En Español [MIRENA DUI]
According to AdverseEvents.com, the top three adverse events related to the use of Mirena were device expulsion, device dislocation and vaginal hemorrhage, with more than six percent of patients requiring hospitalization or surgery. Mirena birth control side effects can include:
- Uterine perforations
- Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
- Intrauterine pregnancy (a pregnancy with Mirena in place)
- Group A streptococcal sepsis
- Pelvic inflammatory disease (PID)
- Embedment of the device in the uterine wall
- Perforation of the uterine wall or cervix
- Infertility, abscesses, erosion of adjacent areas such as the vagina
- Pseudotumor cerebri (PTC), also known as Idiopathic Intracranial Hypertension (IIH)
The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic “hormone” to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combined oral contraceptives.
Pseudotumor Cerebri (PTC) is a condition that causes neurological issues and can mimic the effects of a brain tumor. Another name for PTC is Idiopathic Intracranial Hypertension, meaning “high pressure inside the skull for unknown reasons.”
Mirena, Levonorgestrel and Pseudotumor Cerebri
Since the early 1990s PTC has been associated with levonorgestrel. It is believed that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor. Two cases were reported in 1993. In 1995 researchers warned in the New England Journal of Medicine that levonorgestrel could increase the risk of PTC. In Mirena clinical trials, 7.7 percent of women reported headaches/migraines.
The Mayo Clinic lists the following symptoms associated with PTC:
- moderate to severe headaches originating behind the eyes that worsen with eye movement
- ringing in the ears that pulses in time with a person’s heartbeat
- dizziness, nausea or vomiting
- blurred vision
- double vision
- seeing light flashes
- temporary or passing blindness
- neck, shoulder or back pain
The FDA issued a warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. Up until the FDA’s reprimand for deceptive marketing of Mirena, Bayer held live presentations as part of its “Simple Style” program that targeted “busy moms” and claimed that the IUD would help increase libido and “look and feel great”. Instead, and included in the FDA warning letter, “at least 5 percent of Mirena IUD users reported decreased libido in clinical trials.”
Bayer Mirena Warnings
The FDA’s Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) concluded that the benefits of Mirena were overstated through this program while downplaying its side effects.
(The German pharmaceutical giant had already received a similar warning from the FDA regarding how it advertised Yasmin and Yaz products, along with a large fine against the company.)
As a probable result of Bayer’s multi-million dollar advertising campaign of its IUD directly to the consumer, by 2009 the use of IUDs implanted in American women using birth control had doubled in just two years (about 7.5 percent of all American women using birth control had IUDs).
In 2010 a joint safety information statement issued by Bayer Inc. and Health Canada stated that women in the US and Canada reported injuries related to use of Mirena. Bayer AG and Health Canada said that uterine perforation is a rare complication associated with all intrauterine contraceptive devices/systems, including Mirena. Perforation occurs at a rate between 1/1,000 and 1/10,000 insertions. The statement was issued because Bayer Inc, had received reports of uterine perforation associated with the use of its device. The statement also noted that the risk of perforation may be increased after pregnancy, during lactation, and in women with atypical uterine anatomy.
Bayer is facing a number of lawsuits by women who have suffered injuries from the Mirena IUD device. For claims involving injuries caused by migration of Mirena and perforation of the uterus, a Multi-District Litigation (MDL 2434) has been centralized in federal court in New York, involving more than 500 lawsuits. Nearly 800 additional lawsuits are pending in state court in New Jersey.
Bayer is facing a number of lawsuits by women who have suffered injuries from the Mirena IUD device. The company has petitioned that all cases be consolidated to the New Jersey Superior Court in Middlesex County, where Bayer is headquartered.
A Pennsylvania woman filed a Mirena lawsuit (Civil Action No. MRS-L-272412) against Bayer Healthcare Pharmaceuticals on November 5th, alleging numerous damages as a direct result of Mirena and Bayer’s wrongful conduct and negligence, including severe and permanent injuries and pain and suffering. Further, the lawsuit is also asking for financial compensation due to lost wages and the decreased ability to earn future wages.
According to the lawsuit, the woman had the Mirena IUD implanted in 2008 but did not experience pain until 2010. In November 2010 a CT scan revealed that Mirena was no longer inside her uterus. She underwent a subsequent laparoscopic surgery to have the device removed.
A Florida woman also claims that the Mirena IUD caused physical and emotional damages. Her complaint (also filed Nov 5th, Civil Action No. MRSL-2723-12) states that she had the Mirena IUD implanted in 2008 and in July 2010 suffered from pelvic pain. She had laparoscopic surgery in December 2010 in order to remove the IUD. The lawsuit alleges that the Mirena caused a number of damages, including severe and permanent physical injuries, pain and suffering, and economic losses in the form of medical expenses and lost wages.
In March 2014 the first Mirena pseudotumor cerebri(PTC) and/or idiopathic intracranial hypertension (IIH)lawsuit was filed in Alabama. A federal judge allowed the lawsuit to proceed after plaintiff Shenika Houston sufficiently claimed negligent design, strict liability, breach of express warranty, and fraud. The lawsuit states that patients who develop PTC might continue to use Mirena because the label does not include warnings about this potential risk. This could contribute to the development or progression of PTC or IIH.
Mirena Pseudotumor Cerebri Lawsuits
In May 2014, Law 360 reported that lawyers, on behalf of plaintiffs, asked a panel of federal judges to centralize nine Mirena lawsuits involving PTC/IIH into an MDL in the U.S. District Court for the Middle District of Tennessee, which is separate from the MDL 2434 (above).
Plaintiffs allege that Bayer failed to adequately warn about the link between the hormone levonorgestrel, present in Mirena, and PTC/IIH. The lawsuits allege that levonorgestrel can elevate levels of cerebrospinal fluid in the brain, which increases pressure in the brain, similar to a tumor.
In September 2015 a Florida woman filed a complaint in the U.S. District Court for the Western District of Tennessee, alleging that Mirena caused her to suffer severe migraines, cognitive problems, vision problems, memory loss and other problems. Nicole Hamill claims that she experienced PTC symptoms just one month after being implanted with the IUD in 2004. Hamill required lumbar punctures to relieve intracranial pressure and had the Mirena IUD removed. However, the punctures do not cure the condition.
All plaintiffs claim that Bayer knew or should have known about the link between Mirena and levonorgestrel and PTC, and Bayer should have provided stronger warnings about the risk of PTC/IIH.
The intracranial hypertension from Mirena often presents as a swelling of the optic nerves, called papilledema. Bayer has included information about the risk of papilledema on its warning labels in several countries, such as South Africa and Hong Kong. It has not given doctors or Mirena consumers in the US the same warning.
Mirena IUD Legal HelpIf you or a loved one has suffered illness or an adverse health event resulting from the use of this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Nov-5-15