Table 2.
Associated with Essure reported in the FDA MAUDE database in 2018 (N = 4,994) using nVivo® software.
| Word | Count | Related words |
|---|---|---|
| Top 10 frequently reported adverse events associated with Essure | ||
| Pain | 41,564 | Afflictions, anguish, awful, bother, bothering, distress, dreadful, hurt, hurtful, hurting, hurts, irritability, irritable, irritate, irritated, irritates, irritating, irritation, irritations, pain, painful, paining, pains, sore, soreness, sores, strain, terrible, terribly, trouble, troubled |
| Hemorrhage | 14,620 | Bleed, bleeding, bleedings, bleeds, haemorrhage, haemorrhagic, haemorrhaging, hemorrhage, hemorrhaged, hemorrhages, hemorrhagic, hemorrhaging |
| Surgery | 6,328 | Operated, operating, operation, operations, operative, operatively, surgeries, surgery |
| Menorrhagia | 6,321 | Hypermenorrhea, menorrhagia |
| Migraine | 5,207 | Migraine, migraines |
| Infection | 5,147 | Infected, infection, infections, infectious, infective, septic, transmission |
| Dyspareunia | 4,663 | Dyspareunia |
| Dysmenorrhoea | 3,634 | Dysmenorrhoea |
| Perforation | 3,033 | Penetrated, penetrating, penetration, perforate, perforated, perforating, perforation, perforations, pierced, piercing, piercings, punch, puncture, punctured, punctures, puncturing |
| Anxiety | 3,083 | Anxiety, anxious |
| Top 10 Serious adverse events associated with Essure | ||
| Surgery | 6,328 | Operated, operating, operation, operations, operative, operatively, surgeries, surgery |
| Death | 5,558 | Dead, deadly, death, deaths, decease, deceased, demise, destruction, die, died, dying, end, ended, ending, ends, expiry, last, lasted, lasting, lastly, lasts, mortal |
| Perforation | 3,033 | Penetrated, penetrating, penetration, perforate, perforated, perforating, perforation, perforations, pierced, piercing, piercings, punch, puncture, punctured, punctures, puncturing |
| Hysterectomy | 2,373 | Hysterectomies, hysterectomy |
| Cyst | 1,780 | Cyst, cysts, vesicle, vesicles |
| Salpingectomy | 1,501 | Salpingectomies, salpingectomy |
| Endometriosis | 988 | Adenomyosis, endometriosis |
| Anaemia | 720 | Anaemia, anemia |
| Hospitalization | 469 | Hospital, hospitalisation, hospitalization, hospitalizations, hospitalized, hospitals |
| Incontinence | 351 | Dissolution, incontinence, incontinency |