The Mirena IUD (intrauterine device) is what is known as a hormonal IUD. It is inserted into the uterus for long-term contraception, or birth control. It comes in a T-shaped soft plastic frame that releases a type of progestin (a natural or synthetic steroid hormone), which thins the lining of the uterus and partly suppresses ovulation. Mirena also thickens the cervical mucus, which prevents sperm from reaching or fertilizing an egg.
Mirena is known to prevent pregnancy for up to five years after insertion. It is one of only two hormonal IUDs approved for use by the FDA. The other is Skyla, which is said to prevent pregnancy for up to three years.
Bayer HealthCare Pharmaceuticals is the manufacturer of Mirena. It specifically recommends Mirena’s use by women who have already had children and don’t want more, or who don’t want to have any more children for the foreseeable future.
Mirena is an alternative to surgery, as a doctor can place it inside the patient in a few minutes during a routine office visit. It can be used to treat heavy periods and is estrogen-free.
The manufacturer reports some side effects from the use of Mirena, including discomfort or spotting for four to six weeks after placement. Bayer warns that the product doesn’t protect against STDs (sexually transmitted diseases) and shouldn’t be used by women who get infections easily or have certain cancers. Less than one percent of Mirena users develop what is called pelvic inflammatory disease, according to Bayer.
New Jersey Litigation Related to Mirena
Thousands of women have filed lawsuits against Bayer relating to Mirena. Many of the plaintiffs say that Mirena perforated their organs, including some plaintiffs who claim that the product lacerated parts of their bowels or liver.
Others claim IUD migration occurred. IUD migration refers to when the device moves from the location in the uterus where it was implanted, causing discomfort and injury—and in some cases rendering the device ineffective.
In New Jersey, there are currently over 1800 active Mirena lawsuits. There is now multicounty litigation (MCL) going on over Mirena, presided over by Judge Brian Marinotti. New York has multidistrict litigation (MDL) ongoing over Minera, for a total of over 3000 suits nationwide.
Judge Marinotti of New Jersey has issued an order calling for a selection of a pool of lawsuits from which a second preliminary, or bellwether lawsuit, will be chosen. Case Management Order 35 has outlined a process that will extend until the end of the summer 2016. Both the plaintiffs and the defendant, Bayer, will be allowed to propose lawsuits that might serve as the second preliminary. The lawsuits chosen must be representative of the Minera lawsuits as a whole.
Additional Minera Lawsuits Over Pseudotumor Cerebri (PTC)
Not included in the MCL are additional Minera lawsuits begun by plaintiffs who say that the device is responsible for pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH).
PTC is a neurological condition in which the pressure around your brain increases, causing headaches and vision problems. The name means false brain tumor, because its symptoms are so similar to those of brain tumors. As you can imagine, this must be incredibly frightening for women using Minera who are affected.
A bid to include the pseudotumor cerebri cases in the MCL was rejected because there are too few PTC cases, and the fundamental issues underlying the cases are different.
FDA Approves New IUD
The FDA recently approved a new, more affordable IUD called Liletta, which is already available in Europe. Like Minera, Liletta is a hormonal IUD, so its release is a boon to those who are frightened by Minera’s potential deleterious effects.