Essure can perforate the uterus or the fallopian tubes, resulting in chronic pain, organ damage, migration into the abdomen, and complications that require emergency surgery.
Essure is implanted into a woman’s body through the vagina. Using a flexible tube with a small camera (hysteroscope), doctors carefully guide Essure through the uterus into the fallopian tube. During or after the insertion procedure, Essure can partially penetrate or completely perforate the following organs:
- Uterus: Perforations may occur during insertion or afterward due to normal muscle contractions.
- Fallopian tubes: Perforation most often occurs when Essure is inserted too far, but it can also occur spontaneously after a successful placement.
- Bowel: Essure implants that perforate the fallopian tubes can migrate into the abdomen and cause organ damage, including bowel perforation, laceration, or obstruction..
- Cervix: Occurs most often during insertion procedure.
- Amniotic sac of a developing baby: At least five fetal deaths have been linked to Essure perforating the fetal membrane.
FDA Receives Hundreds of Reports of Essure Perforation
Between 2002 and 2015, the FDA received about 300 reports of perforations, including 12 bowel perforations. Many perforations occurred because Essure was inserted too far into the fallopian tubes or migrated from its intended location.
In the early years after Essure was approved, kits included a “support catheter” that may have also contributed to perforations, according to the FDA.
Did Conceptus Hide Reports of Perforations?
Conceptus Inc. received Pre-Market Approval (PMA) for Essure in 2002. This type of approval gives manufacturers immunity from lawsuits so long as they follow strict rules when studying a device.
Thousands of women have been unable to file lawsuits, but they say Essure’s PMA is invalid because Conceptus had 168 complaints of perforation since December 2007, but only told the FDA about 22 events.
Risk-Factors for Perforations
- 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
Diagnosis of a Perforation
Diagnosis of a perforation can be challenging because it does not always cause symptoms. However, it should be suspected if an X-ray shows that Essure is abnormally positioned, or if the patient has symptoms like chronic pain, abnormal bleeding, nausea, or vomiting. In clinical trials, 3.1% of patients experienced uterine perforation and 1.1% experienced fallopian tube perforation.
Essure Perforation Leads to Bowel Obstruction
In January 2013, Contraception published a case report of a 42 year-old woman who needed emergency surgery after Essure perforated her fallopian tube and migrated into her abdomen. The metal coils stretched and strangled part of her intestines, causing a life-threatening bowel perforation. She required emergency surgery to close the perforation and remove Essure.