There exist a plethora of different birth control methods to suit the body and lifestyle of various individuals. Regardless of the chosen or preferred birth control type, patients have a right to a safe and functional product. Users typically do not anticipate that their birth control device will cause them bodily harm and life-altering complications. However, many women have filed lawsuits against Bayer due to claims that its Essure device caused them chronic pain and severe injuries. If you want to find out more about how an Essure lawsuit can benefit you, reach out today to speak to one of our knowledgeable attorneys.
Our law firm is currently handling lawsuits on behalf of women who received Essure implants. Women with Essure implants report that they experienced long-term adverse health effects related to the defective birth control implant.
The FDA approved the Essure Permanent Birth Control System in 2002, and since then over 750,000 women worldwide have received the device. Doctors do not need to perform surgery to insert Essure. Instead, healthcare professionals situate Essure in the fallopian tubes by entering the uterus. Scar tissue forms around the flexible metal coil, stopping sperm from reaching eggs. After about three months the scar tissue sufficiently builds up thus creating a barrier that is 99.3% effective at preventing pregnancy. Furthermore, the manufacturer of Essure claimed that the insertion procedure would only take roughly 36 minutes and does not necessitate anesthesia, so many women viewed Essure as an easier alternative to surgical methods of permanent birth control.
While seemingly a fast and effective birth control device, issues associated with Essure eventually surfaced. Prior to an Essure postmarket surveillance study, the FDA decided to examine Essure medical device reports to understand why women were removing the device. This evaluation involved more than 17,000 Essure medical device reports submitted to the FDA in 2017 and 2018. Of those 17,000 reports, a staggering 85% referenced device removal. The primary reasons attributed to device removal were:
While implantation of the device does not require surgery, removal of Essure does necessitate surgery. Following these reports, Bayer stopped selling Essure in 2018, but the company did not issue a recall. Then in 2019, Bayer ordered that all Essure products not yet implanted should be returned by the end of the year. Bayer instructed medical facilities and health care providers on how to properly return the devices. As of December 31, 2019, Essure devices are no longer available.
Although Bayer pulled Essure from the market, the FDA stated that it continues to assess medical device reports related to Essure even though the device is no longer sold in the United States. In 2022, the FDA evaluated approximately 67,643 Essure medical device reports submitted between 2002 and 2021. Of these reports, a majority cited acute health problems linked to the Essure implant. According to the FDA, in 2017, 2018, 2019, and 2020, 92.7%, 87.5%, 91%, and 93.5%, respectively, of all reports received related to device removal.
From 2002 to 2018, the FDA received 26,272 adverse reports concerning Essure devices. Many women underwent surgeries to remove the problematic birth control product. Even after surgery many women still experience chronic pain and other injuries because of Essure. Associated risks and injuries related to Essure include:
Countless women reported that Essure malfunctioned immediately after implantation by migrating out of the fallopian tubes or fracturing while inside their bodies, inducing pain and causing other medical issues. Lawsuits against Bayer, the manufacturer of Essure, allege that the company did not report significant side effects of Essure to the FDA. Many women described chronic pain and inflammation even after undergoing surgery to remove fragments left inside their bodies.
In August 2020, Bayer announced that it agreed to settle almost all U.S. lawsuits against Essure for over $1.6 billion, but declined to admit liability. The settlement covers nearly 90% of the 39,000 filed and unfiled claims of injury related to the device, including organ damage, device migration, and corrective surgery. The settlement also includes an allowance for any claims that are still outstanding.
If you or a loved one has been injured by Essure, you may recover compensation for any or all of the following:
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529 or submit an inquiry on this page.