Essure Birth Control Device Update
July 29th, 2018
Bayer Announces Removal of Essure from Marketing Starting 2019
On Friday, medical device manufacturer, Bayer announced that beginning December 31, 2018, they will no longer sell the controversial Essure birth control device in the United States. Bayer announced that its decision to discontinue Essure, “is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” It is important to note that Bayer maintains “the product’s safety and efficacy,” citing what they believe caused the decline in sales to be:
- A decrease in the use of permanent contraception overall
- An increased reliance on other forms of birth control
- Inaccurate and misleading publicity about Essure
Currently, there are thousands of lawsuits that have been filed against Bayer alleging serious injuries sustained by women who had the device implanted. From migrating through the body to perforating organs, the safety associated with the Essure birth control device has long been up for debate.
History of Essure Complications
The Food and Drug Administration (FDA), approved the Essure medical device on November 4, 2002. Since then, the FDA has received more than 26,000 medical device reports related to Essure. In February 2016, the FDA issued a news release acknowledging the need for Bayer to produce more rigorous research it comes to understanding if certain women are at a heightened risk for complications.
The FDA ordered Bayer to conduct a new clinical study to determine what the heightened risks were for particular women. They also required Bayer to make changes to product labeling, including the addition of a boxed warning and checklist that would help ensure women were able to receive and understand the benefits and risks associated with Essure.
Over the years the FDA has maintained that the benefits of Essure outweigh its risks; however, in April 2018, they issued an order restricting the sale and distribution of the Essure in the United States. This order was attributed to the new understanding that some women still were not being adequately informed of Essure’s risks before having the device implanted.
History of Essure Lawsuits
Today, there are more than 16,000 lawsuits filed against Essure manufacturer, Bayer. These lawsuits are all individual legal actions; as no class action lawsuit or multidistrict litigation (MDL) processes have been established at this time.
Can I File an Essure Lawsuit?
Due to the number of lawsuits filed against Bayer regarding the Essure medical device, Simmons and Fletcher, P.C., has compiled a list of related factors in Essure cases we are currently accepting:
- Essure device was implanted from November 2002 to October 2016
- Essure device has been removed, is scheduled to be removed, or cannot be removed due to medical complications
- Individual has sustained one or more injures related to Essure
If you or someone you love has experienced serious injuries as a result of having the Essure birth control device implanted, contact us today to learn more about your rights.
Priyanka Kasnavia is an online marketing specialist who has been working at Simmons and Fletcher, P.C., for over a year. She graduated from Texas Christian University in 2017 with a degree in Strategic Communication and has been accepted to the University of Houston Law Center starting fall of 2018. Priyanka's expertise centers on search engine optimization and content creation.