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Mirena is a type of long-acting, reversible birth control called a hormonal intrauterine device (IUD) and is manufactured by Bayer Pharmaceuticals. An IUD, or intrauterine device, 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 a progestin hormone called levonorgestrel locally into the uterus. It provides continuous, highly effective birth control.
It was approved in 2000 by the Food and Drug Administration (FDA) and is one of two hormonal IUDs approved 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 is claimed to be more than 99 percent effective in controlling pregnancy for up to 5 years, at which point the implant must be replaced. Mirena is recommended for women who have had a child.
Mirena is marketed as more convenient and effective than most oral contraceptives because once it is implanted, women do not have to worry about taking a daily pill. When it is time to remove the device, the health care provider removes it by using the attached string. The arms of the device are flexible and bend up as the device is removed. However, sometimes the device can migrate outside of the uterus or become lodged in the uterine wall. When this happens, the device must be removed surgically. Another device can be implanted if the woman wants to continue to prevent pregnancy.
Mirena Important Safety Information: This device is highly effective at preventing pregnancy, but some women may experience dangerous, life-threatening side effects such as perforation of the uterus, pelvic inflammatory disease and ectopic pregnancy (pregnancy that occurs outside the uterus). The device may also spontaneously move from the uterus and embed in other parts of the body such as the uterine wall or abdomen, requiring difficult surgery to remove. The most common side effects of Mirena are missed periods (amenorrhea), bleeding and spotting between periods, heavier bleeding during the first few weeks after device insertion, abdominal/pelvic pain, ovarian cysts, back pain, headache/migraine, nervousness, dizziness, nausea, vomiting, bloating, breast tenderness, etc.
Lawsuits filed against Bayer Pharmaceuticals, Mirena's manufacturer, claim that the company is guilty of failure to warn the public that the device is prone to spontaneous migration and perforation of the uterus. A number of women claim that the drug manufacturer knew of the dangerous risks and released a defective product. Plaintiffs also accuse Bayer of using misleading advertising, concealing the harmful side effects and misrepresenting the benefits of Mirena. As of June 30, 2012, The US Food & Drug Administration (FDA) received over 45,000 reports of a serious Mirena birth control side effect. The birth control device has recently been associated with neurological side effects, including pseudotumor cerebri (PTC).
Facts About Mirena Pseudotumor Cerebri Lawsuits: Bayer faces a new product liability lawsuit that alleges a Florida woman experienced a buildup of fluid in the brain known as Pseudotumor Cerebri (PTC) or Idiopathic Intracranial Hypertension (IIH), which was allegedly caused by side effects of Mirena birth control. Plaintiffs allege that Bayer knew or should have known about the link between Mirena and pseudotumor cerebri (PTC)/idiopathic intracranial hypertension (IIH), and should have provided stronger warnings about the risk of problems caused by pressure on the brain from the build-up of cerebrospinal fluid while on Mirena birth control. According to the Mirena lawsuit allegations, the birth control implant's warning label should indicate that use of levonorgestrel alone, like with the 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, according to the lawsuit, increases the risk of IIH/PTC.
Evidence to be looked for in potential cases
- Usage of Mirena Device in operative records.
- Product identification (implant stickers) 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.