The U.S. Food and Drug Administration (FDA) has ordered Bayer, the company that manufactures Essure, 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.”
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. Per 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.”
Specifically, the FDA is requiring 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The agency also published a draft guidance with labeling recommendations for Essure, including a boxed warning label, as well as a Patient Decision Checklist to help to “ensure women receive and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.”
Several women have sued Bayer in connection with the Essure device, accusing Bayer of hiding evidence of various risks associated with the birth control device, failing to adequately report adverse events, and failing to properly warn patients and their physicians of the true and serious risks. These women state that if the Bayer had warned of these known risks, they would have chosen a different form of birth control. In some of the cases, the women allege they were forced to undergo hysterectomies as a result of the Essure.
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 or toll-free at (844) LAW-9144. You can also contact Borgess Law, LLC by submitting an online inquiry. Borgess Law never charges a fee for an initial consultation.