Maine Essure Lawyer
Over the last fifteen years, thousands of adverse event reports have been lodged with the FDA regarding the Essure birth control system including cases of fatalities. Public pressure over the safety of the device has led Bayer AG to recall Essure from many European countries, Australia and Brazil. Despite growing calls for removal by patients, physicians, and legislators, Bayer AG has not elected to withdraw the device from the U.S. market and its continued use puts many women at risk for serious injury.
What is the Essure Birth Control System?
The Essure birth control system is a form of permanent sterilization. The device consists of a double metal coil with synthetic fibers which is inserted non-surgically via a hysteroscopic procedure directly into the fallopian tubes. The synthetic fibers facilitate tissue adherence which causes scar tissue to develop around the device blocking sperm from traveling to fertilize an egg.
Essure was developed by Conceptus, Inc. and approved by the FDA via the Pre-Market Approval process in November 2002. In 2013, Conceptus, Inc. was purchased by AG and became a fully owned subsidiary of Bayer AG.
Regulatory Oversight of Essure
Since the time Essure was first approved in November 2002, the FDA has received over 10,000 reports from physicians and patients about significant injuries associated with the device, including 11 deaths.
In October 2016, the FDA mandated that Bayer add a “black box warning” to the labeling for Essure. A black box warning is the most stringent warning that can be placed on a drug or device prior to product recall and indicates that the device may cause death or serious injury. Essure’s black box warning states that some patients using the implant have experienced perforation of the uterus or fallopian tubes, migration of the device into the abdominal or pelvic cavity, chronic pain, and that, if the device is required to be removed, it must be done surgically.
In addition to the black box warning, the FDA has required that patients and doctors sign a “decision checklist” before the device can be implanted. The checklist includes an agreement that the patient will undergo examination three months after insertion to confirm that the device is properly in place and functioning as intended.
In 2017, Essure was withdrawn from the market by Bayer AG in many European countries. Regulators in Australia and Brazil have also recalled Essure form the market in these countries. However, Bayer AG has not recalled Essure in the U.S. and continues to market the device to physicians and patients.
Injuries Related to Essure Birth Control System
Symptoms and injuries associated with the Essure birth control system include:
- Migration of the device
- Perforation of internal organs
- Expulsion of the device
- Surgery to remove the device and repair internal damage
- Pelvic pain
- Ectopic pregnancy
Essure Birth Control Litigation
Thousands of Essure lawsuits have been filed by injured women and their families in various courts around the United States. Plaintiffs allege that Essure is defectively designed because of the propensity for the device to migrate and perforate leading to serious health complications and the need for surgical removal. Plaintiffs further allege that Conceptus, Inc. and Bayer AG have failed to adequately warn physicians and patients about the serious risks of the device.
Essure Birth Control Lawsuit
If you or someone you love has suffered injury from the Essure birth control system, you may be entitled to significant compensation for your injuries.
To speak with an experienced, Essure lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (844) 348-9529, or complete the Case Evaluation Form on this website for a free, confidential, case assessment.