A growing number of women who experienced chronic pain or needed surgery to remove Essure have come forward to file lawsuits against the manufacturer, Conceptus Inc., for downplaying the risk.
Chronic pain has been reported in women who were implanted with Essure, although studies and case reports are lacking. This debilitating condition can partially or totally incapacitate a person — both physically and emotionally.
Percentage of Essure Patients Who Experience Pain
In clinical trials, Essure-related pain was reported by 2.9% of patients — including abdominal pain / cramps (3.8%), back pain (9%), severe menstrual cramps (2.9%), severe pelvic / lower abdominal pain (2.5%), and pain during sexual intercourse (3.6%).
Possible Causes of Chronic Pain from Essure
- Improperly positioned device in the fallopian tubes
- Uterine or fallopian tube perforation
- Migration in the abdomen or pelvis
- Organ damage
- Pressure from more than one Essure implant in a fallopian tube (not recommended)
- Nickel allergy with or without local inflammation
- And more
Conceptus Accused of Falsifying Medical Records
NBC New York reports that several women in clinical trials of Essure have testified that Conceptus falsified their medical records to downplay reports of severe pain.
One woman from Arizona testified that she answered surveys to report “aching” and “unusual” and “severe” pelvic pain after getting Essure. Her answers were changed to “comfort level: excellent.”
Another woman who reported “sharp” pelvic pain also had her answers changed to “comfort level: very good.” Others reported that her answers were altered or researchers “coached” their answers.
At least one woman in California said Conceptus dropped her from clinical trials and stopped sending her follow-up surveys when she developed complications. Now suffering from four autoimmune diseases, she said “They ‘lost’ my medical records. They’re all of the sudden missing.”