INDICATIONS AND USAGE
Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of
reproductive potential for up to 10 years.
IMPORTANT SAFETY INFORMATION
- The use of Paragard is contraindicated when one or more of the following
- Pregnancy or suspicion of pregnancy, abnormalities of the uterus resulting in
distortion of the uterine cavity, acute pelvic inflammatory disease (PID), postpartum or postabortal
endometritis in the past 3 months, known or suspected uterine or cervical malignancy, uterine bleeding of
unknown etiology, untreated acute cervicitis or vaginitis or other lower genital tract infection,
conditions associated with increased susceptibility to pelvic infections, Wilson’s disease, a previously
placed IUS that has not been removed, hypersensitivity to any component of Paragard including to copper or
any of the trace elements present in the copper component of Paragard.
WARNINGS AND PRECAUTIONS
- Ectopic Pregnancy: Evaluate for possible ectopic pregnancy in
female who becomes pregnant while using Paragard.
- Intrauterine Pregnancy: Failure to remove Paragard increases
risk of miscarriage, sepsis, premature labor, and premature delivery.
- Sepsis: Severe infection or sepsis, including Group A
Streptococcal Sepsis (GAS), have been reported following insertion of IUSs, including Paragard.
- Pelvic Inflammatory Disease and Endometritis: Remove Paragard
cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to
- Embedment: Partial penetration or embedment of Paragard in the
myometrium can make removal difficult; surgical removal may be necessary. Breakage of an embedded Paragard
during non-surgical removal has been reported.
- Perforation: Partial or total perforation of the uterine wall
cervix may reduce contraceptive efficacy and result in pregnancy. Delayed detection or removal of Paragard
result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal
obstruction, abscesses and/or damage to adjacent organs. Increased risk when the uterus is fixed,
or not completely involuted during the postpartum period. If perforation does occur, locate and remove
- Expulsion: Partial or complete expulsion of Paragard has been
reported, resulting in the loss of contraceptive protection. The risk of expulsion may be increased when the
uterus is not completely involuted at the time of insertion. Remove a partially expelled Paragard.
- Wilson’s Disease: Paragard may exacerbate Wilson’s disease.
- Bleeding Pattern Alterations: Paragard can alter the bleeding
pattern and result in heavier and longer menstrual cycles with intermenstrual spotting.
- Magnetic Resonance Imaging (MRI) Safety Non-clinical testing has demonstrated that Paragard
is MR Conditional.
- Medical Diathermy: Avoid using high
medical RF transmitter devices in females with Paragard.
- Adverse reactions reported in clinical trials include anemia, backache,
dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting,
pain and cramping, and vaginitis.
Please see full