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Mirena IUD Hormone Releasing Birth Control Device

The Mirena injury attorneys at the Drug Law Center are currently accepting cases where patients suffered injuries caused by the hormone-releasing birth control device.

Introduction

Mirena IUD Hormone Releasing Birth Control Device RecallMirena is a popular IUD (intrauterine device) that contains the female hormone levonorgestrel that causes significant changes in the uterine lining and cervical mucus. These changes make it a challenge for sperm to reach the uterus, which lowers the potential of egg fertilization. The levonorgestrel progestin (without estrogen) hormone is slowly released in the plastic intrauterine device after it is placed in the uterus. The Mirena is designed to prevent pregnancy for five years. The intrauterine device was developed for women but already given birth to at least one newborn. It is also effective as an intrauterine birth control for women with heavy menstrual bleeding.

The History of Mirena

German-owned Bayer AG, a subsidiary of Bayer Pharmaceuticals, created, manufactures, and markets the Mirena IUD. The US Food and Drug Administration approved the device in 2000 as a hormone-releasing birth control device. Additionally, more than 2 million women have been using the IUD in Europe for well over a decade. The small, flexible device must be inserted into the patient’s uterus by a doctor or other trained healthcare professionals.

The Director of the Food and Drug Administration Office of Women’s Health, Dr. Kathleen Uhl stated that menstrual “bleeding can be so heavy that women must miss work, school, or social activities. Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening.” The FDA approved the levonorgestrel intrauterine device as an effective birth control device for women with heavy menstrual bleeding to prevent pregnancy.

How Mirena Works

Like many intrauterine devices, the Mirena is a T-shaped IUD that must be inserted into the patient’s uterus through the vagina by a trained healthcare provider. The timing of insertion usually occurs within seven days after her menstrual cycle starts. Patients often feel dizzy or mild pain when the device is being inserted. Vaginal bleeding might also occur. Common painful and uncomfortable symptoms associated with the device’s insertion usually subside after thirty minutes. If the device is inserted and positioned properly, it does not interfere with sexual intercourse activity, when using vaginal medications, or wearing tampons.

Placement of the device can be detected by inserting clean fingers into the vagina to feel the device’s removal strings. An unexpected increase in the flow menstrual blood may be an indicator that the IUD is no longer in its original position. If the strings cannot be detected, it is important to call a doctor right away because the IUD might have migrated from the uterus or slipped into a lower position.

The Mirena device is not permanent and is designed to last up to five years and can be removed by the doctor at any time the patient decides birth control is no longer necessary. The device can only be removed by a licensed trained healthcare professional.

Mirena Side Effects

Many women experience side effects when the intrauterine device is inserted. Some of these effects include pale skin, sweating, cramping, dizziness, fast heartbeat, fainting, and bleeding. It is important to discuss these symptoms with the doctor if symptoms are severe or last 30 minutes or longer.

Common Mirena side effects include:

  • Bloating
  • Nervousness
  • Any
  • Tender breasts
  • Hair loss
  • Acting
  • Pain and cramping during menstruation
  • Unwanted hair growth
  • Diminished libido (lower sex drive)
  • Nausea

Some women have experienced excessive weight gain after their Mirena intrauterine device was inserted. Doctors and researchers believe some weight gain with intrauterine devices occur because some IUDs contain female hormones like estrogen. However, the Mirena device contains only progestin hormone and not estrogen.

Serious side effects caused by Mirena over short and long-term use could cause serious problems. The severe effects include:

  • Pelvic infections
  • Vaginal bleeding
  • Cervix or uterus issues
  • Liver disease
  • Liver tumors
  • Uterine cancer
  • Weakened immune system
  • Fever or chills
  • Pain during intercourse
  • Heavy or long-lasting bleeding
  • Abdominal pain
  • Some numbing on one side of the body
  • Swelling of the feet, arms, hands, or legs
  • Pressing shoulder or chest pain
  • Difficulty in understanding or speaking
  • Sudden weakness in the leg or arm
  • Jaundice symptoms including the yellowing of eyes or skin

Interactions with the Mirena intrauterine device

Before a Mirena IUD can be prescribed, the doctor must understand all the medications, over-the-counter drugs, prescription meds, recreational and illegal drugs, dietary supplements, herbal remedies, and other medications the patient is taking. Common interactions with the Mirena device include:

  • Blood thinners (anticoagulants) including warfarin (Coumadin, Jantoven), apixaban (Eliquis), and rivaroxaban (Xarelto).
  • Dilantin (phenytoin)
  • Tegretol, Equetro, and Carbatrol (carbamazepine)
  • Tracleer (bosentan)
  • Felbatol (felbamate)
  • Trileptal (oxcarbazepine)
  • Rifampin (rifater, rifamate, rimactane, and rifadin)
  • HIV infection and AIDS medications
  • Griseofulvin (Gris-PEG, Grifulvin V)
  • Steroid medication including dexamethasone (Decadron), prednisone (Orasone, Deltasone, Cortan), Topamax (topiramate)
  • Barbiturates including phenobarbital (Solfoton, Luminal) and pentobarbital (Nembutal)
  • John’s wort

Complications can be minimized if the patient avoids multiple sexual partners. This is because IUDs already increase the potential of developing serious public infections that could be exacerbated by a sexually-transmitted disease.

Mirena Embedment Problems

Many plaintiffs filing Mirena lawsuits have claimed they have suffered serious complications that require medical attention. Migration and embedment can occur when the device moves from its original position and relocate it to other areas of the uterus or perforate (puncture) the uterine wall. A migrating device could diminish the birth control characteristics of the IUD and cause an environment for pregnancy to occur from intercourse.

In some cases, the perforation of the device through the uterine wall was not immediately detected or treated allowing the device to migrate further outside the uterus. Many women have had serious damage to other organs due to Mirena perforation. Perforated organs could include damage to the intestines, intestinal obstructions, abscesses, infections, and other serious, and sometimes life-threatening, complications. Typically, these complications require surgery to repair or treat.

Complications Including Ectopic Pregnancy

Even though the Mirena device is designed to prevent pregnancy, the development of complications including migration, embedment perforation can cause significant injuries to the consumer. Research data indicates that fifty percent of all pregnancies occurring in women using the Mirena device are ectopic. This means that fertilization of the egg and its implantation occurs in the fallopian tubes instead of implanting in the uterus. Ectopic pregnancies can be life-threatening to the mother and usually require surgery to ensure that the fertilized egg is removed safely.

Even non-act topic pregnancies occurring in the woman is using a Mirena device could cause potentially serious complications. The device should never be used during pregnancy and instead be immediately removed. Allowing the Mirena device to remain in place during pregnancy could cause a life-threatening septic abortion caused by an infected uterus. Mirena device pregnancies can also cause a miscarriage or premature delivery.

Mirena Recall

In 2009, a warning was issued to Bayer Pharmaceuticals by the Food and Drug Administration of their concerns of Mirena advertising. The FDA claimed that the company was making false claims stating that the IUD was a “low-hormone” device.

Mirena Lawsuits

Since the initial approval of the IUD by the Food and Drug Administration in 2000, many women have experienced painful side effects, device expulsion, uterine perforation, and other serious side effects. This is led to the filing of thousands of Mirena lawsuits from injured victims who are attempting to hold Bayer Pharmaceuticals financially responsible for the damages their IUD device has caused.

  • April 2012 – An Ohio plaintiff filed the first Mirena IUD lawsuit claiming that she had to undergo a hysteroscopy to have the device removed. At that time, over two million American women were using Mirena, meaning that many more complaints and lawsuits would be filed in the months and years ahead.
  • January 2013 – A Kentucky woman filed a Mirena IUD lawsuit against bear pharmaceuticals alleging she suffered a spontaneous perforation of her uterus that required surgical removal of the device.
  • December 2012 – Bayer Pharmaceuticals was facing another Mirena lawsuit, this time filed by a Florida woman who claimed that her intrauterine device migrated from its inserted position before perforating her uterus. The plaintiff claims she had to undergo surgery to remove the levonorgestrel intrauterine device.
  • January 2013 – US Judicial Panel on Multi-District Litigation (JPML) accepted for the filed motion in an Ohio federal court to consolidate thousands of plaintiff complaints and Mirena IUD lawsuits.

Plaintiffs are alleging that the pharmaceutical manufacturer was negligent, committed fraud and breach their duty to protect the consumer against the harmful defects of their IUD product. Common allegations made in most Mirena lawsuits include:

  • There was a failure to adequately warn patients, doctors, the public and the medical community about concerns and potential risks associated with the Mirena IUD.
  • The pharmaceutical company misled the public by making false statements when advertising and marketing their IUD device.
  • The company failed to perform sufficient research and document known side effects associated with Mirena.
  • The company failed to provide updated warnings or recall the Mirena device once information and facts concerning defects, side effects and adverse events were discovered after women experience them worldwide.

Let Us Resolve Your Mirena Injury Compensation Lawsuit

Many women who suffer serious Mirena side effects are injured because Bayer Pharmaceuticals promised to improve their lifestyle but failed to disclose the potentially serious risks of using the contraception device. The Mirena injury attorneys at the Drug Law Center are currently accepting product liability cases to ensure that Bayer is held financially responsible for its deception and concealment of known defects.

Our law firm is currently reviewing evolving developments in Mirena class-action lawsuits for patients who have experienced complications and serious medical problems from using a Mirena IUD. We build solid cases with provable evidence to ensure adequate financial compensation is obtained for our clients. Our lawyers prove the client’s cases by showing evidence that misleading and false promotional statements and the concealment of known defects caused unnecessary exposure to the risk of serious injuries. Our suits are based on the knowledge that Bayer Pharmaceuticals knew or should have known of the risks and dangers concerning their reversible birth control device.

If you, or a loved one, have suffered a serious side effect, ectopic pregnancy, uterine perforation, infection, or other serious complication including breast cancer after using a Mirena device, we can protect your legal rights to obtain compensation. Contact us today to schedule a complimentary case evaluation to discuss the merits of your case. We can begin your legal representation immediately to ensure that your case is successfully resolved and your family receives the monetary compensation they deserve.

To minimize your financial burden, our product liability injury law firm will postpone payment of our legal services. We guarantee that if we do not win your case at trial or negotiate an acceptable out-of-court settlement on your behalf, we do not get paid. All information you share with our law offices will always remain confidential.

Sources:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf

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