ESSURE is composed of 2 primary components, a metallic component and a polyester or plastic component. The metallic component is composed of nickel and titanium and additional metals in its soldering such as tin. ESSURE has an outer coil which is composed primarily of nickel and titanium (nitinol) designed to hold the device in place in the fallopian tubes and an inner coil which is composed of stainless steel wrapped in polyester fibers (polyethylene terephthalate, or PET fibers).
The purpose of the ESSURE, specifically the PET fibers, is to induce what is described as a benign foreign body reaction when the coils are placed inside of the fallopian tubes. The foreign body reaction induces scarring of the lumen or natural tunnel opening of the fallopian tubes and its opening or connection within the uterus. This scarring effect causes blockage of the fallopian tubes, thus causing permanent sterilization. Or at least that is what the concept was based when it was designed and marketed. And here is where the problem lies.
ESSURE, as a foreign body, causes both local and systemic chronic inflammatory reactions. The thought was that ESSURE's effect would only be localized to the fallopian tubes and temporary until the tubes scarred closed. But the body doesn't work that way. As a foreign body, your immune system continuously tries to break ESSURE down and get rid of it, which it cannot.
The integrity of ESSURE is also unstable. All of its components can degrade over time, especially ESSURE's nickel, tin solder and PET fibers. Its metallic components leach metallic ions into the surrounding tissue and stimulate the immune system to get rid of it. Its PET fibers can oxidize over time. And, as the ESSURE degrades, this continues to stimulate the immune system in an attempt to remove it. But this is not unexpected.
ESSURE was designed to induce an intentional foreign body response; and, based on the use of its components in other types of implants, we were aware that ESSURE would degrade over time and could induce local and systemic chronic foreign body and Inflammatory reactions. These types of reactions are often categorized as Implant Illness (II) and, more specific to ESSURE, Systemic Nickel Allergy Syndrome or (SNAS). Whether described as (II) or (SNAS), all foreign body reactions fall under a much larger classification or umbrella of symptoms generally known as the Autoimmune Inflammatory Syndrome Induced by Adjuvants or (ASIA). So whether it is (II), (SNAS) or (ASIA), your immune system may continuously be fighting against the ESSURE and, rather than it be a benign process, it can induce over 100 symptoms that often mimic, trigger or worsen autoimmine disorders such as Fibromyalgia, Hypothyroidism, Chronic Fatigue Syndrome, Chronic Pain Syndrome, Lupus, Antiphosholipid Antibody Syndrome, Sjorgen's Syndrome, Raynaud's Syndrome, etc....
Based on current clinical data, it is estimated that 20% of women currently implanted with ESSURE may eventually require surgical removal of ESSURE, especially as they age. This is just one of many problems with ESSURE which I will discuss in future Frequently Asked Questions (FAQ) and videos.