Miudella

Miudella is a low-dose copper-releasing intrauterine system (IUS) designed for pregnancy prevention for up to 3 years. This small, flexible, hormone-free birth control device consists of copper attached to a flexible wire frame that allows it to fit various uterus shapes and sizes.

• Effective for 3 years of continuous pregnancy prevention
• Hormone-free contraception alternative
• Reversible birth control solution
• No daily maintenance required
• Suitable for women who have or haven't given birth

The copper component in Miudella works within the uterus by:

• Preventing sperm from reaching the egg
• Preventing fertilization of the egg
• Does not stop monthly ovulation.

Intrauterine systems, such as Miudella, rank among the most effective birth control methods with less than 1 in 100 chance of pregnancy when used correctly.

Miudella is not recommended if you:

• are or might be pregnant; Miudella cannot be used as emergency contraception
• have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
• have a serious pelvic infection called pelvic inflammatory disease (PID)
• have had a serious pelvic infection after pregnancy or an abortion in the past 3 months
• have or suspect you might have cancer of the uterus or cervix
• have unexplained bleeding from your vagina
• have an untreated lower genital infection now in your cervix
• have Wilson’s disease (a disorder in how the body handles copper)
• have an intrauterine system in your uterus already
• are allergic to polypropylene, nickel, titanium, or copper.

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.
• They will then clean your vagina and cervix with an antiseptic solution and measure your uterus.
• Next, they will 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.

You should check that Miudella is in the 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 correct 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.

Common side effects

The most common side effects of Miudella are:

• Pain or bleeding during and after placement
• Changes in menstrual bleeding patterns: Heavier and longer periods Spotting between periods Bleeding usually decreases after the first few months
• Anemia (low red blood cell count)
• Expulsion (complete or partial)
• Pain during sex
• Vaginal irritation and discharge
• Backache
• Pain and cramping

Serious Side Effects

Miudella may cause the following serious side effects:

• Ectopic pregnancy and intrauterine pregnancy risks. There are risks if you become pregnant while using Miudella.
• Risk of life-threatening infection in the first days after placement. Call your health care provider immediately if you develop severe pain or fever shortly after Miudella is placed.
• Pelvic inflammatory disease (PID). Some IUS users may develop a serious pelvic infection called PID, which is usually sexually transmitted. Your risk is higher if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy, and pelvic pain that does not go away. It is usually treated with antibiotics, but more serious cases may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death. Tell your health care provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal stomach area pain, painful sex, chills or fever.
• Perforation (device moving through the uterine wall). Perforation occurs when Miudella becomes embedded in or pierces the uterine wall (1 in 1000 insertions), potentially causing the device to move outside the uterus, no longer prevent pregnancy, and require surgical removal. This complication can lead to internal scarring, infection, organ damage, pain, or infertility, with warning signs including excessive pain or bleeding during/after placement or inability to feel the threads. Perforation risk increases during breastfeeding.
• Expulsion. Miudella may partially or completely come out by itself. This is called expulsion. Expulsion occurs in about 3 out of 100 women. Excessive pain or vaginal bleeding during placement of Miudella, pain or bleeding that gets worse after placement, or not being able to feel the threads may happen with expulsion. You may become pregnant if Miudella comes out. If you think that Miudella has come out, use a backup birth control method like condoms and spermicide and call your health care provider.
• Reactions after placement or removal. Some women have had reactions, such as dizziness (syncope), slowed heart rate (bradycardia), or seizures, immediately after Miudella was placed or removed. These reactions were more common among women who have had these conditions before.

Miudella does not protect against HIV or other sexually transmitted infections (STIs).

For medical advice about side effects, contact your doctor or report side effects to the 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.