Mirena IUD Pseudotumor Cerebri Lawsuit Claims Implant Caused Migraines, Vision Problems
Bayer Healthcare faces a new product liability lawsuit involving allegations that side effects of the Mirena IUD caused a Pennsylvania woman to suffer a serious and dangerous build up of cerebral fluid around her brain, known as pseudotumor cerebri (PTC).
The complaint (PDF) was filed by Brittany Greco in the U.S. District Court for the District of New Jersey on February 15, indicating that she suffered severe migraines, vision problems and other complications after receiving the long-acting birth control implant.
The case is one of a growing number of pseudotumor cerebri lawsuits filed by women who received a Mirena implant, alleging that Bayer failed to adequately warn about the risk that levonorgestrel released by the T-shaped implant may cause the sudden buildup of pressure on the brain, which is sometimes referred to as idiopathic intracranial hypertension (IIH).
Greco is a 31 year old woman from Brackenridge, Pennsylvania, who indicates that she experienced PTC/IIH problems from Mirena after she received the implant in April 2009, suffering symptoms like migrains and pressure headaches associated with visual obscurations, including loss of peripheral vision and sensitivity to light.
In May 2012, Greco indicates that she sought treatment for these vision problems and was diagnosed with papilledema, which involves swelling of the optic nerves. A subsequent MRI and MRV examination of her brain ruled out intracranial abnormalities, and she underwent a diagnostic lumbar puncture for the headaches and vision problems, which ultimately led to a diagnosis of pseudotumor cerebri.
Intracranial hypertension develops when cerebrospinal fluid levels become elevated. This causes increased pressure in the skull, acting like a tumor. Victims develop severe migraines, double vision, temporary blindness, and other vision loss symptoms. They often develop swelling of the optic disk, and ringing in the ears known as tinnitus.
As a result of Bayer’s alleged failure to adequately warn about the link between Mirena and pseudotumor cerebri, most doctors were unaware that the birth control implant may be a potential cause of migraines, vision problems or a build up of pressure around the brain. Greco indicates that her Mirena IUD was not removed until March 2014.
“Defendants knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel causes and/or contributes to the development of IIH/PTC, a severe and possibly irreversible brain condition that can also lead to permanent blindness,” according to the complaint. “Despite an increasing number of adverse events, including reports of intracranial hypertension, blindness, papilledema and increased intracranial pressure, Defendants have made no effort to warn physicians, the healthcare community, or patients of the risks of developing IIH/PTC with Mirena.”
Mirena is an increasingly popular form of long-acting birth control, allowing women to avoid pregnancy for up to five years without needing to remember to take a daily pill. However, a number of women have reported experiencing a number of different complications from Mirena. In addition to problems with pseudotumor cererbri, Mirena has also been linked to reports of the IUD perforating the uterus or moving out of position, causing severe internal injuries for many women.
In several other places around the world, including South Africa and Hong Kong, Mirena warning labels include information about the risk that papilledema as a possible side effect of Mirena. However, Bayer has not given women in America or the U.S. medical community the same warning.
Amid a growing number of Mirena pseudotumor cerebri cases filed throughout the federal court system, a request was filed last year with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize the cases before one judge. However, that request was rejected, so Greco’s claim and others filed by other women are proceeding without coordinated pretrial proceedings.
There is a separate multidistrict litigation (MDL) established for Mirena migration injury lawsuits, which currently includes about 4,000 complaints pending before U.S. District Judge Cathy Seibel in the Southern District of New York, where a small group of “bellwether” cases are being prepared for early trial dates.
LaurenMay 2, 2016 at 1:05 am
I have a pituitary tumor. I was diagnosed w it 3 years after having the mirena IUD placed. It's been hell. And I have an appointment next week to have the second mirena IUD removed. (I've used this IUD since 2008, and had it changed after 5 years per recommendations)
KrystinMarch 7, 2016 at 2:56 am
I had problems the entire time I had the mirena. I would tell my doctor at the time and he'd say there was nothing wrong. I got migraines constantly and I was seeing a neurologist for them and got diagnosed with chronic migraines. I was getting about 25 a month some would stay for 3 days at a time. I couldn't walk or see straight. I was constantly in pain and dizzy. Not to ,metion the pain I got f[Show More]I had problems the entire time I had the mirena. I would tell my doctor at the time and he'd say there was nothing wrong. I got migraines constantly and I was seeing a neurologist for them and got diagnosed with chronic migraines. I was getting about 25 a month some would stay for 3 days at a time. I couldn't walk or see straight. I was constantly in pain and dizzy. Not to ,metion the pain I got from sexual relations with my husband. I got the mirena in 2011 after my son was born in 2010. I kept it for almost 3 years until I switched doctors and he told me that I needed to have it taken out. He didn't trust the mirena with his patience. I still today have some issues because of the mirena. I didn't before my doctor told me it was supposedly safe.
KarenMarch 2, 2016 at 11:55 pm
Mine started when I woke from surgery after a total hysterectomy at age 33, and I was placed on the hormone replacement patch
"*" indicates required fields
More Top Stories
A ProPublica report reveals that Philips officials hid thousands of reports of problems with sound abatement foam used in millions of CPAP machines, failing to recall the devices for more than a decade after receiving the first complaints.
A Suboxone lawsuit claims the opioid addiction treatment's dental side effects can lead to severe tooth damage and decay.
The FDA is requiring new label warnings to alert patients and doctors to the risk of Ozempic intestinal blockage side effects.