How it Works
Essure consists of two small spring-like coils that are made of an alloy containing titanium and nickel. In a 45 minute procedure, one coil is placed at the opening of each of the patient’s fallopian tubes. Inflammation from the tubes causes scar tissue to develop around the tubes. That scar tissue then creates a wall that helps prevent sperm from getting to reach a woman’s eggs.
Some Major Complications
Thousands of women have suffered severe side effects involving the device, and complaints continue to grow. Some of these women have decided to bring personal injury lawsuits against Bayer Healthcare Pharmaceuticals. It stands accused of knowing about the hiding harmful safety evidence from the FDA before Essure was approved, using non-conforming materials when manufacturing devices, failing to report more than 16,000 Essure complications to the FDA, failing to conduct proper post-approval studies and failing to train doctors on proper implantation procedures. Here are some of the alarming side effects that women claim to have experienced from Essure:
- Extraordinarily painful menstruation.
- Perforated fallopian tubes.
- Inaccurately placed devices.
- Broken coils.
- Migrated and expelled Essure devices.
- Extreme pain when attempting sexual intercourse.
- Unintended pregnancies, miscarriages and stillbirths.
The Black Box Warning
The FDA now requires Essure to carry a black box warning to alert patients of the potential complications of the device. This is the strictest warning that the FDA mandates when there is sufficient evidence of possible complications involving a drug or medical device. The black box warning came 14 years after Essure started being sold to women.
No Class Actions or Multidistrict Litigation
The FDA now acknowledges about 10,000 complaints involving Essure. When a large number of people have suffered similar injuries from the same product, lawsuits known as mass tort claim might be brought in the form of class actions or multidistrict litigation. Class actions and multidistrict litigation just aren’t viable alternatives in medical device cases. Instead, some state court judges are consolidating Essure cases for purposes of case management. Consolidation operates in the injured victim’s interests. As opposed to class actions, they still retain control over their cases. More than 900 Essure cases have been consolidated in Alameda County, CA.
The Preemption Issue
When Essure was approved by the FDA in 2002, its manufacturer was granted preemptive status. That meant that people who were injured by the device couldn’t bring a lawsuit against the manufacturer. Bayer has been hiding behind preemption laws for years with Essure. The lawsuits claim that given its past conduct involving Essure, preemptive status should be stripped from the manufacturer. Several state court judges across the country have found accordingly, and individual lawsuits against the manufacturer have been allowed to proceed. Some have been consolidated, but most have not. As a result of growing sales and awareness of Essure complications, more than 10,500 Essure lawsuits are presently pending across the United States. None of the cases have gone to trial, and there are no known settlements.
Statute of Limitations
There’s a small window of opportunity for an Essure victim to bring her lawsuit. That time period is known as the statute of limitations. These statutes vary from state to state. An untimely lawsuit can be dismissed forever. Don’t wait to speak with us about the possibility of pursuing an Essure case. It won’t cost you anything at all, and all consultations are confidential.
Contact a Louisville Kentucky Personal Injury Lawyer
Courts are finally recognizing the rights of Essure victims. We won’t tolerate medical device companies hiding behind federal preemption laws after they’ve caused severe harm, unintended pregnancies and even caused the deaths of innocent adults and babies.