What is Essure?
Essure is a permanent, non-surgical birth control solution for women. Essure is used to prevent fertilization by inserting a coil designed to induce fibrosis and block the fallopian tubes. The product is manufactured by a company owned by Bayer called Conceptus Inc. The company failed to warn patients of the side effects such as chronic pain, puncturing of the uterus or fallopian tubes, stomach and pelvis device migration, abnormal bleeding and unplanned pregnancies. Since women were in the dark about these side effects, many have blindly chosen this method of birth control and suffered the side effects.
Serious Side Effects of Essure
Unplanned pregnancy and increased risk of ectopic pregnancy
Punctured uterus or Fallopian tubes
Stomach and pelvis device migration
Stomach and Pelvis Device migration
The FDA has received more than 5,000 adverse reports involving Essure, including 3,300 claims of abdominal pain, more than 1,400 involving menstrual irregularities, nearly the same amount of unexplained headaches and about a thousand reports of fatigue and weight fluctuation.
In addition to these side effects, Essure is reported to have caused at least 26 deaths, including four adult deaths, miscarriages, and infants that died shortly after birth.
Stomach And Pelvis Device Migration
This serious side effect occurs when the Essure device migrates into the abdominal cavity, the pelvis or bladder through a uterine wall. This can cause internal bleeding, severe pain and damage to several other organs such as the bladder, intestines and many blood vessels. Some women will need multiple surgeries to find and remove the device.
FDA Warning On Essure
The U.S. Food and Drug Administration (FDA) approved Essure in 2002. Since its approval, the FDA has received more than 5,000 reports of injuries and complications. In 2016, a boxed warning and Patient Decision Checklist has been added to Essure labels to help ensure consumers are aware of the risks associated with the device. According to the Food and Drug Administration, the warning and checklist will include information on what to expect after undergoing the birth control procedure, potential side effects to be aware of, safety, effectiveness and other details.
How The Carlson Law Firm Can Help You
Women who underwent an Essure procedure and experienced health complications should know that they have rights, including the right to take legal action against Bayer. If you or someone you know have suffered these serious injuries from Essure, contact our team of defective product attorneys immediately for a free consultation.