Fig. 1
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
Fig. 2
GETTING PREGNANT AFTER ESSURE
Two choices exist.
- in-vitro fertilization (IVF)
- Essure removal and reversal
We 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 small 5 cm (2in) (fig 2) incision into your lower bikini line. We use a special microscope. This is to improve success rates and 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 the surgeon’s cell phone for any and all concerns.