Essure Birth Control Lawsuit
Can I file a lawsuit because I was injured by Essure birth control?
Women who used Essure birth control are filing lawsuits against the device’s maker, Bayer. According to claims, this form of permanent birth control causes serious injuries, which in some cases led to death.
Most recently, a California court ruled the Essure lawsuits filed in the state can move forward. Bayer had disputed legal action claiming that because the device was approved by federal regulators, the company should not be liable for the injuries it caused.
This ruling concerned eleven consolidated cases for fourteen women in California courts, but there are currently more than 200 Essure lawsuits throughout the court system in California. Additional claims have been filed in courts across the country.
According to legal claims regarding the device, the complications caused by Essure were far worse than those mentioned as risks on packaging and in educational literature.
What is Essure?
Essure is a Class III medical device. It received approval from the FDA in 2002.
The device is positioned in the uterus and its small metal coils are inserted into the fallopian tubes. These coils trigger the development of scar tissue, which prevents an egg from reaching the uterus and being fertilized by sperm. Placement of Essure is done on an outpatient basis and does not require surgery or any type of incision.
According to data, there are approximately 750,000 women using Essure throughout the world, but some doctors report women are choosing Essure less and less.
Despite some Essure users reporting success with their device, numerous problems have arisen. The FDA has received more than 5000 adverse event reports regarding the device. The severity of these events range from abnormal bleeding to the device moving out of the uterus and into other parts of the body.
Also included in the database of adverse event reports were claims of:
- Severe abdominal and pelvic pain
- Hair loss
- Internal bleeding
- Autoimmune problems
- Allergic reaction
- Device migration and expulsion
- Perforation of the fallopian tubes
- Miscarriages after unintended pregnancies
Bayer Accused of Filing False Information
According to claims filed against Bayer, the company was aware of the problems related to Essure and failed to make the information public. Worse, it is accused of falsely reporting information
Essure’s original manufacturer was not Bayer, it was a company called Conceptus. The device was approved for Conceptus by the FDA through the agency’s fast-track process, provided the company submitted information from four to five year studies after the device was on the market. Though that time frame expired in 2007, the data was not submitted until 2015.
Furthermore, Conceptus monitored less than three quarters of the women involved in the study for the full five years. Several Essure users involved in the study also reported their results were reported inaccurately.
Upon investigation, the FDA found at least six cases of tampering, but noted it was sporadic and “did not reveal a pattern.”
More than Two Dozen Deaths Linked to Essure Use
So far, 26 deaths have been linked to Essure – four were women using the device and 18 were miscarriages. There were also two infant deaths following a live birth.
In response to the numerous problems with Essure, in 2015, the FDA recommended limiting the use of the device, and later called for a black box warning to be added to Essure packaging.
Patient and consumer advocates are asking for a total recall of Essure. They believe the company misled consumers and not enough research was done in advance to prove Essure’s safety. To date, five federal Essure cases include negligent misrepresentation charges against Bayer.
It is expected the latest ruling in California will launch a number of additional Essure lawsuits.
If you or a loved one was injured by Essure, you should contact an attorney to discuss your case.