Essure Implant Lawsuit

Problems with the design of the Essure birth control implant have been linked to thousands of reports involving severe complications, pain and suffering after the device migrated inside of women’s bodies. 

STATUS OF ESSURE IMPLANT LAWSUITS: Financial compensation may be available through an Essure lawsuit for women who have experienced problems after receiving the birth control implant, including:

• Migration
• Perforation
• Fractures or Breakages
• Allergic Reactions
• Infection
• Blood Clots
• Severe Bleeding, Pain or Cramping

>>REVIEW AN ESSURE INJURY CASE<<

MANUFACTURER: Bayer Healthcare

OVERVIEW: Essure is a form of long-acting birth control offered as an outpatient procedure by many medical facilities, where a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

The birth control implant was first introduced by Conceptus and approved by the FDA in 2002. The company was later acquired by Bayer.

Thousands of women have reported suffering severe Essure complications when the device moved out of position, punctured the fallopian tubes or uterus, or caused infections, severe pain and even headaches for unknown reasons.

ESSURE PROBLEMS: Complications linked to the use of the Essure birth control implant began to gain widespread media attention after many women who experienced problems took to the internet, forming groups on social media and raising awareness about the undisclosed Essure birth control risks.

In October 2013, the FDA published new information on their website in an attempt to address women’s concerns, saying regulators had investigated more than 850 adverse event reports involving problems with Essure birth control implants.

By April 2014, the FDA reported that the number of adverse events linked to the Essure had more than doubled, involving complaints that the implant caused pain, bloating and other problems where it migrated to other areas of the body.

In March, 2015, the FDA closed a citizens petition calling for an Essure recall. The petition claimed that Bayer and Conceptus had committed fraud in the clinical trials and had violated the terms of Essure premarket approval.

An FDA advisory panel was convened to review Essure safety concerns in September 2015, with many critics calling for an Essure recall to be issued.

The FDA panel ordered Bayer to conduct additional studies of Essure and called for the creation of a registry of Essure patients to better track adverse events and problems. A large number of women testified at the hearing about their Essure injuries.

In November 2016, the FDA approved a new black box label warning for Essure, and now calls for doctors to provide a patient checklist to women considering the procedure to ensure that they are aware of the potential risk of complications.

In August 2017, Australian health officials announced an Essure recall and said the device would no longer be implanted in women in that country. Bayer subsequently removed the Essure from all markets worldwide except the United States, saying that it was a marketing decision and not linked to Essure complication concerns.

In March 2018, the FDA noted that it had received more than 12,000 reports of Essure adverse events throughout 2017. In April 2018, the FDA placed new restrictions on Essure, indicating that both the doctor and the patient must sign off on a checklist of potential problems, to ensure that the patient is fully informed about the risks.

In December 2018, Bayer pulled the Essure birth control implant from the U.S. market at last, and the FDA put in place a monitoring program to continue to review the implant’s effects on women who have already received it.

In late September 2021, Bayer issued a final analysis on Essure complication reports, indicating it received nearly 60,000 reports involving serious injuries, nearly 600 reports of Essure malfunctions and at least 115 deaths. According to an analysis of those reports published by the FDA in February 2021, one out of every 50 women who received the permanent sterilization device suffered unintentional perforation of internal organs.

However, an FDA update on the post-marketing studies required by Bayer deemed progress to be “inadequate” due to a high number of study participants dropping out.

FIND OUT IF YOU QUALIFY FOR AN ESSURE LAWSUIT:As a result of the manufacturer’s failure to adequately warn women about the risks associated with the birth control implant, Essure injury lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.

To request a free consultation and claim evaluation to determine whether you, a friend or family member may be entitled to financial compensation through a lawsuit, submit information about an Essure implant injury.