Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Several claims about contraception duration, bleeding outcomes, ectopic pregnancy evaluation, and IUD removal in pregnancy are supported by the provided LILETTA labeling excerpts. However, multiple claims about expiration determination, backup contraception after expiration, use of ultrasound to confirm device age, and claims about regulatory changes/variable approved durations are not supported (or conflict with what is provided), leading to only partial overall alignment.
Category Scores
Accurate Statements
LILETTA is indicated for prevention of pregnancy for up to 8 years.
1.1 Contraception: “LILETTA is indicated for prevention of pregnancy for up to 8 years.”
For contraception, remove LILETTA by the end of the eighth year.
2 Dosing Over Time: “For contraception, remove LILETTA by the end of the eighth year...”
The LNG release rate decreases progressively to ~6.5 mcg/day after 8 years.
2 Dosing Over Time: “This rate decreases progressively to approximately 6.5 mcg/day after 8 years.”
If pregnancy occurs with LILETTA in place, evaluate for ectopic pregnancy; approximately half of pregnancies with an IUS in place are likely ectopic.
5.1 Ectopic Pregnancy: “Evaluate patients for ectopic pregnancy if they become pregnant with LILETTA in place… Approximately half of pregnancies that occur with an IUS in place are likely to be ectopic.”
If pregnancy occurs while using LILETTA, determine if LILETTA is in the uterus and attempt to remove it because leaving it in place may increase risk of miscarriage and preterm labor.
5.2 Intrauterine Pregnancy: “If pregnancy occurs while using LILETTA, determine if LILETTA is in the uterus… attempt to remove LILETTA because leaving it in place may increase the risk of spontaneous abortion and preterm labor.”
Unsupported Statements
Liletta is approved for use for a set number of years depending on the product labeling.
Provided labeling excerpt states “up to 8 years” for contraception but does not state that the approved duration varies depending on product labeling.
The exact expiration for a Liletta IUD can be found on the box or paperwork received when it was placed.
No provided label excerpt supports where to find exact expiration/expiry date.
The label on the device itself or in implant records contains information needed to determine Liletta expiration.
No provided label excerpt supports device-label/implant-record determination of expiration.
A clinician can confirm the specific expiration based on lot/manufacturing and the approved duration at placement.
No provided label excerpt supports confirming expiration using lot/manufacturing.
Using a Liletta IUD beyond its labeled approved duration may reduce contraceptive effectiveness.
The provided label supports removal by end of the eighth year, but does not explicitly state that use beyond labeled approved duration reduces contraceptive effectiveness.
If a Liletta IUD is past its expiration date, backup contraception (such as condoms) should be used until guidance from a clinician.
No provided label excerpt provides instructions about backup contraception after expiration.
If a Liletta IUD is past its expiration date, replacement or discussion of another method should be scheduled promptly.
The label provided specifies removal timing (end of year 8 for contraception), but does not provide guidance about what to do specifically when past expiration.
Liletta’s approved duration can change over time.
No provided label excerpt supports that the approved duration changes over time.
Regulatory approvals and clinical guidance can expand the approved duration for certain IUDs after additional data are reviewed.
No provided label excerpt supports discussion of regulatory expansion/changes for Liletta.
The number of years of use may be updated compared with earlier information.
No provided label excerpt supports updates to duration over time.
The safest approach is to follow the expiration/approved duration stated on the specific product labeling and confirmed by the clinician.
The label provided specifies duration and removal timing but does not support this “safest approach” framing or the claim about clinician confirmation of expiration/approved duration based on product labeling.
If insertion date is unknown, contact the clinician who placed the IUD or request records.
No provided label excerpt supports this record-request guidance.
If paperwork cannot be found, ultrasound can confirm that the IUD is present.
No provided label excerpt mentions ultrasound for confirming presence.
Ultrasound cannot reliably tell the age of the device (date placed).
No provided label excerpt discusses ultrasound’s ability (or inability) to determine device age/date placed.
The date placed matters for expiration and replacement timing.
The label provided specifies removal by end of year 8, but does not explicitly connect this to “date placed” phrasing or discuss determining replacement timing when date is unknown.
Many people remove a Liletta IUD early to become pregnant, switch birth control methods, or manage side effects.
No provided label excerpt supports statements about patient behavior/motives.
Fertility can return after removal of a Liletta IUD.
No provided label excerpt addresses return of fertility after removal.
Contradictions
Important Omissions
Backup contraception/barrier-method instructions tied to expiration/past duration status (if claimed) are not specified in the provided label excerpts and were not evaluated against label language.
Importance:
Moderate
Label-supported timing for contraception discontinuation is “remove by the end of the eighth year”; the response did not directly and explicitly restate this label instruction as the primary duration/termination rule.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Several statements about what to do when past expiration (e.g., use backup contraception, prompt replacement) and about how to determine expiration (box/records/device/lot, ultrasound for age) are not supported by the provided FDA label excerpts. While the label supports removal by end of year 8 and management of pregnancy with ectopic risk, unsupported guidance could lead to incorrect patient management decisions.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Multiple duration/expiration determination and post-expiration management claims are not supported by the provided label excerpts.
Suggested Improvement
Limit statements about duration strictly to label-supported contraception duration (up to 8 years; remove by end of eighth year) and pregnancy management (evaluate ectopic risk; attempt removal if in uterus). Remove or rephrase unsupported claims about finding exact expiration on box/device/records, lot-based confirmation, ultrasound for age, backup contraception after expiration, and duration changes over time.