High patient satisfaction and strong continuation rates1,2

Paragard IUS has high patient satisfaction and strong continuation rates1,2

93%

of women using Paragard have reported satisfaction at 3 and 6 months postplacement.1

Continuation Rates

Paragard continuation rates are equal to or greater than those of other LARCs2*

Contraceptive continuation rates at 12 months among women ≥26 years of age (n=2,956)2†‡

LNG-20-IUS=Ievonorgestrel 20 mcg/day intrauterine system.

*LARC=Long-Acting Reversible Contraceptive.

†From the Contraceptive CHOICE Project (n=7,472). The (n=2,956) is a subset of the total (n=7,472). A prospective cohort study to determine the continuation rates and satisfaction levels with many reversible methods of contraception. To be included in this analysis, study participants had to initiate their chosen contraceptive within 3 months of CHOICE enrollment and reach the time point for a 12-month follow-up telephone survey. Follow-up telephone interviews were conducted at 3, 6, and 12 months. A “continuer” was a participant who reported using her baseline contraceptive without stopping temporarily for ≥1 month.

‡Chart does not compare the safety or efficacy of these methods.

A separate study shows that over the first 6 months using Paragard, women reported3:

Decrease
in cramping

Reduction
in bleeding

Increase
in satisfaction

From a prospective study evaluating bleeding, cramping, and satisfaction among new copper IUS users. The data were collected from 77 women ages 18-45 who reported a regular menses, had no exposure to hormonal contraception in the last three months, and desired and copper IUS for contraception.

Bleeding significantly decreased (∼27%) from an estimated PBAC=195 at one month post-insertion to PBAC=151 at 6 months. IUD satisfaction improved over time, increasing from between “Neutral and Satisfied” to “Satisfied” and cramping decreased from “biweekly and weekly” to “once or twice a month” over the 6-month study.

Bleeding Profile

Paragard users may experience heavier and longer periods with spotting in between. Sometimes the bleeding is heavier than usual at first, but subsides.

Paragard will not interfere with her menstrual cycle or stop ovulation.

  • Many women may wish to keep a menstrual cycle for a variety of personal or cultural reasons4

Patients should be advised to call you if spotting persists or their menstrual flow continues to be heavy or long. If a woman misses her period, she must promptly be evaluated for pregnancy.

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Important Safety Information

CONTRAINDICATIONS

  • The use of Paragard is contraindicated when one or more of the following conditions exist:
    • 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. Continue reading

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

CONTRAINDICATIONS

  • The use of Paragard is contraindicated when one or more of the following conditions exist:
    • 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 any female who becomes pregnant while using Paragard.
  • Intrauterine Pregnancy: Failure to remove Paragard increases the 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 in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment.
  • 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 or cervix may reduce contraceptive efficacy and result in pregnancy. Delayed detection or removal of Paragard may 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, retroverted or not completely involuted during the postpartum period. If perforation does occur, locate and remove Paragard promptly.
  • 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 Information: 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

  • 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 Prescribing Information

References:
1. Diedrich JT, Desai S, Zhao Q, et al. Association of short-term bleeding and cramping patterns with long-acting reversible contraceptive method satisfaction. Am J Obstet Gynecol. 2015;212(1):50.e1-50.e8.

2. Rosenstock JR, Peipert JF, Madden T, et al. Continuation of reversible contraception in teenagers and young women. Obstet Gynecol. 2012;120(6):1298-1305.

3. Sanders JN, Adkins DE, Kaur S, Storck K, Gawron LM, Turok DK. Bleeding, cramping, and satisfaction among new copper IUD users: A prospective study. PLoS ONE. 13(11):e0199724.

4. Data on file. CooperSurgical, Inc.