Women Injured in ParaGard IUD Removal Considering Legal Claims

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Some women who have had the ParaGard IUD birth control device have suffered injuries from the ParaGard and may have grounds for legal action against Teva Pharmaceuticals, which makes the device.

The problem has occurred at the time of removal of the ParaGard. The device can break apart and this has caused injuries.

The device injury attorneys at Parker Waichman LLP stay up to date on safety information about IUD devices and have represented plaintiffs in IUD injury lawsuits.

IUD Background

The IUD is a long-term, reversible birth-control method that is considered one of the most effective birth control methods. An IUD—intrauterine device—is a tiny device that is inserted in the uterus to prevent pregnancy. The IUD prevents fertilization of the egg by damaging or killing sperm. The device also affects the uterine lining (where a fertilized egg would implant and grow). Once the IUD is inserted, it provides continuous contraception without any action on the woman’s part.

An IUD must be inserted and removed by a health care professional but the procedure is simple and can usually be done in a doctor’s office.

Many doctors check the woman four to six weeks after IUD insertion to make sure the device is properly in place. Women should check for the string of the IUD after every menstrual period to be sure is has not been expelled. If a woman cannot feel the string or the rigid end of the IUD, she should contact her doctor.

There are two types of IUD, copper IUDs like the ParaGard and hormonal ones that slowly release hormones.

The ParaGard is a T-shaped, copper-releasing intrauterine contraceptive device (IUD) that was approved by the U.S. Food and Drug Administration (FDA) in 1984. It is a non-hormonal IUD, an alternative to hormonal IUD devices such as Mirena, Skyla, or Liletta. ParaGard releases copper, which acts as a spermicide, producing an inflammatory reaction in the uterus that is toxic to sperm. This inhospitable environment helps prevent fertilization.

ParaGard Complications

The ParaGard IUD can be effective for up to ten years, but complications can occur at the end of the ten years when a health care professional attempts to remove the device.
“Occasionally, ParaGard may be hard to remove because it is stuck in the uterus,” the ParaGard’s patient instructions explain. “Surgery may sometimes be needed to remove ParaGard.”

In a 2015 report to the FDA, when a woman had a ParaGard IUD removed after eight and a half years, the copper coil was found to be missing from the long portion of the IUD. “Copper was present on ‘T’ arms of device and both arms were intact,” according to the report.

According to ParaGard’s patient instructions pamphlet, potential adverse reactions and injuries from the ParaGard include the device’s embedment in the uterus, perforation of the uterus, pelvic infection, pregnancy, ectopic pregnancy (pregnancy outside the uterus), and septic abortion (infection of the placenta and fetus of a pre-viable pregnancy). When a woman becomes pregnant with an IUD in place, she may suffer miscarriage and her fertility may be put at risk.

A woman may have a legal claim, for example, if she had to undergo a hysterectomy because of injuries or infection caused by the ParaGard, or if the device or fragments have migrated and have punctured or become embedded in the colon or other organs.

The ParaGard is not alone in facing legal action over injuries. The Mirena IUD—approved by the Food and Drug Administration (FDA) in 2000—is a long-acting contraceptive device that prevents pregnancy by releasing levonorgestral, a synthetic form of progestin. When properly in place, the Mirena is supposed to remain effective for up to five years. But women who have used Mirena report complications including uterine perforation, pelvic inflammatory disease (PID), ovarian cysts, irregular bleeding, and amenorrhea (absence of menstruation). Hundreds of women using Mirena have developed pseudotumor cerebri, a condition in which pressure builds inside the skull for no obvious reason. Some 500 women who have brought claims against Bayer over pseudotumor cerebri have asked to have their cases consolidated into a multidistrict litigation (MDL), to allow for coordination of pretrial proceedings.

Legal Options for Injured ParaGard Users

If you or a woman you know has been injure when ParaGard IUD breaks during removal or has suffered other complications, including pregnancy, with the device in place, the experienced attorneys at Parker Waichman LLP can provide a free, no obligation case evaluation. To contact the firm, fill out the contact form to schedule a phone call at your convenience, or you can reach the firm by calling 1-800-YOURLAWYER (1-800-968-7529).