develop ovarian cysts
Mirena has become a popular form of birth control since it was approved by the U.S. Food and Drug Administration in 2000. Prescribed to some 2 million women in the U.S. alone, it’s medically known as an intrauterine device (IUD). It is small, plastic, shaped like a “T” and releases synthetic doses of the hormone levonorgestrel to block sperm from reaching and fertilizing eggs. The medical devices are designed as a long-term method to stop unwanted pregnancies for up to five years.
Although Mirena has been aggressively advertised as both safe and effective, The Ezparza Law Group’s Utah Mirena injury attorneys know there have been many reports of women suffering serious complications after having Mirena implanted.
Some of those conditions include:
- Perforation of the uterus – The uterus may be perforated either during insertion or at some later point (the question of when the perforation occurred is an issue of contention in a number of Mirena lawsuits). The device must be located and removed if this occurs, and sometimes this must be done surgically. Delayed detection of a perforation could result in peritonitis, intestinal perforations and intestinal obstruction. This is the reason it’s recommended women wait at least 6 weeks after giving birth to have Mirena inserted.
- Device migration – The device may move out of its original place, putting patient at risk for device failure but also injury.
- Intrauterine pregnancy – If the device fails to work and a woman gets pregnant, the device must be removed. But this can result in a heightened risk of miscarriage, sepsis, premature labor and premature delivery.
- Sepsis – Out of 9.9 million Mirena users, 9 cases of sepsis were reported, in some cases occurring within hours of insertion.
- Pelvic inflammatory disease – This is an infection of a woman’s reproductive organs, and the highest risk associated with Mirena occurs immediately after insertion.
- Ectopic pregnancy – The risk of ectopic pregnancy were 1 per 1,000 users. Ectopic pregnancy may cause loss of fertility.
- Pseudotumor cerebri – This is a form of intracranial hypertension and involves a dangerous increase in the pressure of cerebrospinal fluid. Symptoms include blurred vision and other visual disturbances. The condition can be fatal. A 2017 study published in the journal Neuro-Opthalmology indicated women who take levonorgestrel hormones may be at heightened risk for developing this condition, but indicated more research was needed.
- Embedment – Mirena may become embedded in the myometrium, which could decrease the device’s effectiveness and result in pregnancy. An embedded Mirena must be removed, and in some cases, this must be done surgically.
- Ovarian Cysts. Approximately 12 percent of those using Mirena develop ovarian cysts.
- Breast cancer – The device isn’t recommended for women who have breast cancer (which is a hormone-sensitive condition), but the FDA has received reports of spontaneous breast cancer after having Mirena inserted. The causal connection has yet to be established.
Bayer does adequately warn about some of these conditions, but not all. For example, there is no warning for pseudotumor cerebri or for perforation of the uterus after (not during) insertion. These have become the two most common bases for litigation.
Those affected have demanded a recall of Mirena and some have filed lawsuits. However, neither the FDA nor Mirena manufacturer Bayer Healthcare Pharmaceuticals, Inc., have initiated recall, though there have been some updates to the label. Bayer executives continue to insist Mirena is safe.
Meanwhile thousands of women have filed lawsuits against the company and its subsidiaries for personal injuries they allege were proximately caused after being prescribed and properly using this product, which they assert is both defective and unreasonably dangerous.
Pseudotumor cerebri, also known as idiopathic intracranial hypertension, occurs when there is a heightened pressure of cerebrospinal fluid in the brain. It mimics the symptoms of a brain tumor. It’s not a brain tumor, but that is where it derives its name, which literally means, “false brain tumor” in Latin.
Symptoms of pseudotumor cerebri may include:
- Blind spots
- Visual deficiencies
- Temporary blindness
- Double Vision (diplopia)
- Blurred vision
It’s not clear how many Mirena patients have suffered from pseudotumor cerebri, but we do know links have been established. For example, in the journal Therapeutic Advances in Drug Safety, a 2015 published study concluded a “higher than expected” number of reports of intracranial hypertension involving Mirena patients in the FDA’s Adverse Events Reporting System database, as well as when compared with those using the oral contraceptive EE-norgestimate. Study authors reported this heightened risk needs to be further investigated.
An example of litigation based on this condition is that of Johnson v. Bayer Health Care Pharmaceuticals Inc., et al, in the U.S. District Court for the Southern District of New York. Plaintiff alleges she began taking the medication at age 25 starting in 2014. Within 18 months, plaintiff was reportedly being treated for blind spots, blurred vision and “floaters.” She also was being treated for severe headaches. It was nearly two years before she was diagnosed with pseudotumor cerebri (also known as PTC).
Although the product label does indicate removal of Mirena should be considered if patients develop focal migraines with asymmetrical visual loss or other symptoms, but the warning is insufficient regarding non-stroke neurological conditions, such as PTC, and in fact contains no mention of the condition, despite there being a known link – specifically as a result of the progestin coating used in the IUD. Further, Mirena’s manufacturer never conducted any clinical testing of Mirena for this known link with PTC, despite more than ten years of literature indicating further tests were needed. Plaintiff alleged defendant manufacturer was aware of the risk, despite knowing about it for some time.
This case is separate from the 1,300 that were weighed recently in a multi-district litigation in the U.S. District Court, Southern District of New York.
Perforation After Insertion
Although Mirena’s product label does warn about the possibility of perforation of the uterus and other organs during insertion of the IUD, the company has insisted there is no evidence the device puts patients at risk of perforation once the device is implanted. Thousands of patients had claimed otherwise, and the cases were consolidated into an MDL in New York. They also reported cases of migration and embedding resulting in serious injuries.
However, in the case that alleged negligence, strict liability, breach of express and implied warranties, negligent misrepresentation and manufacturing defect, the district court granted defendant manufacturer summary judgment and in 2017, the U.S. Court of Appeals for the Second Circuit upheld that decision. The primary issue, according to the summary order, was that the plaintiffs’ expert witnesses were not deemed credible under the Daubert standard, so named for the scientific standards established in the 1993 U.S. Supreme Court decision in Daubert v. Merrell Dow Pharm.
Specifically, the appellate court agreed that the theory of secondary perforation was not accepted in the wider obstetrics and gynecological scientific community. This ruling doesn’t necessarily foreclose on any possibility of future cases on this theory, but it does mean plaintiffs may face more of an uphill battle – and they must be prepared with help from an experienced Mirena injury attorney.
Contact the Salt Lake City Mirena injury attorneys at the James Esparza Law Group by calling toll-free 800-745-4050.
Contact our team today
Our dedicated product liability attorneys in Salt Lake City can help you file your Mirena lawsuit and navigate through what is a confusing process.