Paragard Iud

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

• 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 Paragard only if you are a healthcare provider trained on these procedures.
  
  
• See the Full Prescribing Information for recommended timing of insertion preparation instructions, insertion procedures, postplacement management, and instructions on removing Paragard
  
  
• Following the insertion, examine the patient after her first menses to confirm Paragard is still in place.

Paragard is a T-frame copper-containing intrauterine system (IUS) consisting of a polyethylene frame with barium sulfate measuring 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical arm and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arm with a total exposed copper surface area is 380 ± 23 mm², packaged with an insertion tube with blue flange and solid white rod. A monofilament polyethylene thread is tied through the tip of the vertical arm resulting in two white threads, each at least 10.5 cm in length. Figure 1 displays the contents of the package

Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes. If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery

Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Paragard and birth defects have not been conducted.

• Ectopic Pregnancy:
  Promptly evaluate women who become pregnant for ectopic pregnancy while using Paragard.
  
  
• Risks with Intrauterine Pregnancy
  : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock and death if pregnancy occurs. Remove Paragard if pregnancy occurs with Paragard in place.
  
  
• Sepsis:
  Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion
  
  
• Pelvic Inflammatory Disease (PID) and Endometritis:
  Before using Paragard, consider the risks of PID and endometritis. Promptly assess and treat patients with signs and symptoms of PID.
  
  
• Embedment
  : Surgical removal may be necessary.
  
  
• Perforation
  : May reduce contraceptive effectiveness and require surgery. Risk is increased if inserted in lactating women and may be increased if inserted in women with fixed, retroverted uteri or noninvoluted uteri.
  
  
• Expulsion:
  Partial or complete expulsion may occur. Remove a partially expelled Paragard.
  
  
• Bleeding patterns:
  May be altered and result in heavier and longer bleeding with spotting.
  
  
• MRI Safety Information
  : Patients using Paragard can be safely scanned with MRI only under certain conditions.