Failure to place 1 or both of the Essure™ micro-inserts in the correct location or to obtain tubal occlusion by 3 months after the procedure

In the clinical studies, approximately 1 out of every 7 women were not able to have the microinserts placed in both fallopian tubes during the first placement procedure. At routine 3-month follow-up, 4% of the women who did receive placement in both tubes were found to have micro-inserts in the incorrect position. The types of incorrect positions included:

• The micro-insert(s) was (were) too far or not far enough into the tube
• The micro-insert(s) had been poked through the wall of the fallopian tube or uterus (perforation)
• The micro-insert(s) had come out of the body (expulsion)
• The micro-insert(s) was (were) in the body, but outside the fallopian tube
  
  

As a result of the above-listed incorrect positions of the micro-insert(s), these women could not initially rely on the Essure micro-inserts for birth control. Some of the women whose micro-inserts had come out of their bodies decided to undergo a second placement procedure and were then able to rely on the Essure micro-inserts for birth control. Approximately 3.5% of women did not have occlusion of both fallopian tubes at the HSG performed 3 months after the procedure. All of the women, however, did have occlusion of both fallopian tubes at a second HSG performed approximately 6 months after the procedure.

Other complications that can occur during the Essure placement procedure and postprocedure recovery

• Pain/vaginal bleeding. Most women in the clinical studies reported mild to moderate pain during the Essure micro-insert placement procedure. Many women reported mild to moderate pain and/or cramping and vaginal bleeding for a few days following the procedure
• Nausea/vomiting/fainting. Some women in the clinical studies reported nausea and/or vomiting or fainting following the procedure
• Overabsorption of fluid. Rarely, women in the clinical studies absorbed too much of the fluid used to expand the uterus during the placement procedure. This can result in shortness of breath or the need for medication to get rid of the excess fluid. If this condition is not treated by your doctor immediately, serious complications can occur, including death
• Broken Essure micro-insert. Rarely in the clinical studies, a portion of the Essure micro-insert was broken off during the placement procedure. This occurrence has not been reported to have caused a problem in preventing pregnancy or to have resulted in pain or other problems
• Undiagnosed pregnancy at time of Essure placement procedure. Women who undergo the Essure placement procedure, or any other sterilization procedure, during the second half of their menstrual cycle (after ovulation) are at an increased risk of unknowingly being pregnant at the time of the placement procedure. Therefore, the micro-insert placement procedure should be scheduled during the first half of the menstrual cycle, before ovulation occurs. On rare occasions during the clinical studies, when the Essure procedure was performed in the second half of the menstrual cycle, the women in whom the procedure was performed were unknowingly pregnant at the time of the procedure. The effects of the micro-inserts on you or the developing fetus are not known
• Anesthesia risks. There are risks associated with the anesthesia (medicine to control sensation or consciousness) used during the Essure placement procedure. You should discuss with your doctor the risks of the particular anesthesia method recommended for you
• Infection. You should contact your doctor if you have fever, vaginal discharge or odor, or severe pain following the procedure
  
  

Complications that may occur after the Essure™ placement procedure

• Pregnancy. No method of birth control is 100% effective, so pregnancy can occur even with a permanent birth control procedure such as Essure. Essure has been demonstrated in clinical studies to be 99.8% effective at 2 years of follow-up
  
• Ectopic pregnancy. Ectopic pregnancy is when the pregnancy occurs outside of the uterus (womb), usually in one of the fallopian tubes. While this did not occur in the clinical studies, it is still possible with the Essure procedure. Women who undergo sterilization, by Essure or incisional tubal ligation, are more likely to have an ectopic pregnancy if they get pregnant. If your period is more than 5 days late, or you suspect for any reason that you might be pregnant, call your doctor immediately so that you can be tested for pregnancy and monitored for the possibility of ectopic pregnancy. Ectopic pregnancy can be life threatening if not treated
  
• Risks to mother/fetus if you become pregnant. If you do become pregnant, the risk of the Essure micro-inserts to you, the continuation of the pregnancy, the fetus, childbirth, or a pregnancy termination procedure (abortion) are unknown
  
• Changes in menstrual cycle (period). Some women in the clinical studies reported temporary changes in their periods; however, very few women reported permanent changes. These temporary/permanent changes included the following:
  —periods that were heavier or longer than normal
  —bleeding or spotting between periods
  
• Pelvic/back/abdominal pain. Some women in the clinical studies reported 1 or more episodes of pelvic, back, or abdominal pain. Very few women reported persistent pain
  
• Regret. As with any major decision, there is the risk that you will regret your decision to end your fertility. The risk is much greater for younger women
• Pelvic inflammatory disease. If an infection occurs, there is the potential for pelvic inflammatory disease. This was not reported during the clinical trials
• Risks of hysterosalpingogram (HSG)/X ray. There are risks associated with the HSG that is performed before you can rely on Essure for contraception. You should discuss these risks with your doctor
• Risks of future medical procedures. In the future, you may be offered or require medical procedures that involve the uterus or fallopian tubes. The safety and effectiveness of these procedures, such as those identified below, in women who have the Essure micro-inserts are not known. In addition, such procedures could interrupt the ability of the Essure micro-inserts to prevent pregnancy. Whenever you have any medical procedure or see a new doctor, tell the doctor that you have this device. Some of the procedures that can involve possible risks are:
  —dilation and curettage of the uterus (D&C) or endometrial biopsy, because these methods may snag the portion of the micro-insert that is in the uterus
  —hysteroscopy or endometrial ablation, because these methods sometimes use electrical energy, which may heat the micro-inserts and cause tissue damage
  —in vitro fertilization (IVF), because this method may snag the portion of the micro-insert that is in the uterus or the micro-inserts may interfere with successful implantation of the fertilized egg. There are no data on the safety or effectiveness of IVF with Essure. If pregnancy is achieved, the risks of the micro-inserts to your health, the continuation of the pregnancy, the fetus, or childbirth are unknown
  
• Magnetic resonance imaging (MRI). The Essure micro-inserts were found to be safe at a high MRI field strength. However, when undergoing MRI, the presence of the micro-inserts can produce an obscure image of tissue at or near the micro-inserts. Whenever you have a medical procedure or see a new doctor, tell the doctor that you have this device and show your patient identification card to your doctor