What Are The Risks of ParaGard? ‹ ParaGard Lawsuit ›

Although ParaGard is considered a safer alternative to hormonal birth control, which is infamous for increasing the risk of blood clots, it does not come without some risks [1]. Here, we provide a description of some of the risks associated with the use of ParaGard. The U.S. Food and Drug Administration (FDA) acknowledge these following risks [2]:

Pregnancy and Pregnancy-Associated Risks of using ParaGard

ParaGard is not 100% effective in preventing pregnancy, but it is pretty close. Less than 1% of women who use ParaGard will become pregnant. In the rare case that pregnancy does occur, the pregnant woman is at high risk of having an ectopic pregnancy. This means that the fertilized egg does not implant (adhere) itself in the uterus like in a normal pregnancy. Instead, in an ectopic pregnancy, the fertilized egg usually implants itself in the fallopian tubes (uterine tubes that connect the ovaries to the uterus). About 6-9% of the pregnancies that do occur in women with copper IUDs (such as ParaGard) are ectopic. However, the risk of ectopic pregnancy in women using ParaGard is lower than the risk of ectopic pregnancy in sexually active women who are not on ParaGard [3].

If a normal pregnancy (intrauterine pregnancy) does occur, ParaGard should be removed. This is because the presence of ParaGard is associated with an increased risk of preterm labor (which can result in premature birth), and a heightened chance of a miscarriage (spontaneous abortion). However, removal of ParaGard may also cause spontaneous abortion. Studies have shown that 27% of pregnant women with copper IUDs have a miscarriage when the IUD is removed, but 77% of women with copper IUDs have a miscarriage if the UD is left inside the uterus [4].

Women on ParaGard with an intrauterine pregnancy are also more susceptible to septic abortion (infections of the placenta and fetus). This infection can spread to the uterus and become systemic (when infection is carried in the blood to the whole body). This is referred to as “septicemia” and can lead to septic shock (organ failure and low blood pressure) and even death. If the infection is severe, hospitalization is required. Sometimes, a hysterectomy (surgery to remove the uterus) may also be required. This results in a permanent loss of fertility.

Severe Infections Not Associated with Pregnancy

Sepsis can also occur after the initial insertion of ParaGard. The infection can involve bacteria known as Group A Streptococcus. This infection causes Group A Streptococcal Sepsis (GAS) which can be deadly and must be addressed as early as possible. GAS usually occurs if the ParaGard, or any of the supplies and equipment used for the initial insertion of the ParaGard, were contaminated before the insertion procedure.

Perforation of Uterus or Cervix

Sometimes ParaGard can perforate (puncture) the wall of the uterus or cervix (lowest part of the uterus that connects the vaginal canal to the uterus). This can occur during the insertion of ParaGard. The risk of perforation is greater in women who are lactating. The risk of perforation is also increased if ParaGard is inserted when the uterus is retroverted (tipped backwards) or has not completely returned to normal after a woman has given birth— a process called “involution”.

Perforation can decrease how effective ParaGard is in preventing pregnancy. Once a perforation is detected, ParaGard must be removed. Surgery may be required to remove ParaGard once it punctures through the uterus.

If perforation is not detected ParaGard can move out of the uterus and cause further complications by puncturing nearby organs. This is a serious risk as it can lead to peritonitis (inflammation of the abdomen), punctured intestines, intestinal blockage and accumulation of pus (known as abscesses).

Pelvic Inflammatory Disease (PID)

ParaGard has been associated with an increased risk of developing PID. PID is known to have serious consequences when left untreated. It can result in sepsis and even death. If PID does not progress to death, it can damage the fallopian tubes which can lead to ectopic pregnancies. Untreated PID may ultimately require a hysterectomy. Again, this results in permanent loss of fertility. Unfortunately, PID is sometimes not caught in a timely manner because some people do not present any symptoms.

Expulsion of ParaGard

Some people expel (naturally drive out of the uterus) the ParaGard IUD. Sometimes, the expulsion is not even felt. Expulsions are more likely to happen if the person using ParaGard is under 25 years of age, has been pregnant, had ParaGard inserted immediately after childbirth, has prolonged or heavy periods, has previously expelled other IUDs, or usually experiences severe pain during menstruation. Expulsion results in no protection from pregnancy.

No Protection from STIs

Another risk associated with the use of ParaGard is that it does not protect against sexually transmitted infections (STIs). For this, a barrier method of contraception (birth control such as a condom) is recommended. Since STIs can cause PID, it is important for women who have had PID to know that they are at higher risk of re-infection.

Copper Excretion

ParaGard is an IUD covered in copper. The copper is what gives it its contraceptive qualities. Wilson’s Disease is a genetic disorder that prevents proper copper excretion (the process of eliminating) from occurring in the body. Due to this, people with Wilson’s disease accumulate toxic amounts of copper in their body. ParaGard may worsen the condition of women with Wilson’s Disease.

The Unknown Risks

It is currently not known if ParaGard is genotoxic (causes damage to genetic information in cells) [5]. Genotoxicity can result in cancer.

It is also unstudied if ParaGard can lead to birth defects.

Overall, it is important to understand the known risks associated with ParaGard before deciding to use it as a form of birth control.

Frequently Asked Questions:

Is the copper in ParaGard safe or can it be toxic?

The amount of copper in ParaGard is safe for people who do not have copper allergies or issues eliminating copper. However, ParaGard may not be a good option for people with conditions that prevent their bodies from naturally eliminating copper.

Is there still a chance I could get pregnant while using ParaGard?

Yes. However, the chance of conceiving while using ParaGard is smaller than the chance of conceiving on oral contraceptives.

Can ParaGard cause infections?

Yes. Although the chances are slim, the use of ParaGard may result in severe infections that can have lasting consequences such as infertility.

References:

What Are the Risks of ParaGard?