Essure Safety Results
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).
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|Adverse Event/Side Effect||Phase II Trial||Pivotal|
*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 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.
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 over represent the percentage of women who have experienced that event.
|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%|
|Musculo-skeletal||Back pain/low back pain||43||9.0%|
|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%|
*Only events occurring in ≥0.5% are reported.
**8 women reported persistent decrease in menstrual flow.
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.
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.
- 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).
- 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.
- 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
Posible 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.
- 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 (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).
- Changes in the pattern or amount of menstrual bleeding have been reported. Changes in menstrual bleeding may occur following discontinuation of hormonal contraception.
- 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 reactions including hives, urticaria, rash, angioedema, facial edema and pruritis 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 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).
Adverse Event Reporting
Report any adverse event involving the Essure system to Bayer immediately by calling 888-84 BAYER (888-842-2937).