FDA approved Paragard T 380A (copper IUS) for Prevention of Pregnancy for Up to 10 YearsFDA approved copper birth control device that prevents pregnancy for up to 10 years

Not reported in label.

Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. It is a copper-containing intrauterine system (IUS).

Insert a single Paragard at the fundus of the uterine cavity. Remove Paragard no later than 10 years from the date of insertion. Insert and remove only if you are a healthcare provider trained on these procedures. Following insertion, examine the patient after her first menses to confirm Paragard is still in place. Paragard should only be inserted by a healthcare provider trained in Paragard's insertion procedures, because insertion for Paragard is different from that used for other intrauterine systems. Healthcare providers should become thoroughly familiar with the product, product educational materials, product insertion instructions, and prescribing information before attempting insertion. May replace Paragard at the time of removal with a new Paragard if continued contraceptive protection is desired. Before considering use, make sure that the female is an appropriate candidate and exclude pregnancy prior to use. Recommended timing of insertion: in females not currently using contraception, at any time during the menstrual cycle; when switching from an oral, transdermal, or vaginal hormonal contraceptive or an injectable progestin, at any time during the menstrual cycle and discontinue the previous method; when switching from a contraceptive implant or other intrauterine system, on the same day the implant or IUS is removed (insert at any time during the menstrual cycle); after abortion or miscarriage, immediately after abortion (immediate placement has a slightly higher risk of expulsion than placement at other times; insertion after second trimester abortion is associated with a higher risk of expulsion than after first trimester abortion); after childbirth, may insert immediately postpartum (insertion before uterine involution is complete, which may not occur until the second postpartum month, has been associated with increased risk of expulsion; there appears to be an increased risk of perforation in lactating women). For immediate insertion post childbirth, remove the inserter and Paragard from the tray, move the button forward and then completely back to release the Paragard unit from the inserter and insert Paragard. Preparation: use strict aseptic techniques; prepare placement tools; consider use of an analgesic; establish size and position of uterus by bi-manual examination; insert speculum and cleanse cervix and vagina with antiseptic solution; apply tenaculum and use gentle traction; gently insert a sterile uterine sound to measure depth (uterus should sound to 6 to 9 cm except when inserting immediately postabortion or postpartum). Insertion may be associated with pain and/or bleeding, vasovagal reactions, or seizure, especially in patients with a predisposition. Insertion into a uterine cavity measuring less than 6 cm may increase the incidence of expulsion, bleeding, pain, and perforation. If cervical stenosis is encountered, avoid undue force; dilators and analgesia/local anesthesia may be helpful.

Trial data not available in label.

Not reported in label.

Not reported in label.