Essure: A Historical and Informational Guide to the Discontinued Contraceptive Device

The Essure system was a form of permanent, non-incisional female sterilization that was available to women for a number of years as an alternative to traditional tubal ligation surgery. The procedure involved the placement of small, flexible micro-inserts into each of the fallopian tubes. It was a hysteroscopic procedure, meaning it was performed by a gynaecologist using a thin camera passed through the vagina and cervix into the uterus, requiring no cuts to the abdomen. The underlying principle of the Essure system was to stimulate the body's own natural healing response to create a permanent blockage in the fallopian tubes, thereby preventing sperm from ever reaching and fertilizing an egg.

Initially, Essure was presented as a revolutionary option for permanent contraception, offering the benefit of a less invasive procedure that could be performed in a doctor's office without the need for general anesthesia. However, over its years of use, a significant number of women reported experiencing serious and persistent adverse health events following the device's placement. These widespread reports led to increased scrutiny from global regulatory bodies, patient advocacy campaigns, and ultimately, the decision by the manufacturer to voluntarily halt sales and discontinue the product worldwide. It is crucial for all patients to understand that Essure is no longer an available option for contraception, and this guide serves as a historical and informational resource to explain what the procedure was, the issues that arose, and the proven, safe alternatives that are the current standard of care.

The Intended Scientific Principle of Essure

To understand the history of the Essure device, it is important to first understand the intended biological mechanism by which it was designed to work. The entire concept was based on creating a natural tissue barrier through a process called fibrosis.

Anatomy of the Female Reproductive System

The key structures involved in conception are the ovaries, the fallopian tubes, and the uterus. Each month, an ovary releases an egg, which travels into the fallopian tube. Fertilization by a sperm, which has traveled up from the vagina through the uterus, typically occurs within the fallopian tube. The fertilized egg then travels the rest of the way down the tube to implant in the uterus. Permanent sterilization methods are designed to permanently block the fallopian tubes to make this meeting of egg and sperm impossible.

The Essure Device and its Intended Mechanism

The Essure system consisted of two small, flexible micro-inserts, each about 4 centimeters long. Each insert was comprised of two main components:

1. An Inner Coil: Made of stainless steel, this provided structural support.
2. An Outer Coil: Made of a nickel-titanium alloy, this outer coil was designed to expand slightly upon placement to hold the device securely within the fallopian tube.
3. Polyethylene Terephthalate PET Fibers: Woven throughout the inner and outer coils were these crucial PET fibers. These are the same type of inert fibers used in many medical implants.

The intended mechanism of action was a process of benign tissue occlusion:

• Hysteroscopic Placement: A gynaecologist would insert one micro-insert into the opening of each fallopian tube from within the uterine cavity.
• The Inflammatory and Fibrotic Response: The presence of the foreign material, specifically the PET fibers, was designed to elicit a mild, chronic inflammatory response from the body. In response to this, the body's natural healing process would be initiated, causing fibroblasts to produce scar tissue.
• Tubal Occlusion: Over a period of approximately three months, this scar tissue, or fibrosis, was intended to grow into and completely around the micro-inserts, permanently and irreversibly blocking the fallopian tubes.
• The Confirmation Test: After three months, the patient was required to have a special X-ray test called a Hysterosalpingogram HSG to confirm that both tubes were completely blocked before she could rely on the device for contraception.

The Historical Context and Clinical Application

When it was available, Essure was presented as a significant advancement over traditional tubal ligation surgery.

The Intended Advantages

• Non-Incisional: The procedure was performed through the natural pathway of the vagina and cervix, avoiding any cuts to the abdomen, which meant no external scarring.
• No General Anesthesia: It could often be performed in a gynaecologist's office or an outpatient setting with only local anesthesia or mild sedation.
• Faster Recovery: The recovery time from the placement procedure itself was much shorter than from a laparoscopic surgery.

The Intended Candidate

The procedure was intended for women who were absolutely certain they did not want any more children and desired a permanent form of contraception.

The Complications and Reasons for Discontinuation

Despite its innovative design, the Essure system became the subject of widespread patient complaints and medical concerns, which ultimately led to its removal from the market. A significant number of women reported experiencing a range of severe and often chronic adverse events after the device was implanted.

Reported Adverse Events and Complications

• Chronic Pelvic and Abdominal Pain: This was one of the most frequently reported long-term side effects.
• Perforation: In some cases, the micro-inserts would perforate or migrate through the wall of the fallopian tube or the uterus, sometimes embedding into adjacent organs in the pelvic or abdominal cavity.
• Device Migration: The entire device could become dislodged from the fallopian tube and migrate to other parts of the body.
• Allergic and Hypersensitivity Reactions: The materials in the device, particularly the nickel component, were found to cause allergic or hypersensitivity reactions in some women. This could manifest as skin rashes, hives, and a range of systemic symptoms.
• Autoimmune-like Symptoms: Many women reported the onset of new symptoms such as profound fatigue, joint pain, brain fog, and hair loss after the device was placed, which they believed were related to an autoimmune or inflammatory response to the implant.
• Abnormal Uterine Bleeding: Changes in menstrual patterns, including heavy or prolonged bleeding, were commonly reported.
• Unintended Pregnancy: While rare, pregnancies did occur, including a higher proportion of ectopic pregnancies, a life-threatening condition where the pregnancy implants outside the uterus.

The Path to Discontinuation

The growing volume of these patient reports led to action from regulatory bodies like the U.S. Food and Drug Administration FDA, which issued a "black box warning," its most stringent warning, for the device and mandated further safety studies. Faced with mounting lawsuits and declining sales, the manufacturer ultimately decided to stop distributing and selling the Essure device globally.

Important Information for Women Who Currently Have Essure

For women who had the Essure device implanted before it was discontinued, it is important to have clear, factual information.

• If You Are Not Experiencing Symptoms: If you have the Essure inserts and are not having any adverse symptoms, and your three-month HSG confirmation test showed that your tubes were blocked, major medical societies currently recommend that you can continue to rely on the device for contraception and do not need to have it removed. You should continue with your routine gynaecological check-ups.
   
• If You Are Experiencing Symptoms: If you have Essure inserts and are experiencing symptoms such as chronic pain, abnormal bleeding, or other systemic issues that you believe may be related to the device, it is crucial that you seek a consultation with a gynaecologist who has specific expertise in this area. They can perform a thorough evaluation, which may include imaging studies, to assess the position of the devices and discuss your options.
   
• Essure Removal: The removal of Essure inserts is a surgical procedure. The recommended approach is typically a laparoscopic salpingectomy, which is the removal of the fallopian tubes with the inserts contained inside. Attempting to simply pull the inserts out is not recommended, as they can fragment and the scar tissue can make this difficult and incomplete.

Myths vs Facts

Safe and Effective Alternatives: The Current Standard of Care

While Essure is no longer an option, there are several highly effective and safe methods of permanent sterilization available.

For Women: Laparoscopic Tubal Ligation

This is the current gold standard for female sterilization.

• The Procedure: It is a minimally invasive surgical procedure performed under general anesthesia. The surgeon makes one or two small incisions in the abdomen, and a laparoscope, a thin camera, is inserted. The surgeon then closes off the fallopian tubes, usually by placing clips or rings on them, or more commonly today, by completely removing them from a salpingectomy.
• The Benefit of Salpingectomy: Removing the fallopian tubes entirely not only provides highly effective contraception but has also been shown to significantly reduce the future risk of developing the most common type of ovarian cancer, which is now believed to originate in the fallopian tubes.

For Men: Vasectomy

A vasectomy is a highly effective, minimally invasive procedure for male sterilization.

• The Procedure: It is a minor surgical procedure, often performed in the urologist's office under local anesthesia. It involves cutting or sealing the vas deferens, the tubes that carry sperm from the testicles.
• The Advantage: A vasectomy is a simpler, safer, and less expensive procedure with a faster recovery compared to a female tubal ligation.

An Important Lesson in Medical Device Safety

The history of the Essure device serves as a powerful reminder of the importance of long-term, post-market surveillance for all new medical technologies and the critical role that patient reporting plays in ensuring medical safety. It highlights the need for open and honest conversations between doctors and patients about the full spectrum of potential risks and benefits associated with any medical procedure.

If you are considering permanent contraception, the most important step you can take is to have a comprehensive discussion with your gynaecologist. They can provide you with detailed, up-to-date information on the safe, effective, and evidence-based options that are the current standard of care, helping you to make an informed decision that is right for your body and your life.

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