What is Essure®?
Essure® is a medical device manufactured by Bayer. It is intended to be a permanent birth control solution that a patient can have implanted quickly in a non-invasive in-office procedure. The Essure® device is intended to be an alternative to traditional tubal ligation (“tube tying”) surgeries. The Essure® device is made of two soft spring-like coils that are implanted into each of the patients’ fallopian tubes. The metal portion of the device is made of a stainless steel inner coil and an expanding nickel titanium outer coil. The device causes scar tissue to form in the fallopian tubes, which blocks sperm and prevents fertilization. The Essure® device has been implanted into more than half a million women in the United States since its approval by the U.S. Food and Drug Administration in 2002.
Essure® Side Effects
Reports of severe complications following implantation of an Essure® device include the following:
- The need for surgery, including hysterectomy, to remove the device and repair damage to internal organs
- Autoimmune responses to the device, including fatigue, rashes, hair loss and weight gain
- Chronic pelvic pain
- Life-threatening ectopic pregnancy
- Migration of the device (or a piece of the device) to other parts of the body
- Expulsion of the device
- Perforation or tearing of pelvic organs such as the uterus or colon
- Severe allergic reactions to the device or its components
The Controversial History of Essure®
Between 2002 and 2015, the FDA received nearly 10,000 reports of Essure® related complications from doctors and women, including 11 deaths. As a result of the higher than expected number of complications reported to the FDA, in 2015 the FDA held a public meeting of the Obstetrics and Gynecology Devices Panel “to discuss the risks and benefits of Bayer Healthcare’s Essure® System for permanent female sterilization.”
In February 2016, in response to the thousands of reported complaints associated with the Essure® device, the FDA announced that it would require Bayer to conduct a clinical trial on Essure® to study the safety and efficacy of the device. Later that year, in October 2016, the FDA required Bayer to add a black box warning, the strongest type of warning required by the FDA, to the Essure® device.
One of the barriers to Essure® lawsuits has been the fact that the Essure device was approved by the FDA through the Premarket Approval Process in November 2002. When a device is approved through the Premarket Approval Process, as opposed to the 510(k) process, the manufacturer of the device is protected against many lawsuits alleging violation of state law because those claims are preempted by the federal regulations that set forth the requirements of the Premarket Approval Process.
However, in August 2016 Judge Winfred Smith of the Alameda County Superior Court in California ruled that claims brought by 14 women were not expressly or impliedly preempted under federal or state law, allowing the litigation to proceed. In October 2016, Judge Smith ordered that all California cases involving Essure® be coordinated for pre-trial purposes in a JCCP. There are currently several hundred women who have filed cases in the JCCP.