FDA Reports 30 Essure Deaths and 10,000 Injuries
The U.S. Food and Drug Administration (FDA) had updated its ongoing safety review of birth control device Essure saying that it is now linked to 30 deaths and 10,000 serious injuries. According to a report in the Daily Hornet, the FDA received 5,016 reports involving Essure in 2016 another 6,176 reports in 2015 and 30 reports of fatalities. The deaths include four adult women, 18 pregnancy losses, two infants who died after they were born and a possibly stillborn baby.
What is Essure?
Essure is a metal coil that is permanently implanted in a woman’s fallopian tubes, where it causes irritation and growth of scar tissue. Essure is supposed to block the fallopian tubes to prevent pregnancy. Instead, many women ended up getting pregnant or developed severe side effects. The FDA added a “black box” warning label to Essure in November 2016, which is essentially the strongest label the FDA could require on a device.
While Essure has been touted by manufacturer, Bayer, as a 30-minute non-surgical outpatient procedure with less pain and quicker recovery compared to tubal ligation, lawsuits filed by women across the country, tell a different story. In fact, an entire community of women has banded online and on social media sites, sharing horror stories about how this device has turned their lives upside down.
Severe Side Effects
Many of the reports listed multiple side effects. The most common and serious of Essure problems included:
- Severe abdominal pain
- Heavier menstrual bleeding or irregular periods
- Severe and chronic headaches
- Fatigue or exhaustion
- Patient-device incompatibility, such as rashes caused by nickel allergy
- Weight gain or weight loss
- Migration of the device causing organ perforation
- Pregnancy losses, ectopic pregnancy, abortion or miscarriage
- Surgery to remove the device
If You Have Been Affected
If you or a loved one has suffered serious side effects as a result of using Essure, you may be able to seek compensation for your injuries, damages and losses by filing a product liability lawsuit. Injured victims in such cases can seek compensation for damages such as medical expenses, lost income, hospitalization, cost of unnecessary or additional surgeries to remove the device, pain and suffering and emotional distress. An experienced product liability attorney will be able to fight for victims’ rights and help them secure fair and full compensation for their tremendous losses.