Chronic pain is one of the most debilitating side effects reported in women who were implanted with Essure. Now, a growing number of lawsuits accuse Conceptus Inc. of failing to adequately warn about this risk.
What is the problem?
Hundreds of women who were implanted with the Essure sterilization device have reported chronic pain. This side effect can devastate a woman’s quality of life and lead to permanent disability. Often, the only cure is another surgery to remove Essure.
FDA Reviews Reports of Chronic Pain Linked to Essure
Over 5,000 women have reported severe side effects of Essure, including chronic pain. One of these women, Elena Mendez, was implanted with Essure in February 2008. She told NBC New York:
“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.”
Doctors discovered the source of her pain was an Essure coil embedded in her endometrial cavity. She was forced to undergo emergency surgery, which cured her condition. In an interview with the Chicago Tribune, she said: “Pain became my norm every day. This negatively impacted my marriage and I could not be the mother my children deserved.”
What Percentage of Women Experience Chronic Pain from Essure?
Nearly 3,000 women have reported pain as a side effect of Essure, but the risk of persistent or chronic pain is not well-studied. Clinical trials estimated that about 2.9% of women who get Essure experience pain.
The most commonly-reported events included back pain (9%), abdominal pain or cramps (3.8%), pain during sexual intercourse (3.6%), severe menstrual cramps (2.9%), and severe pelvic or lower abdominal pain (2.5%).
What Could Cause Chronic Pain?
After reviewing adverse events, the FDA determined that Essure could cause chronic pain in the following ways:
- Improper positioning of Essure in the fallopian tube, including kinked implant
- Perforation of the uterus or fallopian tube
- Migration into the abdomen or pelvis
- Organ damage
- Multiple Essure implants putting pressure on the fallopian tube (not recommended)
- Allergic reaction to nickel (with or without inflammation)
- And more
Women Accuse Conceptus of Hiding Chronic Pain Reports
Conceptus Inc., the manufacturer of Essure, has been accused of falsifying medical records from women who participated in clinical trials to downplay the risk of side effects like chronic pain.
Kimberly Lira talked to KSHB News and said Conceptus crossed out her report of “extreme” pain and replaced it with an “excellent” comfort level. She also said she was kicked out of the clinical trial after asking for surgery to remove Essure.
Conceptus was in charge of follow-up surveys for women who got Essure in its early years. One woman said her report of “sharp” pelvic pain was changed to “comfort level: very good.” Another said her reports of “aching” and “severe” pelvic pain were changed to “comfort level: excellent.”
Other women said Conceptus “coached” them through the survey or stopped sending follow-up surveys when they reported complications. According to one woman from California, “They ‘lost’ my medical records. They’re all of the sudden missing.”