ParaGard T 380A

PARAGARD T 380A- copper intrauterine device
CooperSurgical, Inc.

1 INDICATIONS AND USAGE

Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.

2 DOSAGE AND ADMINISTRATION

Figure 1: Paragard Intrauterine System (IUS) with Insertion Tube and Solid White RodFigure 2: Inserting Tips of T-Arms of Paraguard into Insertion TubeFigure 3: Bending T-Arms of Paraguard While in Sterile Packaging Figure 4: Inserting Tips of T-Arms of Paraguard into Insertion Tube While in Sterile Packaging Figure 5: Insertion Tube with Paraguard in UterusFigure 6: Release of T-Arms of Paraguard in Uterus Figure 7: Placement of Paraguard in Fundus of Uterus Figure 8: Withdraw Solid White Rod from Uterus Figure 9: Appropriate Paraguard Placement in Uterus

2.1 Important Dosage and Administration Instructions

• 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 of Paragard.
  
• Insert one Paragard at the fundus of the uterine cavity [see Dosage and Administration ( 2.4)].
  
• Remove Paragard on or before 10 years from the date of insertion [see Dosage and Administration ( 2.6)].
  
• May replace Paragard at the time of removal with a new Paragard if continued contraceptive protection is desired.
• Before considering use of Paragard, make sure that the female is an appropriate candidate for Paragard. Exclude pregnancy (consider the possibility of ovulation and conception) prior to use [see Contraindicati ons ( 4) and Warnings and Precautions ( 5.2)].

2.2 Timing of Insertion

Refer to Table 1 for recommended timing of Paragard insertion.

Table 1: Recommended Timing of Paragard Insertion

Clinical Situation	Recommended Timing of Paragard Insertion
1. Start Paragard in females not currently using contraception	At any time during the menstrual cycle.
2. Switch to Paragard from an oral, transdermal, or vaginal form of hormonal contraception or an injectable progestin contraceptive	At any time during the menstrual cycle; discontinue the previous method.
3. Switch to Paragard from a contraceptive implant or other intrauterine system	Same day the implant or IUS is removed (insert at any time during the menstrual cycle).
4. Insert Paragard after abortion or miscarriage	Immediately after abortion, although 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 insertion after a first trimester abortion.
5. Insert Paragard 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 [see Warnings and Precautions ( 5.6, 5.7)].
	There appears to be an increased risk of perforation in lactating women [see Warnings and Precautions ( 5.6)].

2.3 Preparation Instruction

Before insertion:

• Use strict aseptic techniques throughout preparation [see Warnings and Precautions ( 5.4)].
  
• Prepare placement tools (e.g., speculum, cotton swab, tenaculum, uterine sound, scissors, and forceps).
• Place the package containing Paragard (face-up), sterile card, and solid white rod on a sterile field (see Figure 1) and open package from the bottom end where arrow says “open”.

Figure 1: Paragard Intrauterine System (IUS) with Insertion Tube and Solid White Rod

• Consider the use of an analgesic
  
• Establish the size and position of the uterus by performing a bi-manual examination.
  
• Insert a speculum and, using a cotton swab, cleanse the cervix and vagina with an antiseptic solution.
  
• Apply a tenaculum to the cervix and use gentle traction to align the cervical canal with the uterine cavity.
  
• Gently insert a sterile uterine sound to measure the depth of the uterine cavity. The uterus should sound to a depth of 6 to 9 cm except when inserting Paragard immediately postabortion or immediately postpartum.
  • Insertion of Paragard may be associated with pain and/or bleeding or vasovagal reactions (e.g. syncope, bradycardia, or seizure) especially in patients with a predisposition to these symptoms. 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 in this situation.

2.4 Insertion Procedure

• Use strict aseptic techniques throughout the insertion procedure [see Warnings and Precautions ( 5.4)]. Using sterile gloves, bend the T-Arms of Paragard by folding the two horizontal arms down against the stem.

• Slightly withdraw insertion tube, push arms down along the stem, slide insertion tube over the tips of the T-Arms (see Figure 2). Only the tips of the T-Arms should be in the insertion tube. Do not advance beyond the copper collars. Insert solid white rod into bottom of insertion tube until it touches the bottom of the IUS. Do not leave the horizontal arms of Paragard bent for more than 5 minutes, as the arms may not open properly.

Figure 2: Inserting Tips of T-Arms of Paraguard into Insertion Tube

• Although using sterile gloves is recommended, in situations where sterile gloves are not available, you can perform this step while Paragard is in the sterile package. Place the package face up on a clean surface. Open from the bottom end where arrow says “open”. Pull the solid white rod from the package and put it back in the package laying it carefully alongside the insertion tube, making sure the distal end of the rod remains sterile. Place thumb and index finger on the outside of the package, on top of the ends of the horizontal arms. Use other hand to push insertion tube against arms of Paragard (shown by arrow in Figure 3). This will start bending the T-Arms downward. Note that the arms of Paragard should be folded downward to ensure proper insertion.

Figure 3: Bending T-Arms of Paraguard While in Sterile Packaging

• Bring the thumb and index finger closer together on the outside of the package to continue bending the arms until they are alongside the stem. Use the other hand to withdraw the insertion tube slightly so that the insertion tube can be pushed and rotated over the tips of the T-Arms (see Figure 4). Only the tips of the T-Arms should be in the insertion tube. Do not advance beyond the copper collars. Insert solid white rod into bottom of the insertion tube until it touches the bottom of the IUS. Do not leave the horizontal arms of Paragard bent for more than 5 minutes, as the arms may not open properly.

Figure 4: Inserting Tips of T-Arms of Paraguard into Insertion Tube While in Sterile Packaging

• Once the above steps are completed and Paragard is in the insertion tube, grasp the insertion tube at the open end of the package; adjust the blue flange so that the distance from the top of the Paragard insertion tube is the same as the uterine depth measured with the uterine sound or use the sterile card to adjust the blue flange according to the premeasured uterine depth.

• Rotate the blue flange so that the horizontal arms of Paragard and the long axis of the blue flange lie in the same horizontal plane to ensure the arms open up in the proper direction.

• To orient the uterus in an axial position, apply gentle traction to the tenaculum. Then pass the loaded insertion tube through the cervical canal until Paragard just touches the fundus of the uterus. The blue flange should be at the cervix in the horizontal plane (see Figure 5).

Figure 5: Insertion Tube with Paraguard in Uterus

• Release the arms of Paragard by holding the solid white rod steady and withdrawing the insertion tube no more than one centimeter. This releases the arms of Paragard high in the uterine fundus (see Figure 6).

Figure 6: Release of T-Arms of Paraguard in Uterus

• Gently and carefully move the insertion tube upward toward the fundus of the uterus, until slight resistance is felt. This will ensure placement of Paragard at the highest possible position within the uterus (see Figure 7). Do not use the white rod as a plunger to push or insert Paragard.

Figure 7: Placement of Paraguard in Fundus of Uterus

• Hold the insertion tube steady and withdraw the solid white rod (see Figure 8). Do not remove the solid white rod and the insertion tube at the same time to prevent accidental pulling of the threads.

Figure 8: Withdraw Solid White Rod from Uterus

• Gently and slowly withdraw the insertion tube from the cervical canal.

• Only the threads should be visible protruding from the cervix (see Figure 9). Trim the threads so that 3 to 4 cm protrude into the vagina. Measure the length of protrusion of the threads.

• Recommend recording length of threads, date of placement and Paragard lot number.

Figure 9: Appropriate Paraguard Placement in Uterus

If you suspect that Paragard is not in the correct position, check placement (with ultrasound, if necessary). If Paragard is not positioned completely within the uterus, remove it and replace it with a new Paragard. Do not reinsert an expelled or partially expelled Paragard.