New Case Study Highlights Risks of Mirena Side Effects

Wilma Tucker | March 15th, 2013 | Posted in Mirena Lawsuits
 
A recent case study involving Mirena side effects highlights the risks associated with this method of contraception. A 26-year old woman had to have the intrauterine device (IUD) removed from her abdomen after she discovered she was 12 weeks pregnant. The device had migrated outside the uterus, where it remained undetected for a number of years.


Misdiagnosis made due to migration of the device
 
The woman had the device inserted into her uterus nearly four years prior to the pregnancy. After the IUD was implanted, the woman realized the guide strings that indicate the device is in the proper place went missing. Her physician performed an ultrasound, but could was unable to find the Mirena IUD inside her uterus. It was then determined that the device must have fallen out of the woman’s body.
 
Unfortunately, a Mirena uterine perforation had occurred instead, and the device had migrated to another area of the woman’s abdomen. The device went undetected for a number of years, until abdominal pain brought the woman back to her doctor’s office. At this point, the woman had a viable uterine pregnancy, and the decision was made to remove the device surgically to prevent further Mirena side effects and pregnancy complications.

Risk of Mirena uterine perforation higher than indicated

Although the procedure was successful in this case study, even the physicians performing the procedure questioned their decision to remove the device during the woman’s pregnancy. Removal of the IUD carried its own risks, but doctors were also concerned that leaving the device in situ could result in infection or organ injury. Removal could prohibit risks to the fetus and mother from hormones released by the IUD during pregnancy and lower the risk of a septic pregnancy or miscarriage.
 
Despite the risks, doctors treating the patient had no way of knowing for sure if the IUD would actually result in any unwanted side effects during pregnancy. There were also risks involved with the surgery to remove the device, particularly in light of the patient’s current condition. Even after the procedure, doctors involved continue to question whether surgical removal was the most prudent decision at that time.

Mirena IUD injuries not uncommon

This is not the first complication involving a Mirena IUD. The device was approved by the FDA in 2000 as a means of contraception that could last for up to five years. However, reports of Mirena side effects, including migration of the device outside the uterus have been received by the FDA. In some cases, the migration occurred long after the device was inserted, despite product packaging that suggests most migrations occurred during the insertion process.
 
If the IUD migrates outside of the uterus, the woman can experience pain, infection and damage to surrounding organs. The device must be located using ultrasound technology and then surgically removed. Surgical procedures carry their own risks, including infection, pain and organ damage. Some women who have experienced these side effects have been unable to have biological children after the device was removed.
 
Women who become pregnant while the Mirena IUD is inserted face additional risks during pregnancy, including a septic pregnancy, ectopic pregnancy and miscarriage. Ectopic pregnancies occur when the fertilized egg begins development in an area other than the uterus, such as the Fallopian tube. A fetus cannot survive in the case of an ectopic pregnancy, and if the condition is not promptly diagnosed and treated, it can be dangerous for the mother as well. The rate of ectopic pregnancies in women with the Mirena IUD may be as high as 50 percent.
 
Today, injured women are bringing their claims against manufacturer Bayer to courtrooms across the country. These women are alleging Bayer downplayed the potential risk of Mirena uterine perforation while overstating product safety and benefits. Women are seeking compensation from Bayer for medical bills, pain and suffering and lost wages.

One of the most common Mirena Coil side effects is yeast infection. Have you read this? "Yeast Infection No More" by Linda Allen. Linda is an author, researcher, nutritionist and health consultant who dedicated her life to creating the ultimate holistic yeast infection solution guaranteed to permanently cure the root of Candida and dramatically improve the overall quality of your life, naturally, without the use prescription medication and without any side effects. Learn more by visiting her website YeastInfectionNoMore.com

New York Plaintiff Files Mirena IUD Lawsuit

A new Mirena IUD lawsuit was filed on February 21, 2013 against Bayer Pharmaceuticals. The case is currently proceeding in the U.S. District Court in the Southern District of New York. The plaintiffs, Julie Cantor Miller and Jonathan Miller, allege significant Mirena IUD side effects. The plaintiff was diagnosed with uterine perforation.

Mirena, which was designed and manufactured by Bayer, is a hormonal intrauterine device (IUD) that is intended to provide long-term birth control. It is a small, T-shaped plastic device that a doctor inserts into a woman’s uterus. It works by releasing a synthetic progestogen, a hormone, in order to thicken the cervical mucus and inhibit ovulation. Mirena was first approved by the FDA in 2000, and has since been used by more than 15 million women. However, a growing number of adverse events have been reported by women using the device.

Plaintiff suffers alleged Mirena uterine perforation

On June 26, 2009, Julie Cantor’s physician inserted the Mirena IUD, and at that time, no indications were given that anything was medically wrong. However, on April 21, 2011, the plaintiff learned that she had suffered a uterine perforation as an alleged result of the device. Laparoscopic surgery, which was conducted on May 18, 2011, was needed to remove the IUD, which had migrated outside the uterine cavity.

According to the Mirena IUD lawsuit complaint, the plaintiff has suffered significant pain and suffering, along with severe physical injuries that are expected to be permanent. The plaintiff also cites significant emotional trauma. The complaint notes that the plaintiff could be at risk for additional side effects that have been cited by other complainants.

Some of these possible Mirena side effects could include:

  • Ectopic pregnancy
  • Intrauterine pregnancy
  • Cysts
  • Fetal injury/death
  • Premature menopause
  • Cancer
  • Adhesions
  • Embedment of the IUD

Mirena IUD side effects may warrant MDL

In January 2013, a motion for consolidation of Mirena lawsuits was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML). The motion requested the formation of a Mirena multidistrict litigation (MDL), which is a way to centralize proceedings and group together lawsuits with commonalities. For example, the proposed MDL might possibly group together lawsuits that allege uterine perforation as a result of Mirena.

An MDL serves to streamline the pre-trial process and conserve resources. When a plaintiff joins an MDL, that party retains the right to an individual trial. The JPML is scheduled to hear arguments regarding the proposed MDL on March 21, 2013.

Mirena IUD lawsuit alleges negligence

The complaint filed by lawyers for Julie Miller alleges that Bayer knew of defects in the product, but failed to adequately warn patients and doctors about the risks. The complaint further alleges that the product fails to meet established performance standards, contains false or misleading labeling, and does not provide adequate instructions for insertion of the device. The complaint also alleges that the defendant failed to adequately test the device to determine safety prior to marketing.

Pursuant to these allegations, the plaintiff is seeking compensatory damages for medical expenses, loss of earning capacity, and pain and suffering. Julie Miller’s husband, Jonathan Miller, is also a plaintiff, and cites loss of consortium. The plaintiffs have also requested punitive damages.

One of the most common Mirena Coil side effects is yeast infection. Have you read this? "Yeast Infection No More" by Linda Allen. Linda is an author, researcher, nutritionist and health consultant who dedicated her life to creating the ultimate holistic yeast infection solution guaranteed to permanently cure the root of Candida and dramatically improve the overall quality of your life, naturally, without the use prescription medication and without any side effects. Learn more by visiting her website YeastInfectionNoMore.com