Somerville, NJ-A new mid-urethral sling device from the Women's Heath & Urology division of Ethicon, Inc., has received 510(k) approval from the FDA for use beginning in autumn 2006. The Gynecare TVT SECUR System is a polypropylene mesh tape that is inserted through the vagina and positioned under the urethra to form a supportive scaffold. It prevents urine loss by maintaining the seal in the bladder neck during movement. No incisions are required, and the procedure can be conducted under local anesthesia, minimizing post-surgical pain and complications. The device is contraindicated for women who are or who intend to become pregnant and those who are on anticoagulant therapy.