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.
Need a Texas Essure Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by chronic pain, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
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.
FDA Experts Question Safety of Essure
Chicago Tribune talked to Elena Mendez, a woman who developed chronic pain after the Essure coils were implanted in her body in 2008. She said, “Pain became my norm every day. This negatively impacted my marriage and I could not be the mother my children deserved.”
Her doctors discovered Essure embedded in her endometrial cavity. After undergoing surgery, the pain went away. In another interview with NBC New York, Mendez said:
“It felt like this constant either dragging or shooting, stabbing pains. Almost like someone literally had a knife — sitting inside of you with a knife like poking downward.”
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.”
KSHB talked to Kimberly Lira, a woman who said her reports of “extreme” pain were crossed out, and her comfort level rated as “excellent.” After she asked to remove Essure, she was kicked out of the clinical trial.
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