Pharmaceutical

Essure complications can present years after implantation

Essure Essure complications can present years after implantation Side effects from the controversial birth control method Essure have surfaced almost immediately for some women, but for others, problems arose years later.

Essure is the only non-surgical permanent birth control method on the market. It consists of nickel alloy coils that are implanted in each fallopian tube where they create a barrier that prevents sperm from reaching the egg. The implants have been associated with thousands of adverse event reports including allergic reactions, autoimmune disorders, pain, bleeding and infections. The coils can also migrate and puncture the fallopian tubes or uterine wall and perforate other organs.

In February, the Food and Drug Administration (FDA) recommended that the manufacturer, Bayer Healthcare, place a black box warning on packages of the device.

In a case study featured in The Journal of Minimally Invasive Gynecology, a 30-year-old woman went to her doctor complaining of new irregular periods and right-side abdominal pain. Three years earlier, she had been implanted with the Essure contraceptive device. At the time of placement, a hysteroscopy showed that the coils were properly implanted in the fallopian tubes.

An x-ray three years later when the woman presented with symptoms showed that the Essure coils were within the pelvis and appeared normal. However, the patient was taken for a diagnostic laparoscopy and removal of the Essure device along with the removal of her fallopian tubes. That’s when doctors discovered that the left coil had “transversed through the proximal fallopian tube and had adhered to the omentum on tension with the hepatic flexure.” Despite this complication, doctors were able to remove the device.

Six weeks later, the woman reported that her abdominal pain and menstrual problems had largely resolved.

Dozens of women have filed lawsuits against Bayer claiming the company did not adequately warn about Essure complications.

Source: The Journal of Minimally Invasive Gynecology