Hundreds of claims have been filed against Bayer and Conceptus, Inc. (manufacturers of Essure®) by women who have suffered severe abdominal damages when the birth control device moves and punctures the uterus and/or fallopian tubes causing permanent damage.
What is Essure®?
Essure® is a permanent, non-surgical birth control device for women developed by Conceptus, Inc., a company owned by Bayer. Essure® was approved for use in the United States in 2002. The insertion of Essure® does not require an incision (cut) or general anesthesia, and is also non-hormonal.
During the procedure flexible metal coils (containing nickel and titanium) are inserted through the vagina and cervix and into the fallopian tubes. Once in place, tissue grows in and around the devise over a period of three months and forms a blockage in the fallopian tubes. The buildup prevents the egg from entering the uterus.
If the Essure® implant separates, breaks and/or moves, attempted removal often requires multiple surgeries, sometimes requiring removal of the uterus entirely, a hysterectomy.
Essure® Recent News 04/10/18
The FDA mandated new warnings, new data for Essure® contraceptive device: The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure®, an implantable permanent contraceptive device. A black box warning in the labeling of products is ‘designed to call attention to serious or life-threatening risks,” according to the FDA website.
The FDA determined that women were not being adequately informed of Essure’s® risk before getting the device implanted. The new procedure requires a patient brochure, titled Acknowledgement,” be reviewed with the prospective patient by the health care provider to ensure the patient understand the risks, benefits and other information about Essure® implantation. The patient must be given the opportunity to sign the acknowledgment, and it must be signed by the physician implanting the device. Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure® implantation. For More information