Mirena IUD and Pelvic Inflammatory Disease

Countless women have used the Mirena intrauterine device (IUD) to prevent unwanted pregnancies. It is a hormonal birth control device that is inserted into the uterus by a healthcare professional and is left in place for no longer than five years. Its manufacturer, Bayer HealthCare Pharmaceuticals, Inc., had marketed it as a solution for busy moms; however, many women have stepped forward with complaints of pelvic inflammatory disease (PID). Mirena side effects, including PID, perforation of the uterus, and revision surgery to remove the device, have been the subject of thousands of adverse event reports and a growing number of lawsuits.

What is PID?

Pelvic inflammatory disease is an infection of the uterus, fallopian tubes, or other female reproductive organs. It is a bacterial infection that is typically caused by sexually transmitted bacteria that migrate up to the uterus. When the Mirena IUD is inserted, it can cause the transference of bacteria from the cervix to the other reproductive organs. Women are at the greatest risk of these types of Mirena IUD side effects within the first 20 days of receiving the device.

According to the Centers for Disease Control (CDC), about 750,000 women in the U.S. are diagnosed with acute PID every year. Some of those women experience serious complications from PID. About 10 to 15 percent of women become infertile, for example, while others suffer from ectopic pregnancy, a potentially life-threatening condition.

Other potential complications of pelvic inflammatory disease include chronic pelvic pain that may linger for months or even years. This can be caused by the scarring of the fallopian tubes, which results in pain when a woman engages in exercise or sexual activity, as well as during ovulation.

Risk factors for PID

According to the Mayo Clinic, one of the risk factors for the development of pelvic inflammatory disease is the insertion of an intrauterine device, such as Mirena. The CDC recommends testing for sexually transmitted diseases (STDs) prior to the insertion of an IUD.

In addition to this method of birth control, other factors that can increase the risk for PID include:

• Being sexually active
• Being younger than 25 years old
• Engaging in unprotected sexual activity
• Having sex with multiple partners
• Having sex with a partner who has other, multiple partners
• A history of PID or STDs
• Regular douching (which can encourage the migration of bacteria to the reproductive organs)

Signs and symptoms of PID

Pelvic inflammatory disease can cause serious symptoms that require emergency medical care.

Women who have an IUD and experience any of the following symptoms should go to the clinic immediately:

• Fainting and other signs of shock
• A high fever
• Vomiting
• Lower abdominal pain

Other symptoms of PID, which may not necessarily require emergency medical care, can include the following:

• Pain during sexual intercourse
• Pain in the pelvis and lower abdomen
• Pain in the lower back
• Painful urination
• Difficult urination
• A low-grade fever accompanied by diarrhea and vomiting
• Fatigue
• Irregular menstrual cycle
• Abnormal vaginal discharge with a foul odor

Treatment options for pelvic inflammatory disease

Women who seek treatment for PID should notify the doctors if they have a Mirena IUD. Those who have a severe case of PID, or those who are HIV-positive, pregnant, or do not respond to medications, may require hospitalization for the disease. Doctors will administer intravenous antibiotics along with a course of oral antibiotics. Sometimes, surgery may be necessary, particularly if an abscess in the area is at risk of rupturing.

If the symptoms are not as severe and the woman does not have additional risk factors for complications, the doctor will prescribe antibiotics. Patients are also advised to get plenty of rest and instruct their partners to get tested for the bacteria.

FDA warned Mirena manufacturer about infections

Despite these treatment options, many women have suffered permanent complications from pelvic inflammatory disease. Patient complaints to the FDA about Mirena IUD complications such as PID, perforation of the uterus, and infertility have often cited a lack of inadequate warnings about these side effects by the manufacturer.

On December 30, 2009, the FDA sent a warning letter to Bayer regarding its “misleading” advertising campaign. The warning letter notes that the advertisement “omits the contraindications… and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility.”

The FDA warning letter adds further weight to the lawsuit complaints of numerous women that Bayer failed to adequately warn them about the potential risks of pelvic inflammatory disease, along with other significant Mirena IUD side effects, many resulting from spontaneous migration of the IUD device.