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Patients should be counseled that this product does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
IMPORTANT NOTE - This information is a BRIEF SUMMARY of the complete prescribing information (Instructions for Use) provided with the product and therefore should not be used as the basis for prescribing the product. This summary was prepared by deleting from the complete Instructions for Use certain text, tables and references. The physician should be thoroughly familiar with the complete Instructions for Use before using or prescribing this product.
INDICATIONS FOR USE: The Essure System is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
CONTRAINDICATIONS:
The Essure System should not be used in any patient who is:
- Uncertain about her desire to end fertility.
- Patients in whom only one micro-insert can be placed (including patients with apparent contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus).
- Patients who have previously undergone a tubal ligation.
Or any patient with any of the following conditions:
- Pregnancy or suspected pregnancy.
- Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement.
- Active or recent upper or lower pelvic infection.
- Known allergy to contrast media or known hypersensitivity to nickel confirmed by skin test.
WARNINGS:
- The patient must use alternative contraception (cannot rely on the Essure micro-inserts for contraception) until an HSG performed three months post-micro-insert placement demonstrates satisfactory micro-insert location and tubal occlusion. During this time frame, the patient may be at an increased risk of ectopic pregnancy.
- The Essure procedure should be considered irreversible. There are no data on the safety or effectiveness of surgery to reverse the Essure procedure. Any attempt at surgical reversal will likely require utero-tubal reimplantation. Pregnancy following such a procedure carries with it the risk of uterine rupture and serious maternal and fetal morbidity and mortality.
- The Essure micro-insert will conduct energy if directly or closely contacted by an active electrosurgical device. If this occurs, then there is a risk of patient injury. Therefore, electrosurgery should be avoided in procedures undertaken on the uterine cornua and proximal fallopian tubes without either hysteroscopic visualization of the micro-inserts, or visualization of the proximal portion of the fallopian tube via open surgical procedures or laparoscopy. During LAVH and other procedures in which electrosurgical instruments could contact the serosa of the fallopian tube, instruments should not be placed more proximal than the ampullary portion of the tube.
- Bench studies suggest that endometrial ablation using radio frequency (RF) energy will cause significant damage to surrounding tissue if an active RF instrument comes into direct contact with the Essure micro-inserts. Consequently, if using RF energy to perform endometrial ablation, direct contact with the Essure micro-inserts should be avoided. Global auto-ablative systems that employ RF energy should not be used in women with the Essure micro-inserts in place.
- Bench studies suggest that endometrial ablation of the uterus with thermal (heated fluid) techniques can be done with the Essure micro-inserts in place without significant tissue damage, however, there is little clinical data regarding the safety of thermal endometrial ablation in women with the Essure micro-inserts.
- There are no data regarding cryo-ablation techniques or the use of laser for endometrial ablation of the uterus with the Essure micro-inserts in place.
- There are also no data regarding the use of endometrial ablation devices that operate at microwave frequencies with the Essure micro-inserts in place. The use of microwave energy near metallic implants has been shown to pose significant risk of serious injury to patients. Use of microwave endometrial ablation devices near the Essure micro-inserts therefore should be avoided.
- Although not reported in the clinical trials of Essure, there is a theoretical increased risk of ectopic pregnancy in patients with the Essure micro-inserts, should they become pregnant.
- A very small percentage of women in the Essure clinical trials reported recurrent or persistent pelvic pain, and only one woman requested device removal due to pain; however, if device removal is required for any reason, it will likely require surgery, including an abdominal incision and general anesthesia, and possible hysterectomy.
- Patients may decide, in future years, to undergo in vitro fertilization (IVF) to become pregnant. The effects of the Essure micro-inserts on the success of IVF are unknown. If pregnancy is achieved, the risks of the Micro-insert to the patient, to the fetus and to the continuation of a pregnancy are also unknown.
PRECAUTIONS: Women should be counseled that:
- No contracepive is 100% effective. Ectopic and intrauterine pregnancy can occur in contraceptive failure, even years after the procedure.
- Data on Essure beyond two years are not yet available and may be different than current data.
- Women who undergo sterilization at a relatively young age are at greater risk of regretting their decision to undergo sterilization.
- Any intrauterine procedure performed without hysteroscopic visualization following Essure implantation could interrupt the ability of the Essure micro-inserts to prevent pregnancy. Following such procedures, device retention and location should be verified by hysteroscopy, x-ray, or ultrasound. In addition, the presence of the Essure micro-inserts could involve risks associated with intrauterine procedures that, at this time, have not been identified.
- Testing to ensure safety and compatibility with Magnetic Resonance Imaging (MRI) has been conducted using a 1.5 tesla magnet. The Essure micro-inserts were found to be MR safe at this field strength. Test results at 1.5 tesla indicate zero magnetic force and radio frequency (RF) heating of 0.60 C in a phantom when a whole body specific absorption rate (SAR) of 1.3 W/kg was applied. The presence of the micro-inserts produces an MR artifact, which will obscure imaging of local tissue. The artifact is expected to be larger at higher field strength.
ADVERSE EVENTS:
A total of 745 women underwent an Essure placement procedure in two separate clinical investigations to evaluate the safety and effectiveness of the Essure System (227 in the Phase II study and 518 women in the Pivotal trial). Some women underwent more than one procedure if successful bilateral placement was not achieved in the initial procedure. Placement of at least one Essure Micro-insert was achieved in 682 women (206 in the Phase II study and 476 in the Pivotal trial). Adverse events, which prevented reliance on Essure for contraception, were reported as follows: failure to place two micro-inserts in first procedure (14%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.5%), or other unsatisfactory device location (0.6%). All of the patients who experienced tubal patency at the 3-month HSG were found to have bilateral occlusion at a repeat HSG performed at approximately 6 months after Essure placement. In addition, all of the patients who chose to undergo a second Essure placement procedure following a micro-insert expulsion, achieved successful micro-insert placement and were subsequently able to rely on Essure for contraception. The most frequent adverse events and side effects reported as a result of the hysteroscopic procedure to place the Essure micro-inserts were as follows: cramping (29.6%), pain (12.9%), nausea/vomiting (10.8%), dizziness/light headedness (8.8%), and bleeding/spotting (6.8%). Hypervolemia occurred in less than one percent of cases. During the first year of reliance on Essure for contraception (approximately 15 months after micro-insert placement), the following episodes were reported as at least possibly related to the Essure micro-inserts: back pain (9.0%), abdominal pain (3.8%), dyspaurenia (3.6%). All other events occurred in less than 3% of women.
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