) encourages healthcare providers to have their patients clarify decisions about their reproductive life plans.1

Here are examples of patients who might be appropriate for the discussion about Essure®.

The American College of Obstetricians and Gynecologists (ACOG) recommends counseling pregnant patients regarding their postpartum contraceptive options during the second trimester.2 Essure is contraindicated in pregnant women and in 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
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, and a repeat confirmation test at 6 months will be required

Essure is contraindicated in 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 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
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
Does not want to worry about getting 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, and a repeat confirmation test at 6 months will be required
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 for patients who are seeking a permanent birth control option

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

Example of Hormone-Averse Patient Why Essure May Be Right for Her
Uncomfortable using hormonal contraception, or is contraindicated to hormone-based birth control Essure is permanent, nonhormonal birth control
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 Essure is the only nonincisional permanent birth control procedure that can be done in the doctor's office

Women undergoing sterilization at a younger age are at a 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.1

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 of 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 (eg, 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 pruritus. 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

References: 1. Gavin L, Moskosky S, Carter M, et al; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: recommendations of CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep. 2014;63(4):1-56. 2. American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 7th ed. Elk Grove Village, IL: American Academy of Pediatrics, and Washington, DC: The American College of Obstetricians and Gynecologists; 2012.

How to Counsel Patients

As with any procedure, hysteroscopic placement of Essure inserts into the fallopian tubes is NOT without risks. Essure placement is an elective procedure, and the patient must be well counseled and understand the risk/benefit relationship. The patient should read the Patient Information Booklet (PIB). While the PIB is not intended to replace appropriate physician counseling, each patient should receive the PIB during her initial visit/consultation to allow her sufficient time prior to the procedure to read and adequately understand the important information on the risks, the need for the confirmation test, and the contraceptive benefit associated with Essure. Allow the patient adequate time after reviewing and considering this information before deciding whether to have the Essure procedure. The Patient-Doctor Discussion Checklist should be reviewed with the patient, and all of the patient’s questions should be answered.

  • Patient must be certain about her desire to end fertility
  • The procedure is permanent and irreversible. Safety and effectiveness of insert removal for the restoration of tubal patency are unknown
  • It is important that all patients seeking to undergo the Essure procedure understand the risks and benefits of Essure
  • No contraceptive method is 100% effective. Like all birth control methods, there is a risk of pregnancy; pregnancies have been reported with Essure
  • A complete medical and social history should be obtained to determine if the patient has a condition that may make her an unsuitable candidate or place her at increased risk for adverse events. The patient should be encouraged to discuss any history of chronic pain or mental health disorders, including a clinical diagnosis of depression, during her consultation visit. Results of an evaluation for upper or lower genital tract infection, undiagnosed vaginal bleeding, or anatomical variants and/or uterine pathology may make the patient unsuitable for the procedure
  • 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 pruritus. Prior to the Essure procedure, all patients should be counseled on the materials contained in the insert, as well as the 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. For more information, please review the Instructions for Use
  • Essure may be placed with an IUD in the uterine cavity. In some cases, the IUD may need to be removed to complete the placement procedure and the patient must use alternative contraception until a satisfactory Essure Confirmation Test is documented. While highly unlikely, there is a theoretical risk of dislodgement of an Essure insert at the time of IUD removal
  • Bilateral insert placement may not be successful. Discuss a management plan with the patient in the event that bilateral placement is not achieved
  • Patient must use alternative contraception for at least 3 months post placement procedure until a satisfactory Essure Confirmation Test is documented. Physician must counsel patients regarding the risk of pregnancy (including ectopic pregnancy) attributable to noncompliance during all steps of the Essure procedure. Ensure patient is supplied with the most effective means of contraception for which she is a candidate during this time frame
  • Discuss the 2 methods utilized in the Essure Confirmation Test (TVU and modified HSG). Inform patients of the differences between the methods, including benefits and risks (including possible increased risk of pregnancy if TVU is the only confirmation method utilized)
  • The management of adverse events may include surgery and removal of the inserts. The management of an unsatisfactory confirmation test may include a repeat of the Essure procedure or alternative contraception, including laparoscopic tubal sterilization
  • As with any procedure, hysteroscopic placement of Essure inserts into the fallopian tubes is NOT without risks. Essure placement is an elective procedure, and the patient must be well counseled and understand the risk/benefit relationship. The patient should read the Patient Information Booklet (PIB). While the PIB is not intended to replace appropriate physician counseling, each patient should receive the PIB during her initial visit/consultation to allow her sufficient time prior to the procedure to read and adequately understand the important information on the risks, the need for the confirmation test, and the contraceptive benefit associated with Essure. Allow the patient adequate time after reviewing and considering this information before deciding whether to have the Essure procedure. The Patient-Doctor Discussion Checklist should be reviewed with the patient, and all of the patient's questions should be answered
  • The decision to undergo treatment is at the patient's discretion, following physician counseling and informed consent
  • Following the procedure, the patient should be counseled to inform all of her healthcare providers that she has the inserts before undergoing any planned gynecological, lower-abdominal surgical, or imaging procedure

IMPORTANT: Counsel patients that this product does not protect against HIV infection or other sexually transmitted infections.

  • The procedure involves permanently placing soft, flexible inserts into the fallopian tubes
  • Essure works with the body to create a natural barrier against pregnancy
  • After about 3 months, tissue forms around the inserts
  • This buildup of tissue keeps sperm from reaching the eggs and prevents conception
  • An Essure Confirmation Test should be performed 3 months after insert placement to evaluate insert retention and location
  • Patient must use alternative contraception for at least 3 months post procedure until a satisfactory Essure Confirmation Test is documented

The Essure procedure should be considered irreversible; therefore, confirm with the patient that she is certain her family is complete

  • The Essure procedure is >99% effective at preventing pregnancy (based on clinical study data) in women told to rely on Essure as their only form of birth control
  • No pregnancies were reported in clinical study data (Phase II, Pivotal, and extended 5-year studies) among women with successful bilateral placement relying on Essure
    • However, no method of contraception is 100% effective, and pregnancies have occurred in the commercial setting
  • 60% of women return to normal activity within 1 day or less, and more than 75% return to normal activity within 2 days
  • Not all women will achieve successful placement of both Essure inserts. Discuss a management plan with the patient in the event that bilateral placement is not achieved
  • Essure does not protect against HIV infection or other sexually transmitted infections
  • Ensure that the patient uses alternative contraception until a satisfactory Essure Confirmation Test is documented. Counsel the patient regarding the risk of pregnancy (including ectopic pregnancy) attributable to noncompliance during all steps of the Essure procedure. Ensure the patient is supplied with the most effective means of contraception for which she is a candidate during this time frame

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.

  • Meet with patients to discuss the results of the Essure Confirmation Test with transvaginal ultrasound (TVU) or modified hysterosalpingogram (modified HSG). Counsel patients to remain on alternative contraception until a satisfactory Essure Confirmation Test is documented
  • If location of the inserts is classified as either satisfactory or optimal, instruct the patient to discontinue alternative contraception and that she can rely on Essure for contraception. If not, the patient cannot rely on Essure. She must remain on alternative contraception and proceed to the Essure Confirmation Test with modified HSG
  • Patients on active immunosuppressive therapy (eg, systemic corticosteroids or chemotherapy) may experience delay or failure of the necessary tissue in-growth for tubal occlusion. For these patients, physicians must use the modified HSG as the Essure Confirmation Test. TVU should not be used as the Essure Confirmation Test, as TVU cannot confirm tubal occlusion. Clinical trials were not conducted with patients undergoing immunosuppressive therapy
  • If using modified HSG, and location and tubal occlusion are both rated satisfactory, instruct the patient to discontinue alternative contraception
  • If using modified HSG, and insert location is satisfactory but occlusion is unsatisfactory, instruct the patient to remain on alternative contraception. Repeat the Essure Confirmation Test with the modified HSG in 3 months. If occlusion is still unsatisfactory, instruct the patient not to rely on Essure for contraception
  • If using modified HSG and insert location is unsatisfactory, instruct patient to not rely on the inserts for contraception. For patients who are not able to rely, management may include a second placement attempt, incisional sterilization, or remaining on alternative contraception. The patient should be informed that her permanent contraception has not been successful and she should continue to use alternative contraception.
  • The following additional risks are associated with the modified HSG: vasovagal response; infection, which may require antibiotic treatment and in rare cases could require hospitalization; intravasation; perforation of the uterus; uterine cramping and/or bleeding; and pain or discomfort
  • The use of contrast media, used to perform a modified HSG which may be required for the Essure Confirmation Test, has been associated with allergic reaction in some patients. Allergic reaction can result in hives or difficulty breathing. In some individuals, an anaphylactic response may occur, which may lead to death
  • Pregnancies, including ectopic pregnancies, have been reported among women who have undergone the Essure procedure
  • The patient must use alternative contraception until a satisfactory Essure Confirmation Test is documented
  • If the Essure inserts are not properly placed or are not in a satisfactory location, then the patient should be advised to not rely on Essure and use alternative contraception
  • Clinicians must counsel patients regarding the risk of pregnancy (including ectopic pregnancy) attributable to noncompliance during all stages of the Essure procedure
  • In the case of unintended pregnancy that occurs at least 3 months after insertion, Essure cannot be relied on for future contraception, and alternative contraception is required to prevent subsequent unintended pregnancies
  • Physicians must adhere to the Essure Confirmation Test algorithm (see Information for Use, Section XV: ‘ESSURE CONFIRMATION TEST’). Incorrect execution and/or interpretation of the Essure Confirmation Test results have led to unintended pregnancy
  • Effectiveness rates for the Essure procedure are based on patients who had bilateral placement and a satisfactory Essure Confirmation Test
  • If the patient conceives and chooses to continue an intrauterine pregnancy, she should be informed that there may be risks of an in situ insert to the patient, to the fetus, and to the continuation of the pregnancy. While successful pregnancies with healthy deliveries have been reported with Essure devices in place, pregnancy loss, premature labor, premature rupture of membranes, preterm delivery, stillbirth, and genetic and developmental abnormalities have been reported in pregnancies with Essure

Patient Information Booklet

A resource for patients explaining the risks and benefits of Essure.

Download

Patient Education Video

The Patient Education Video is intended to support your efforts in counseling your patients on the benefits and risks of Essure. This video reviews several topics for your patients, including permanent birth control options, the Essure Confirmation Test, and risks and considerations with Essure, to name a few.

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.

IMPORTANT

  • 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.
  • The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.

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

  • The Essure procedure should be considered irreversible.
  • Pain (acute or persistent) of varying intensity and length of time may occur following Essure placement. This is also more likely to occur in individuals with a history of pain. If device removal is indicated, this will require surgery.
  • 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. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported for this device that may be associated with an allergic reaction include hives, urticaria, rash, angioedema, facial edema and pruritus. Patients should be counseled on the materials contained in the insert prior to the Essure procedure. Currently there is no test that reliably predicts who may develop a hypersensitivity reaction to the materials contained in the insert.
  • Patients on immunosuppressive therapy may experience delay or failure of the necessary tissue in-growth for tubal occlusion. For these patients, physicians must use the modified HSG as the Essure Confirmation Test. Transvaginal ultrasound (TVU) should not be used as the Essure Confirmation Test, as TVU cannot confirm tubal occlusion.

Pregnancy Risk

  • Pregnancies, including ectopic pregnancies, have been reported among women who have undergone the Essure procedure.
  • The patient must use alternative contraception until a satisfactory Essure Confirmation Test is documented. If the Essure inserts are not properly placed or are not in a satisfactory location, then the patient should be advised to not rely on Essure and use alternative contraception.
  • Counsel the patient on the need for the Essure Confirmation Test, the options for the confirmation test including their risks and benefits, and the possibility that the Essure Confirmation Test may be unsatisfactory.
  • Effectiveness rates for the Essure procedure are based on patients who had bilateral placement and a satisfactory Essure Confirmation Test.

Procedure Warnings

  • Never attempt to advance Essure insert(s) against excessive resistance. If a perforation occurs or is suspected, do not continue procedure and monitor the patient for signs and symptoms of possible complications related to perforation which may include unusual post-operative pain.
  • To reduce the risk of hypervolemia, terminate procedure if distension fluid deficit exceeds 1500cc or total hysteroscopic procedure time exceeds 20 minutes. Excess fluid deficit may signal uterine or tubal perforation. If noted, discontinue procedure and evaluate patient for possible perforation.
  • Do not attempt hysteroscopic Essure insert removal during the placement procedure unless 18 or more trailing coils are seen inside the uterine cavity due to risk of a fractured insert, fallopian tube perforation, or other injury.
  • DO NOT perform the Essure procedure concomitantly with endometrial ablation.

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 side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

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