Hundreds of women have been injured by broken pieces of an Essure implant that fractured, perforated organs, failed to prevent pregnancy, or had to be removed with a hysterectomy.
Essure is a sterilization implant made of a plastic tube about the width of pencil-lead, which is surrounded by two metal coils. Each of these three components can fracture. Fracture is most likely to occur during a difficult implantation procedure. However, Essure can also break after months or years inside a woman’s body.
Sharp edges of a fractured Essure can puncture the fallopian tube or the uterus. This could cause internal bleeding, organ damage, and allow Essure to migrate into the abdomen. If pregnancy occurs, Essure can also puncture the fetal membrane and cause miscarriage.
Broken pieces of Essure do not always cause problems, and doctors sometimes choose to leave them inside a patient’s body rather than risk surgery. For patients who are experiencing problems like chronic pain, a hysterectomy may be necessary. Any pieces left behind or persistent symptoms may need additional surgery.
FDA Reviews Hundreds of Reports of Essure Fracture
From 2002-2015, the FDA received over 5,093 adverse events linked to Essure. According to the safety review, 259 of those events involved “device breakage.” The FDA also said fractured Essure implants could potentially cause chronic pain.