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

Placement Procedure

Placement Procedure Video

The Essure® Insert Placement Procedure and the Essure Confirmation Test comprise the Essure procedure. Both are equally important, and instructions for completing each should be followed exactly.

IMPORTANT:

Bayer is providing this information to you for informational and educational purposes only. This is not intended for training. You and your staff must be properly trained in all aspects of providing the Essure procedure. For complete placement procedure, please refer to Instructions for Use and Physician Training Manual

Placement Procedure Overview

Note: The following overview is not intended to act as a substitute for the complete Essure Placement Procedure. Please refer to Section XIII of the Essure Instructions for Use for complete details.

Essure inserts are intended to be left in place permanently. If removal is necessary, please see Instructions for Use for more information.

Safety Considerations

Adverse Events in Phase II/Pivotal Premarketing Studies

From November 1998 - June 2001, a total of 745 women underwent the Essure procedure in two clinical trials that evaluated safety and effectiveness (227 Phase II; 518 Pivotal). Placement of at least one insert was achieved in 682 women (206 Phase II study; 476 Pivotal). If bilateral placement was not initially achieved, some women underwent additional procedure(s).

The majority of women experienced mild to moderate pain during and immediately following the procedure. Pain was managed with oral nonsteroidal anti-inflammatory drugs (NSAIDs) or oral narcotic pain reliever. The majority of women experienced spotting for an average of 3 days after the procedure.

  Phase II Trial Pivotal
Adverse
Event/Side Effect
Number
(N=233 procedures)
Percent Number
(N=544 procedures)
Percent
Cramping * * 161 29.6%
Pain 2 0.9% 70 12.9%
Nausea/vomiting * * 59 10.8%
Dizziness/light-headed * * 48 8.8%
Bleeding/spotting * * 37 6.8%
Other * * 16 2.9%
Vaso-vagal response 2 0.9% 7 1.3%
Hypervolemia * * 2 0.4%
Band detachment 3 1.3% 2 0.4%

*Data not collected.

Includes: ache (3), hot/hot flashes (2), shakiness (2), uncomfortable (1), weak (1), profuse perspiration (1), bowel pain (1), sleepiness (1), skin itching (1), loss of appetite (1), bloating (1), allergic reaction to saline used for distension (1).

The following adverse events were rated as “possibly” related to the insert or procedure during the first year of reliance in the Pivotal trial (approximately 15 months post-device placement). Percentages reflect the number of events divided by the number of participants in the trial. When numerous episodes of the same event were reported by one participant, each report was counted as a separate event. Therefore, percentages may overrepresent the percentage of women who have experienced that event.

In the Phase II trial, 12/206 (5.8%) women with at least 1 insert reported episodes of period pain, ovulatory pain, or changes in menstrual function. Some patients have reported pelvic pain that may be device-related. If device removal is indicated, this will require surgery. Please refer to the Instructions for Use for more information.

Pivotal Trial Adverse Events by Body System, First Year of Reliance*
(N=476 patients implanted with at least one insert)
Number (N=476) Percent
Abdominal Abdominal pain/
abdominal cramps
18 3.8%
Gas/bloating 6 1.3%
Musculo-skeletal Back pain/low back pain 43 9.0%
Arm/leg pain 4 0.8%
Nervous/Psychiatric Headache 12 2.5%
Premenstrual syndrome 4 0.8%
Genitourinary Dysmenorrhea/
menstrual cramps
(severe)
14 2.9%
Pelvic/lower
abdominal pain
(severe)
12 2.5%
Persistent increase
in menstrual flow
9 1.9%
Vaginal discharge/vaginal infection 7 1.5%
Abnormal bleeding—
timing not specified
(severe)
9 1.9%
Menorrhagia/prolonged
menses (severe)
5 1.1%
Dyspareunia 17 3.6%
Pain/discomfort—uncategorized 14 2.9%

*Only events occurring in ≥0.5% are reported.

8 women reported persistent decrease in menstrual flow.

The following adverse events have occurred (in clinical trials and/or commercial usage) or may potentially occur during the Essure placement procedure and with wearing the insert, however, there is the potential that unknown risks exist. Symptoms other than those listed in the sections below have been reported to FDA by women implanted with Essure, although they were not seen in the clinical trials supporting Essure approval. The more common symptoms reported include headache, fatigue, weight changes, hair loss and mood changes such as depression. It is unknown if these symptoms are related to Essure or other causes.

Risks Associated with the Insert Placement Procedure

Possible adverse events that have been reported within 24 hours following the Essure placement procedure include; nausea/vomiting, dizziness/lightheadedness, vaso-vagal response/syncope, pain, dysmenorrhea, uterine bleeding/spotting, infection, fluid overload, anesthetic complications, detachment difficulties and unsatisfactory insert location.

Anesthesia

  • Local anesthesia, oral analgesia/sedation, regional anesthesia (i.e., spinal, epidural), oral or conscious (intravenous) sedation, or general anesthesia may be administered to the patient to prevent or reduce discomfort. Regardless of the type of anesthesia, patients may not be able to resume normal activities for 12-24 hours following the procedure. Risks and benefits associated with the planned anesthesia should be discussed prior to performing the procedure.
  • Serious reactions to anesthesia including general anesthesia and paracervical block have been reported. Risks and benefits associated with the planned anesthesia should be discussed prior to performing the procedure.

Intra-operative and post-operative symptoms:

  • Pain, cramping, vaginal bleeding, nausea/vomiting, and dizziness, lightheaded, vaso-vagal response may occur during and following the insert placement procedure. Typically, these incidents are tolerable, transient and successfully treated with medication.

Device Properties and Deployment:

  • Bending of the insert tip or catheter, breakage of the catheter during attempted insertion and difficulty in deployment or detachment may occur, especially in tubal ostia that are more laterally located or in cases of tubal spasm.

Unsatisfactory Insert Location:

  • Any insert that is not satisfactorily located within the fallopian tube can NOT be relied on for effective contraception. Unusual pain or uterine bleeding after the placement procedure should prompt investigation of an unsatisfactory insert location.
  • There is a risk of uterine perforation by the hysteroscope, Essure system or other instruments used during the procedure with possible injury to the bowel, bladder, and major blood vessels. Depending on symptomatology, surgical intervention at the time of placement or shortly thereafter may be required, however for asymptomatic perforations, intervention may not be necessary. To reduce the risk of uterine perforation, the procedure should be terminated if excessive force is required to achieve cervical dilatation.
  • There is a risk of perforation or dissection of the fallopian tube or uterine cornua. Bleeding and scarring may result from such a perforation or dissection; however, treatment is typically not required.
  • There is a risk of perforation of internal bodily structures other than the uterus and fallopian tube for inserts located outside the fallopian tube and uterus.
  • Additional imaging may be required to identify the location of the inserts. Removal of an unsatisfactorily located insert (perforation, embedment, migration expulsion, proximal or distal fallopian tube placement, or within the peritoneal cavity) may require surgery (see Information for Use, Section XVII, INSERT REMOVAL).

Infection:

  • As with all hysteroscopic procedures, insert placement can cause an infection. An infection could cause damage to the uterus, fallopian tubes, or pelvic structures, which may require antibiotic therapy, or rarely, hospitalization or surgery, including hysterectomy.

Fluid Overload:

  • There is a minimal risk of excess fluid absorption of the physiologic saline fluid, used for distention of the uterus, to perform the hysteroscopic procedure.

Risks Associated with the Insert Wearing

  • Possible adverse events that have been reported (>24 hours) following the Essure placement procedure include; uterine bleeding, dysmenorrhea, dyspareunia, vaginal discharge/infection, headache, upper genital tract infection, lower abdominal pelvic and back pain, abdominal distention/bloating, unsatisfactory insert location, hypersensitivity and allergy including rash and urticaria.

Pregnancy:

  • There is a possibility of pregnancy and ectopic pregnancy each of which has risks. 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.

Pain:

  • Pain (acute or persistent) of varying intensity and length of time may occur and persist following Essure placement. Individuals with a history of pain are more likely to experience both acute and chronic pelvic pain following Essure placement. Unsatisfactory device location including perforation, uterine embedment and expulsion may result in pain. Patients should be advised to contact their physician if there is significant pain or if pain persists. In addition to pain associated with Essure, unrelated gynecological (e.g. endometriosis, adenomyosis) or non-gynecological (e.g., irritable bowel syndrome, interstitial cystitis) conditions that may result in pain should be considered during evaluation.
  • Pain and cramping may be more likely during the menstrual period, during and after sexual intercourse or with other physical activity.
  • Surgery including device removal, hysterectomy or other procedures may be required to treat the pain (see Information for Use, Section XVII, INSERT REMOVAL).

Bleeding:

  • Changes in the pattern or amount of menstrual bleeding have been reported. Changes in menstrual bleeding may occur following discontinuation of hormonal contraception.

Infection:

  • Endometritis, and pelvic inflammatory disease, including tubo-ovarian abscesses, have been infrequently reported in individuals with Essure. Surgery including hysterectomy may be required for treatment.

Hypersensitivity:

  • Hypersensitivity reactions including hives, urticaria, rash, angioedema, facial edema and pruritus have been reported with Essure (see Information for Use, Section VI, WARNINGS AND PRECAUTIONS). If a patient is experiencing a reaction suspected to be due to material(s) contained in the insert, removal of the inserts should be considered (see section XVII, INSERT REMOVAL).

Sterilization Regret:

  • Sterilization regret can be associated with emotional disturbances including depression. Patients should be counseled prior to the Essure procedure (see Information for Use, Section X, PATIENT COUNSELING INFORMATION).

Possible Risks Associated with Follow-up Procedures

  • 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.

Possible Risks Associated with Future Procedures

  • Patients who undergo placement of the Essure insert may, in future years, be offered gynecological therapies that pose additional risk due to the presence of the insert.
  • Some surgical instruments utilize energy sources such as electrosurgical devices, radio frequency, thermal energy, or freezing (e.g., cryotherapy). There is a risk of fragmentation of the insert and/or conduction of energy to surrounding structures if these energy sources are used adjacent to or in contact with the insert. There may be risks associated with such procedures that, at this time, have not been identified. Endometrial ablation using microwave energy is contraindicated when an Essure insert is in place.
  • Other surgical instruments such as a morcellator, clamp, or scissors can result in fragmentation of the inserts and should therefore be avoided or used with caution in proximity to the insert. Care must to taken to completely remove the inserts when performing a hysterectomy when the adnexa are being retained.
  • Intrauterine procedures such as endometrial biopsy, dilation and curettage (D & C), and hysteroscopy may involve the use of instrumentation that may come into contact with the inserts. If the inserts are displaced or removed by such instrumentation, the patient’s ability to rely may be affected. Endometrial ablation can result in thermal injury to the GI tract or abscess formation around the inserts. It may also cause intrauterine synechiae that can compromise conduct and interpretation of a modified HSG which may be needed for the Essure Confirmation Test.
  • Endometrial ablation (if medically appropriate) should only be performed after correct location of the Essure insert is confirmed by a satisfactory Essure Confirmation Test, in order to minimize injury to the surrounding tissue (e.g. bowel). Bench and clinical studies demonstrated that endometrial ablation of the uterus can be safely and effectively performed with the endometrial ablation systems and the Essure inserts in place (following a satisfactory Essure Confirmation Test performed three months post-insert placement). Endometrial ablation or other intra-uterine procedures may result in stretching or removal of the Essure insert.
  • Performing endometrial ablation following placement of Essure inserts may increase the risk of post-ablation tubal sterilization syndrome, a rare condition that has been reported in women with a history of tubal sterilization who undergo endometrial ablation.
  • There are limited data related to the effects, including risks, of Essure inserts on in vitro fertilization (IVF).
  • The Essure inserts are radiopaque. The Essure inserts are also MR conditional, except for pelvic imaging, where they may cause some artifacts (see Information for Use. Section VI, WARNINGS AND PRECAUTIONS, MRI Safety Information).

Procedure Warnings

  • In order to reduce risk of uterine perforation, the procedure should be terminated if excessive force is required to achieve cervical dilation.
  • Never attempt to advance Essure insert(s) against excessive resistance. If a perforation occurs or is suspected, discontinue procedure and monitor the patient for signs and symptoms of possible complications related to perforation which may include unusual post-operative pain. If unusual post-operative pain occurs, imaging to localize the insert should be performed prior to the 3-month confirmation test. A small percentage (12/682 [1.8%]) of women in Essure clinical trials were identified as having device related perforations. Retrieval of perforating inserts, if necessary, will require surgical removal (see section XVII. INSERT REMOVAL). A false positive modified HSG and pregnancy have been associated with tubal perforation by the insert in the literature; evaluate Essure Confirmation Test for perforation if excessive resistance is experienced during procedure.
  • If Essure insert placement attempts are not successful after 10 minutes of attempted cannulation per tube, the procedure should be terminated and potentially rescheduled. Do not advance the catheter under excessive resistance and avoid repeated removal and recannulation.
  • To reduce the risk of hypervolemia, terminate procedure if distension fluid deficit exceeds 1500cc or total hysteroscopic procedure time (scope in-scope out) exceeds 20 minutes. Excess fluid deficit may signal uterine or tubal perforation. If noted, discontinue procedure and evaluate patient for possible perforation.
  • Once the insert has been placed (i.e., detached from the delivery wire), hysteroscopic insert removal (at the time of placement procedure) should not be attempted unless 18 or more coils of the Essure insert are trailing into the uterine cavity, indicating proximal tubal placement. Removal of such an insert may be attempted immediately following the placement (see section XVII. INSERT REMOVAL, subsection ‘At time of Placement Procedure’). Attempted removal with less than 18 trailing coils may result in a fractured insert, fallopian tube perforation, or other injury.

Adverse Event Reporting

Report any adverse event involving the Essure system to Bayer immediately by calling 888-84-BAYER (888-842-2937).

Insert Card Sample

See a sample of the Insert Card for Essure. To obtain this card, please contact your Bayer Sales Consultant.

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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