What is Essure?
Essure is permanently implanted birth control device. The device was developed for women by Conceptus, Inc. and purchased by the pharmaceutical company Bayer. The device was quickly approved for use by the FDA in the United States on November 4, 2002.
How does Essure work?
The implantation of Essure is non-surgical and generally takes about 10 minutes. During the implantation, a healthcare provider inserts flexible coils through the vagina, cervix and fallopian tubes, which carry eggs from the ovaries to the uterus. Over the course of 3 months, a buildup of tissue forms around the inserts. This buildup creates a barrier that keeps sperm from reaching the egg, thus preventing conception.
Unlike Mirena or Norplant, Essure is a permanent form of birth control.
Side Effects of Essure
The FDA has been closely monitoring the adverse effects of Essure over the last several years. They have received reports of adverse side effects including:
- Persistent pain
- Perforation of the uterus and/or fallopian tubes
- Intra-abdominal or pelvic device migration
- Abnormal or irregular bleeding
- Allergy and/or hypersensitive reactions
- Unintended and ectopic pregnancies.
As a result of these adverse effects, some women have had surgical procedures to remove the device. Unfortunately, these surgical procedures often require the removal of the uterus entirely, resulting in added turmoil, pain and suffering.
Essure and the FDA
Notably, the FDA imposed several requirements on the manufacturer upon approving the device.
First, the FDA required that the manufacturer create a training program for physicians in the implantation of Essure. They also required that the device’s warning label include information about both failure and success rates, and that the manufacturer continue to gather information about women’s injuries from clinical trials and publish a report within five years of the device’s approval. Incredibly, Conceptus did not issue a report of its findings until April 24, 2015 – nearly 8 years later too late. By the time the report was published, several lawsuits attesting to the failure of Essure were already making their way through the court system.
Who might have an Essure claim?
At this time, there are no class-action lawsuits against Essure. But based on our analysis, there are two groups of women who may have an Essure claim.
- Women needing multiple surgeries beyond implantation – According to the FDA, Essure implantation has resulted in a wide variety of surgical complications. Some of these include: failure to properly place the implant, tearing or perforation of the fallopian tube and nearby organs, migration of the implant after implantation and subsequent surgeries including total hysterectomies (remove of the uterus). If you needed to undergo another procedure after the implantation of your Essure, we believe you may have a claim. This includes so-called “minimally-invasive” procedures such as laproscopic.
- Women with unusual reactions to Essure- There have also been reports of a wide variety of allergic reactions to Essure including recurrent pelvic pain, inflammation and metal toxicity. If you suffered continuing pain or allergic reactions to Essure, then we believe you may have a claim.
Call Techmeier Law Firm
If you have needed multiple surgeries beyond implantation of Essure (including a total hysterectomy), or if you’ve had experienced any adverse side effects such as device migration, organ perforation, allergic reactions, or continued pain, please get in touch with the experts at Techmeier Law Firm. Let our skilled Milwaukee defective medical device lawyers help you. Contact our firm today.