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Shezad Malik MD JD
Shezad Malik MD JD
Attorney • (888) 210-9693

Mirena Uterine Perforation and Pseudotumor Cerebri

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Mirena Intra Uterine Device (IUD) was apparently designed for convenience and worry-free contraception requiring no management. But for some women, the IUD has become a risk factor for uterine perforation and migration.

Mirena and Peudotumor Cerebri

We are investigating these injuries associated with Mirena. We have received several reports of women suffering from this disorder who had no signs or symptoms of the condition before being implanted with Mirena.

Pseudotumor cerebri is a serious condition that affects the brain and mimics a tumor. According to experts, pseudotumor cerebri occurs when the cerebro spinal fluid flow surrounding the brain is disrupted, leading to elevated pressure in the skull. The fluid within and around the brain is constantly circulating and must be removed at the same rate. When this balance is disrupted, the pressure increases. Often, the condition is diagnosed and in the short-term treated by a lumbar puncture, or spinal tap, which relieves the pressure by extracting some of the fluid that has built up.

In severe cases, invasive brain surgery and shunts are required. The use of levonorgestrel contraceptive implants is contraindicated in patients with a current or past history of idiopathic intracranial hypertension (pseudotumor cerebri, benign intracranial hypertension). This disorder is most commonly seen in obese women of reproductive age and has been reported in users of levonorgestrel implants. Patients who experience symptoms of this disorder (e.g., headaches associated with changing frequency, pattern, severity or persistence; visual disturbances) while on levonorgestrel therapy should be referred to a neurologist. If the diagnosis is confirmed, the implants should be removed permanently.

Mirena Uterine Perforation Lawsuits

The US Food and Drug Administration (FDA) approved the T-shaped plastic device in 2000. The IUD is inserted into the uterus by a doctor. The flexible IUD remains in the woman’s body for up to five years and releases female hormones from a reservoir to prevent pregnancy. After about five years, the device becomes depleted and must be replaced.

Mirena manufacturer Bayer has warned about the potential for uterine perforation at the time of insertion. But, Mirena side effects have included migration of the device and uterine perforation long after insertion. Plaintiffs have alleged that Bayer Mirena warnings about the risk of perforation and spontaneous migration are inadequate.

In some instances, the devices have migrated and women have become pregnant. Others have filed Mirena lawsuits after their IUD became attached to the bowels. Invasive surgery is required to locate and then remove the device.

According to expert reports, more than two million women in the US have used the Mirena IUD in the last decade.

Federal MDL Southern District of New York

The US Judicial Panel on Multidistrict Litigation ordered about 40 cases coordinated before US District Judge Cathy Seibel in White Plains, New York. The order was issued April 8, and Seibel has scheduled the first status conference in the litigation for May 17.

The Mirena litigation was consolidated in the federal court system to reduce discovery, avoid inconsistent rulings from different judges and to serve the convenience of the parties and the courts. Federal consolidation is common in complex pharmaceutical claims where a large number of lawsuits have been filed involving similar injuries allegedly caused by the same medication or medical device.

At the time the Mirena MDL was established, nearly 50 lawsuits were pending in 17 different federal district courts throughout the country, and Mirena IUD lawyers investigating cases have suggested that thousands of cases are likely to be filed in the coming months. Another 85 Mirena lawsuits are reported to be pending in state courts in New Jersey.

Bayer Mirena Advertising

Bayer marketed the IUD to “busy moms,” and claimed Mirena would enhance their sex drive, and promise to make them “look and feel great.” However, according to the US Health and Human Services’ Division of Drug Marketing, Advertising and Communications, the opposite was true with the agency, concluding that Mirena birth control side effects include decreased libido, weight gain and acne.