A Medical Device Daily
Conceptus (Mountain View, California), developer of the Essure procedure, reported that it has filed a lawsuit in U.S. District Court for the Northern District of California against Hologic, (Bedford, Massachusetts) seeking a declaration by the court that Hologic's planned importation, use, sale or offer to sell of its forthcoming Adiana Permanent Contraception system will infringe several U.S. patents owned by Conceptus, including U.S. atent Nos. 6,634,361, 6,709,667, 7,237,552, 7,428,904 and 7,506,650.
Conceptus seeks an injunction prohibiting Hologic from importing, using, selling or offering to sell its Adiana system in the U.S.
The Essure procedure is a permanent birth control method that can be done in a physician's office in about 13 minutes (average hysteroscopic procedure time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation.
Small, flexible micro-inserts are placed in the woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg.
Essure is 99.8% effective (based on four years of follow-up), with zero pregnancies reported in clinical trials. Three months after the Essure procedure, a doctor performs an Essure confirmation test to confirm that the fallopian tubes are fully blocked and that the patient can rely on Essure for permanent birth control with full confidence.
Essure was FDA-approved in 2002 and more than 280,000 women worldwide have undergone the procedure.