Mirena is an intrauterine device (IUD) which is designed in a ‘T’ shape and is very small. The device is placed into the uterus during an office visit by a trained healthcare provider. Putting the device in place takes only a few minutes, and is reversible, so you can change your mind about this contraceptive at any time and have it taken out.
How Does Mirena Work?
The small IUD, Mirena, releases a small amount of the progestin hormone known as levonorgestrel into the uterus. The release of the hormone creates a thickened mucus in the cervix, which stops the sperm from reaching or fertilizing a woman's egg. It also partially controls ovulation by making the lining of the uterus thinner. This device will prevent pregnancy for up to five years after it has been inserted.
Why Do Women Choose Mirena?
The IUD, Mirena, is an effective long-term contraceptive, which can be used by premenopausal women of all ages. Teenagers can also use this device. This small device offers women several benefits:
- There is no need to ask or require partner participation in controlling pregnancy
- There is no interruption during a sexual encounter to stop and apply another form of birth control
- The device stays in place for five years, so reinsertion is not necessary on a monthly or weekly basis
- The device does not have to remain in place, and the woman can choose at any time to have it removed, and she then returns to normal fertility
- Women can use this device while breastfeeding, although some doctors recommend reinsertion or having a new one placed six to eight weeks after giving birth as it can increase the risk of damaging the uterus during its placement
- There are no side effects associated with Mirena like there are with birth control methods containing estrogen
Twenty percent of the women who have used Mirena reported their menstrual bleeding decreased after using the device for three months or more. Other decreases associated with the use of this small IUD include:
- Pain or cramps associated with menstrual cycles and the abnormal growth of uterine lining tissue outside of the uterus
- Pelvic infections
- Endometrial cancer
These benefits make the contraceptive Mirena a good solution for women who:
- Experience heavy menstrual bleeding
- Suffer from endometriosis
- Have experienced the growth of the lining in the uterus or endometrial hyperplasia
- Have developed the growth of uterine lining tissue of the muscular wall in the uterus
- Suffer from fibroids
- Have developed anemia
Mirena is not a choice for everyone. You should talk with your physician about all possible alternatives for a contraceptive.
Who Should Not Use Mirena?
Women with these conditions should not use the contraceptive Mirena:
- If you have cervical or uterine cancer
- If you have breast cancer or have ever had it
- Unexplained vaginal bleeding
- Abnormalities such as fibroid or others that will interfere with Mirena’s placement
- If you have a pelvic infection or pelvic inflammatory disease
- If you have liver disease
Always talk with your physician when beginning any new contraceptive method about possible risks and side effects. You should also make sure they know all medications you are taking, including supplements that are not prescription. Your physician should know if you have diabetes, high blood pressure, migraines, heart conditions, or if you have ever had a heart attack. The physician should also know if you suffer from a blood-clotting problem or if you’ve had a stroke, have recently given birth, or are breastfeeding your baby.
Risks Involved with Taking Mirena
There is less than a one-percent risk of becoming pregnant by women who use Mirena in a year of typical use. If one should become pregnant while this device is implanted, it is likely the pregnancy will be ectopic. This type of pregnancy is when the fertilized egg attaches outside the uterus, typically inside the fallopian tube. Since Mirena is contraceptive and is intended to prevent pregnancy, women using this device are at a lower risk of having an ectopic pregnancy than are other sexually active women not using the device.
While Mirena is intended to prevent pregnancy, there are conditions it cannot prevent:
- The Mirena device cannot protect against sexually transmitted diseases
- When implanting the Mirena device, it is possible to perforate the uterus. Perforation is a higher risk when inserted during the postpartum period.
Side effects associated with the Mirena device include:
- Mood changes
- Cramping in the pelvic area
- Breast tenderness
- Irregular bleeding which is usually controlled after six months following insertion
The Mirena device can expel from your uterus. Risk of the device expelling increase when:
- You have a prolonged or heavy menstrual cycle
- You are under the age of twenty
- If you have had a previous expulsion of the IUD
- If you have had the device inserted immediately after childbirth
- You have severe menstrual pain
- If you have never been pregnant
This device should be removed if:
- You develop inflammation of the endometrium
- Experience pain in the pelvic area during sex
- You develop severe migraines
- You experience a significant increase in blood pressure or have suffered a heart attack or stroke
- If you have had a possible exposure to an STI
- If you develop a pelvic infection
- If you are suffering from endometrial or cervical cancer
How a Woman Prepares for a Mirena Insertion
Before receiving a Mirena insertion, your physician will evaluate your overall health, and perform a pelvic exam, and some may want to screen for STIs before inserting the device. Mirena can be installed anytime during your menstrual cycle, as long as you are not pregnant. The device can be installed immediately after a pregnancy has been terminated.
STIs, or sexually transmitted infections, or STD (sexually transmitted diseases) are transferred from one person to another during sexual interaction. These infections are passed between sexual partners from vaginal, oral, or anal sex. They spread when one has unprotected sex with an infected partner.
The device can also be inserted after delivering a baby vaginally or by cesarean section, although it is not recommended to place the device until six to eight weeks after the delivery. If the device is put into place more than seven days after the beginning of your menstrual cycle, you should be sure to use backup contraception for one week.
When getting ready to have the device inserted, it is suggested you take ibuprofen one to two hours before the procedure to help reduce cramping.
How the Mirena Device is Inserted
Your doctor or healthcare provider will use a speculum inserted into your vagina and then clean both the vagina and cervix with an antiseptic solution. There may be a need for special instruments to align your cervical canal and uterine cavity gently. The depth of the uterine cavity is also measured during this step.
Your doctor will fold the Mirena’s horizontal arms and place the device into an applicator tube. The doctor will take the tube and insert it into your cervical canal, and the Mirena device is then carefully placed in your uterus. The applicator tube is removed, and the device stays in place.
The doctor will then trim the strings on the Mirena, so they do not protrude too far into the vagina and records their length. During this procedure, patients have reported feeling dizziness, cramping, fainting, and a slower than average heart rate.
Once Mirena is in Inserted
Once a month the strings on the Mirena, which are protruding from the cervix, should be checked to ensure they are still where placed following the insertion. Your doctor may want to check the insert about one month after the procedure to make sure there are no signs of infection.
If while having the device in place you experience any of these symptoms, you should contact your healthcare provider immediately:
- Notice an unusual or foul-smelling vaginal discharge, sores, or lesions
- Have been exposed to an STI
- Think you might be pregnant
- Cannot feel the strings from the Mirena or feel they have gotten longer
- Develop severe headaches or migraines
- Notice your skin or eyes beginning to look yellowish
- Have heavy and persistent vaginal bleeding
- Experience abdominal pain during sex
- Develop an unexplained fever
If at any time you feel the device is no longer in place, you have to contact your healthcare physician immediately.
Removing the Mirena Device
The Mirena device can stay in place for up to five years. Your physician will most likely use forceps to grasp the strings on the Mirena and gently pull it out when the time is up, or you request removal earlier. The arms on the device fold upward when it is withdrawn from the uterus. There may be some cramping and light bleeding after and during the removal.
FDA and Mirena
The contraceptive device Mirena has several warning issued by the FDA regarding its effectiveness, long-term use, and insertion:
- If pregnancy occurs
Mirena FDA warnings state should a woman become pregnant with the device inserted; they should immediately have it removed. The device can cause loss of the pregnancy. Almost half of all pregnancies occurring while the Mirena device was inserted ended in ectopic pregnancies.
- Long-term use causes anomalies
Long term use of the Mirena device can cause congenital disabilities. Specifically, Mirena has shown to cause masculinization of the female genitalia in fetuses. This anomaly can occur even after the mother removes the device.
- Congenital Anomalies
Congenital anomalies are also called birth defects, congenital malformations, or congenital disorders. These anomalies are structural or functional disorders occurring during intrauterine life and are identified prenatally, when a child is born, or later on in life. These anomalies are caused by single gene defects, multifactorial inheritance, environmental teratogens, chromosomal disorders, or micronutrient deficiencies.
The term masculinization is the biological development of sex differences. It involves the changes that make a male body different from the female body.
- Unintended positioning when embedded
The embedment or positioning of this IUD device can occur in the uterine wall. The FDA warns that this decreases the effectiveness of this contraceptive and makes it difficult to remove when the patient has reached the five-year life span of the device or chooses to have it removed early. When the device is embedded into the wall of the uterus, it also increases the patient's chances of becoming pregnant.
- Perforation of the uterine wall
The Mirena IUD device may perforate the uterine wall or the cervix when inserted. Women who were lactating showed an increased risk of the Mirena device perforating their uterine wall. The FDA warns there have been cases of the Mirena device migrating outside the patient’s uterine cavity and results in having to remove the device prematurely as it increases the chances of pregnancy when this happens.
- Complete or partial expulsion of the device
The Mirena has been known to partially or entirely remove itself from the woman’s body. When this occurs, there is pain and bleeding. A sign of the device expulsion would be an increased menstrual flow as the device typically decreases the flow when properly inserted. The FDA warns if the device has wholly or partially expelled, the chances of pregnancy have increased.
- Mirena and ovarian cysts
The FDA warns women that symptoms of ovarian cysts are not always able to be detected. Patients using the Mirena device may experience dyspareunia or pelvic pain if they do develop while using Mirena. Dyspareunia is painful sexual intercourse that can happen from psychological or medical conditions.
- Breast cancer and Mirena
The FDA reminds and warns women that Mirena is a hormonal contraceptive. If a woman currently has breast cancer or has previously battled breast cancer, she should not use this device. Breast cancer is a hormone-sensitive tumor.
- Sepsis and Mirena
Reports have been made that severe pain occurred within hours of the Mirena device being implanted. The FDA warns there are medical reports that this led to sepsis, a dangerous infection that has been known to occur within a matter of days after the device was inserted.
Sepsis is a serious infection that results from the presence of dangerous microorganisms in the tissue or blood. The body’s response to their presence is a pain, and this infection can lead to malfunctioning organs, shock, and even death.
- False claims regarding Mirena
The HHS (Department of Health and Human Services) released a letter in 2009 regarding Mirena’s promotional material. The material suggested that Mirena would add ‘intimacy’ and ‘simplicity’ to sexual relationships. This idea did not coincide with what the product’s label stated:
Mirena’s labeling on the product said more than five percent of patients experience these symptoms after insertion of the device:
- Decreased libido
- Pelvic or abdominal pain
A researcher with the FDA found the claims by Mirena suggested that users of the device would ‘look and feel great’ were wrong. This statement by Mirena was incorrect and was made apparent when the side effects of the product were disclosed:
- Irregular bleeding
- Weight increase
- Breast pain
- Ovarian cysts
- Back pain
Another false claim uncovered was Mirena claimed that the use of their device eliminated ‘monthly’ routines. This statement is also incorrect as patients are required to check the threads each month to verify they are still attached properly.
Lawsuits Against Mirena
Mirena received it’s FDA approval in 2000 as a contraceptive. It was declared to be a highly innovative form of birth control, but since has caused thousands of life-threatening complications for women. Some of these complications arose from uterine perforation, device migration, and ectopic pregnancies.
- Ectopic Pregnancy
An extrauterine, or ectopic pregnancy occurs when the fertilized egg attaches itself to somewhere other than inside the uterus. Most of these pregnancies occur inside the fallopian tube and are often known as tubal pregnancies. The fallopian tubes cannot hold an embryo. Therefore the fertilized egg cannot develop and must be removed.
When an ectopic pregnancy occurs, women often experience stabbing or sharp pains in the pelvic area, abdomen, and sometimes in their shoulders and necks as the blood from a ruptured ectopic pregnancy gathers under the diaphragm. This pain is often accompanied by vaginal bleeding, gastrointestinal symptoms, fainting, dizziness, and weakness.
While Mirena has effectively helped women prevent pregnancy, it has also caused some severe side effects that victims are seeking justice and compensation from this pharmaceutical company.
One of the most significant issues involved with the thousands of lawsuits filed against this company is their failure to warn women of the potential dangers involved having the device inserted. Victims believe the company knew there were design flaws that led to the device malfunctioning, yet continued to market their faulty medical device. Some of the different lawsuits involving the device include:
- Device migration
The company states that the only way the device can migrate is if the physician has implanted it incorrectly. Patients who have the device migrate after years of being implanted disagree with this statement and are seeking compensation.
One case shows a woman who’s device had spontaneously migrated needed to have the device surgically removed. The surgery was unsuccessful as the IUD had moved all the way into her abdominal cavity. A second surgery was necessary to remove the device.
Another example of a claim against the company involves Bayer Pharmaceuticals being guilty of fraud, failure to warn, and negligent misrepresentation of the dangerous side effects of the device. Severe abdominal pain and cramping were occurring within the first year after implantation and showed the device had migrated into a woman’s fallopian tube. The migration resulted in two surgeries to remove the device and severe infection.
Bayer Pharmaceuticals, the manufacturers of Mirena, has a long history of questionable conduct. In 2009, they were warned by the FDA that their TV commercials were misleading women as well as their internet advertisements.
The Mirena prescribing information states the device should be used with caution if a patient has a focal migraine connected with asymmetrical visual loss, migraine or other symptoms that would lead to a condition known as transient cerebral ischemia. This warning tells patients there is a possibility of an ischemic stroke, which would send a blood clot into the brain. What the warning from Mirena does not say is that there is the chance of idiopathic intracranial hypertension. Victims are claiming Bayer was negligent as they did not warn about these conditions they were aware of which resulted in injuries to women.
- Idiopathic Intracranial Hypertension
Idiopathic intracranial hypertension is when a person has the symptoms of a brain tumor, but there is no actual tumor. This disease arises spontaneously within the skull. Symptoms of this condition include brief blindness, visual loss, the ringing of the ears, headaches, the unusual beating of the heart. Most times, the eye problems are connected to a swelling of the optic nerve caused by increased blood pressure in the skull. These symptoms can turn into permanent conditions even after the cause for the condition is removed.
Mirena Mass Tort
A Federal Judicial Panel on Multidistrict Litigation was granted on the lawsuits surrounding Mirena manufactured by Bayer Pharmaceuticals. It was created to centralize all of the hypertension lawsuits into a single federal court. This type of centralization is typical when nationwide drug lawsuits are filed. The court will consider scientific arguments for the Mirena lawsuits and evidence of Bayer’s guilt in these cases.
A separate Multidistrict Litigation, mass tort, was filed on behalf of women across the country claiming Minera poked a hole through an organ. These patients have suffered from migration or the device causing organ perforation, which leads to serious injuries and infections, causing women to require surgery, often multiple surgeries to remove the device from where it traveled to in their bodies. Some of these cases were dismissed; however, attorneys for the plaintiffs appealed the dismissal to the Court of Appeals in the United States. Some of the lawsuits were resolved, and one remains open.
Find a Mass Tort Against The Mirena Implant Near Me
Mirena has resulted in severe side effects, some of which have altered women’s life or cost thousands to fix. If you are one of the women who has suffered from the implantation of a Mirena IUD, contact Consumer Alert Now- 800-511-0747 today. Thousands have experienced dangerous and painful side effects from the implanted Mirena device, so know that you are not alone. We can review your information and determine if there is help for you to receive the justice and compensation you deserve.