Uterine Perforation by Mirena IUD

Mirena is a long-term method of birth control that works by slowly releasing hormones in the body. Bayer marketed Mirena aggressively following the approval of the plastic intrauterine device (IUD) in 2000. Though a popular choice of contraception among women, serious Mirena IUD side effects have been reported including uterine perforation and puncture of other organs.  Patients nationwide have filed claims against Bayer, and federal lawsuits have already been consolidated as part of a multidistrict litigation in the Southern District of New York.

Side effects from Mirena IUD

More than 45,000 reports of problems with the Mirena IUD have been made to the Food and Drug Administration through the agency’s Adverse Event Database.  The most serious of the complaints allege that the device has perforated the patient’s uterus, causing significant pain and potentially fatal infection.

Perforation of the uterus can occur when the Mirena IUD device is being inserted. The device can also migrate in the body over time, eventually piercing the wall of the uterus. When the perforation occurs during insertion, symptoms may not become apparent right away and the patient may not be aware of the complication until weeks or months later when severe pelvic pain and cramping begin.  When the perforation occurs as a result of the migration of the Mirena IUD, the complications may not occur until the device has already been implanted in the body for years.

The perforation may also be either partial or complete, depending on the circumstances:

• When only part of the IUD device is lodged in the uterine wall, this is called partial perforation
• Complete perforation occurs when the whole IUD is able to puncture the wall of the uterus and migrate outside of the uterine area into a fluid-filled body cavity that divides the organs and abdominal wall.

While complete perforation is much more serious, acute and partial perforation may have similar symptoms. Patients may become aware that their IUD has perforated their uterus either completely or partially when they begin experiencing symptoms.

Common symptoms of uterine perforation may include:

• Pelvic pain, especially severe or extreme pain
• Pain in the lower abdomen
• Exhaustion
• Bloating
• Unplanned pregnancy
• Vomiting or nausea
• Chills
• Fever
• Irregular periods or unusually heavy menstrual bleeding
• A rapid heart beat

Surgical removal of the IUD device typically becomes necessary when uterine perforation occurred.  Unfortunately, multiple surgeries may be required to locate the device in the body so it can be removed.

Physicians may also be unaware that the symptoms the patient is experiencing are caused by device migration, thus delaying treatment. In one documented case, a patient was misdiagnosed multiple times and underwent multiple invasive surgeries before the problems with the IUD were finally discovered.

Complications from uterine perforation

Surgical treatment for uterine perforation must be provided promptly to reduce the risk of potentially life-changing complications for women.

Potential complications of delayed treatment include:

• Scarring of the uterus
• Tearing of the uterus
• Perforation of organs
• Bleeding or hemorrhaging
• Infection
• Miscarriage
• Infertility

Other problems caused by Mirena

While perforation of the uterine wall is often cited as the biggest cause for concern with Mirena use, there are also other potential complications may arise with method of birth control.

Other reported side effects  of IUD use include:

• Abscesses
• Erosion of the IUD into the uterus
• The IUD becoming embedded in the uterine wall
• Pelvic inflammatory disease (PID)
• Ectopic pregnancy
• Scarring

Mirena may also “wander” in the body, migrating even outside of the uterus to affect other body systems. A 2011 study in the Journal of Laparoendoscopic Surgeons reported on cases where the device migrated to the patient’s abdomen and where the device migrated to an area close to the diaphragm called the peritoneal cavity.    Laparoscopic surgery to remove the device became necessary for the patients.

Mirena lawsuits could hold Bayer accountable

Patients who underwent surgery or who needed other treatment because of complications may have a claim for damages against Bayer.   Many women have already taken action and filed a lawsuit to recover compensation for their losses, including medical bills, lost income and pain and suffering.  Because multiple cases are pending against the drug company, federal claims have been consolidated into a multidistrict litigation to expedite pretrial procedure.

The petition to consolidate all federal Mirena lawsuits was filed by plaintiffs in January of 2013 and the MDL was formed in the Southern District of New York in April of 2013.  The MDL initially involved 40 cases though additional plaintiffs have continued to come forward, adding to that number.

Companies that manufacture dangerous devices may be held liable for the damage caused by their products.  Patients who experience uterine perforation or other serious Mirena side effects can obtain compensation for losses if they can prove the device caused their harm and that the maker of the IUD was indeed negligent.  Mirena IUD lawsuits typically allege breach of warranties, defective design and manufacture, strict liability, and derivative loss of consortium actions filed by spouses.

Those who feel they meet the criteria to file a lawsuit against Bayer, should contact a Mirena lawyer to discuss their experience and legal options.

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