Emergency surgery is often necessary when the Essure birth control device perforates the fallopian tubes, uterus, cervix, fetal membrane, bowel, or abdominal organs.
Essure is a plastic cylinder surrounded by sharp metal springs. It is implanted with a device called a hysteroscope, which inserts Essure through the vagina and uterus into the fallopian tubes.
Perforations can occur during the implantation procedure or afterward — typically when Essure is inserted too far into the fallopian tube. Even when Essure is inserted correctly, normal muscle spasms can cause perforations months or years later.
Types of Perforations
- Uterine: Perforation of the uterus can occur during insertion or afterward, sometimes as a complication of a broken Essure coil.
- Fallopian tubes: Often occurs when Essure is inserted too far into the fallopian tube, but it may also occur spontaneously due to tubal spasms.
- Intestinal: After Essure has perforated the fallopian tube and migrated into the abdomen, it can perforate the bowel or cause other organ damage.
- Cervix: Most often occurs during the insertion procedure.
- Fetal membrane: The FDA has received five reports of fetal death, including three late-term miscarriages, when Essure perforated the amniotic sac or the uterus.
Hundreds of Perforations Reported to FDA
The FDA received nearly 300 reports of perforations linked to Essure between 2002-2015, including 12 bowel perforations. In the early years, Essure kits included a “support catheter” that may have contributed to some perforations.
Essure Perforation Risk-Factors
- Difficult insertion procedure
- Poor visualization of the tube due to excess tissues (endometrium, adenomyosis, fibromas)
- Tubal spasm
- Anatomic abnormalities including an obstructed or narrow fallopian tube
- Uterine or abdomino-pelvic adhesions
- Prior history of STD
- Larger uterine size
- Patient procedural pain or discomfort
How is a Perforation Diagnosed?
The diagnosis of a perforation from Essure is not always easy, especially because many women do not experience symptoms. When symptoms do appear, they may include chronic pain, abnormal bleeding, nausea, or vomiting. Doctors should also suspect a perforation if X-rays show Essure is malpositioned or migrated into the abdomen.
Bowel Perforation May Require Emergency Surgery
A case report of a severe perforation was published by the journal Contraception in January 2013. The victim required emergency surgery when Essure perforated her fallopian tube, migrated into her abdomen, and strangled part of her intestines.
Conceptus Accused of Hiding Perforation Reports
Lawsuits challenging the validity of Essure’s Pre-Market Approval (PMA) accuse Conceptus of failing to report adverse events. For example, an FDA inspection report from 2010 found that Conceptus had received 168 reports of perforations since December 2007, but only told the FDA about 22 events.