Essure is a permanent birth control method for women. It is called permanent birth control, or female sterilization, because the procedure is irreversible. This method of sterilization is referred to as “tubal sterilization,” and it consists of permanently closing the fallopian tubes. The closing of the fallopian tubes is intended to prevent eggs from exiting the tubes and sperm from reaching the eggs; this method does not use hormones. In the case of Essure, the fallopian tubes are encouraged by the small device to grow scar tissue that will eventually block the tubes permanently. The Essure micro-implant is a 4-centimeter-long device with a stainless steel inner coil and a Nickel titanium (Ninitol) expanding outer coil. Also, polyethelene terephthalate (or PET) fibers are wound around the inner coil to encourage the scar tissue.
The FDA approved the Essure birth control for use in the United States in 2002. FDA Approval was based on two studies conducted by Conceptus, the original manufacturer of Essure (acquired by Bayer in 2013). The Pivotal Study (with 1 year follow up) tested 657 women and the Phase II study (with 2 year follow up) tested 269 women. The Essure birth control was already approved for use in twenty countries, but the CDRH Obstetrics and Gynecological Devices Advisory Panel gave three conditions for approval in the United States.
According to the FDA, some of the Essure problems that Essure patients are reporting were present in the clinical studies and addressed on the Essure device’s labeling for doctors and patients. However, women have also experienced Essure side effects and Essure complications such as weight gain, depression, and extreme fatigue. The FDA admitted that these Essure side effects were not found in clinical studies and not present on the Essure device’s labeling. In September of 2015, the FDA held an advisory panel to discuss Essure. They recommended that Essure remain an option for women, but they also called on Bayer to update the labeling. The FDA required that Bayer more prominently warm women not to get the Essure device if they have metal allergies, a history of pelvic inflammation, or experienced abnormal uterine bleeding. Ultimately, the FDA released its formal findings on Essure in the middle of November 2016.
As reported on November 15, 2016 in a report title “Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement – Lable Changes,” the Essure labeling now includes a black box warning and Patient Decision Checklist. The black box warning includes safety statements to clearly communicate significant side effects and adverse outcomes associated with the Essure device and information about the potential need for removal. This is the FDA’s highest level of warning on a drug or device. The Patient Decision Checklist provides key information about the device, its use, and the safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer was also required to disclaim patient counseling and device removal sections of the new labeling.
In the original Essure studies, nearly 3% of women experienced perforation and nearly 3% of them expelled the device. In some cases, doctors could not successfully insert devices into one or both fallopian tubes. The results of the 5-year PMA study found that many of these symptoms and Essure side effects began to decline after 1 year. However, a total of 32 women from the studies had to have the Essure device removed. Some of the women had to have a hysterectomy to address continued bleeding, persistent pain, and other symptoms.
The FDA reapproved Essure after the Post-Market Analysis. The FDA, in response to many reports of serious and adverse Essure side effects from women with Essure, has recently reexamined the Essure device. One way the FDA collects data is through mandatory or voluntary Medical Device Reports (MDR) from doctors and patients. From 2002 to 2015, there were 5,093 reports. In 2013, the number of MDR’s related to Essure jumped from 152 in the previous year (the highest number since 2004) to 817. Since 2014, the number of adverse reports continues to increase.
We are dedicated to helping all women who have been harmed by the Essure product. We have filed lawsuits on behalf of hundreds of women across the country and are committed to driving the litigation aggressively until they receive the compensation that they deserve.
Our clients are also entitled to know the truth about the history of the Essure product and its effects on the body. Our goal is to uncover it for them. We have formed a team comprised of FDA regulatory experts, biomechanical engineers, metallurgists and database analysts to do just that.
Most importantly, we want our clients to get access to the best medical care possible and benefit from the most cutting edge procedures available so that they can solve these problems and move on with their lives.