Table of Contents
- 1 Mirena IUD PTC Lawsuit Information
- 1.1 Are You Experiencing Vision Problems, Migraine Headaches or Memory Problems After Being Implanted with the Mirena IUD?
- 1.2 Important Warning Video
Mirena IUD PTC Lawsuit Information
Are You Experiencing Vision Problems, Migraine Headaches or Memory Problems After Being Implanted with the Mirena IUD?
There’s a large variety of birth control product on the market today, so you’d think it would be easy to find one that fits your lifestyle. Unfortunately, that’s not the case, and many women end up trying out several different types before they find that one that works best for them and their partner.
Mirena IUD has been the choice for millions of women because it doesn’t require a surgical procedure, (like having your tubes tied), there’s no daily pills to take, and it’s effective for up to five years. Little did the public know that this device had serious side-effects that have hurt thousands of women. Possible one of the most serious side effects is brain injury and pseudotumor cerebri, which symptoms include:
- Changes in the frequency, severity, or duration of migraine headaches
- Blurry or dim vision
- Difficulty looking sideways
- Double vision
- Seeing flashes of light
- Moments of blindness
- Headaches that start behind the eyes
- Headaches that get worse with eye movement
- Hearing your heartbeat in your ears
- Nausea and vomiting
- Pain in the neck, shoulder, or back
- Tinnitus – a whooshing sound in the ear
- “Halo” vision
If you were implanted with the Mirena IUD and are experiencing any of these symptoms of PTC, see your doctor as soon as possible.
Important Warning Video
The Mirena IUD is a small, t-shaped device that releases a synthetic hormone directly to the uterine tissue. It is implanted in the uterus by a doctor and remains effective for up to five years. Mirena manufacturer Bayer says the device is at least 99 percent effective in preventing pregnancy and does not decrease the chance of pregnancy after it is removed.
Mirena was approved for sale on the U.S. market in 2000 as a contraceptive device and then was approved in 2009 by the U.S. Food and Drug Administration as a treatment for heavy menstrual bleeding. Mirena IUD is the only device approved for this treatment by FDA.
FDA Warnings and Busy Mom Campaigns
The Mirena IUD is not recommended for women who have yet to have a child. To increase its market presence, Bayer marketed the birth control device as a convenient, safe, and effective birth control for busy moms. The company went so far as to suggest the use of their birth control would help women look and feel great and even enjoy a better intimate life with their partner. They did through marketing avenues that included live “parties.”
In 2009, the FDA warned Bayer over its marketing claims saying “these claims misleadingly over the proven efficacy of Mirena. The FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners.”
The government agency also warned Bayer against overstating the efficacy of Mirena and making unsubstantiated claims and false and misleading statements. Marketing materials also omitted contraindications and failed to convey that women with Mirena who get pregnant may lose their baby or their fertility.
Within a few years, thousands of women realized that Mirena wasn’t all it was promoted to be, and by 2013, more than 47,000 reports of adverse events with Mirena had been reported to the FDA. Some of these adverse events included pelvic infections, persistent pain, ovarian cysts, uterine perforation, device migration, pregnancy, infertility, and brain injuries.
Brain Injuries – Pseudotumor Cerebri
Women using Mirena and some other IUDs containing the hormone levonorgestrel began complaining of serious side effects including brain injury, blindness and a devastating condition known as Pseudotumor Cerebri. These women claim that Bayer knew or should have known about the increased risk of PTC and warned physicians and their patients about these risks. These women claim they would not have chosen the Mirena IUD if they would have known about the risks.
Medical professionals became aware of the link between certain hormones used in birth control methods and complications of pseudotumor cerebri in the 1990s. In fact, one of the first studies linking specific types of contraceptives, like Mirena, and pseudotumor cerebri was published in 1995 in the New England Journal of Medicine. This study found that contraceptives with the synthetic hormone levonorgestrel were linked to a significantly increased risk of causing the user to develop PTC.
In 2015, researchers published a study in the journal Therapeutic Advances in Drug Safety that quantified the risk of intracranial hypertension, also known as PTC, with the use of the Mirena IUD. In the study, researchers analyzed the FDA’s Adverse Events Reporting System to quantify a reporting odds ratio for intracranial hypertension and Mirena. The study found a high than expected number of reports of intracranial hypertension and papilledema (swelling of the optic disc) with Mirena.
People who are overweight, especially those who recently gained weight, as well as those taking tetracycline, steroids, or vitamin A are most susceptible to developing pseudotumor cerebri. This is particularly alarming as many women suffer weight gain after having Mirena implanted.
Conservative management calls for the patient to lose weight, no matter how severe the condition. Researchers have found that weight loss reduced headaches, papilledema, and intracranial pressure and that maintaining that weight loss was critical in preventing the recurrence.
Medical management is indicated when the patient has good vision but is troubled with headaches. Drugs used to manage intracranial pressure include –
- Acetazolamide (Diamox) and methazolamide (neptazane), to decrease cerebrospinal fluid (CSF) production. They are mild diuretics.
- Corticosteroids will acutely lower intracranial pressure, but the side effects of weight gain and fluid retention make them more suitable for use prior to surgery to reduce optic disc swelling.
- Topiramate is also used to treat pseudotumor cerebri, as it works well as a migraine treatment and reduces papilledema, and has an added benefit of greater weight loss over acetazolamide.
Surgical management of ICP is indicated when the patient is experiencing severe optic neuropathy, and cerebrospinal fluid shunting is the most common surgical treatment for PTC. Shunting, also called CSF diversion, allows for rapid normalization of intracranial pressure, resolution of papilledema, and improvement of vision. However, shunting has a high long-term failure rate and often needs revision because of failure or obstruction.
Optic nerve sheath decompression effectively treats papilledema and severe vision loss but does alleviate headaches.
Venus sinus stenting is used to open a narrow venous sinus, to allow blood to flow easier, and reduce the buildup of pressure in the head. This is a relatively new treatment for PTC and is used when there is no alternative after surgical and medical treatments have failed.
In May 2008 the U.S. Food and Drug Administration (FDA) required Bayer to update the warning label for Mirena IUD including –
|Mirena Warning (May 2008)||Details|
|Pelvic infections||An infection that occurs when bacteria move beyond the vagina and cervix and infect the uterus, fallopian tubes, and reproductive organs.|
|Ectopic pregnancies||The FDA warned that nearly half of pregnancies that occur with Mirena IUD in place are ectopic pregnancies|
|Sepsis||In some cases, severe pain occurred within hours of insertion followed by sepsis within days|
|Uterine perforation||Perforation or penetration of the uterine wall or cervix may occur during insertion although it may not be detected until some time later|
|Ovarian cysts||Increased risk of ovarian cysts though “surgical intervention is not usually required.”|
|Updated the precautions||Should be monitored in nursing mothers and for interaction with other medications|
In July of that same year, the FDA required more warning label changes including –
|Mirena Warning (July 2008)||Details|
|Intrauterine pregnancy||If pregnancy occurs with Mirena in place, the device should be removed, which may result in pregnancy loss. Possible long term effect and congenital anomalies that include masculinization of the external genitalia of a female fetus. Embedment may occur with the device, which decreases contraceptive effectiveness. An embedded Mirena IUD should be removed, and surgical removal may be necessary.|
|Perforation||If perforation occurs, the device must be located and removed, surgery may be required, delayed detection of perforation may result in migration|
|Expulsion||Partial or complete expulsion, may occur.|
|Ovarian cysts||Cysts may be accompanied by pelvic pain or dyspareunia, may spontaneously absolve, persistent cysts should be evaluated|
|Breast cancer||Women who have had, have, or suspect they may have breast cancer should not use this product.|
In 2014, the first Mirena PTC lawsuits were filed, and a growing number continue to be filed by women who suffered PTC after being implanted with the Mirena IUD. These women are alleging that Bayer Healthcare –
- Knew or should have known about the increased risks of PTC
- Failed to warn physicians and their patients about the dangerous side effects of the device, including brain injury and blindness
- Engaged in deceptive marketing practices
- Concealed the harmful side effects of the Mirena, including the increased risk of developing PTC
- Produced, marketed, sold, and distributed a knowingly defective product
- Failed to provide adequate warnings about PTC
These PTC lawsuits are in addition to the thousands of lawsuits that have been filed against Bayer alleging the company failed to disclose the risk of spontaneous uterine perforation and device migration of Mirena. These lawsuits also allege the company used deceptive marketing practices to increase sales and profits.
How We Can Help
Our firm believes that many women would not have used Mirena birth control if they had known about the increased risks of developing pseudotumor cerebri. We also believe that women who developed this serious condition should be compensated for their mental anguish, pain and suffering, lost wages, disability, and diminished quality of life. Our attorneys have a proven record of fighting dangerous drug makers and their deceptive marketing practices. We will do the same for you.
If you have suffered PTC, vision loss, blindness, or cognitive impairment after being implanted with the Mirena IUD, contact us today. We are aggressive advocates for the victims of Mirena side effects, and we fight to get you the damages you need and deserve.