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Mirena IUD

Mirena IUD Birth Control Side Effects Lawsuits | Side Effects: Miscarriage, Risk Of Infertility, Intrauterine Pregnancy, Streptococcal Sepsis, Pelvic Inflammatory Disease Cervix, Severe Pain, Contraceptive Perforation | False Statements, Misleading Inform

Mirena IUD Side Effects May Lead To Perforation Lawsuits, Pseudotumor Cerebri Lawsuits

Our firm is investigating potential lawsuits on behalf of users of the Mirena IUD. Bayer Inc., the maker of Mirena, has used deceptive tactics to market Mirena and, as a result, many women were left unaware of its potential risks and complications, some of which are very serious.

Mirena (levonorgestrel-releasing intrauterine system), also known as LNG-IUS, is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to five years. Mirena is also used in the treatment of heavy periods in women who choose intrauterine contraception.

Mirena injuries may be extremely painful, and may impact the lives of victims and their families for years. Some injuries are lifelong and life altering, and Mirena's complications may include uterine perforation, pseudotumor cerebri, pelvic inflammatory disease (PID), ovarian cysts, irregular bleeding, and amenorrhea. Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility may be put at risk.

Mirena IUD Side Effects

Mirena and Pseudotumor Cerebri Injuries

According to the Mayo Clinic, pseudotumor cerebri occurs when the intracranial pressure (pressure in the skull) increases for no obvious reason. Such pressure typically occurs when excess cerebrospinal fluid is present. Symptoms appear to be similar to those of a brain tumor; however, no tumor is present.

Increased intracranial pressure associated with pseudotumor cerebri may lead to swelling of the optic nerve, which may lead to vision loss or blindness, among other injuries. In some cases, surgery is necessary. The makers of Mirena are facing lawsuits involving allegations that they minimized the tie between Mirena and neurological side effects that include pseudotumor cerebri. Symptoms of this disorder may include:

  • Back pain
  • Blurred vision, double vision
  • Dizziness
  • Headache
  • Nausea
  • Neck pain
  • Shoulder pain
  • Tinnitus (buzzing, ringing in the ears)
  • Vision loss
  • Vomiting

Mirena and Breast Cancer

In June 2015, the journal Acta Oncologica published a study investigating the link between breast cancer and the use of levonorgestrel-releasing intrauterine system such as Mirena. The authors of the study sought to test whether devices such as Mirena increase the risk of lobular breast cancer; they noted that, while prolonged steroid hormone therapy is associated with an increased risk, the link to LNG-IUS is uncertain. The researchers found that LNG-IUS "is not only related to an excess risk of lobular cancer but also, contrary to previous assumptions, to an excess risk of ductal breast cancer."

The researchers used data from the national Medical Reimbursement Registry of Finland to identify women between the ages of 30 and 49 who used levonorgestrel-releasing IUDs to treat or prevent menorrhagia (abnormally heavy menstrual bleeding) between 1994 and 2007. Women diagnosed with breast cancer before the age of 55 and by the end of 2012 were identified using data from the Finnish Cancer Registry. In a cohort of 93,843 women using LNG-IUS, a total of 2,015 were diagnosed with breast cancer. Use of LNG-IUS was associated with a higher risk of both lobular cancer and ductal breast cancer compared to the general population. The highest risk was found in women who were implanted with the Mirena contraceptive at least twice.

Bayer's Mirena Deception

The Mirena IUD was originally approved as an intrauterine contraceptive (IUD), and later, as a treatment for heavy menstrual bleeding in women who had given birth at least once. Mirena works by slowly releasing the chemical progestogen levonorgestrel into the uterus and is indicated for intrauterine contraception for up to five years. At that point, the Mirena system should be replaced if continued contraception is desired. Mirena is only recommended for women who have had at least one child.

Bayer has marketed Mirena as a way in which "busy moms" may simplify their lifestyles. One of the ways Bayer did so was through "Mirena Parties." Working with the social networking site, Mom Central, Bayer created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. The program was set up to be presented in a consumer's home or other private setting (e.g. private restaurant party) by a representative from Mom Central and a nurse practitioner. The script followed by the nurse practitioner at one of these Mirena Parties included phrases like "look and feel great," "simple ways to reconnect with ourselves and our partners," and "more likely to be more intimate."

According to a U.S. Food and Drug Administration (FDA) Warning letter issued to Bayer in December 2009, the claims made in the script "clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena."

The letter went on to say that the FDA was "not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great." The agency also indicated that the script omitted certain information regarding the risks of using Mirena, and minimized risks by utilizing the statement "look and feel great." Finally, the FDA faulted the script for including a statement that Mirena "has no daily, weekly, or monthly routines to comply with," which the agency stated was false.

Bayer stopped holding Mirena Parties in early 2009. But because of such misleading information presented at these events, many women who chose Mirena for its purported convenience may not have been aware of its many serious side effects.

Mirena Side Effects

In addition to pseudotumor cerebri , since its approval, serious Mirena side effects have long included ectopic pregnancy, intrauterine pregnancy (a pregnancy that occurs in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.

In June 2010, the Canadian regulatory agency, Health Canada, reminded healthcare providers there of important safety information regarding reports of uterine perforation in women using Mirena. According to Health Canada, Bayer Inc. continues to receive post-market reports of uterine perforation associated with the use of Mirena.

According to Health Canada, some cases of Mirena uterine perforation were not detected during or immediately after the insertion. The risk of perforation may be increased with use in the post-partum period, during lactation, and in women with an atypical uterine anatomy (such as fixed retroverted uterus). Uterine perforation may occur with Mirena at the time of insertion or after insertion with limited clinical symptoms, Health Canada indicated.

The highly experienced medical device attorneys at Parker Waichman LLP are investigating an association between Mirena IUD and a range of serious side effects, including uterine perforation and Breast Cancer.

Bayer itself has warned about the potentially detrimental effects associated with Mirena's hormones, cautioning against using the IUD "if you have a pelvic infection, get infections easily, or have certain cancers. Less than 1 percent of users are diagnosed with a serious infection called pelvic inflammatory disease (PID). If you have persistent pelvic or abdominal pain, see your healthcare provider."


Mirena IUDRSS Feed

2nd MDL Granted for Mirena IUD Intracranial Hypertension Lawsuits

May 4, 2017
Mirena IUD Pseudotumor Cerebri Claims Consolidated in New York The U.S. Judicial Panel on Multidistrict Litigation (JPML) has granted a second multidistrict litigation (MDL) for Mirena IUD lawsuits. The recently created MDL consolidates lawsuits alleging that the contraceptive device caused intracranial hypertension, or pseudotumor cerebri. The previous MDL consolidates lawsuits alleging device migration. The drug and medical device attorneys at Parker Waichman LLP have decades of...

Mirena IUD Plaintiffs Seek a New MDL

Jan 26, 2017
The Bayer company is facing lawsuits concerning injuries allegedly caused by increased intracranial pressure in relation to the Mirena IUD (intrauterine device). Ten plaintiffs have asked the Judicial Panel on Multi-District Litigation (JPMDL) to set up a new MDL focusing on those injuries. An MDL is when lawsuits are consolidated when a number of cases have common allegations. MDLs make complex litigation more efficient as similar lawsuits are brought together in one court...

Mirena IUD Lawsuit Alleges Device Caused Pseudotumor Cerebri

Dec 21, 2016
Mirena IUD Plaintiff Suffered from Headaches, Vision Problems A new lawsuit has been filed against Bayer over the Mirena intrauterine device (IUD). The plaintiff is a Maryland woman who alleges that the birth control device caused pseudotumor cerebri, a condition that mimics the symptoms of a brain tumor when no tumor is present. According to the complaint, she was implanted with the Mirena IUD contraceptive in June 2005. In April 2009, she went to the doctor complaining of pressure...

Judge Rachelle Harz Takes over Mirena IUD Litigation in NJ

Jul 14, 2016
Mirena IUD Litigation Holds By The New Judge A new judge is overseeing the Mirena IUD multicounty litigation in Bergen County, New Jersey. Court documents indicate that Judge Brian Martinotti, who has presided over proceedings up until this point, will be leaving the Bergen County bench to assume new duties in Federal Court. He will be replaced by Judge Rachelle Harz. The next upcoming conference call with Judge Harz will take place on August 3rd at 11 am. The case is In Re: Mirena...

Court Directs Parties to Select Potential Cases for Second Mirena IUD Disposition Pool

Mar 27, 2015
A judge in the Mirena intrauterine device (IUD) multidistrict litigation (MDL) recently issued an order directing both side to select five cases each for potential inclusion in the litigation's Second Disposition Pool. An additional five cases will be randomly selected from those filed. The case is In Re: Mirena IUD Products Liability Litigation, MDL No. 2434 in the United States District Court Southern District of New York. For three years, national law firm Parker Waichman LLP has...

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