Levonorgestrel IUDs Are Safe and Effective for Eight Years of Use
FDA approves Mirena IUD for eight years
October 1, 2022 3 minutes read
Two of the most popular hormonal intrauterine devices (IUDs) can be used for eight years, which can make them an even better option for women seeking long-term, highly effective contraception.1,2
A recent study revealed that levonorgestrel 52 mg intrauterine system (Liletta) is highly effective for eight years of use and has an excellent safety profile.1 The FDA approved the Mirena IUD for eight years of use in August 2022.2
“The bottom line is Liletta and Mirena are the same,” says Mitchell Creinin, MD, lead author of the Liletta study and professor and director of the Complex Family Planning Fellowship at the University of California, Davis Health. “This means the 52 mg is safe and effective for eight years. That’s the evidence. Lower-dose products are not as effective for as long.”
Since placement and removal can be time-consuming and painful, a longer use of IUDs may appeal to women who might otherwise be considering tubal ligation.
“The importance of this is when a woman has an IUD placed, it’s hopefully a one-time procedure that will last her as long as possible, until she wants to have children or it really has expired,” Creinin says.
For reversible contraception, this gives women the biggest window of effectiveness. “Implants and IUDs are so highly effective that likely you won’t get pregnant,” Creinin says. “You can set and forget it, and for as long as possible. You don’t have to worry about it.”
IUDs also thin the lining of the uterus, so most people experience little to no bleeding, and they reduce menstrual cramping.
From a family planning provider’s perspective, the longer time between placement and removal of IUDs means fewer risks for patients.
“Think of all the women who got the IUD for five years and then had it removed and replaced and went through the pain and risks again,” Creinin says. “I tell my patients to not look at this long-term, to look at it as a highly effective contraceptive with minimal hormones and that provides them with contraception that decreases their flow and gets rid of cramps.”
Although the FDA has approved the hormonal IUDs for eight years, safety data suggest promise for a decade of use.
“All the data we had prior to starting the study in 2009 said this likely would be good for eight to 10 years,” Creinin explains. “But we didn’t have sufficient numbers because the FDA changed the rules about who could be included in efficacy. We didn’t have enough people to satisfy the FDA’s new rules.”
When counseling a woman using a Mirena IUD, the duration of effectiveness might best be expressed as “Your IUD is effective for at least eight years.” This is far better than saying to a woman, “Your IUD should be removed at eight years.”
The one drawback is that the data were not available to women who have already gone through multiple IUD insertions and removals. “If you were 30 and done with childbearing, it used to be that you needed three IUDs to get to 15 years, and now you need just two,” Creinin says. “I feel bad that if we had studied it sooner, it would have been effective this long.”
But going forward, the FDA change and data hold great promise for patient autonomy, safety, and ability to better determine if, and when, to become pregnant. “This is really great for women,” Creinin says.
It may reduce hesitancy about the pain of IUD insertion. “I had someone email me from Minnesota who said she had it in for 10 years and didn’t want her doctor to take it out and put in a new one,” Creinin recalls.
The pain of insertion is enough of a deterrent that doctors should offer women local anesthesia or other techniques to make it less painful, Creinin adds.
REFERENCES
- Creinin MD, Schreiber CA, Turok DK, et al. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use. Am J Obstet Gynecol 2022;S0002-9378(22)00366-0.
- FDA extends Mirena IUD for eight years of use. Formulary Watch. Aug. 19, 2022.
Two of the most popular hormonal IUDs can be used for eight years, which can make them an even better option for women seeking long-term, highly effective contraception.
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