On June 15, the FDA approved a premarket application for a third-generation implant (Essure Permanent Birth Control, Conceptus, Inc) for permanent birth control. The approval covered design and material changes to the microinsert, delivery catheter, and introducer of the system. The modifications were physician recommended and intended to reduce the number of steps required during an implantation procedure.
Originally approved by the FDA in 2002, the implant was developed as a less invasive alternative to tubal ligation for women. During the procedure, a hysteroscope is used to guide a soft microinsert through the vagina, cervix, and uterus into the fallopian tubes. Once placed in the fallopian tubes, the device elicits tissue growth in and around the microinsert, forming a blockage that prevents fertilization within approximately 3 months. The resulting sterilization is not reversible.
According to Conceptus, approximately 700,000 tubal ligations and 400,000 vasectomies are performed annually in the United States.
Tiré de Medscape