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A number of women have reported suffering serious and debilitating injuries from side effects of Mirena IUD, where the implanted birth control increases fluid pressure in the brain, causing migraines and permanent vision loss. There are also claims that it perforates the uterus, migrates to other areas of the body and causes infections or other problems.
MIRENA IUD LAWSUIT STATUS: Financial compensation may be available through a Mirena IUD lawsuit as a result of the manufacturer’s failure to adequately warn about the risks associated with the device.
Lawyers are reviewing potential Mirena cases for women throughout the United States who have suffered:
- Pseudotumor Cerebri or Idiopathic Intracranial Hypertension
- Perforation or Puncture of the Uterine Wall
- Migration of the Mirena IUD Outside the Uterus
- Surgical Removal of the IUD Due to Complications
OVERVIEW: Mirena, which is sometimes referred to as an IUD (Intrauterine Device) or IUS (Intrauterine System) is a long-acting form of birth control that is placed into the uterus to prevent pregnancy. The IUD disrupts the connection between the egg and sperm, and Merina also releases levonorgestrel, a progestin that helps keep the woman’s ovaries from releasing eggs.
Mirena was approved by the FDA in 2000, and use has grown in recent years amid heavy promotion as a hassle-free form of birth control that lasts for 5 years or longer. The manufacturer has been attempting to promote Mirena IUD to appeal to younger and younger women and girls, despite serious risks that they may not be adequately disclosing or warning about.
MIRENA LITIGATION STATUS UPDATE: Although the Mirena warning labels do indicate that there is a risk of perforation, the information provided to consumers and the medical community suggests that such problems only occur during insertion of the IUD, which is misleading and inaccurate. A large number of women have experienced “spontaneous” Mirena IUD complications that may occur years after the device was inserted.
Lawsuits over Mirena migration problems have been centralized at the state level in New Jersey Superior Court in Bergen County as part of an MCL, or Multicounty Litigation. At the federal level, all Mirena IUD injury lawsuits have been centralized and consolidated for pretrial proceedings before U.S. District Judge Cathy Seibel in the Southern District of New York. In August 2016, Judge Seibel dismissed all federal Mirena IUD migration lawsuits, but state lawsuits and claims of other injuries, like pseudotumor cerebri, were unaffected.
In January 2017, some women who have filed Mirena pseudotumor cerebri lawsuits called for the creation of a new MDL specifically to address the PTC/IIH claims. Bayer opposes the consolidation.
MIRENA IUD PROBLEMS: A number of potentially serious problems and complications have been associated with Mirena IUD side effects, some of which the manufacturer may not have adequately researched or warned about, including:
- Pseudotumor cerebri/idiopathic intracranial hypertension: An increase in cerebrospinal fluid which causes pressure on the skull, resulting in migraines, vision loss and other problems.
- Uterus Perforation: Mirena may puncture the uterus or embed in the uterine wall. Mirena IUD perforation can cause internal scarring, infection or damage to other organs and may result in the need for surgery.
- Migration: Delayed detection of a perforation may allow the Mirena IUD to migrate through the intraabdominal cavity, potentially resulting in intestinal peforations, intestinal obstruction, absecesses or adhesions.
- Expulsion: Partial or complete expulsion of Mirena IUD may occur. It may be more common among younger women using Mirena IUD, women who have not had children or women who have the device inserted immediately after childbirth or abortion.
- Infection: As a result of infection from Mirena IUD, women could suffer serious scarring that may deminish fertility or their ability to conceive, and in severe cases infection may be life-threatening and result in death from Mirena.
An analysis released in May 2013 by a private company found that the FDA had received more than 47,000 reports of Mirena IUD injuries and complications between November 1997 and late August 2012. Most of the problems involved the Mirena being expelled from women’s bodies, migrating to different locations, or causing vaginal hemorrhaging.
BAYER ADVERTISING WARNING: In December 2009, the FDA issued a warning letter to Bayer over its promotions of Mirena. The FDA accused the drug manufacturer of overstating the efficacy of Mirena, presenting unsubstantiated claims, minimizing the risks of Mirena and using false and misleading presentations.
The FDA accused Bayer of organizing live in-home Mirena promotional events that claimed that the use of the IUD would improve couples’ relationships and sex lives. They also blasted the company for telling women that using Mirena would help them “look and feel great.” The FDA said that there was no evidence the device did any such thing.
The FDA also pointed out that at least 5% of Mirena IUD recipients reported decreased libido in clinical trials, which would certainly not help a couple’s intimacy or sex life. They also noted that women using Mirena had reported side effects including irregular bleeding, ovarian cysts, back pain, weight increase, breast pain and tenderness, and acne. None of those things will help someone look or feel “great,” FDA officials said.