Mirena (Bayer Healthcare Pharmaceuticals product) is a levnonorgestrel-releasing intrauterine contraceptive method which received FDA approval in 2000. Mirena IUS (intrauterine system) has been associated with severe side effects, which include perforation and migration into the abdominal cavity, abdominal organs, bladder and intestines. Extrauterine migration of an IUS can cause serious and fatal injury in various ways:

  • Perforation of the uterine wall, abdominal cavity, rectum, and the intestinal area
  • Embedment in the uterine wall and cervix
  • Fetal reproductive organ abnormalities (lesions and infections)
  • Fetal injuries leading to birth defects
  • Infertility

At Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP, we help people who have been harmed by Mirena Intrauterine Sytem (IUS). We litigate your case and do not refer the case to other firms. Our firm's founder, Paul Rheingold, was a leading trial attorney for the Dalkon Shield litigation in the 1980s, with David Rheingold handling Dalkon Shield mediations. If you or a family member has been impacted by Mirena product, our experienced attorneys are here to help.

Contact us today online or by telephone at 888-335-9457 to speak with a knowledgeable New York product liability lawyer. You will be able to talk to someone in our birth control litigation department. If you would prefer to speak with a female partner, please ask for Sherri Plotkin.

Mirena Complications

In the FDA adverse event reporting database, Mirena has a higher incidence of embedment and perforation than similar devices. If the Mirena string is absent and you have not witnessed the device being expelled, there is a high probability that the device has perforated your uterus or become embedded. Healthcare providers who are not aware of migration problems do not order a sonogram, x-ray, or CT scan to confirm the location.

In Canada, Bayer has sent doctors letters stating that Mirena can at any time during its use. However, Bayer has not done so in the United States. In fact, in this country doctors are only warned that embedment and perforation are associated soley with the insertion process.

Embedment and Perforation: Mirena Dangers

Embedment and perforation of Mirena may not present any symptoms. Some women, however, may experience irregular bleeding, pelvic pain, nonvisible strings, and abnormal heavy cramping. On examination, if the string is not visible, gynecological consultation is recommended. Testing by your doctor may include:

  • Radiological testing (X-Ray)
  • Transabdominal ultrasound
  • Transvaginal ultrasound (TVUS)

If the IUS is seen via any of the methods mentioned above and the position is determined, surgical intervention may be needed.

Our attorneys will work with you personally to determine how this product has impacted your life and what legal remedies are at your disposal. We have been serving the legal needs of people from New York and across the nation for over 30 years. We understand the hardships you are facing and are prepared to help.

Mirena causing Pseudotumor Cerebri (PTC)

In addition to lawsuits for perforations and emblements, Bayer Pharmaceuticals is facing potential litigation for failure to update its warning label with the serious side effect known as PTC.

PTC, also referred to as idiopathic intracranial hypertension (IIH), literally means "false brain tumor." Mirena may cause PTC via levonorgestrel, its main ingredient. When left unchecked by another hormone, levonorgestrel can cause cerebrospinal fluid buildup, which causes high pressure within the skull. PTC symptoms include:

  • headaches and migraines,
  • ear ringing,
  • nausea, vomiting, dizziness
  • range of vision impairments, and
  • neck, shoulder or back pain.

While the FDA has issued warnings about an increased risk of PTC with other products containing levonorgestrel, they have yet to issue one specifically for Mirena.

Contact Us for a Case Evaluation

At Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP, we have extensive experience handling mass tort and individual medical device liability claims. We are currently investigating cases involving the Mirena Intrauterine System, manufactured by the Fortune 500 Company, Bayer Healthcare Pharmaceuticals. We are currently litigating and settling a significant number of claims involving Bayer's Yaz and Yasmin birth control pills

Have you or someone close to you been harmed by Mirena? Please contact us today online or by telephone at 888-335-9457 to speak with an experienced New York medical device recall lawyer. Our law office is conveniently located in a brownstone in Midtown Manhattan located at 113 East 37th Street.

For more information, please visit our drugs and medical devices information center.