On August 2, 2016, Judge Winifred Smith in the Superior Court of California, Alomeda County, issued a decision that allowed the claims of 14 women injured by Essure to proceed against the manufacturer, Bayer. Bayer argued that it was immune from liability and that the women were barred from bringing their claims under a doctrine called “preemption.” However, the Court disagreed and found that the women could proceed with their lawsuits. These lawsuits allege that Bayer failed to adequately warn the FDA, and thereby the public, of Essure’s potential dangers and adverse side effects. The lawsuits also allege that Bayer breached Essure’s warranties and misrepresented Essure’s safety and efficacy through advertising and promotional materials that were not approved by the FDA.
Essure is a permanent birth control method for women that is not intended to be removed. Implantation of Essure does not require a surgical incision. Instead, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes. Over a period of about three months, tissue forms around the inserts, which creates a barrier that keeps sperm from reaching the eggs and prevents conception.
Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. According to the FDA, “the reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.”
In February, 2016, the FDA ordered Bayer to conduct a new postmarket surveillance study for the permanent birth control device. The purpose of the study is “to provide important information about the risks of the device in a real-world environment.” Specifically, the FDA required Bayer to develop and conduct a post-market study that will provide data to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. According to the FDA,
“This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how much these complications affect a patient’s quality of life. Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed three months after insertion. The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health.”
The agency also published a draft guidance with labeling recommendations for Essure, including a boxed warning label, as well as a Patient Decision Checklist to help to “ensure women receive and understand information regarding the benefits and risks of this type of device.” According to the FDA, a black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks.”
For more information about the Essure litigation, feel free to contact Pharmaceutical/Medical Device Litigation Attorney Pamela A. Borgess of Borgess Law, LLC at (567) 455-5955. You can also contact Borgess Law, LLC by submitting an online inquiry. Borgess Law never charges a fee for an initial consultation.