ESSURE is advertised as a permanent form of birth control for women. This device is manufactured by Bayer. The intent of the device is to create an irreversible form of birth control for women who no longer wish to have children. According to the FDA, studies have shown that if the device is correctly implanted, the chance of pregnancy is less than (1) one percent. Bayer claims that about 750,000 women have received ESSURE since 2002.

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.

In comparison to other forms of permanent sterilization, ESSURE is significantly inferior in comparison to other forms of tubal ligation. In standardizing the nomenclature for general comparison, tubal ligation can be described as any procedure that is intended to permanently damage the fallopian tubes in such a manner to prevent conception or pregnancy. As such, ESSURE is intended to permanently damage the fallopian tubes in such a manner to block the passage of sperm and egg to create a pregnancy and so can be described as a form of tubal ligation or tubal sterilization.

Other techniques include Filschie clips, Hulka clips, Falope bands or cutting, burning, tying of the fallopian tubes or removal of segments of the tubes causing tubal blockage.

ESSURE was originally advertised as being 99.8% effective in preventing pregnancy, but fallacy was dependent on 2 very important caveats:

1. ESSURE had to be successfully inserted (failure of up to 14%)
2. ESSURE had to successfully scar the tubes closed (failure rate of 5-10%)

For example, if you start with 100 women, only about 76 of these women would eventually be told that she could rely on ESSURE as a permanent form of sterilization. So as many as 1 out of 4 women having ESSURE placed will not reach the point of successful tubal blockage.

If blockage is achieved, best case scenarios estimate that ESSURE fails 1 out of 180 times when the patient is told she can rely on it for birth control. Post implantation migration or expulsion of the ESSURE from the fallopian tubes is appropriately 4% which further increases it failure rate. Considering all variables, ESSURE is estimated to fail to prevent pregnancy in 9% of patients who attempt its placement and rely on it to prevent pregnancy.

In comparison, other forms of tubal ligation fail in 2% of patients. Since ESSURE is calculated to have a significant rate of failure over time, most women should not consider it a reliable form of birth control. Additionally, if a patient becomes pregnant greater than 3 months after the insertion of ESSURE, even after her 3 month ESSURE Confirmation Test (ECT) confirms tubal blockage, she should consider herself fertile and should never rely on ESSURE as her sole form of contraception.

Failure of ESSURE leading to successful delivery of a baby is often referred to as having an E-baby.

Yes. Although my comments are not to be considered as medical or legal advice, they are meant to provide accurate information in order to give you more information when discussing your concerns with your doctor or lawyer.

Each post is public and is welcome to be shared with all persons that are interested in sharing the comments and are welcome to do so.

More importantly, most of my comments, especially those posted in videos and on my NoEssure.com website have a transcript available to be downloaded.

You are welcome to take the transcript and translate the information into your native language and share it with friends, family or professional representatives.

Currently, I use Google translate for this purpose in order to share my messages with everyone throughout the world.

Current insurance policy and regulations do not cover the removal of an implant, such as IUD, ESSURE, Filschie clips, Nexplanon, etc... once the patient loses their insurance. I can appreciate the frustration regarding the cost of removal of any of these devices.

The placement of the ESSURE was heavily promoted to Medicaid patients, even to those that only had temporary insurance, without any consideration of what could happen if the patient had no insurance in order to perform her 3 month ESSURE Confirmation Test or if the patient had complications to the placement of the device.

I believe that there should be a special and specific insurance law that states that if a patient has a complication associated with the placement of an implant, then coverage for its removal should automatically be available even if they don't have general insurance coverage at the time of removal.

Under no circumstances should the retention of ESSURE fragments, segments of ESSURE, or microscopic remnants of ESSURE in scar tissue be considered benign or inert. Based on the FDA, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, "Since there is no known lower limit on the amount of nickel that can elicit allergic reactions in some patients, we recommend that the risk of potential allergic reaction to nickel be mitigated through labeling for nitinol containing devices."

ESSURE is a nitinol containing device. The opinion that the retention of ESSURE fragments or PET fibers are inert is fundamentally FALSE.

The ESSURE nitinol and other metallic components are protected my anti-corrosives to reduce oxidization and degradation over time.However, both the ESSURE metals and PET fibers degrade over time and therefore are not inert.The unintentional fragmentation of the coils accelerates the degradation and leaching of metallic ions into surrounding tissue and systemically.Further, the retention of PET fibers, which are undetectable by scan, can induce uncontrolled scarring of pelvic and abdominal tissue including intestines.

Many surgeons equate retained fragments of ESSURE like retained shrapnel, which is also erroneously considered to be inert.In no uncertain terms, retained fragments of ESSURE may pose the same foreign body reactions and autoimmune symptoms as intact ESSURE coils and, when possible, ESSURE fragments should be removed.Further, careful consideration of leaving the tubes behind with microscopic remnants of ESSURE embedded in tubal scar tissue should be considered as potential risks of still inducing foreign body and autoimmune reactions.

Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

Current data suggests that sexual response can be significantly affected by tubal ligation and is included as symptoms as part of the Post Tubal Ligation Syndrome (PTLS). Sexual function, from baseline, changes as a woman ages and generally affects 1 in 3 women. Female Sexual Dysfunction (FSD) is defined as an impaired or the inadequate ability of a woman to engage in or enjoy satisfactory sexual intercourse and orgasm. Worldwide, FSD occurs in 30-60% of sexually active women. The most common sexual disorders include orgasm, arousal, and desire. Pain disorder is generally the least common, EXCEPT with ESSURE.

ESSURE, as a form of tubal ligation, is plagued with the same symptoms seen in PTLS. However, ESSURE, as a foreign body and one specifically located in the uterus and fallopian tubes, causes chronic pelvic pain and pain with intercourse with a prevalence of 5-10%.

The presence of pain disorder as well as the increased prevalence of other FSD disorders, affects up to 80% of women with ESSURE. In most cases, chronic pain and pain with intercourse (dyspareunia) does not improve once the ESSURE coils scar in place. Once scarred in place, there is little flexibility in the cornual to mid-ampullary regions of the fallopian tubes where the ESSURE rests inside the tubes. As such, intercourse can become painful as the penis pushes against the cervix or the vaginal erogenous zones and meets with resistance from the scarred ESSURE coils.

The prevalence of FSD is so high, that removal of the ESSURE coils due to pain disorder may be the only option available for the patient to revert back to a pre-ESSURE state of sexual gratification.

Unfortunately, dyspareunia alone or FSD is rarely used to approve ESSURE removal, yet these disorders are often the primary reason why women suffer from significant issues with sexual gratification and a primary issue leading to divorce.

Bayer has published recommendations for the removal of ESSURE in the ESSURE Information for Use (IFU) handout, currently available as a link to this question.

Removal is dependent on three primary considerations:

• Time of placement to time of removal
• Implant Grading position
• Desire to retain tubes or uterus

This comment is true for all of my friends in ALL of the foreign body groups, including PTLS, FILSCHIE CLIPS, MESH and ESSURE. The majority of doctors simply have no idea what they are talking about in regards to symptoms and their management.

A smaller but very significant group of doctors are actually lying to their patients.

What is my best advice? Always get multiple opinions on your management and never take NO for an answer.

ESSURE removal via hysterectomy is generally the easiest to get approval by insurances if the patient has general GYN related complaints such as:

1. Pelvic Pain
2. Abnormal Uterine Bleeding
3. Pain with Intercourse
4. Adenomyosis
5. Endometriosis
6. Abnormal or Improper Position of ESSURE

Although ESSURE is associated with multiple foreign body reactions and autoimmune symptoms, these are systemic in nature and most Gynecologists will not use these associated conditions as a reason to remove ESSURE. On the contrary, if a patient presents with non-GYN symptoms as their primary reasoning to get ESSURE removed, their doctor may completely shut down and refuse to perform the surgery.

Removal of ESSURE alone through Salpingotomy, Salpingectomy, or Cornual resection is much more difficult to get approval through insurance since tubal removal and reversal will not guarantee the correction of any of the aforementioned symptoms.

Insurance companies that use algorithms to approve ESSURE removal will focus on the aforementioned GYN diagnoses for approval for ESSURE removal via hysterectomy.

The mention of a foreign body reaction or autoimmune symptoms will neither improve nor reduce the chances of insurance approval.

The algorithms will generally require a mention of the following:

1. Failure of hormonal therapy, including birth control pills
2. Failure or Contraindication of a hormonal IUD
3. Failure or Contraindication of Endometrial Ablation
4. Abnormal Position of ESSURE coils

Justification for ESSURE removal when challenged by the algorithms are as followed:

1. OCP Failure or not attempted:
   Patient over age 35, elevated BMI, increased risk of Deep Venous Thrombosis, smoker, prior history of unacceptable hormonal medication side effect or patient refuses hormonal therapy.
2. Hormonal IUD Failure or not attempted:
   Prior history of IUD failure or adverse side-effect. IUD relatively contraindicated with ESSURE in place due to risk of coil entanglement.
3. Endometrial ablation Failure or not attempted:
   Endometrial Ablation is contraindicated with ESSURE placement. Increased risk of Post Ablation Tubal Ligation Syndrome (PATLS).
4. Abnormal ESSURE Position:
   Abnormal position of ESSURE coils are associated with significant pain, increased risk of adenomyosis and endometriosis, tube perforation, ESSURE migration and ESSURE expulsion (especially in Grade 1 presentation).
   
   

   *HOWEVER, EVEN WHEN THE COILS ARE FOUND TO BE IN OPTIMAL GRADE 2 PRESENTATION OR "PROPERLY PLACED", ESSURE can cause serious and debilitating side-effects and complications.

   Bottom line. When your doctor focuses on GYN related diagnoses, they are more inclined to offer surgery as a definitive solution and insurance is more willing to approve surgery even when it doesn't fit the steps of their algorithms.

   But your doctor has to be willing to support their diagnoses with reasonable explanations in order to get approval.

Information for Use (IFU) from Bayer states that endometrial ablation is contradicted when performing ablation immediately following ESSURE placement due to the difficulty or inability to properly perform a hysterosalpingography (HSG) at the 3 month Post Confirmation Test which confirms tubal closure.

After the FDA approved ultrasound screening as acceptable to confirm proper insert position in the tubes, which was equated to closure, endometrial ablation became more popular with ESSURE. However, the studies used to justify endometrial ablation with ESSURE are significantly lacking in confirming the safety of combining these techniques.

Consider the following:

1. Endometrial ablation with an ESSURE in Grade 1 or 2 allows for a significant exposure of the coil to the damaging effects of the energy source used to destroy the endometrial lining.

   No study has addressed the short or long term effects of heat, cold, thermal or microwave energy on the coils. However, it is well known that metallic coils and PET fibers degrade over time and that metallic implants are specifically covered by materials designed to decrease the oxidization and degradation process.

   No metallic implant lasts forever, and it is also well known that as the metal degrades or oxidizes, metallic ions leach into surrounding tissues.

   Energy sources great enough to cause tissue damage can damage the coils which accelerates the degradation process of the coils.

   No study has reviewed this long term effect.

   Studies associated with combined ESSURE and endometrial ablation reviewed only the effects of tubal injury from the energy source and, in most cases, the increase in thermal energy or heat within the tube As such, the clinicians were only looking at what happened to the tube as it was heated or cooled, not what was happening to the coil, and none looked at what happened to the coil over time.

   The FDA has subsequently come out with recommendations as to labeling nitinol containing devices, which ESSURE is one.

   The recommendation clearly address the nature of metal degradation and oxidization over time.

   The effects of metal degradation, oxidation and ion leaching are continuous sources of foreign body reactions and potential local and systemic autoimmune reactions.

2. All endometrial ablation energy sources are associated with potential injury to adjacent organs to the uterus, which include the tubes, bladder and intestines.

   Unfortunately, they have also been associated with catastrophic organ damage and death.

3. the use of endometrial ablation with ESSURE assumes proper placement of the ESSURE coils.

   Unfortunately, this cannot always be confirmed.

   Combined with the fact that ESSURE can migrate over time, endometrial ablation can pose a serious risk for the patient.

4. Endometrial ablation has a failure rate of approximately 25% and long term side-effects including chronic pelvic pain and pain with intercourse.

   As such, the combined use of ESSURE and endometrial ablation pose very high risks of complications and should be carefully considered before agreeing to this procedure in cases of abnormal uterine bleeding.