Question:
"I have a patient that had a copper IUD placed and was advised that it was effective for 12 years. She looked at the Paragard website and of course it reiterates that the FDA has only approved Paragard for 10 years. She is my patient and is asking my advice. I was wondering if there was a study indicating continued safety or the method whereby they determined 2 additional years was OK. Any insight or thoughts on this topic would be great!"
Answer:
The Copper TCu380A, or ParaGard IUD is labeled for ten years of use. It is interesting to note that when it was first approved in 1984 (although not marketed until 1988), it was for 4 years of use.
Subsequently as more data were collected, the duration of approved use was incrementally lengthened until the current approval for ten years.
There are data that support use through twelve years.
→ In two studies of 314 women who used the TCu380A from years 10-12, there were no reported pregnancies. (Contraception. 1997;56(6):341)
→ A group of 8 women continued use for a total of 16 years with no pregnancies.
→ The authors of one study of 238 women reported their findings as “No pregnancy was observed in 366 woman-years of observation beyond 10 years of use.” (Bahamondes et al, Contraception. 2005;72(5):337.
→A systematic review on the topic concluded “The available evidence suggests that rates of pregnancy, adverse events, and discontinuation owing to side effects during the first 2 years of extended use of the 52 mg levonorgestrel intrauterine device and the T380A copper intrauterine device are low and comparable to rates during approved duration of use. Data were limited in quantity and quality, and may not be generalizable to all intrauterine device users.” (Ti et al, Am J Obstet Gynecol. 2020;223(1):24)
Bottom Line: Good idea to present your patient with data and give her a choice. If she chooses to extend use through twelve years, she avoids a procedure and may save cost depending on her insurance. Her age should be considered in the decision because as she ages, her fertility declines and extended use would have less potential to fail. For example, if she had the IUD placed at age 35 or older, she can probably leave it in longer than 12 years, until menopause, if she is satisfied with the method. If she was younger than 25 when it was placed, she may want to replace it at ten years, to ensure the best efficacy during her fertile years. For the years in between, the data suggest it is acceptable to use for 12 years.
Other things to know about the Copper TCu380A IUD
→ Works immediately after insertion, so no back-up method needed
→ Is the most effective emergency contraceptive available. For this use, it may be inserted up to 5 days after unprotected intercourse. This is an “off-label” use of the product.
→ Works by preventing fertilization not by interfering with embryo implantation
DISCLAIMER: This information is for educational purposes only and not intended to guide individual therapy. Answers should never substitute for consultation with a healthcare provider or counselor who can make decisions based on an individual’s history, desires, and circumstances. Always seek the advice of a clinician for any questions regarding health, medical condition, birth control method or other family planning or social issues. Under no circumstances should an individual use this information in lieu of, or to override, the judgment of a treating clinician. Dr. Zieman, or SageMed LLC, is not responsible, or liable, for errors, omissions, or any damage or loss incurred as a result of use of any birth control method or use or reliance on any material or information provided through this website.