Essure is a permanent, non-surgical birth control method for women (transcervical sterilization).
During the procedure, a physician implants the Essure system, small, flexible inserts, through the vagina and cervix and then into both fallopian tubes- the tubes that carry eggs into the uterus from the ovaries. The insert contains inner polyethylene terephthalate fibers and are held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. The inserts induce a benign fibrotic reaction and elicit tissue growth around the inserts. Over a three month period, the tissue build-up forms a barrier in the fallopian tubes that keeps sperm from reaching the eggs, subsequently preventing pregnancy. Essure is permanent and is not intended for removal.
Initially, Conceptus, a subsidiary of Bayer, manufactured and marketed Essure. The Food and Drug Administration (FDA) approved Essure on November 4, 2002. It was approved through the Premarket Approval (PMA) process as a Class III device, generally the highest risk devices and subject to the highest level of regulatory control. Despite this “high” level of regulatory control, many women are experiencing life-threatening side effects from Essure.
According to the FDA, “Over the past several years, the [agency] has been examining the growing number of reports of harm with Essure. The adverse events reported associated with the use of the Essure System 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 System failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies.”
On September 24, 2015, the FDA met with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, to hear expert scientific, clinical opinions as well as patients’ experiences regarding the benefits and risks of Essure. The FDA is reviewing information from the panel meeting and over 2,000 comments submitted to a public docket. On February 29, 2016, the agency released a press announcement recommending that sterilization devices, such as Essure, include a Black Box warning label, a label required for devices that potentially cause death or serious injury, explaining the possible side effects.
Our product liability attorneys at Kershaw, Cook & Talley have extensive experience and knowledge in successfully representing individuals nationwide in cases involving defective medical device injuries and dangerous pharmaceuticals.
If you, or a loved one, had an Essure System and experienced severe injuries, you are potentially eligible to file a lawsuit. Contact us for a free case evaluation at 877-925-5011, or fill out our confidential online form.