More than 3,700 women have filed personal injury lawsuits against the Bayer Group, alleging that use of the manufacturer’s metal permanent sterilization product Essure has caused injuries including hysterectomy, perforation, bleeding, weight gain, pain, depression and more. This implanted birth control, which consists of two metal coils that are implanted in the fallopian tubes and that prompt scarring to block tubes and prevent fertilization, continues to be sold on the market.
Essure’s problems have affected up to 4 percent of its more than 1 million users worldwide users, most of who are in the United States, and more than 16,000 reports of injuries or harm caused by Essure have been sent to the Federal and Drug Administration (FDA) in recent years. According to the FDA, some Essure failures have even resulted in unexpected pregnancy.
Essure acknowledges the problems users have experienced with the implantation on its own website, including finding inserts in the pelvic or abdominal cavity and suspected hypersensitivity or allergic reactions. Adverse events such as these require surgery, while many patients who decided to use Essure did so because they wanted to avoid surgery altogether.
If you are an Essure user, have a loved one who uses it, or are considering using Essure as a permanent birth control solution, here is what to consider and when a lawsuit regarding your Essure use may be wise.
Essure is a non-hormonal form of birth control that is not intended to be removed. It’s available by prescription only and consists of coils made of nickel, polyethylene fibers and titanium. It’s an alternative to surgery for permanent birth control, such as tying tubes (tubal litigation), and takes usually less than an hour to administer in a doctor’s office without general anesthesia.
In 2015, after the FDA convened a meeting of its Obstetrics and Gynecology Devices Panel because of thousands of complaints from women about Essure, it decided to recommend that women with hypersensitivity or an allergy to nickel, long-lasting pelvic pain, autoimmune disorders and prior uterine surgery do not use Essure. Also in November 2015, a bill was introduced in Congress to call for a recall of the Essure product.
Plaintiffs in claims against Essure accuse the company of covering up dangers in their studies, as well as continuing to insist their products maintain a successful history of safety and effectiveness. The company has also been accused of failing to collect data from problems women were having, which may have been able to improve their product or provide more adequate warnings. It also misused non-blind and non-randomized studies to gain pre-marketing approval.
This can be constituted as negligence by the company, which is why so many lawsuits have been filed against Bayer.
Some women experienced symptoms such as weight fluctuation, headache, fatigue and abdominal pain without knowing the cause until they discovered niche information sites like Facebook Groups. Even doctors have been slow to point out dangers or recognize problems for their patients.
Since problems started surfacing, there have been several labeling changes mandated by the FDA. In 2011, a nickel sensitivity warning was issued. In 2013, a warning about device migration and chronic pain was issued. In 2016, a black box warning, which is the strictest warning the FDA can label on a product, was issued.
If you or a loved one has been implanted with Essure and has experienced adverse side effects, it is vital to consult with an attorney because you may have a lawsuit. Thousands of women have already sued Bayer for Essure, and many more are expected. As evidence grows to support the dangers that Essure poses to its users, it’s vital to be aware of the risks, talk with your doctor about your concerns, and consult an attorney because you may have a potential claim.
Some of the issues that are addressed in lawsuits against Bayer/Essure include:
- Defective and dangerous product
- Failure to comply with federal safety laws
- Failure by manufacturer to provide proper warnings
- Insufficient testing of Essure
- Improper warning about Essure side effects before using
- Negligence on behalf of Bayer/Essure to keep patients safe
You or a loved one may have a case if there has been harm caused by Essure. To learn if you have a potential claim, it is wise to consult with an attorney for a free consultation, where they’ll learn your unique details and give you the support and help you need. Contact Pittman, Dutton, Hellums, Bradley & Mann at (205) 322-8880, or contact us online for information about a potential Essure lawsuit.