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WARNING
RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION
Miudella (copper intrauterine system) contains 99.99% pure copper for use as a contraceptive. Copper (Cu) has a molecular weight of 63.546 g/mol. Miudella consists of ten copper sleeves attached to a flexible nitinol (nickel-titanium alloy) frame measuring 32 mm horizontally and 30 mm vertically, and a polypropylene monofilament retrieval thread tied to the vertical stem. Miudella has a total exposed copper surface area of 175 mm2 and is provided sterile and preloaded in an inserter.
Figure C: Diagram of Miudella
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The inserter device provided with Miudella is a single use, disposable, sterile insertion system (insertion tube with a tapered rounded tip, depth markings and flange, and handle with slider and endcap); preloaded with the IUS for intrauterine administration. Once Miudella has been inserted, the inserter is discarded.
Figure D: Diagram of Inserter
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Miudella is indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.
Figure A: Miudella Intrauterine System (IUS) Preloaded Inserter
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Figure B: Detailed diagram of Miudella
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Table 1: Recommended Timing of Miudella Insertion
| Clinical Scenario | Recommended Timing of Miudella Insertion |
| 1. Start Miudella in females not currently using contraception | At any time during the menstrual cycle. |
| 2. Switch to Miudella from an oral, transdermal, or vaginal form ofhormonal contraception or an injectable progestin contraceptive | At any time during the menstrual cycle; discontinue the previous method. |
| 3. Switch to Miudella from a contraceptive implant or other intrauterinesystem | Same day the implant or IUS is removed (insert at any time during the menstrual cycle). |
Step 1 - Open the Sterile Package
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Step 2 - Setting the Flange
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Step 3 - Inserter Placement
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Step 4 -Miudella Placement
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Do not cut the white release thread.
The length of the release thread is approximately twice the length of the inserter.
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Step 5 - Confirm the Retrieval Thread Ends
Important information to consider during and after placement:
Intrauterine system: 175 mm2 exposed copper surface area. Miudella is a copper-containing IUS that has a flexible nitinol frame with copper sleeves and monofilament polymer retrieval thread, preloaded in a sterile inserter with a tapered rounded tip and packaged in a sealed tray with lid.
Miudella (copper intrauterine system) is a copper-containing sterile IUS preloaded in a single use inserter. Each single-use unit is packaged in a sealed tray with lid (NDC-82686-300-01). The IUS is comprised of a nitinol frame with 10 copper sleeves attached to provide a total copper surface area of 175mm2, and a monofilament polymer retrieval thread tied to the vertical arm.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Manufactured for: Sebela Women’s Health Inc. Roswell, GA 30076. Revised: Feb 2025.
The following serious adverse reactions are discussed elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure of 1,904 healthy 17- to 45-year-old women (mean age 27.5 ± 5.72 years) to Miudella. These data come from two multi-center contraceptive trials with a 3-year duration and a single, multi-center comparative bioavailability study with a 3 year duration, all conducted in the United States, enrolling generally healthy, postmenarcheal females to 45 years old. In total 1,904 subjects were exposed to Miudella for one year and 916 completed three years. The data in these trials cover approximately 51,692 cycles of exposure.
The following adverse reactions have been observed in ≥5% of users in clinical trials with Miudella: heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, and dyspareunia.
Table 2 shows discontinuation rates from the 3 multi-center clinical studies by adverse reaction and year.
Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation
| Year | |||
| 1 | 2 | 3 | |
| Number of Women at Start of Year | 1,904 | 1,463 | 1,118 |
| Bleeding/Paina | 8.5 | 5.1 | 3.2 |
| Expulsion | 1.9 | 1.0 | 0.9 |
| Other Medical Eventb | 0.2 | 0.1 | 0.3 |
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*Rates were calculated by weighting the annual rates by the number of subjects starting each year. a Bleeding/Pain includes the preferred terms (PTs) Abdominal pain, Abdominal pain lower, Post procedural discomfort, Procedural pain, Coital bleeding, Dysmenorrhea, Dyspareunia, Heavy menstrual bleeding, Intermenstrual bleeding, Menometrorrhagia, Pelvic discomfort, Pelvic pain, Polymenorrhea, Uterine hemorrhage, Uterine spasm b Includes PTs embedded device (n=6) and uterine perforation (n=1) |
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According to the safety analyses of these three studies, it was determined the incidence of expulsion of Miudella did not vary significantly by body mass index (BMI). There was no statistically significant difference in the incidence of expulsion of Miudella in normal weight versus obese females.
No Information Provided
Included as part of the "PRECAUTIONS" Section
Improper insertion of intrauterine systems, including Miudella, increases the risk of perforation, infection, undiagnosed abnormal bleeding, pregnancy loss (if pregnancy occurs with IUS in situ), and expulsion.
Proper training prior to first use of Miudella can minimize the risk of improper insertion. Miudella is available only through a restricted program under a REMS [see Miudella REMS].
Miudella is only available through a restricted program under a REMS called Miudella REMS Program to ensure healthcare providers are trained prior to first use [see Risk Of Complications Due To Improper Insertion]. Notable requirements include the following:
Further information is available at miudellarems.com and 1-855-337-0772.
Evaluate for possible ectopic pregnancy in any female who becomes pregnant while using Miudella because a pregnancy that occurs with Miudella in place is more likely to be ectopic than a pregnancy in the general population. However, because Miudella prevents most pregnancies, females who use Miudella have a lower risk of an ectopic pregnancy than sexually active females who do not use any contraception.
The incidence of ectopic pregnancy in the clinical trials with Miudella was approximately 0.3%. Ectopic pregnancy may require surgery and may result in loss of fertility. Patients who use Miudella should be informed about recognizing the signs and symptoms of ectopic pregnancy and promptly reporting them to their healthcare professional, and about the associated risks of ectopic pregnancy (e.g., loss of fertility).
If intrauterine pregnancy occurs with Miudella in place and the thread ends are visible or can be retrieved from the cervical canal, remove Miudella. Leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Miudella may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Miudella, consider the following:
In females becoming pregnant with an intrauterine system (IUS), including Miudella in place, septic abortion, with septicemia, septic shock, and death, may occur. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility.
If a female becomes pregnant with Miudella in place and if Miudella cannot be removed or the female chooses not to have it removed, warn her that failure to remove Miudella increases the risk of miscarriage, sepsis, premature labor, and premature delivery. Prenatal care should include counseling about these risks and that she should report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid, or any other symptom that suggests complications of the pregnancy.
Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of IUSs. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion of Miudella is essential to minimize serious infections such as GAS.
Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Remove Miudella in cases of recurrent pelvic inflammatory disease or endometritis, or if an acute pelvic infection is severe or does not respond to treatment.
Miudella is contraindicated in the presence of known or suspected PID or endometritis [see CONTRAINDICATIONS]. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion.
Females at increased risk for PID
PID is often associated with a sexually transmitted infection (STI), and Miudella does not protect against STI. The risk of PID is greater for females who have multiple sexual partners, and also for females whose sexual partner(s) have multiple sexual partners. Females who have had PID are at increased risk for a recurrence or re-infection. In particular, ascertain whether the female is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome [AIDS], intravenous drug abuse).
Subclinical PID
PID may be asymptomatic but still result in tubal damage and its sequelae.
Treatment of PID
Following a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained and antibiotic therapy should be initiated promptly. Removal of Miudella after initiation of antibiotic therapy is appropriate in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment.
Actinomycosis has been associated with IUS use. Symptomatic patients with known actinomycosis infection should have Miudella removed and receive antibiotics. Actinomycetes can be found in the genital tract cultures in healthy patients without IUSs. The significance of actinomyces-like organisms on Pap test in an asymptomatic IUS user is unknown, and so this finding alone does not always require Miudella removal and treatment. When possible, confirm a Pap test diagnosis with cultures.
Partial or total perforation of the uterine wall or cervix may occur during insertions, although the perforation may not be detected until sometime later. Perforation may also occur at any time during IUS use. Perforation that results in embedment or translocation may reduce contraceptive efficacy and result in pregnancy. The incidence of perforation during or following Miudella insertion in clinical trials was 0.1% (2 out of 1904).
A post-marketing safety study conducted in Europe (EURAS IUS) with IUSs, including copper IUSs, demonstrated an increased risk of perforation in postpartum and lactating women. The risk of perforation may be increased if an IUS, such as Miudella, is inserted when the uterus is fixed, retroverted or not completely involuted during the postpartum period.
If perforation is suspected or if known perforation occurs during placement, the IUS should be removed as soon as possible. Surgery may be required. Preoperative imaging followed by laparoscopy or laparotomy may be required to remove the IUS from the peritoneal cavity. Delayed detection or removal of Miudella in cases of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal penetration, intestinal obstruction, abscesses and/or damage to adjacent organs.
Partial or complete expulsion of Miudella has been reported, resulting in the loss of contraceptive protection. The incidence of expulsion in the clinical trials with Miudella was 3.6% through 3 years of use. Consider further diagnostic imaging, such as x-ray, to confirm expulsion if the IUS is not found in the uterus on ultrasound.
Miudella should be placed no earlier than 4 weeks post-pregnancy to mitigate the risk of expulsion that may be increased when the uterus is not completely involuted at the time of insertion. Remove a partially expelled Miudella and do not attempt to push a partially expelled Miudella into the uterus. If expulsion has occurred, a new Miudella may be inserted when there is reasonable certainty the patient is not pregnant.
Miudella may exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion; therefore, the use of Miudella is contraindicated in females with Wilson’s disease [see CONTRAINDICATIONS].
Miudella can alter the bleeding pattern and result in heavier and longer menstrual cycles with intermenstrual spotting.In three clinical trials with Miudella [see ADVERSE REACTIONS], menstrual changes were the most common medical reason for discontinuation. Discontinuation rates for pain and bleeding combined were highest in the first year of use and diminished thereafter. The percentage of females who discontinued Miudella because of bleeding problems or pain during this study ranged from 8.5% in the first year to 3.2% in Year 3. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue Miudella [see ADVERSE REACTIONS].
MRI Safety Information MR Conditional |
The Miudella Intrauterine Device (IUD) is MR Conditional. A patient with Miudella may be safely scanned under the following conditions.Failure to follow these conditions may result in injury to the patient. |
| Nominal Values of Static Magnetic Field (T) | 1.5-Tesla or 3.0-Tesla |
| Maximum Spatial Field Gradient | 40 T/m (4,000 gauss/cm) |
| Type of RF Excitation | Circularly Polarized (CP) (i.e., QuadratureTransmission) |
| Transmit RF Coil Information | There are no transmit RF coil restrictions. Accordingly, the following may be used: body transmit RF coil and all other RF coil combinations (i.e., body RF coil combined with any receive-only RF coil, transmit/receive head RF coil, transmit/receive knee RF coil, etc.) |
| Operating Mode | Normal Operating Mode |
| Maximum Whole-Body Averaged SAR | 2 W/kg (Normal Operating Mode) |
| Limits on Scan Duration | 2 W/kg whole body average SAR for 60 minutes of continuous RF exposure (a sequence or back to back sequences/series without breaks) |
| MR Image Artifact | The presence of this implant produces an imaging artifact. In testing with gradient-echo sequencing, the shape of the image artifact follows the approximate contour of the device and extends radially up to 0.7 cm from the device. |
Medical equipment that contains high levels of Radiofrequency (RF) energy such as diathermy may cause health effects (by heating tissue) in females with a metal-containing IUS including Miudella. Avoid using high medical RF transmitter devices in females with Miudella.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Before inserting Miudella, counsel patients on the following:
Advise patients that Miudella does not protect against HIV infection and other sexually transmitted infections.
Advise patients to report pregnancies and be evaluated immediately, as a pregnancy with Miudella in place is more likely to be an ectopic pregnancy, and the risks of ectopic pregnancy include the loss of fertility [see WARNINGS AND PRECAUTIONS].
Advise the patient to contact her healthcare provider if she thinks she might be pregnant. Inform the patient about the risks of intrauterine pregnancy while using Miudella, including the risks of leaving Miudella in place and the risks of removing Miudella or probing of the uterus. An intrauterine pregnancy with Miudella in place may result in septic abortion, with septicemia, septic shock, and possible death. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility.
If Miudella cannot be removed in a pregnant patient and remains in the uterus during a pregnancy, there is an increased risk of miscarriage, sepsis, premature labor and premature delivery. Advise patients that a pregnancy must be followed closely and advise patients to report immediately any symptom, such as flu- like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leaking of fluid, or any other symptom that suggests complications of the pregnancy. [see WARNINGS AND PRECAUTIONS and Use In Special Populations].
Advise the patient that severe infection or sepsis, including Group A streptococcal sepsis (GAS), can occur within the first few days after Miudella is inserted. Instruct her to contact a healthcare provider immediately if she develops severe pain or fever shortly after Miudella is inserted, as untreated sepsis can result in death [see WARNINGS AND PRECAUTIONS].
Advise the patient about the possibility of pelvic infections, including PID, after insertion of Miudella and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. Teach patients to recognize and report to their healthcare provider promptly any symptoms of pelvic infection. These symptoms include development of menstrual disorders (spotting or prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever. [see WARNINGS AND PRECAUTIONS].
Advise the patient that the IUS may be expelled from or perforate the uterus and instruct her on how she can check that the thread ends still protrude from the cervix. Inform her that excessive pain or vaginal bleeding during Miudella placement, worsening pain or bleeding after placement, or the inability to feel Miudella strings may occur with Miudella perforation and expulsion. Caution her not to pull on the thread ends and displace Miudella. Inform her that there is no contraceptive protection if Miudella is displaced (for example, expelled or perforated through the uterus). If perforation resulting in displacement occurs, Miudella will have to be located and removed; surgery may be required. Instruct the patient to contact her healthcare provider if she cannot feel the thread ends and to avoid intercourse or use a non-hormonal back-up birth control (such as condoms or spermicide) until the location of Miudella has been confirmed [see WARNINGS AND PRECAUTIONS].
Advise patients that heavier or longer periods and spotting between periods may occur. Instruct patients to report continued or severe symptoms to their healthcare provider [see WARNINGS AND PRECAUTIONS].
Inform patients that Miudella can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their healthcare provider that they have Miudella. [see WARNINGS AND PRECAUTIONS].
Instruct patients to tell their healthcare provider that they have Miudella prior to undergoing medical diathermy [see WARNINGS AND PRECAUTIONS].
Adequate long-term studies in animals to assess the carcinogenic potential of a copper-containing IUS have not been performed.
A chemical characterization and toxicological risk assessment of the extractables derived from the copper-containing IUS were utilized to address carcinogenicity, mutagenicity and reproductive/developmental toxicity risks. The toxicological risk assessment indicates that the risks of carcinogenicity, mutagenicity and reproductive/developmental toxicity caused by the copper-containing IUS are negligible.
Use of Miudella is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Miudella may cause adverse pregnancy outcomes. If a female becomes pregnant with Miudella in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]. Advise the female of the potential risks if pregnancy occurs with Miudella in place.
Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Miudella and birth defects have not been conducted.
No difference has been detected in concentration of copper in human milk before and after insertion of copper IUSs, such as Miudella. There is no information on the effect of copper in a breastfed child or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Miudella and any potential adverse effects on the breastfed child from Miudella.
In Study 1 (NCT03633799), return to fertility was investigated in a total of 63 women who desired pregnancy after study discontinuation and provided follow-up information. The probability to conceive within 12 months after removal of Miudella was 74.1% [see Clinical Studies].
The safety and effectiveness of Miudella have been established in females of reproductive potential. Efficacy is expected to be the same for postmenarcheal females regardless of age. Miudella is not indicated in females before menarche.
Miudella has not been studied in women over 65 years of age and is not indicated in this population.
No Information Provided
The use of Miudella is contraindicated when one or more of the following conditions exist:
Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of Miudella. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg.
The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Miudella have not been fully characterized.
The pharmacokinetics (PK) of copper following insertion of Miudella were investigated in 20 healthy premenopausal female adult subjects. Table 3 shows PK parameters of serum copper with or without baseline-adjustment following 57 days after insertion, and serum copper concentrations during 3 years after insertion.
Table 3: PK parameters and copper concentrations after Miudella insertion
| Parameters | Mean (standard deviation) | ||
| No adjustment | Baseline-adjusted | ||
| PK parameters | Cmax, Day1-57 (ng/mL) | 1210 (202) | 63.5 (84.1) |
| AUCDay1-57 (day×ng/mL) | 59700 (8310) | 992 (1680) | |
| CYear1 (ng/mL) | 965 (197) | 7.5 (19.4) | |
| C Year2 (ng/mL) | 1020 (168) | 25.7 (48.7) | |
| CYear3 (ng/mL) | 986 (148) | 17.2 (43.0) | |
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Cmax: peak concentration C: concentration AUC: area under the serum concentration-time curve |
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The efficacy of Miudella for the prevention of pregnancy in women of reproductive potential for up to 3 years was demonstrated in Study 1 (NCT03633799), a multi-center, single-arm, open-label study conducted in the U.S. Women were excluded if they were less than six weeks postpartum, had a history of previous IUS complications, were known to be HIV positive, or were otherwise at high risk for sexually transmitted infections. There were no exclusions based on BMI.
Study 1 included 1601 generally healthy women aged 17 to 45 years who had Miudella successfully placed. Of these 60% (960/1601) were nulliparous. Successful placement of Miudella with first attempt occurred in 96% of the subjects and 99% with two insertion attempts by healthcare providers who received training on proper insertion prior to first use. The median age was 27 years, the mean weight was 75.3 kg (range 40.6 kg to 170.1 kg); mean BMI was 27.9 kg/m2 (range 15.8 kg/m2 to 63.5 kg/m2); 74% were White, 15% were Black, 5% were Asian, and 6% were Other; 19% were Hispanic.
The primary endpoint for Study 1 was the contraceptive efficacy of Miudella through 3 years of use as measured by the Pearl Index (PI) in women 17 to 35 years of age. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which no intercourse occurred, or back-up contraception was used unless a pregnancy occurred in that cycle. Women enrolled in the study provided 12,493 evaluable 28-day cycle equivalents in the first year and 27,115 evaluable cycles over the three-year treatment period. The PI for Year 1 was based on 9 pregnancies and the cumulative 3-year pregnancy rate was based on 22 pregnancies that occurred after the onset of treatment and within 7 days after Miudella removal or expulsion.
Table 4 shows the calculated annual pregnancy rates and cumulative 3-year pregnancy rate estimated by Pearl Index.
Table 4: Pearl Indices by Year and 3-Year Cumulative Pregnancy Ratea
| Miudella Clinical Trial | Pearl Index | Cumulative 3-YearPearl Index | ||
| Year 1 | Year 2 | Year 3 | ||
| Number of Evaluable 28-day Cycles of Exposure | 12,493 | 8,150 | 6,472 | 27,115 |
| Pregnancy Rate (95% Confidence Interval) |
0.94 (0.43,1.78) |
1.60 (0.76, 2.93) |
0.60 (0.12, 1.76) |
1.05 (0.66, 1.60) |
| a Of the 22 pregnancies, 2 occurred within 7 days of in-clinic removal of Miudella. | ||||
Of 54 subjects who desired pregnancy after study discontinuation and provided follow-up information, approximately 74.1% conceived within 12 months after removal of Miudella. The majority of these subjects conceived within 4 months of removal and as early as the first week post-removal, demonstrating the reversibility of Miudella.
Miudella®
(mye yoo de' lah)
(intrauterine copper contraceptive)
Miudella® does not protect against human immunodeficiency virus (HIV) or other sexually transmitted infections (STIs).
Read this Patient Information carefully before you decide if Miudella is right for you. This information does not take the place of talking with your health care provider (HCP). If you have any questions about Miudella, ask your health care provider. You also should learn about other birth control methods to choose the one that is best for you.
What is Miudella?
Miudella is a small, flexible, hormone-free intrauterine system with copper attached to a flexible wire frame that allows it to fit different uterus shapes and sizes. The wire frame is made of a material used in many medical products.
Miudella has a thin, soft retrieval thread attached to its base. Once Miudella is placed in your uterus, the thread ends extend into the vagina and can be felt. However, unlike a tampon string, the thread ends do not extend outside of your body.
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What if I need birth control for more than 3 years?
Miudella must be removed at or before 3 years from the date of placement. Your health care provider can place a new Miudella during the same office visit if you choose to continue using Miudella.
What if I want to stop using Miudella?
You can stop using Miudella at any time by asking your health care provider to remove it. Your ability to get pregnant goes back to whatever is normal for you as soon as Miudella is removed; therefore, you should immediately use another birth control method if you do not want to become pregnant. Talk to your health care provider about the best birth control method for you because your new method may need to be started 7 days before Miudella is removed in order to prevent pregnancy.
How does Miudella work?
The copper in Miudella works in the uterus by preventing sperm from reaching the egg, or preventing sperm from fertilizing the egg. Miudella does not stop your ovaries from making an egg (ovulating) each month.
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How well does Miudella work as a birth control method?
The following chart shows the chance of getting pregnant while using different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Miudella, an intrauterine system (IUS), is in the box at the top of the chart.
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Who might use Miudella?
Do not use Miudella if you:
Before having Miudella placed, tell your health care provider if you have:
How is Miudella placed?
Miudella is placed in your uterus during an in-office visit.
First, your health care provider will examine your pelvis to find the exact position of your uterus. Your health care provider will then clean your vagina and cervix with an antiseptic solution and then, measure your uterus. Your health care provider will then slide a slim, tapered plastic tube containing Miudella into your uterus. The tube is removed, leaving Miudella inside your uterus. Two soft thread ends will extend into your vagina. The thread ends are just long enough for you to feel with your fingers when doing a self-check. You may experience pain, bleeding, or dizziness during and after placement. Your health care provider may ask you to lie down until you are feeling better, and to get up slowly. Contact your health care provider if you have prolonged symptoms.
Should I check that Miudella is in place?
Yes, you should check that Miudella is in proper position by feeling the threads. It is a good habit to do this 1 time a month. Your health care provider should teach you how to check that Miudella is in place. First, wash your hands with soap and water. You can check by reaching up to the top of your vagina with clean fingers to feel the 2 thread ends.
Do not pull on the thread ends.
If you feel changes in the length of the thread ends, or you cannot feel them, or you can feel any other part of Miudella other than the thread ends, Miudella may not be in the right position and may not prevent pregnancy. Use back-up birth control (such as condoms and spermicide) and ask your health care provider to check that Miudella is still in the right place.
How soon after placement of Miudella should I return to my health care provider?
Call your health care provider if you have any questions or concerns (see “After Miudella has been placed, when should I call my health care provider?”). Otherwise, you should return to your health care provider for a follow-up visit after your first menses after Miudella is placed to make sure that Miudella is in the right position.
Can I use tampons with Miudella?
Yes, tampons may be used with Miudella.
Can I use a menstrual cup or menstrual disc with Miudella?
Menstrual cups and menstrual discs are not recommended for use with Miudella. Menstrual cup and menstrual disc use may cause Miudella to become displaced or come out.
What if I become pregnant while using Miudella?
Call your health care provider right away if you think you may be pregnant. If you get pregnant while using Miudella, you may have an ectopic pregnancy. This means the pregnancy is not in your uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of an ectopic pregnancy.
Ectopic pregnancy is a medical emergency that requires prompt treatment with surgery or medication. Ectopic pregnancy can cause internal bleeding, infertility and even death.
There are also risks if you get pregnant while using Miudella and the pregnancy is in the uterus. Infection, miscarriage, and premature delivery can occur with pregnancies that continue with an intrauterine system. Because of this, your health care provider may try to remove Miudella, even though removing it may cause a miscarriage. If Miudella cannot be removed, talk with your health care provider about the benefits and risks of continuing the pregnancy.
If you continue your pregnancy, see your health care provider regularly. Call your health care provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina.
These may be signs of infection.
It is not known if Miudella can cause long-term effects on the fetus if it stays in place during a pregnancy.
How will Miudella change my periods?
Your period may become heavier and longer. Sometimes the bleeding is heavier than usual at first then often tapers off over the first few months of use. You may also have spotting between periods.
Is it safe to breastfeed while using Miudella?
You may use Miudella when you are breastfeeding. Miudella is not likely to affect the quality or amount of your breast milk or the health of your nursing baby. The risk of Miudella becoming attached to (embedded) or going through the wall of the uterus is increased if Miudella is placed while you are breastfeeding.
Will Miudella interfere with sexual intercourse?
You and your partner should not feel Miudella during intercourse. Miudella is placed in the uterus, not in the vagina. Sometimes your partner may feel the thread ends. If this occurs, or if you or your partner experience pain during sex, talk with your health care provider.
Can I have an MRI with Miudella in place?
Miudella can be safely scanned with magnetic resonance imaging (MRI) under specific conditions. Before you have an MRI, tell your health care provider that you have Miudella, an intrauterine system (IUS), in place.
Can I have a medical procedure using heat therapy with Miudella in place?
Before you have a medical procedure using heat therapy tell your health care provider that you have Miudella in place.
What are the possible side effects of Miudella?
Miudella can cause serious side effects, including:
Common side effects of Miudella include:
Other common side effects include:
This is not a complete list of possible side effects with Miudella. For more information, ask your health care provider.
Tell your health care provider about any side effect that bothers you or does not go away.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to the manufacturer at 1-866-246-2133.
After Miudella has been placed, when should I call my health care provider?
Call your health care provider if you have any questions or concerns about Miudella.
Be sure to call if you:
General information about the safe and effective use of Miudella. Medicines are sometimes prescribed for conditions that are not mentioned in a Patient Information leaflet. You can ask your health care provider for information about Miudella that is written for health care providers.
For more information, go to www.miudella.com or call 1-866-246-2133
Miudella® is a registered trademark of Sebela Women’s Health Inc. The other brands listed are trademarks of their respective owners.
This Patient Information has been approved by the U.S. Food and Drug Administration.
