New York Product Liability Litigators
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
At Rheingold Giuffra Ruffo & Plotkin LLP, we help people who have been harmed by Mirena Intrauterine Sytem (IUS). Our firm's founder, Paul Rheingold, was a leading trial attorney for the Dalkon Shield lawsuits during the 1980's, with David Rheingold handling Dalkon Shield mediations.
Our team of New York dangerous medical device lawyers are here to help. Call (888) 260-0473 for a free consultation.
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.
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.
Mirena causing Pseudotumor Cerebri (PTC)
In addition to lawsuits for perforations and embedments, 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.
Call in an experienced legal team
Due to the serious injuries associated with Mirena, it is never advisable to press charges without having an experienced New York defective medical device attorney at your side. The creators of Mirena have a wealth of resources at their disposal to dismiss injury claims, but the team at Rheingold Giuffra Ruffo & Plotkin LLP has been fighting big pharmaceutical companies for years.