Counseling Your Patients About Essure
Important factors to be discussed with the patient:
- 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 is 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. Patients should be encouraged to discuss any history of chronic pain, 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, anatomical variants and/or uterine pathology may make 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 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
- 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 three 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 non-compliance 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 two 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 their 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 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 prior to 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.
Be sure to counsel your patients with key discussion points and address any questions or concerns they may have regarding the mechanism of action, the permanency of tubal occlusion, the Essure procedure and recovery, and the importance of the Essure Confirmation Test.
The Patient Information Booklet with Patient-Doctor Discussion Checklist should be offered to the patient during the initial visit to allow her sufficient time to understand the risks and benefits of Essure. The Patient-Doctor Discussion Checklist should be reviewed with the patient and all her questions answered.
How Essure Works
Additional points to discuss with your patients
- 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 build-up 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 permanency of tubal occlusion
Additional point to discuss with your patients
- The Essure procedure should be considered irreversible; therefore, confirm with the patient that she is certain her family is complete
Essure procedure and recovery
Additional points to discuss with your patients
- The Essure procedure is >99% effective at preventing pregnancy based on clinical study data in women told to rely
- 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 activities 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 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 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
The importance of the Essure Confirmation Test
Additional points to discuss with your patients
- Meet with patients to confirm 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 TVU evaluation is confirmatory and shows both inserts in a satisfactory position, the patient may rely on Essure for birth control and discontinue alternative 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 (e.g. 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
- 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 non-compliance 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, genetic and developmental abnormalities have been reported in pregnancies with Essure.
Please click here for more information about the Essure Confirmation Test.