Copper Intrauterine Contraceptive

Copper intrauterine contraceptive is a hormone-free device that prevents fertilization by releasing copper ions and is indicated for preventing pregnancy in females of reproductive potential.

• Copper intrauterine contraceptive is available under the following different brand names: Miudella, Paragard

Common side effects of Copper intrauterine contraceptive include:

• anemia
• backache
• dysmenorrhea
• dyspareunia
• complete or partial expulsion
• prolonged menstrual flow
• menstrual spotting
• pain and cramping
• vaginitis

Serious side effects of Copper intrauterine contraceptive include:

• ectopic pregnancy and intrauterine pregnancy risks
• sepsis
• pelvic inflammatory disease (PID)
• perforation
• expulsion
• reactions after placement or removal may include syncope, bradycardia, or, rarely, seizures, especially in those with a history of such episodes

Rare side effects of Copper intrauterine contraceptive include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intrauterine device

• copper surface area 175 mm2 (Miudella)
• copper surface area 380 mm2 (Paragard)

Contraception

Adult and pediatric dosage

• Miudella: Remove on or before 3 years from insertion date
• Paragard: Remove on or before 10 years from the insertion date
• Replace at the time of removal with a new contraceptive device if continued contraceptive protection is desired

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Pregnancy or suspicion of pregnancy
• Congenital or acquired uterine abnormalities (eg, leiomyomas) that cause uterine cavity distortion
• Acute pelvic inflammatory disease (PID)
• Postpartum or postabortal endometritis in the past 3 months
• Known or suspected uterine or cervical malignancy
• For use as post-coital contraception (emergency contraception)
• Uterine bleeding of unknown etiology
• Untreated acute cervicitis, vaginitis, or other lower genital tract infections
• Conditions associated with increased susceptibility to pelvic infections
• Wilson disease
• Intrauterine device in place that has not been removed
• Hypersensitivity to any component of including polypropylene, copper, nitinol, an alloy of nickel and titanium, or any trace elements present in the copper component

Effects of drug abuse

• None

Short-Term Effects

See “What Are Side Effects Associated with Using Copper intrauterine contraceptive?”

Long-Term Effects

See “What Are Side Effects Associated with Using Copper intrauterine contraceptive?”

Cautions

• Risk of ectopic pregnancy
  • Evaluate for possible ectopic pregnancy in any female who becomes pregnant while using an intrauterine device (IUD) because a pregnancy that occurs with an IUD in place is more likely to be ectopic compared with the general population
  • However, because IUDs prevent most pregnancies, females who use an IUD have a lower risk of ectopic pregnancy than sexually active females who do not use any contraception
  • Ectopic pregnancy may require surgery and may result in loss of fertility
  • Inform patients about recognizing signs and symptoms of ectopic pregnancy and promptly reporting them to their healthcare professionals and about associated risks of ectopic pregnancy (e.g., loss of fertility)
• Risks with intrauterine pregnancy
  • If intrauterine pregnancy occurs with an IUD in place and thread ends are visible or can be retrieved from the cervical canal, remove the IUD
  • Leaving it in place may increase the risk of spontaneous abortion and preterm labor
  • Removal of an IUD may also result in spontaneous abortion
  • If an intrauterine pregnancy occurs, consider the potential risk of septic abortion or the risk of pregnancy continuation
• Septic abortion
  • Septic abortion (with septicemia, septic shock, and death) may occur in females who become pregnant with an IUD in place
  • Septic abortion typically requires hospitalization and treatment with IV antibiotics
  • Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination
  • Hysterectomy may be required if severe uterine infection occurs, which will result in permanent infertility
• Continuation of pregnancy
  • If a female becomes pregnant with an IUD and it cannot be removed or the patient chooses not to have it removed, warn her that failure to remove the IUD increases the risk of miscarriage, sepsis, premature labor, and premature delivery
  • Prenatal care should include counseling about these risks; advise patients to immediately report any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests pregnancy complications
• Sepsis
  • Severe infections or sepsis, including Group A streptococcal sepsis (GAS), reported following IUD insertion
  • In some cases, severe pain occurs within hours of insertion, followed by sepsis within days
  • Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections
  • Aseptic techniques during IUD insertion are essential to minimize serious infections
• Pelvic infection
  • Promptly examine patients with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores
  • Remove IUD in cases of recurrent pelvic inflammatory disease or endometritis, or if an acute pelvic infection is severe or does not respond to treatment
  • Pelvic inflammatory disease is contraindicated in the presence of known or suspected PID or endometritis
  • IUDs have been associated with an increased risk of PID, often due to organisms being introduced during insertion
• Increased risk for PID
  • PID is often associated with a sexually transmitted infection (STI), and IUDs do not protect against STIs
  • Risk of PID is greater for females who have multiple sexual partners, and for females whose sexual partner(s) have multiple sexual partners
  • Females who have had PID are at increased risk for a recurrence or reinfection
  • Ascertain an increased risk of infection (e.g., leukemia, AIDS, IV drug abuse)
• Subclinical PID
  • PID may be asymptomatic, but still result in tubal damage and its sequelae
• PID treatment
  • Obtain bacteriologic specimens after diagnosis (or suspected PID) and initiate antibiotic therapy promptly
  • Removal of IUD after initiation of antibiotic therapy is appropriate in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment
• Actinomycosis
  • Actinomycosis has been associated with IUD
  • Remove the IUD in symptomatic patients with known actinomycosis infection and initiate antibiotics
  • Actinomycetes can be found in genital tract cultures in healthy patients without IUDs
  • The significance of actinomyces-like organisms on Pap test in asymptomatic IUD users is unknown, and so this finding alone does not always require IUD removal and treatment
  • When possible, confirm a Pap test diagnosis with cultures
• Perforation
  • Partial or total perforation of the uterine wall or cervix may occur during insertions, although perforation may not be detected until sometime later
  • Perforation may also occur at any time during IUD use
  • Perforation that results in embedment or translocation may reduce contraceptive efficacy and result in pregnancy
  • Risk of perforation may increase if an IUD is inserted when the uterus is fixed, retroverted, or not completely involuted during the postpartum period
  • If perforation is suspected or if a known perforation occurs during placement, remove the IUD as soon as possible
  • Surgery may be required; preoperative imaging followed by laparoscopy or laparotomy may be necessary to remove the IUD from the peritoneal cavity
  • Delayed detection or removal may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses, and/or damage to adjacent organs
• Expulsion
  • Partial or complete expulsion reported, resulting in loss of contraceptive protection
  • Consider further diagnostic imaging (e.g., x-ray) to confirm expulsion if the device is not found in the uterus on ultrasound
  • Insert no earlier than 4 weeks post-pregnancy to mitigate expulsion risk; if the uterus is not completely involuted at the time of insertion, the expulsion risk increases
  • Remove a partially expelled device and do not attempt to push a partially expelled device into the uterus
  • If an expulsion has occurred, a new device may be inserted when there is reasonable certainty that the patient is not pregnant
• Wilson disease
  • May exacerbate Wilson disease, a rare genetic disease affecting copper excretion; therefore, use is contraindicated in females with Wilson disease
• Bleeding pattern alterations
  • Device can alter the bleeding pattern and result in heavier and longer menstrual cycles with intermenstrual spotting
  • Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue use
• MRI safety information
  • May be safely scanned under the following conditions
  • Miudella
  • Static magnetic field nominal values (T): 1.5-Tesla or 3-Tesla
  • Maximum spatial field gradient: 4,000 gauss/cm (40 T/m)
  • Maximum whole-body averaged specific absorption rate (SAR): 2 W/kg (normal operating mode)
  • Type of RF excitation: Circularly polarized (CP) (i.e., quadrature transmission)
  • Transmit RF coil information: No transmit RF coil restrictions; may use body transmit RF coil and all other combinations
  • Operating mode: Normal operating mode
  • Limits on scan duration: 2 W/kg whole body average SAR for 60 minutes of continuous RF exposure (a sequence or back-to-back sequences/series without breaks)
  • MR image artifact: Presence of device produces imaging artifact; image artifact follows approximate device contour and extends radially up to 0.7 cm from device
• Paragard
  • Static magnetic field nominal values (T): 1.5-Tesla or 3-Tesla
  • Maximum spatial field gradient: 4,000 gauss/cm (40 T/m)
  • Maximum whole-body averaged specific absorption rate (SAR): 2 W/kg (normal operating mode)
  • Expected to produce a maximum temperature rise of the device below 0.5 °C after 15 minutes of continuous scanning
• Medical diathermy
  • Medical equipment that contains high levels of radiofrequency (RF) energy (e.g., diathermy) may cause health effects (by heating tissue) in females with a metal-containing IUD
  • Avoid using high medical RF transmitter devices in females with copper IUDs

Pregnancy and Lactation

• Contraindicated
  • Studies on pregnancy outcomes exposed to copper intrauterine systems report up to 27% miscarriage when the device was removed, compared with 77% miscarriage when the device remained in the uterus
  • Return to fertility after device removal
  • Return to fertility was investigated in 63 women who desired pregnancy after study discontinuation and provided follow-up information
  • Probability of conceiving within 12 months after removal was 74.1%
• Lactation
  • No difference detected in the concentration of copper in human milk before and after insertion of copper contraceptive devices
  • Data are not available on the effect of copper in breastfed children or on milk production