WHAT IS ESSURE?
Essure is a form of tubal occlusion. A hysteroscope ( a device that scopes inside of the uterus) is used to place two separate sterile metallic coils into each fallopian tube. They stimulate an inflammatory response and scar into the lining of the fallopian tube. This is how they occlude the fallopian tubes where they connect to the uterus. Essure was first approved by FDA for use in the United States in 2002.
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a sterile coil that is inserted into the fallopian tube through hysteroscopy. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure’s safety and efficacy with laparoscopic tubal sterilization.
These were all due to extensive complications such as experienced complications such as:
- pain
- cramping
- vaginal bleeding
- pelvic or back discomfort
- headaches
- nausea and/or vomiting
- Fatigue
- Weight changes
- Hair loss
- Mood changes and depression
- Allergy and hypersensitivity reactions
- Joint or muscle pain
- Muscle weakness
For these reasons, many patients desire to have their Essure coils removed from their body regardless of their future plans for pregnancy. Patients travel nationally and internationally to come to our center to have their Essure coils removed or removed and reversed with a desire for future pregnancy. We have the most seasoned Essure removal and reversal experts at our center. Don’t wait! Get those coils out of your body.
ESSURE REMOVAL
It should be done in expert hands. The coils should be removed in their entirety. They tend to get fragmented and broken if not properly handled. That could continue to give the patient the same symptoms and complications that we discussed above.
· Hysterectomy: Through different approaches, i.e. abdominal, vaginal or laparoscopically assisted methods this is a straight forward outpatient surgery in the hands of our experts. This method does not involve removing of the ovaries that are the woman’s source of hormone production.
· Complete bilateral Salpingectomy: This involves complete removal of both fallopian tubes. Must be done meticulously in expert hands to remove both Essures without fragmentation. This could be achieved through laparoscopic approach with 10 millimeters ( less than half of an inch) incisions. This procedure also helps reduce the chances of ovarian and fallopian tube cancers.
· Partial bilateral salpingectomy: Only the segments of the fallopian tubes that contain the Essures would be removed. This could also be achieved through laparoscopic approach with 10 millimeters ( less than half of an inch) incisions.
· Salpingostomy and Essure removal: This technique is used to just extract the Essure coils and their surrounding fibrotic scar tissues utilizing a special microscope. In expert hands, this method is more commonly used if Essure reversal and future pregnancy is desired.
GETTING PREGNANT AFTER ESSURE
Two choices exist. 1) in-vitro fertilization (IVF) or 2) Essure removal and reversal. We do specialize in the surgical removal of Essure coils and surgical reversal of Essure sterilization. Isthmic –Interstitial ( two anatomical segments of the fallopian tube with the smallest caliber could be re-connected in expert hands utilizing a special microscope. Alternatively, re-implantation of the fallopian tubes into the uterus could also be done. Our experts perform this procedure under general anesthesia through a 5 cm (2 inch – Fig.2) incision into your lower bikini line. We use a special microscope. This is to improve success rates, help reduce postoperative pain, while improving fast and smooth postoperative recovery. Surgery is about 2 hours in uncomplicated cases. Patients go home the same day on painkillers and antibiotics. Patients will have 24-7 access directly to surgeon’s cell phone for any and all concerns.
Literature lacks evidence based articles to explore different techniques, success rates, complications and outcome measurements. It is unclear what the effects of the Essure micro-insert devices are on IVF success rates and pregnancy outcomes. Pregnancy with Essures in place may have its own risks. Maternity candidates should make themselves aware of the composition of the Essure micro-insert system and reasons for concern with pregnancy.
Our world-class clinics are in Beverly Our world-class clinics are in Beverly Hills, and Marina Del Rey in California. Our guests are referred to us from all over the world. We pride ourselves in providing the latest techniques in the hands of our world renowned experts in a safe, cost effective, compassionate and private manner.
Figure 2
