Bayer has announced that they will stop selling and distributing the Essure device in the United States after December 31, 2018 due to declining sales of the product. Bayer will continue to implement the restriction on sale and distribution placed by the FDA on the device in April 2018, to ensure women are fully informed of the risks associated with the device.
Essure is a permanent implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.
Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. 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.
For more on the FDA and ESSURE click on FDA.
Watch this video to learn more –
If you or a loved one has experienced severe complications following the Essure procedure, please call the Law Firm of Michael B. Serling at (248) 647-6966 or toll free at (800) 995-6991. or Click on the: Free Evaluation