Contraception 118 (2023) 109909

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Contraception
journal homepage: www.elsevier.com/locate/contraception

Brief research article

Trends in copper versus hormonal intrauterine device breakage

reporting within the United States’ Food and Drug Administration
Adverse Event Reporting SystemR,RR,RRR
Kyle R. Latack a,∗, Brian T. Nguyen b
a
Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, United States
b
Department of Obstetrics and Gynecology, Section of Family Planning, University of Southern California, Los Angeles, CA, United States

a r t i c l e i n f o a b s t r a c t

Article history: Objective: To examine trends in national reporting of broken intrauterine devices (IUDs).
Received 4 April 2022 Study design: We enumerated IUD device “breakage” reports in the Food and Drug Administration Ad-
Received in revised form 13 October 2022
verse Event Reporting System from inception (1998) until February 2022. We explored associations of
Accepted 21 October 2022
breakage with IUD type (copper versus hormonal), year reported, reporter (consumer versus clinician),
and patient characteristics (age and weight).
Keywords: Results: We identified 4144 breakage reports for copper versus 2140 for hormonal IUDs. Among the
Intrauterine devices 170,215 adverse events reported, breaks were disproportionately reported for copper (9.6%) versus hor-
IUD-removal monal (1.7%) IUDs.
LARC
Conclusion: National pharmacovigilance data suggests disproportionate breakage in copper versus hor-
Pharmacovigilance
monal IUDs though the true prevalence of breaks cannot be calculated from this dataset.
© 2022 Elsevier Inc. All rights reserved.

1. Introduction One method for identifying rare or significantly delayed events

Intrauterine Devices (IUDs) are an increasingly popular form of
contraception [1,2]. While insertion and removal are typically un-
complicated, recent media reports of IUDs breaking at the time of
removal are becoming more common, with anecdotal observations
of the copper IUD as one that might break more commonly [3].
Removal of IUD fragments can entail invasive, painful procedures
(e.g., ultrasound guided, forceps removal or vacuum aspiration) [4].
Possible reasons for breakage include removal of a malpositioned
IUD, forces generated by the myometrium, and decline in struc-
tural integrity over time [5,6]. The incidence of IUD breakage dur-
ing removal is not known. Clinical trials likely underestimate the
incidence of breakage given their insertion and removal by experts
or insufficient time passing for breakage or its antecedents to oc-
cur.
R
Publication disclosure: This manuscript and its abstract have never been pub-
lished in any peer-reviewed journal.
RR
Conflicts of interest: None of the authors have financial conflicts of interest re-
lated to this research.
RRR
Funding: This research did not receive any specific grant from funding agencies
in the public, commercial, or not-for-profit sectors.
∗
Corresponding author.
E-mail address: kyle.latack@gmail.com (K.R. Latack).
related to medication use is through postmarket surveillance [7].
The Food and Drug Administration Adverse Event Reporting System
(FAERS) database captures reports of IUD breakage by type of IUD.
We identified temporal trends and associations with IUD breakage.
2. Methods
We captured all adverse events in the FAERS related to IUDs
available in the United States (“Paragard [CuT380A], Mirena [52
mg LNG IUS], Liletta [52 mg LNG IUS], Kyleena [19.5 mg LNG
IUS]”), and Skyla[13.5 mg LNG IUS] from inception (1998) through
February 2022 [8]. Of note, users may submit events backdated
from year of inception for any timepoint that the adverse event
occurred. We grouped the four hormonal IUDs into one group
given similar mechanism and placement/removal technique; the
Paragard T380a was the only FDA-approved copper IUD within
the database. We enumerated “device breakage” reports, a specifi-
cally reported adverse event in database. We additionally collected
linked data, inclusive of reporter type (IUD user versus clinician),
as well as user age and weight (the only patient demographics
available). We removed any adverse events that listed more than
one IUD type. To identify temporal trends, we calculated breakage
incidence by year of occurrence. For the association of breakage
with IUD type, we performed a disproportionality analysis for ad-
verse events [9] where we calculated the reporting odds ratio us-

https://doi.org/10.1016/j.contraception.2022.10.011
0010-7824/© 2022 Elsevier Inc. All rights reserved.
K.R. Latack and B.T. Nguyen Contraception 118 (2023) 109909

Table 1
Reports of breakage compared to all other adverse events as reported by IUD type

Breakage reports (total #) All other adverse events (total #)

Copper IUD 4144 (a) 39,056 (b)

Hormonal IUDs 2140 (c) 124,875 (d)

IUD, intrauterine devices.

To put these results into context, for Copper IUDs the three highest reported adverse events
were; device expulsion (30.0%, n = 11,650), device dislocation (22.3%, n = 9647), and uter-
ine disorder (10.2%, n = 4418). For hormonal IUDs, the highest reported adverse events
were; device expulsion (33.8%, n = 42,886), device dislocation (12.2%, n = 15,467), and
genital hemorrhage (6.96%, n=8,836). Perforation proportions were 1.02% (n = 440) and
5.19% (n = 6593) for copper and hormonal IUDs respectively.
Reporting Odds Ratio (ROR) calculated using the following formula: ROR=(a/c)/(b/d)=ad/bc

ing a two-by-two contingency table containing the adverse event
of interest (i.e., IUD breakage) versus all other adverse events by
IUD type (copper versus hormonal). We repeated this analysis for
any association with reporter group (IUD user versus clinician).
We used SAS Studio (Version 3.9 SAS Institute Inc., Cary, NC) for
statistical analyses, inclusive of the disproportionality analysis and
Mann-Whitney U-tests for association of breakage with user char-
acteristics (i.e., weight, age). We performed a logistic regression to
identify factors independently associated with increased odds of
IUD breakage. As age, weight, and IUD type were the only patient
level variables available in the database, they were all included
in the model. To explore the possibility of IUD size contributing
to breakages, we created a binary variable for “large” (Paragard,
Mirena, Liletta) and “not large” IUDs (Skyla and Kyleena) into the
regression model. For bivariate analyses, we defined statistical sig-
nificance at p < 0.05; we included all significant factors into the
regression, removing non-significant covariates in a step-wise fash-
ion to arrive at the final model.
3. Results
We identified 170,215 adverse events within the database for
all IUDs (43,200 copper; 127,015 hormonal) after removal of events
with more than one IUD code (n = 145). Breakages comprised 9.6%
(n = 4144) of adverse events for the copper IUD; breakages com-
prised 1.7% (n = 2,140) of adverse events for hormonal IUDs. The
disproportionality analysis comparing breakage reports for copper
versus hormonal IUDs noted reports for copper IUDs being 6.19
(95%CI: 5.87−6.53) times more likely to be a breakage as compared
to reports for hormonal IUDs (Table 1).
When examining reporting proportions over time, 29.6%
(n = 1,228) of copper IUD breakage reports did not include an as-
sociated report filing year; comparatively, 21.1% (n = 452) of break-
age reports for hormonal IUDs did not include an associated year.
Figure 1 presents the total number of breakages by year, noting
considerable rise in breakage reports, from 33 to 110, for the cop-
per IUD starting between 2012 and 2013.
Of the 6221 reported breakages with linked data on the re-
porter (IUD user vs clinician), 60.2% (n = 3742) came from clin-
icians. In comparison, for the 163,994 nonbreakage events, 52.2%
(n = 85,685) came from clinicians. Within this dataset, clinicians
disproportionately reported breaks rather than other types of ad-
verse events (OR 1.36; 95%CI 1.29−1.43).
With respect to available IUD user characteristics, the median
age of users reporting breakage (34 years; IQR 28−43) was signifi-
cantly higher than that of those reporting a nonbreakage event (30
years; IQR 25−36; p < 0.001). The median weight in those report-
ing breakage (70.3 kg; IQR 60.4−84.8) was significantly higher than
that of those reporting a nonbreakage event (68 kg; IQR 59−81.2;
p < 0.001).
We included significant factors from the bivariate analyses
above in a logistic regression model (IUD type, age, and weight),
noting increased odds of breakage with increasing user age (aOR
1.08; 95%CI: 1.07−1.09) and weight (aOR 1.01; 95%CI: 1.01−1.01) at
time of the event, as well as IUD type, with copper IUDs carrying
greater odds of reported breakage (aOR: 1.93; 95%CI: 1.74−2.15).
Size of IUD was not significantly associated with breaks and there-
fore not included in the final model (data not shown).
4. Discussion
Reports of IUD breakage are increasing, with disproportionately
more reports noted in our analysis for copper versus hormonal
IUDs, even when controlling for user age and weight. Additionally,
we noted an inflection point between 2012 and 2013 where more
breakages were reported, with a sharper increase noted for copper
versus hormonal IUDs.
The disproportionate reporting of breakage for copper versus
hormonal IUDs may be partially explained by the length of time
that copper IUDs are used in comparison to hormonal IUDs; de-
vices used for longer might be less robust. Further, the plastic
frames of copper T versus hormonal IUDs, as well as their inser-
tion mechanisms, differ in ways that may impact breakage risk.
The arms of the copper T IUD are folded downwards toward the
stem when inserted; if not fully extended upon removal, the arms
may become embedded in the myometrium when traction is ap-
plied to the IUD strings. Even if the copper IUD arms are fully ex-
tended, removal of the copper T requires that the arms fold up in
the opposite direction, which might increase the risk of breakage
as compared to hormonal IUDs where the arms are folded up and
away from the stem during both insertion and removal.
Regarding patient level characteristics, the clinical significance
of an approximately 2 kg difference between the median weight
of users reporting breaks versus other adverse events is unclear.
However, the difference in median user age of 4 years at the time
of report may represent a difference in the length of time the
IUD remained in utero and its associated device integrity; unfortu-
nately, the FAERS did not capture the length of time the IUD was
in place. Interpretation of these data are limited as they were the
only two patient demographics available and were reported in only
a subset of the data.
Within our data set, we had approximately 17,0 0 0 adverse
events of which roughly 43,0 0 0 (25.4%) were for copper IUDs and
approximately 127,0 0 0 (74.6%) were for hormonal IUDs. To put this
difference into context, our review of National Survey for Family
Growth data from 2017 to 2019 found similar proportions with
21.4% of IUD users using a copper IUD and 78.2% using a hormonal
IUD [10]. This suggests proportions of adverse events by IUD type
in the FAERS are similar to proportion of use.
The limitations of the FAERS and its voluntarily populated data
prevent estimation of the true incidence of IUD breakage as the ac-
tual number of IUDs in use is not factored into the disproportion-
ality analysis. Additionally, there were notably more adverse event
reports for hormonal IUDs and therefore the calculated proportions

2
K.R. Latack and B.T. Nguyen
Fig. 1. Total number of breakage reports since 20 0 0 for copper versus hormonal IUDs. Due to date of data extraction, reports from 2021 may be limited and still continued
to be reported during 2022. IUDs = intrauterine devices.
may also be diluted if there exists a common adverse event for
hormonal IUDs but not for copper. There is also a lack of clini-
cal information within this database. For these reasons, this analy-
sis serves to be hypothesis generating. Nevertheless, while adverse
events are under-reported in public surveillance systems [11], the
temporal trends for and associations with IUD breakage from this
analysis are reliable, as breakage is a discrete, well-defined event,
contributed primarily by clinicians in the FAERS. Additionally, these
results only apply to individuals with a T380A IUD, the only avail-
able copper IUD in the United States.
This analysis of IUD-related adverse events in a public pharma-
covigilance database found increasing reports of IUD breakage over
time for both copper and hormonal IUDs, with disproportionately
more breakage reports identified for copper versus hormonal IUDs,
as well as older age and heavier weight individuals. Future stud-
ies should examine patient-related and mechanical factors that can
account for these differences.
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