Informed Consent for Intrauterine Device (IUD) Insertion

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Informed Consent for Intrauterine Device (IUD) Insertion

Patient and Device Information

Device Description and Mechanism

An IUD is a small, T-shaped device inserted through the cervix into the uterine cavity by a trained clinician. Two categories are available: (1) Copper IUD (Paragard): non-hormonal; copper ions interfere with sperm motility and fertilization; effective immediately upon insertion; approved for up to 10 to 12 years; may be used as emergency contraception if inserted within 5 days of unprotected intercourse; may cause heavier, more crampy periods particularly in the first 3 to 6 months; (2) Hormonal IUD (LNG-IUS): contains levonorgestrel which thickens cervical mucus, thins the uterine lining, and partially suppresses ovulation in some cycles; available in varying dose strengths (52mg/Mirena: 8 years; 19.5mg/Kyleena: 5 years; 13.5mg/Skyla: 3 years); typically reduces menstrual bleeding significantly and may cause periods to stop; effective within 7 days of insertion (immediately if inserted within first 7 days of menstrual cycle). Both devices have greater than 99 percent efficacy for contraception. The IUD does NOT protect against sexually transmitted infections.

Insertion Procedure Description

The insertion procedure is performed in a clinic setting without sedation or anesthesia. The patient lies on an examination table in the lithotomy position. A speculum is inserted to visualize the cervix, the cervix is cleansed with antiseptic solution, and a uterine sound is passed to measure the depth of the uterine cavity. The IUD is loaded into an insertion tube and passed through the cervical canal into the uterine cavity, where the arms of the T-shape deploy. The insertion strings (threads) are trimmed to approximately 2 to 3 cm below the cervix and remain inside the vagina for the patient to feel. The procedure typically takes 5 to 10 minutes. Pre-procedure NSAIDs (ibuprofen or naproxen) taken 1 hour before insertion may reduce cramping discomfort.

Material Risks and Potential Complications

Uterine perforation: the insertion instrument or IUD may inadvertently perforate the uterine wall, occurring in approximately 1 in 500 to 1 in 1,000 insertions. Risk is higher in breastfeeding women and in uteri with extreme ante- or retroflexion. A perforated IUD requires surgical removal (hysteroscopic or laparoscopic).
Expulsion: the IUD is partially or completely expelled from the uterus in approximately 5 to 10 percent of users, most commonly within the first year and especially in nulliparous women. Expulsion may go unnoticed, leaving the patient without contraception. Patients should check their strings monthly.
Ectopic pregnancy: the IUD is highly effective, but in the rare event that pregnancy does occur, a disproportionate percentage are ectopic (fallopian tube implantation). The overall risk of ectopic pregnancy with an IUD in place is lower than without contraception, but if pregnancy occurs, the risk that it is ectopic is higher. Ectopic pregnancy is a life-threatening emergency.
Pelvic infection (PID): IUD insertion in a patient with pre-existing cervical chlamydia or gonorrhea infection may introduce bacteria into the uterine cavity, causing pelvic inflammatory disease. Patients are screened for STIs before or at the time of insertion where clinically indicated.
Cramping and pain: moderate to severe uterine cramping during and immediately after insertion is common, typically lasting 30 to 60 minutes but occasionally for several hours. NSAIDs provide effective relief for most patients.
Hormonal IUD side effects: irregular spotting or bleeding in the first 3 to 6 months, breast tenderness, mood changes, acne, and headache are uncommon but recognized side effects of the levonorgestrel IUS.
Amenorrhea: hormonal IUD users commonly experience significantly reduced or absent menstrual bleeding, particularly with the 52mg LNG-IUS. This is not harmful; menstruation returns promptly after removal.
Failure to insert: in approximately 1 to 2 percent of attempts, the IUD cannot be inserted due to cervical stenosis, uterine abnormality (fibroid, septum, congenital anomaly), or extreme uterine angulation.

Alternatives to IUD

Progestogen implant (Nexplanon): subdermal rod implanted in the upper arm; greater than 99 percent efficacy for 3 years; reversible; does not require uterine insertion.
Combined oral contraceptive pill (COCP) or progestogen-only pill: daily oral contraception; reversible; user-dependent efficacy; not suitable for some women due to cardiovascular or migrainous contraindications.
Depot medroxyprogesterone acetate (DMPA/Depo-Provera): injectable contraception every 12 weeks; reversible but with delayed return to fertility (up to 12 to 18 months in some patients).
Barrier methods: male and female condoms; protect against STIs; less effective for contraception (85 to 98 percent typical use).
Permanent sterilization (tubal ligation or vasectomy): for patients who have completed their family.

Expected Benefits

The IUD provides highly effective, long-acting, reversible contraception with efficacy exceeding 99 percent, without requiring daily or coitally dependent user action. Fertility returns promptly after removal. The hormonal IUD additionally provides significant reduction in menstrual flow, often improving quality of life in women with heavy menstrual bleeding or dysmenorrhea. The copper IUD provides non-hormonal contraception and can serve as emergency contraception.

Post-Insertion Follow-Up and String Check Instructions

A follow-up appointment is recommended 4 to 8 weeks after insertion to confirm correct IUD position. You will be shown how to check your IUD strings monthly by inserting a clean finger into the vagina to feel the threads. If you cannot feel your strings, if you can feel the hard plastic of the IUD device itself, or if you have any of the following symptoms, contact your provider immediately: severe pelvic pain, unusual discharge, fever, missed period, or symptoms of pregnancy. If you cannot feel your strings after insertion, a pelvic ultrasound will be performed to confirm the IUD is correctly positioned within the uterus.

Right to Refuse or Withdraw Consent

You have the right to refuse this procedure or withdraw your consent at any time before the IUD is inserted without penalty or adverse effect on your medical care. The IUD can also be removed at any time by your healthcare provider.

Questions and Understanding Confirmation

I confirm that I have been counseled on the type of IUD selected, its mechanism of action, its duration, and its failure rate. I understand that the IUD does not protect against STIs. I have been instructed on monthly string checks and when to seek urgent care. All my questions have been answered to my satisfaction.

Language Access and Interpreter Services

If English is not your primary language or if you require assistance communicating, a qualified interpreter is available at no cost. Please notify your care team before signing.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this informed consent form for my own records.

Patient Authorization

I consent to insertion of the IUD type indicated above and understand that I can request removal at any time. I have been counseled on the risks, including uterine perforation and expulsion, and on how to check my IUD strings.

Signatures and Verification

Patient Signature
Clinician Signature
Date and Time
Document ID: CC-PENDING
CONSENTCOLLECT