Mirena (Levonorgestrel) IUD Device
The Mirena IUD is a long-term contraceptive with an extremely high effective rate. It has also been linked to reproductive organ injury and cranial pressure that can cause permanent vision loss.
Mirena is a small, plastic second-generation intrauterine device that uses the progestogen hormone levonorgestrel to prevent pregnancy. It is manufactured by German pharmaceutical company Bayer.
Intrauterine devices for contraception were first developed as silver rings in the 1920s and copper implants in the 1960s. Scientists then discovered hormonal alternatives beginning with the progestasert in 1976. Dr. Jouni Luukkainen of Finland created the t-shaped Mirena IUD in the late 1980s.
Mirena was first introduced in 1990 and approved by the FDA for use in the United States in 2000. The device releases a regulated 20 micrograms of levonorgestrel directly into the uterus each day for 5 years, compared to birth control pills that release 150 micrograms per day.
Mirena IUD Showing Strings
Mirena is implanted by a doctor or nurse during an outpatient office visit, and must be monitored for some time with follow-up visits. Normal removal of the device also requires the help of a medical professional.
While Bayer claims Mirena is effective for up to 5 years, research has suggested it may retain prevention for as many as seven.
The hormone levonorgestrel in Mirena works by preventing the survival and penetration of sperm, thickening mucus in the cervix, and reducing endometrium. It can also cause some patients to stop ovulating.
With an effective rate between 99.3% and 99.8%, Mirena can prevent pregnancy as well as tubal sterilization.
In addition to contraception, Mirena may be prescribed to treat excessive menstrual bleeding, thickening of the uterus, pain in the pelvis or pain during menstruation, endometriosis and low red blood cell counts.
Unfortunately, reports have linked the device to uterine wall perforation and a rare cranial hypertension disorder called PTC that can cause headaches, hearing problems and vision loss. Lawyers have helped many of those affected file lawsuits.
Clinical trials have shown women who use Mirena may be more likely to develop certain side effects. These include:
In addition, the device is not recommended for women who may be pregnant, breastfeeding, have vaginal bleeding or inflammation, have cervical, uterine or breast cancer, liver disease, certain STDs or a recent abortion.
In recent years, experts have also warned of more serious Mirena side effects like uterine wall perforation that may require surgery, and a rare neurological disorder called PTC that can cause migraines, blindness and hearing problems.
Thousands of patients have reported these adverse Mirena side effects to the FDA’s MedWatch reporting program, and many have filed claims for compensation in special federal drug injury courts.
The hormone levonorgestrel in Mirena has been associated with a neurological condition called pseudotumor cerebri that causes increased fluid levels in the skull. The resulting pressure can produce ongoing headaches, optic pressure and ringing in the ears.
Pseudotumor cerebri, or PTC, is also known as idiopathic intracranial hypertension (IIH). It is caused when cerebrospinal fluid is not released or adequately absorbed. The name “pseudotumor” denotes the condition’s similarity in symptoms to a brain tumor.
If not properly treated, the increased optic pressure associated with PTC/IIH can cause vision problems that range from temporary to permanent.
Common symptoms of Mirena PTC may include:
Those implanted with a Mirena IUD that have experienced any of these symptoms should consult a doctor immediately.
PTC can be diagnosed with a lumbar puncture, or spinal tap, to measure fluid levels in the skull. However, this is usually only done after a tumor is ruled out with an MRI or CT scan. If PTC/IIH is not correTreatment is often done with the insertion of tubes in the spine or skull to drain fluid, called shunts. A brain stent may also be beneficial.
Although PTC/IIH is rare, women who use contraceptives with levonorgestrel are more likely to develop the condition. Experts believe this synthetic hormone may cause an increased risk of vision problems for those with the IUD. Also, weight gain, a common side effect of Mirena, may increase the likelihood of PTC/IIH.
Lawyers have helped those affected by PTC or intracranial hypertension after using Mirena file lawsuits. For more information or to speak with a lawyer about your situation, contact us today.
For years, doctors have cautioned that the hormone levonrogestrel used in Mirena may be linked to increased cranial pressure and the condition pseudotumor cerebri (PTC). In fact, the contraceptive implant NorPlant, sold from 1990-2002, warned of the possible side effect. However, most don’t know of a potential Mirena blindness risk.
Mirena Has Been Linked to Vision Problems
One of the most severe effects of PTC is pressure on the optic nerve that can cause blind spots, blurred vision, double vision and temporary blindness. Without quick and adequate treatment, patients can also experience some permanent vision loss.
Even with treatment, it can take an extended time for the cranial pressure from PTC to return to normal, and the condition can reappear throughout a patient’s lifetime.
So far, there is limited research on the Mirena blindness risk that may be present from intracranial hypertension. However, the condition has been linked to the active ingredient levonorgestrel, as well as weight gain, a common Mirena side effect.
If you have experienced any vision problems or headaches while using Mirena, it is important to see a doctor immediately.
The t-shaped Mirena is designed to sit comfortably in the uterus with no effect on surrounding reproductive tissue. However, reports show many may be at risk for tearing or movement of the device.
Mirena Perforation Requiring Surgery
The FDA has added warnings to Mirena that the procedure required for implantation can in rare cases puncture a patient’s uterine wall. While the product does not mention a risk of perforation over the remaining five years of use, this may also be a danger.
A study from the United Kingdom found that 60% of patients discontinue use of the Mirena IUD before five years due to side effects.
The Society of Laparoendoscopic Surgeons has also cautioned that Mirena IUDs can dislocate and perforate internal organs after insertion.
According to FDA records, the agency has already received 70,072 adverse event reports of patients suffering complications while using Mirena, with as many as 6,000 involving device dislocation or Mirena uterus perforation.
IUD perforation can cause damage to reproductive organs, or in rare cases it may pass into the abdominal cavity. Often, victims need painful surgery to have the device removed and repair the harm.
If you or a loved one have suffered Mirena uterus perforation, you may be eligible to join hundreds of victims in ongoing litigation in a special Mirena federal court. Contact us today for more information or to speak with a lawyer.
So far, more than 600 women have filed lawsuits alleging they suffered reproductive organ tearing while using the Mirena IUD. The lawsuits claim the manufacturer, Bayer, failed to properly test for these risks, did not warn patients, and sold a dangerous and defective product.
In most cases, victims underwent abdominal surgery to have the IUDs removed and repair damage. These lawsuits have been consolidated to a special multidistrict litigation court and are awaiting trial.
In addition, several cases have also been filed this year in federal court alleging patients suffered blindness or vision problems from the neurological condition PTC while using Mirena. A federal panel has scheduled a hearing to determine if these claims will be combined into one central Mirena court.
For now, lawyers continue to help new patients that have been injured file claims and join the litigation.
Although no verdict or settlement has been reached, those affected may be entitled to substantial compensation to cover their medical expenses, lost time, future needs and pain and suffering.
For more information, or to speak with a lawyer, contact us today.