Why are women with Essure suing the device’s manufacturer?
Essure is a permanent birth control device offered as an alternative to tubal ligation. Originally manufactured by Conceptus Inc., which was later purchased by Bayer HealthCare, Essure has been promoted as an effective, non-surgical, and permanent form of birth control.
However, women having undergone the Essure implant procedure report experiencing numerous, serious, and often debilitating, side effects.
At present, more than 16,000 lawsuits have been filed against Bayer alleging that, despite having knowledge of the serious injuries caused by this device, rather than take steps to pull it from the market or provide stronger warnings, Bayer continued to promote this device as a safe and effective form of permanent birth control.
How Essure works
Essure has been available in the U.S. since November 2002. The Essure System consists of flexible metallic coils and polyethylene (PET) fibers, which are inserted into the fallopian tubes.
Over a period of about three months, the PET fibers cause a chronic and permanent inflammatory response that causes scar tissue to form around the coils. The scar tissue creates a barrier that keeps sperm from reaching the eggs, thereby preventing conception.
Three months after Essure is implanted, women must undergo a second procedure, an Essure confirmation test, or hysterosalpingogram (HSG), to confirm that the fallopian tubes are completely blocked.
Until having received confirmation that the fallopian tubes are fully blocked, women are advised to take/use alternative forms of birth control or abstain from sexual intercourse.
Injuries caused by Essure
|• Hysterectomy||• Unintended/Ectopic Pregnancy|
|• Breakage of One or Both Micro-Inserts||• Migration of one or both micro-inserts|
|• Nickel Poisoning (hair loss, rashes,|
metal taste in mouth, joint/muscle pain,
tooth decay, etc.)
|• Perforation of the Uterus, Fallopian|
Tube(s), and/or Other
|• Abnormal/Heavy Menstrual Bleeding||• Severe Abdominal/Pelvic Pain|
|• Autoimmune Disorders||• Severe Menstrual Pain|
Essure, injuries & problems
Since introduced to the market in 2002, over 26,000 complaints about Essure have been reported to the FDA. Injuries reported to the FDA include, but are certainly not limited to:
What is a black box warning?
Safety testing of a drug and/or device is the responsibility of the manufacturer. The FDA approves a drug or device based on the safety studies conducted and reported by the manufacturer. Unfortunately, however, some safety issues do not become apparent until after the drug or device has been approved and is already on the market.
In such instances where the side effects are serious and life-threatening, short of pulling the drug or device from the market, the FDA will require the manufacturer to add a box warning, or “black box warning”, to the package insert, and sometimes even on the labeling of a prescription drug itself. The black box warning is the strongest warning required by the FDA and is designed to call attention to the severity of the side effects.
As noted above, the FDA issued a black box warning for Essure in February of 2017, and further restricted the sales of the device to doctors and facilities who use the FDA-approved checklist in April of 2018. While these may seem like steps in the right direction, more can be done to protect women considering permanent sterilization.
In fact, aside from the United States, Essure is no longer being sold in any other country in the world. More specifically, in February of 2017, ANVISA, the Brazilian equivalent of the USA’s FDA, suspended the importation, distribution and use of Essure in Brazil. Thereafter, Bayer voluntarily withdrew the product from Finland, the Netherlands, the United Kingdom, and Canada.
More recently, Essure was banned in Australia, which was followed by a suspension of sales in Europe, pending a safety review and investigation by the National Standards Authority of Ireland; Europe’s equivalent to the USA’s FDA.
Do I have a case?
Currently, The Yost Legal Group is investigating Essure birth control claims from all 50 states. If you or a loved one has undergone the Essure implant procedure for permanent birth control and has suffered one or more of the Essure side effects outlined above, please contact our dangerous device attorneys today at 1-800-YOST-LAW for a free consultation.