Essure is the only nonsurgical permanent birth-control option approved for women ages 21 to 45. But Bayer’s device has been linked to varying side effects that can be serious and potentially life-threatening.
The severity and extent of the side effects spurred an FDA panel hearing in September 2015 as well as agency recommendations to health care providers and patients. These recommendations included advising women with nickel allergies, autoimmune disorders, chronic pelvic pain and prior pelvic surgeries to avoid using Essure.
Debilitating headaches, nausea, allergic reactions to the nickel in the device, the need for hysterectomies following use of the device and colon perforation are among the problems linked to Essure.
Clinical trial data and adverse event reports submitted to the FDA since 2004 show long-term risks of Essure include:
- Chronic pelvic pain
- Allergic reactions to the nickel
- Fallopian tube, uterus and/or colon perforation
- Device movement
- Ectopic pregnancy risk
Autoimmune Disorders and Essure
When the body’s immune system attacks itself by mistake, destroying otherwise healthy body tissue, it is called an autoimmune disorder. An Essure device can trigger such a response.
Typically, the blood cells within the immune system protect the body against harmful substances, such as bacteria, viruses, toxins, cancer cells and other foreign agents from outside the body.
These harmful substances contain what is called antigens. The immune system produces another substance called antibodies that guard against and destroy these antigens. But when a person suffers from an autoimmune disorder, the immune system cannot determine what is an antigen and what is actually healthy tissue. This results in the body reacting to and destroying healthy tissues.
Symptoms of Autoimmune Disorders
Symptoms of an autoimmune disorder can vary based on the location of the body affected by the immune response. In individuals with lupus, each person may experience symptoms differently. The symptoms can also come and go.
Common symptoms of autoimmune disease and lupus include:
- Fever without a known cause
- Chest pain when taking a deep breath
- Pale or purple fingers or toes
- Sensitivity to the sun
- Joint pain and swelling
- Swelling in the legs or around the eyes
- Muscle pain
- Mouth ulcers
- Swollen glands
- Rash (typically red in color and most often on the face, referred to as the “butterfly rash”)
Diagnosis and Treatment of Autoimmune Disorders
There is no one test to diagnose an autoimmune disorder or lupus. Often, a diagnosis will involve excluding other conditions as well. A patient’s health care provider will start with a complete physical exam and medical history prior to using other diagnostic tools.
Several tests that may be done to derive a diagnosis include:
- Antinuclear antibody tests
- Autoantibody tests
- Blood tests, such as:
- CBC (complete blood count)
- Comprehensive metabolic panel
- C-reactive protein (CRP)
- Erythrocyte sedimentation rate (ESR)
- Skin biopsy (looking at skin samples under a microscope)
- Kidney biopsy (looking at tissue from your kidney under a microscope)
- Urinalysis (urine tests)
Most autoimmune disorders are chronic (long-term). There is no cure for lupus, but symptoms can be controlled with medications and lifestyle changes. Medicines to suppress the immune system, or reduce its abnormal response, are called immunosuppressive medicines. These can include corticosteroids, such as prednisone, and other non-steroid drugs. These medications can sometimes cause severe side effects, such as a higher risk of infections.
Perforated Organs and Essure
A perforation, or hole, in the colon (bowel) allows the contents of the colon to leak into the generally sterile (free from bacteria) environment of a patient’s abdominal cavity. Essure devices have been linked to organ perforations.
The condition is a medical emergency that can result in severe pain, bleeding, infection (peritonitis or sepsis) and even death.
"“The most common cause of colon perforation is due to doctor error during an [abdominal] procedure.”
- Colon Health Magazine
Other conditions, such as Crohn’s disease, ulcer, or gastrointestinal cancer, can also cause the development of a hole in the bowel.
If the colon is punctured by an object inserted into the abdominal cavity, it can result in a serious or potentially life-threatening situation as toxins from the bowel are released into the bloodstream. Patients will often experience pain several days before the perforation of the bowel occurs.
Colon Perforation Symptoms
Leakage of the bowel’s contents into the abdominal cavity can cause a serious infection called peritonitis (inflammation of the peritoneum — the thin tissue that lines the inner wall of the abdomen and covers many abdominal organs). If toxins invade the patient’s bloodstream, sepsis (a potentially life-threatening complication of an infection) can occur.
The most common signs and symptoms of colon perforation include:
- Abdominal pain (often severe and widespread)
- Change in bowel movements
- Fever without a known cause (often gradual)
- Loss of appetite
- Nausea and vomiting
- Rectal bleeding
- Severe abdominal cramping
Diagnosis and Treatment of Colon Perforation
If a colon perforation is suspected, diagnostic tests, such as an abdominal X-ray, CT scan of the abdomen (with or without contrast), or a barium enema (X-ray of the large intestine, including the colon and rectum), may be used to determine if a hole is present in the bowel.
Blood tests, such as a complete blood count (CBC), may also be done to see if there’s an elevation in the patient’s white-blood cell count (signaling infection) or evidence of anemia (low red blood cells) due to bleeding.
Treatment generally involves surgery to repair the hole. Sometimes, a portion of the colon may need to be removed or a temporary colostomy (a surgical procedure that exposes part of the large intestine through an opening [stoma] in the abdominal wall to drain the bowel), may be required. If the perforation closes on its own, a patient may only need to be treated with antibiotics, but this is rare.
While the success rate of surgery for a bowel perforation is high, resulting complications are dependent on the extent (including size and location) of the damage and its duration.
Chronic Pelvic Pain (Abnormal Bleeding) and Essure
Chronic pelvic pain can be intermittent or constant, but it is generally pain in the pelvic area that persists for more than six months. The pain can be sharp or stabbing in a specific location, or it can be dull and widespread. It can be debilitating, interfering with normal daily activities.
Surgery, serious illness or severe infections are the most common causes of chronic pelvic pain. Adhesions or scar tissue that develop as a result of these conditions, throughout the healing process, are associated with the pain and/or abnormal bleeding a woman may experience. Adhesions can also cause organs and other structures inside the abdomen to attach to each other causing additional problems and pain.
Women may feel more pronounced pain during their periods or when having sexual intercourse. Pelvic pain that persists, especially when accompanied with abnormal bleeding, is typically a sign that there is a problem with one of the organs present in the pelvic area, such as the uterus, ovaries, fallopian tubes, cervix or vagina. It can also be the result of a problem related to the urinary tract, lower intestines (such as the colon), rectum, muscle or bone.
Lab, imaging or other medical tests may be done to find the source of the pain. Treatment is dependent upon the cause, the severity of the pain, and how often the pain or other symptoms occur.
If chronic pelvic pain and/or abnormal bleeding occurs following certain surgical procedures or the insertion of certain medical devices, such as Essure, an additional surgical procedure may be required to fix the problem or to remove the device.
Allergic Reactions (Hypersensitivity) to Nickel
It is estimated that more than 18 percent of people in North America are allergic to nickel, including 36 percent of women and 11 million children in the U.S., according to the America Academy of Dermatology. Nickel is one of the most common causes of a type of skin rash called dermatitis, caused by contact with an allergen (a substance that is generally harmless to most individuals).
While most often associated with jewelry, nickel can be found in many everyday items, such as coins, pens, zippers, cellphones, eyeglass frames, and even dental or medical devices, such as orthodontic braces and Essure.
In patients with an allergic reaction to nickel, the immune system mistakes nickel for a harmful substance, or an intruder, and produces certain chemicals called histamines to eliminate it. This triggers an allergic reaction.
It may take coming into contact with nickel often or for prolonged periods of time for an allergy to develop; but once it’s apparent, a patient must continue to avoid contact with the substance for life. Some researchers think nickel allergies may be genetic.
Nickel Allergy Symptoms
The most common symptom associated with a nickel allergy is an itchy skin rash. Nickel allergies can cause other skin reactions too, such as redness and blistering. Skin reactions, including dry, rough skin, warm, tender skin, and scaly, raw or thickened skin, typically begin within 12 to 48 hours from exposure to nickel.
A severe reaction, called anaphylaxis, can be potentially deadly and requires immediate medical attention. It can come on suddenly and progress very quickly. Foods, medications and insects that sting are the most common causes of this type of reaction.
Some signs and symptoms linked to a more severe allergic reaction include:
- Chest pain or tightness
- Coughing and/or wheezing
- Dizziness or fainting
- Loss of consciousness
- Shortness of breath
- Swelling of the lips, tongue or back of the throat
- Tightness in the throat
- Trouble swallowing
- Vomiting, diarrhea and/or cramps
- Weak pulse
Diagnosis and Treatment of Allergic Reactions to Nickel
Severe allergic reactions require immediate medical attention. Auto-injectors containing a hormone called epinephrine may be given right away to treat existing symptoms and to prevent the onset or worsening of additional symptoms or complications. This medication is associated with many different side effects, some severe, and its use may require monitoring by a health care professional.
A patch test can be performed by applying a small amount of nickel over a patch placed on the patient’s skin. The doctor will observe signs of an allergic reaction, such as skin irritation, over the course of about 48 hours.
If a person has a nickel allergy, the best way to avoid having an allergic reaction is to avoid coming into contact with nickel altogether. Medications used to reduce skin reactions and inflammation resulting from a nickel allergy may include corticosteroids, such as prednisone, or oral antihistamines.
Ectopic Pregnancy and Essure
An ectopic pregnancy is a pregnancy that occurs outside the uterus. In a normal pregnancy, the fertilized egg travels through the fallopian tube to the uterus. If the movement of the egg is blocked or slowed through the tubes, such as is the case with Essure, it can lead to an ectopic pregnancy.
Did You Know
An ectopic pregnancy occurs when the egg is blocked or slowed through the fallopian tubes, such as is the case with Essure.
The most common site for the egg to implant in an ectopic pregnancy is within one of the two fallopian tubes, according to the National Institutes of Health (NIH). As the fetus grows, the tube can rupture, or burst. This is a life-threatening condition to both the mother and the fetus, requiring immediate emergency surgery.
Ectopic Pregnancy Symptoms
An ectopic pregnancy may present with typical signs and symptoms of early pregnancy, such as breast tenderness or nausea. But other symptoms may be apparent to differentiate between the serious medical condition and a normal pregnancy. These symptoms may even occur before a woman suspects she is pregnant.
The most common early symptoms of an ectopic pregnancy include:
- Abnormal vaginal bleeding (may be light or heavy)
- Gastrointestinal symptoms
- Low back pain
- Mild cramping on one side of the pelvis
- No periods
- Pain in the lower belly or pelvic area
If the pregnancy ruptures or bleeds, symptoms may worsen. These signs and symptoms that require immediate medical attention may include:
- Fainting or feeling faint (due to blood loss)
- Intense pressure in the rectum
- Low blood pressure
- Pain in the shoulder area (due to blood from the ruptured tube building up under the diaphragm – or the area between the chest and stomach)
- Severe, sharp and sudden pain in the lower abdomen
Diagnosis and Treatment of Ectopic Pregnancy
A woman’s health care provider will do a pelvic exam as well as a pregnancy test and vaginal ultrasound to confirm an ectopic pregnancy. Also, blood levels of HCG (a hormone normally produced during pregnancy) will be checked. Low levels may signal an ectopic pregnancy.
A rupture can lead to bleeding and shock. When this happens, the following methods may be used as treatment:
- Blood transfusion
- Fluids given through a vein
- Keeping warm
If an ectopic pregnancy is determined, the developing cells (fetus) must be removed to save the mother’s life, according to the National Institutes of Health (NIH). The government health organization says that “the pregnancy cannot continue to birth (term).”
Two methods are available to treat an ectopic pregnancy — medication and surgery. Prior to a rupture, and when the pregnancy is still small, it may be able to be treated with medication to stop the growth of the pregnancy and allow the body to absorb it over time. This will also allow a woman to keep her fallopian tube.
Surgery may be needed when the pregnancy is large or blood loss is a concern. Some or all of the tube may need to be removed during surgery.
If the area of the ectopic pregnancy (typically the fallopian tubes) ruptures, or bursts, emergency medical care is required.
A surgery will be done to stop the blood loss and remove the pregnancy. Typically, the doctor will also have to remove the affected fallopian tube.
Please seek the advice of a medical professional before making health care decisions.
Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.