Broken pieces of a fractured Essure implant may fail to prevent pregnancy or perforate internal organs. In many cases, they must be surgically removed.
Essure is a delicate medical device that consists of a plastic micro-insert surrounded by two metal coils (one made of nickel-titanium and one of stainless-steel) and covered in polyester fibers.
During the implantation procedure, part of an Essure insert may break off (fracture). This complication can also occur spontaneously, months or even years after Essure is successfully placed in the fallopian tube.
Fractured metal coils can cause serious complications. The sharp edges can lacerate the fallopian tubes or cause a perforation, allowing Essure to migrate into the abdomen or pelvis. It may also fail to prevent pregnancy and increase the risk of miscarriage.
Removing Broken Pieces of Essure
After an X-ray locates the broken pieces, surgery may be necessary to remove Essure. If pieces are left behind, symptoms may not improve and additional surgery may be necessary. Some women have needed a complete hysterectomy (surgical removal of the reproductive organs) to remove Essure.
In September 2015, the FDA completed a safety review of over 5,000 adverse events linked to Essure since it was approved in 2002.
Those reports included 259 reports of “device breakage.” In some cases, broken pieces of Essure also migrated and caused complications. The FDA warned that fractured Essure implants could cause chronic pain.