Essure, a device that promises permanent birth control, is under scrutiny by the U.S. Food and Drug Administration (FDA) after complaints from thousands of women about long-lasting and painful side effects, which they say, are related to this device. According to an NBC news report, the manufacturer of the device, Bayer, estimates that currently about 750,000 women are using Essure, most of them in the United States. The complaints of injuries and negative side effects in connection with the use of Essure have recently been the topic of numerous Essure lawsuits.
How Does Essure Work?
Essure is a small spring-like device that is inserted into the fallopian tubes through the cervix. Within three months, scar tissue builds up around the coils creating a physical barrier preventing the sperm from reaching the eggs. This is a quick procedure and women go home 45 minutes after it is completed. Patients are supposed to go back to the doctor after three months for a confirmation check to make sure Essure is working properly to prevent pregnancy. The device is made of a nickel titanium alloy, a material commonly used in other medical devices such as heart stents.
What Injuries and Health Complications are Being Reported?
Thousands of women who have been implanted with the Essure device say they’ve suffered painful and serious complications including ovarian cyst ruptures, fatigue, significant weight loss and chronic pain. Many women have had to get these devices removed because of how they migrate and rupture vital organs. However, even removing the devices has not been easy because of the way the coils are implanted. The Essure device usually cannot be removed without a complete hysterectomy, which is the removal of the uterus.
What is the FDA Doing?
The FDA approved Essure for use in 2002. Since that time, the FDA has received more than 10,000 complaints about health complications related to the use of Essure. On September 24, 2015, the FDA held hearings on the growing number of complaints about Essure side effects. Following that hearing, where doctors and patients testified about their Essure experiences, the FDA ordered Bayer to conduct a post-market study to gather more data about the risks and benefits of using Essure. In February of this year, the FDA mandated an Essure Black Box Warning, the most severe warning that can be issued for a drug or medical device.
Contact an Experienced Essure Lawyer
Our law firm is working with experienced Essure lawyers, who are investigating these cases. If you have suffered a serious injury after using Essure, you may be entitled to compensation for your medical bills, lost income and pain and suffering, among other losses. There is no fee unless you receive an award or settlement. Call our toll free number at 1-800-992-6878 or fill out a contact form online for a free (no obligation) case evaluation.