Mirena

  • Mirena

Mirena is a type of long-acting, reversible hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. It is a small T-shaped flexible device that is placed into the uterus by a trained healthcare provider during a routine office visit. Once implanted, Mirena releases small amounts of progestin hormone called Levonorgestrel, locally into the uterus. It provides continuous, highly effective birth control.

It was approved in 2000 by the U.S Food and Drug Administration (FDA) and is one of two hormonal IUDs for use in the United States. In 2009, the FDA expanded Mirena's approval to treat heavy menstrual bleeding in women already using an IUD. It was also claimed to be more than 99 percent effective in controlling pregnancy for up to 5 years, after that the implant needed replacement.

Mirena is marketed as more convenient and effective than oral contraceptives because once implanted, women do not have to worry about taking a daily pill. Additionally, the removal of this device is also quick and hassle-free. However, there were incidences where the device got migrated outside the uterus or got lodged in the uterine wall, some females conceived in spite of the device placement and landed up in undue complications. All these evidences brought Mirena device in trouble.

Pseudotumor Cerebri Lawsuits: Pseudotumor Cerebri (PTC) or Idiopathic Intracranial Hypertension (IIH), is a condition caused by pressure on the brain from the buildup of cerebrospinal fluid, while on birth control like Mirena. This condtion can lead to severe headaches, migraines, and vision loss/permanent blindness.

Serious Alleged Injuries may include:

  • Perforation of the uterus
  • Pelvic inflammatory disease
  • Ectopic pregnancy (pregnancy that occurs outside the uterus)
  • Displacement
  • Perforation of organs other than uterus
  • Menstrual Bleeding abnormalities
  • Abdominal/Pelvic Pain and Discomfort
  • Headache/Migraine

FDA safety Warnings

In 2009, the Food and Drug Administration sent Bayer two warnings about Mirena, including a warning that their television commercials were misleading and a warning that their internet advertisements were misleading.

Until June 30, 2012, US Food & Drug Administration (FDA) received over 45,000 reports of Mirena birth control side effects.

Lawsuit Allegations:

Lawsuits filed against Bayer Pharmaceuticals allege that the company is guilty of their failure to warn that the device is prone to spontaneous migration and perforation of the uterus. Plaintiffs accused Bayer of using misleading advertising, concealing the harmful side effects and misrepresenting the benefits of Mirena.

Mirena IUD Lawsuits were 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 were centralized and consolidated for pretrial proceedings before the U.S. District Judge Cathy Seibel in the Southern District of New York as MDL 2434 In re Mirena IUD Products Liability Litigation with over 1800 cases.

In August 2016, Judge Seibel dismissed all federal Mirena IUD migration lawsuits, but the claims like pseudotumor cerebri remained unaffected.

Lawsuits are being filed by women who have developed PTC after taking birth control pills or using a birth control implant like Mirena,  (Yaz, Yasmin, Ocella, NuvaRing) and many others. According to the Mirena lawsuit allegations, the birth control implant warning label should indicate that use of Levonorgestrel alone, like with Mirena, suppresses the levels of sex hormone binding globulin (SHBG) in the body. When SHBG levels are lowered, it can cause stronger hormonal effects from LNG and similar hormones. This may increase the risk of IIH/PTC.

In January 2017, plaintiffs suffering from pseudotumor cerebri filed lawsuits and demanded creation of a new MDL specifically to address their claims separately.

In April 2017, MDL No. 2767, (In Re:  Mirena IUS Levonorgestrel-Related Products Liability Litigation [No. II], was established under Judge Paul A. Engelmayer in the U.S. District Court for the Southern District of New York. This centralized more than 150 Mirena intracranial hypertension lawsuits.

Evidences:

  • Usage of Device in operative records.
  • Product identification (Implant sticker) in the medical records.
  • Proof of Injury in Medical Records.
  • Treatment provided for the injuries.

Medical Record Review and claim validation of Mirena case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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