On February 9, 2016, the US Food & Drug Administration released a massive trove of adverse event reports, representing every reported side effect submitted to the agency in relation to Essure. Made publicly-available, the PDF document contains a total of 9,884 reports submitted between Essure’s FDA approval on November 4, 2002 and January 1, 2016.

It is not light reading.

Which Essure Problems Are Most Common
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The 10 Most Commonly Referenced Essure Side Effects

We searched through these reports to find out which potential side effects are most commonly reported, and then widened our search to compile statistics on nearly every reported side effect, no matter its incidence.

Here are the results, starting with the 10 most commonly-cited symptoms:

  1. Pain, ranging from pelvic pain to neck pain. Nearly every report mentions “pain.” In fact, the word “pain” is used 24,015 times, or roughly 2.4 times per report. “Pelvic pain” is far and away the most common, with 2,885 individual mentions. “Back pain” is also frequent, at 1,837 instances.
  2. Bloating. Variations of “bloat” and “bloated” appear 2,385 times. Abdominal and stomach bloating are most frequently referenced, and many women say they have become bloated that acquaintances think they are pregnant.
  3. Headaches are mentioned a total of 2,261 times. 126 of these references are specified as “migraine headaches.”
  4. Fatigue, often qualified as “severe,” “extreme” or “chronic” is referenced 2,010 times.
  5. Hives and / or rashes are mentioned 1,778 times, and many women suspect their skin problems are caused by an undiagnosed nickel allergy.
  6. Weight gain is referenced 1,619 times.
  7. Brain fog and closely-related descriptors, including “cloudiness,” “forgetfulness” and “memory loss,” are referenced 1,343 times.
  8. Cysts are mentioned 1,299 times. In 392 instances, “ovarian cysts” are specified.
  9. Depression is noted 1,293 times. Suicidal ideation is mentioned 133 times. Variants of “sad” and “sadness” appear an additional 74 times, while “anxiety” is mentioned 853 times. “Panic attacks” are referenced 195 times. Because these symptoms can arise from a wide variety of clinical conditions, we have chosen to rank this category of potential side effects based solely on the number of references to “depression” itself.
  10. Nausea and vomiting are mentioned 1,248 times, often, but not always, in combination.

Below, you’ll find a comprehensive list of potential side effects and symptoms reported in Essure adverse event reports. Within each category, we’ve ranked the conditions from most commonly referenced to least commonly referenced.

Pain – 24,015 references

Here are statistics for specific types of pain:

  • “pelvic pain” is mentioned 2,885 times. Some reports get even more specific. “Chronic pelvic pain” is mentioned 320 times.
  • “back pain” is mentioned 1,837 times.
  • “joint pain” is mentioned 982 times.
  • While “dyspareunia,” the medical term for painful sexual intercourse, is mentioned “only” 81 times, “painful intercourse” is referenced 402 times. Variations on the phrase, like “pain during intercourse” and “painful sex,” appear in at least 410 more locations.
  • “hip pain” is mentioned 270 times.
  • “spine pain” or “spinal pain” are mentioned 23 times specifically, but references to “spine,” usually in relation to pain, appear 126 times. “Back ache” or “aches” are referenced 107 times.
  • “chest pain” is mentioned 207 times.
  • “stomach pain” is mentioned 217 times.
  • “breast pain” is mentioned 110 times, while “breast tenderness” is referenced 58 times and “tender breast” or “tender breasts” appear 12 times. That’s an estimated 180 references to breast sensitivity issues.
  • “leg pain” is mentioned 170 times, while “swelling of legs” (and / or feet) is mentioned 87 times. “Knee ache” is mentioned twice.
  • Mittelschmerz” (from the German, literally “middle pain”), a frequently-used term to describe one-sided abdominal pain usually associated with ovulation, is mentioned 19 times. “Painful ovulation” is referenced 117 times, usually (but not always) without a concurrent reference to Mittelschmerz. Other variations on the phrase, including “pain during ovulation,” appear at least 31 times.
  • “neck pain” is mentioned 68 times.
  • generalized “body pains” are mentioned 47 times.
  • “face pain” is mentioned 12 times.

Menstrual & Gynecological Issues – 10,576 references

  • “pregnancy” appears 1,857 times. The term is repeated at least once in most reports.
  • “cysts” are mentioned 1,299 times. Of those references, at least 392 are specified as “ovarian cysts.” “Breast cysts” are mentioned in 3 reports. There are 5 specific references to “uterine cysts” and 9 references to “fallopian tube cysts.”
  • “Menstrual cramps” or simply “cramps” are mentioned 942 times.
  • “night sweats” are referenced 329 times, while “sweating” issues in general are mentioned 545 times.
  • a wide range of menstrual cycle problems are referenced, from abnormally long periods to blood clotting. Issues involving a patient’s “menstrual cycle” are referenced 773 times.
  • “endometriosis,” a condition in which tissue that usually lines the uterus grows outside the uterus, is referenced 429 times.
  • “painful period” or “periods” are mentioned 250 times, “menstrual pain” 44 times, “painful menstruation” 21 times, “pain during menstruation” or “during period” 19 times and the medical term for painful menstruation, dysmenorrhea, 78 times. That’s a total of 412 references specifically to pain during menstruation.
  • “hot flash” appears 365 times.
  • menorrhagia,” or excessive bleeding, is mentioned 353 times.
  • “spotting” is mentioned 352 times.
  • “miscarriage” is referenced 284 times, while 4 reports list “stillbirth” as a suspected consequence of Essure implantation.
  • “ectopic pregnancy” is mentioned 265 times.
  • “yeast infections” are referenced 263 times.
  • “fibroids,” generally uterine, are mentioned 243 times.
  • “irregular period” appears 227 times.
  • “adenomyosis,” in which uterine tissue grows into the uterine wall, appears 216 times.
  • amenorrhea,” or absence of menstrual cycle, is mentioned 37 times, while “period stops” and variations on that phrasing (including “skipped” and “missed”) appear at least 103 times.
  • “urinary tract infection” appears 131 times, while “bladder infection” is mentioned 94 times.
  • “bacterial vaginosis,” a common bacterial infection of the vagina, is referenced 116 times.
  • “pelvic inflammatory disease” is specifically mentioned 73 times. The condition’s acronym “PID” is referenced 240 times, but note that several words commonly used in reports, such as “rapid,” contain the sequence of letters “PID.”
  • “abdominal spasm” is mentioned 67 times.
  • “polycystic ovary syndrome,” a condition causing enlarged ovaries, is referenced 64 times, including the condition’s acronym “PCOS.”
  • metrorrhagia,” bleeding between periods, is mentioned 30 times, while “continuous bleeding” is referenced 30 times.
  • “early menopause” is referenced 37 times.
  • “abnormal menses” are mentioned 35 times.
  • “uterine infection” appears 33 times.
  • cervicitis,” inflammation of the cervix, appears 31 times.
  • “Premenstrual Dysphoric Disorder” or “PMDD,” in which patients suffer severe depression and tension prior to menstruation, is referenced 29 times.
  • “uterine inflammation” and variations on the phrase are noted 19 times.
  • vulvodynia,” an inexplicable chronic pain in the vulvar area, is referenced 19 times.
  • hydrosalpinx,” in which a Fallopian tube fills with fluid, is mentioned in 15 separate reports.
  • Polymenorrhea,” the medical term for an abnormally long menstrual cycle is referenced 12 times.
  • 12 separate reports refer to “cervical cancer” as a possible consequence of Essure. “Cervical dysplasia,” a precancerous condition, is mentioned in 11 separate reports.
  • Bartholin’s cyst,” a swelling of glands near the vaginal opening, is mentioned 11 times

Sexual Problems – 312 references

  • “loss of libido” is mentioned 143 times, while variations on “lost interest in sex” appear an additional 14 times.
  • “bleeding after sex” and “spotting after sex” appear 125 times
  • “sexual dysfunction” (or “disfunction”) appears 30 times

Neurological Problems & Mental Health – 13,157 references

  • “headaches” are mentioned 2,261 times, while “migraine headaches” are referenced specifically 126 times.
  • “fatigue” is mentioned 2,010 times.
  • “brain fog” is mentioned 535 times, while “cloudiness” and “cloudy brain” are referenced 93 times. “Forgetfulness” and various references to “forget” appear 307 times. “Confusion” is referenced 126 times. “Memory loss” is mentioned 267 times and “loss of memory” 14 times. “Lack of clarity is mentioned once. That’s 1,343 total references to symptoms of cognitive impairment.
  • “depression” is referenced 1,293 times. Variations on “sad” and “sadness” are mentioned 74 times.
  • “dizziness” and “dizzy spells” are referenced 947 times. “vertigo” is mentioned 111 times. “lightheaded” appears 116 times.
  • “anxiety” is noted 839 times, while “anxious” is used 14 times. “Panic attacks” are mentioned 195 times. References to suicidal ideation appear 133 times.
  • “mood swings” are mentioned 776 times.
  • references to “tremors,” often described as full body reactions, appear 64 times, while “spasms” are mentioned 528 times. “Shakiness” is referenced 82 times.
  • “numbness” (usually in hands or feet) appears 612 times.
  • Paresthesia” the feeling of “pins and needles,” is mentioned 10 times. “Pins and needles” itself is noted 4 times. “Tingling,” confined to the extremities in most reports, is referenced 485 times.
  • “insomnia” is referenced 392 times.
  • “fibromyalgia,” chronic musculoskeletal pain researchers believe may be caused by a problem with the way your brain interprets nerve signals, is referenced 267 times.
  • “tinnitus,” a ringing or buzzing in the ears, is referenced 29 times, while “ringing” in the ears is mentioned 132 times.
  • “fainting,” “fainting spells” and “faint” are mentioned 119 times, while variations on “black out” are referenced in 5 separate reports.
  • “Stroke” is referenced 85 times. In several reports, “stroke” is a pre-existing condition noted in a patient’s medical report. In others, patients say they were hospitalized for “stroke-like symptoms” after being implanted with Essure.
  • “nerve pain” is mentioned 80 times.
  • trigeminal neuralgia,” a cause of chronic pain in one of the head’s most important nerves, is referenced 8 times. “Brain shocks,” a symptom some reports say was diagnosed as trigeminal neuralgia, are mentioned 38 times.
  • References to seizures are surprisingly common. The term “seizure” appears in 87 reports.In more than half of these reports, “seizure” seems to be used not as a medical diagnosis, but as an analogy, a way of describing unfamiliar cognitive or neurological symptoms.In one report, the term is used to refer to a fainting episode. In another, it is used to describe the onset of tremors. Four reports mention “seizure-like brain activity,” information that may have been gleaned from an MRI. One report comes from a patient with pre-existing epilepsy, whose well-controlled seizures became worse after she received the Essure implants. In one report, a patient uses the phrase “as though my body was going to have a seizure” to describe a general sense of ill-health.In 40 reports, “seizure” is listed as a suspected side effect of Essure.
  • “post-traumatic stress disorder” and “PTSD” are referenced 35 times.
  • meralgia paresthetica,” a condition marked by tingling, numbness and burning in the outer thigh, is referenced 6 times. Specific symptoms of meralgia paresthetica, including formulations like “numbness in thigh” and “burning in thigh,” are mentioned 24 times.

Gastrointestinal Conditions & Side Effects – 4,890 references

  • “bloat,” “bloated” and “bloating” appear a total of 2,385 times.
  • “nausea” appears 919 times; “sick,” an admittedly non-specific term, occasionally used in reference to “sick leave” or as a synonym for general ill health, is mentioned 428 times.
  • “vomiting” is mentioned 308 times; variations on “throw up” 21 times.
  • “constipation” is mentioned 255 times.
  • a “metallic taste” in a patient’s mouth is mentioned 232 times.
  • “diarrhea” is referenced 209 times.
  • Various formulations of “heartburn” are mentioned 156 times. “Indigestion” appears 15 times.
  • “Irritable bowel syndrome” or “IBS” (often described as a potential misdiagnosis) occurs 137 times.
  • “incontinence” is mentioned 108 times.
  • “frequent” and “urgent urination” are referenced 108 times.
  • “diverticulitis,” a condition in which small pouches form in the GI tract’s lining, appears 21 times.
  • “gastritis,” an inflammation of stomach lining, is referenced 16 times.

Cardiovascular & Hematological Issues – 1,674 references

  • “blood clots” are mentioned 567 times.
  • variations on “vitamin D deficiency” are mentioned 256 times.
  • “heart palpitations” are referenced 221 times.
  • anemia,” a condition in which the blood lacks sufficient red blood cells, is mentioned 172 times. “Iron deficiency,” a common cause of anemia, is referenced 31 times.
  • “high blood pressure” appears 172 times, while “low blood pressure” is mentioned 20 times. The phrase “blood pressure” itself appears a total of 294 times.
  • “bruising”-related side effects are referenced 112 times.
  • “vitamin B12” deficiencies are referenced 38 times.
  • abnormalities in “blood count,” often elevated white blood cell counts, are mentioned 30 times.
  • “Raynaud’s syndrome,” in which the blood vessels that supply skin are abnormally narrow, is referenced 29 times.
  • “pulmonary embolism,” a blockage of lung arteries usually caused by a blood clot, is referenced in 14 separate reports.
  • hypoglycemia,” or low blood sugar, is mentioned 12 times.

Autoimmune Disorders – 376 references

  • “arthritis” is referenced 184 times, while the more specific “rheumatoid arthritis” appears 60 times.
  • “lupus,” a chronic inflammatory disease, is mentioned 109 times.
  • “Hashimoto’s disease,” in which the immune system attacks the thyroid gland, is referenced 45 times.
  • “multiple sclerosis,” a disorder in which the immune system attacks the cellular sheathe surrounding nerves, appears 31 times.
  • “chronic fatigue syndrome,” an as-yet unexplained disorder marked by fatigue, enlarged lymph nodes, muscle pain and sore throat (among other symptoms) is mentioned 22 times. Researchers aren’t sure what causes chronic fatigue syndrome, though there’s some evidence that patients with the condition have impaired immune systems.
  • myasthenia gravis,” a chronic autoimmune disorder that causes weakness in the skeletal muscles, is mentioned 7 times.

Skin Disorders & Allergies – 4,743 references

  • “hives” are referenced 438 times. Skin “rashes” are mentioned 1,340 times.
  • “itch” or “itching” are mentioned 1,045 times.
  • “nickel allergy” is mentioned 524 times. “Allergic reaction,” often but not always specified as a reaction to the nickel of which Essure implants are constructed, is referenced 767 times.
  • “acne,” occasionally specified as “cystic acne,” is referenced 332 times.
  • “dry skin” is mentioned 112 times.
  • “boils” are mentioned 96 times.
  • “gluten sensitivities” or variations on the phrase are mentioned 47 times.
  • previously unnoticed / non-existent “food allergies” are referenced 42 times.

Other Health Conditions & Potential Side Effects

  • “weight gain” is referenced 1,619 times. “weight loss” is mentioned 113 times.
  • “hair loss” is mentioned 1,099 times. The phrase “hair changes” is referenced 3 times, while abnormal changes in “hair growth,” including facial hair, are mentioned 61 times.
  • “Teeth” problems are referenced 349 times. Variations on “dental problems” or “dental issues” appear 130 times. 7 reports mention “fillings” falling out.
  • “fever” is mentioned 255 times.
  • references to “floaters” or “seeing spots” appear 72 times. “blurred vision” is mentioned 157 times, and “double vision” 4 times.
  • “adhesions,” bands of scar-like tissue that form between organs or surfaces in the body, are mentioned 179 times.
  • “liver” issues are mentioned 93 times.
  • There are 102 references to specific thyroid conditions. Of these, 91 note “hypothyroidism,” while 11 note “hyperthyroidism.”
  • “dry eyes” and “eye dryness” are mentioned 40 times.
  • “sleep apnea” is referenced 35 times.
  • variations on “adrenal problems” appear 35 times.
  • “swollen gland” appears 26 times.
  • “blood in urine” is referenced 17 times.
  • “dry hair” is mentioned 9 times.
  • “degenerative bone disease” is mentioned 5 times.

Device Failure

  • “perforation,” usually of the Fallopian tube or uterus, is referenced 2,149 times.
  • “migration” of an implant is mentioned 1,065 times.
  • there are 471 references to an implant “embedded” in an internal organ.

Finally, the term “hysterectomy” is mentioned 4,159 times. Many of these references relate to women who underwent hysterectomy after experiencing what they concluded were side effects of the Essure implant. From a preliminary search, it appears that this is the case for the majority of references to “hysterectomy,” but some reports speak only of a “suggested hysterectomy.” In many reports, the word is repeated twice.

Notes On Our Analysis

This report is by no means a scientific endeavor. Some reports repeat a symptom more than once, so be wary of assuming that the number of times a side effect is mentioned represents the number of women who have experienced that side effect. Entire reports can be duplicated, and we have not made an effort to eliminate these duplicates in our analysis. We have, however, attempted to eliminate negative references to symptoms from our counts. For example, after searching for “fever,” identifying 261 instances of the word, we then searched for “no fever,” subtracting the result (only 6) from our initial finding.

We’ve also tried our best to capture the numerous ways in which any one condition can be phrased, but of course, we’ll have missed some references to side effects. This point is particularly relevant, since thousands of these reports came from patients, some of whom may be unaware of standardized medical terminology.