This year the Food and Drug Administration (FDA) ruled that the permanent implantable birth control device Essure, manufactured by Bayer, requires a “black box” warning on the label. This type of warning is the most serious warning that the FDA can put on a drug product. It only is used when there are life-threatening or other serious complications that may arise from the use of the drug. Yet the manufacturer continues to produce the drug and claim that it is both safe and effective. So why are so many women filing lawsuits against this product?
What Is Essure?
Essure is a birth control solution for women, first approved and introduced into the United States in 2002. It differs from other more common types of birth control in that it is considered both permanent and irreversible. Essure is not a hormone-based method of birth control, either; instead, it is a small, implantable medical device, designed to be placed into the fallopian tubes.
Essure was created as an alternative to a common form of permanent surgical birth control called a tubal ligation, sometimes referred to as “having your tubes tied.” Tubal ligation is considered to be a major surgical procedure. It typically requires the support of a hospital surgical suite, including surgeons and other healthcare professionals.
Essure implantation is considered a “minimally invasive” procedure and can be performed in a doctor’s office by a doctor who has been trained in the procedure. The process involves the feeding of a special catheter tube into the vagina, through the cervical os (a small opening in the cervix, which expands during childbirth) and into the uterus. The doctor then guides an implant into each of the two fallopian tubes. The implant expands to fit into place, blocking the tubes permanently. The catheter is then removed and the procedure is done, often in only a few minutes.
How Does Essure Prevent Conception?
The fallopian tubes are the channels that carry eggs from the ovaries and into the uterus, where the eggs can be fertilized by sperm. The Essure coil causes a temporary inflammation at the implant site, and over the course of about three months the body creates new tissue that grows through the implant that completely blocks the fallopian tubes. This prevents an egg from ever passing into the uterus, greatly reducing the chance for fertilization and conception. The manufacturer claims that it is over 99% effective.
What Makes Essure Attractive to Women?
For women who never want to give birth or choose not to have any more children, the idea of Essure is appealing for a number of reasons. The procedure is quick, permanent, maintenance-free, and, though potentially uncomfortable, minimally painful. Other more invasive surgical procedures, such as hysterectomy or tubal ligation, require hospital trips and potentially long recovery times with significant pain, inconvenience, and expense.
Why Are There Lawsuits?
Essure may sound appealing to some women, but all is not as it seems, unfortunately. Early in 2016, it was revealed that over 5,000 women filed complaints with the FDA between 2002 and 2015 about Essure. Issues included pregnancies, stillbirths, miscarriages, and the death of four women. Other complaints have involved issues with the metals (nickel and stainless steel) leaching into the blood and causing pain and neurological damage, device migration, organ perforation, or spontaneous ejection.
So many women filed complaints that members of a women’s group called Essure Problems, which was started by noted activist Erin Brockovich, planned a hunger strike in front of FDA headquarters in 2015. The FDA finally was forced to take notice and issued final guidance requiring post-market surveillance to collect more data and a “black box” warning label stating the potential risks.
Holding Medical Device Companies Accountable
Many women feel that while the FDA’s ruling was a good first step, it’s not nearly enough to hold Bayer truly accountable for the dangers of this device. For women who have been injured by Essure, the next step is to consider filing a lawsuit against Bayer AG to recover damages, including the costs of medical bills from Essure side effects and difficult, painful removal surgeries, lost wages and time, suffering, and more.
If you’ve been hurt by Essure and would like to talk to a law firm that isn’t afraid to stand up to these defective device manufacturers, Wayne Wright LLP is a Texas law firm with years of experience battling on the behalf of the sick and injured in the court of law. We would like to help you fight for the compensation that’s rightfully yours. Call us today at 800-237-3334 for a free consultation and case evaluation.