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The FDA has approved a new labeling claim by the maker of Essure, a nonincisional permanent birth control procedure, which extends the product's claim of contraceptive effectiveness (99.8%) from 2 years to 3 years. Essure is a product of Conceptus (San Carlos, Calif.).


Clinical trials of Essure provided data demonstrating zero pregnancies in more than 21,000 women-months of reliance on Essure.


The Essure procedure uses a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to produce tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tube. No cutting or penetration of the abdomen is required and general anesthesia is not necessary.