Paragard is a small intrauterine device (IUD) designed to prevent pregnancy. Women have used the device throughout the United States since 1984. Though many women have used it successfully and without complication, that has not been the case for many other women.
Paragard IUD users have experienced many complications from their use, especially when they need to be removed. This has led to significant health problems, including the need to have surgery to remove the device, infections, and other organ damage. As a result of these losses, many women have taken the step of pursuing legal action against the manufacturers of the product, and numerous lawsuits are pending in the U.S. as a result.
If you used Paragard IUD and suffered complications, Join the Many can help you learn if you have a case against device makers. We can provide you with insight into what to expect and how to benefit from taking action.
What Is Paragard?
According to Paragard itself, the device is a small IUD that has only a single active ingredient that works to prevent pregnancy when placed. The manufacturer claims it is 99% effective in preventing pregnancy over time. The device is placed within the uterus by your doctor during a simple office visit. It remains there long term, staying for up to 10 years. At that time, the device needs to be removed. The company states the removal process is simple and straightforward, taking just seconds to complete in a doctor’s office.
The device is made of a soft, flexible plastic material that is wrapped with a very thin layer of copper. The copper wrap is on the base and the arms, which extend in a T shape. These T-shaped ends are positioned in the uterus and hold the device in place. The company states that once it is in place, you should not feel anything.
There are a number of claims about the product, including that it does not use hormones. In fact, the device has been designed as a way to prevent the need to use hormones to avoid pregnancy. The company also claims that it is one of the most effective types of birth control available.
When the device is removed, Paragard states that the effects of the device are immediately reversible, allowing women to get pregnant if they decide to do so. They also state there is no hassle, no routines, and a non-surgical placement for this device, all of which promise that the entire process is very simple and straightforward.
Is Paragard Still in Use?
Yes, healthcare providers are still placing Paragard. It continues to be used as a method for preventing pregnancy in many women. The U.S. Food and Drug Administration has not created any significant warnings not to use the device. It maintains its FDA approved status.
What Is the History of Paragard?
The IUD is not all that new in terms of overall use. These devices have been in development in various ways since the early 1900s. Dr. Ernest Graefenberg created one of the earliest versions of a ring that was designed to fit onto the cervix to prevent pregnancy. In one of his most successful attempts, he used German silver wire that was fused with a mixture of metals, including copper. The device worked and dropped the pregnancy rate as low as 1.6%, according to Reproductive Health Access Project. This device was then used throughout England, though it did not make it to the U.S.
After World War II, the research and development of these products increased. There was a significant amount of development in the devices that worked to reduce the risk of infection. A variety of devices were created and tested for the next few decades.
It would not be until 1988 that the Copper T 380A was designed. This was the Paragard IUD. It was the first and only such device approved by the FDA. Initially, it was approved for use for just four years. However, data from its use suggested it could be continued longer, allowing the FDA to approve its use for a period of 10 years at a time.
In 2001, a competitor in the Mirena IUD was developed and approved. It does not use copper but instead has a levonorgestrel-releasing design. Other products, including low-dose versions of IUDs, have been released and shown to be successful. However, Paragard remains one of the few products on the market that has a high success rate of use that does not use hormones in the treatment.
How Do People Get Paragard IUD?
In order for anyone to have the Paragard device, they must first have a consultation and exam with their doctor. Their physician will explain the process and ensure that it is safe for the patient specifically. From there, the device’s risks are discussed, and if approved by the doctor and agreed upon by the patient, the device can be inserted.
The insertion of an IUD like this occurs in the doctor’s office. It does not require any type of surgical procedure, and there are few complications during the initial positioning of the device for most people. Individuals will be able to discuss their concerns with their doctor before the device is placed.
What Complications Are Women Facing?
While the Paragard IUD has been used for nearly 30 years, there have been instances in which there are risks evident. Some women have experienced numerous complications from the use of the device, specifically when the device is removed.
After 10 years, or sometimes sooner, for women who wish to get pregnant, the device must be removed. Paragard states that this process can be done in a doctor’s office and takes only a few minutes to complete. However, the device may break during the process, or other types of complications may arise, leading to health risks for women.
Some women have suffered injuries as a result of the device. For example, in some women, the device broke during the removal process. As a result of this, the fragments moved around in the uterus and the pelvis and, ultimately, can become lodged in other tissues. Here is a look at some of the most common injuries women have reported to the FDA:
- Perforation of the uterus or the cervix upon removal or insertion of the device
- Inflammation development that causes allergic reactions, specifically when components of the IUD break off and remain in the body
- IUD migration to other tissues and nearby organs, sometimes not possible to be found
- IUD pieces that lodge into surrounding organs, causing damage to them
- Infertility that develops as a result of damage to the area
- Required surgical procedures to remove the device if it is embedded in tissues
- Need for full hysterectomy, laparotomy, or laparoscopy procedures to remove the components, causing a woman to be infertile
- Pain ranging from chronic to severe
- Infection risks often due to the presence of the broken IUD pieces
If you have suffered any injury associated with the use of the Paragard IUD, know that it is possible for you to file a claim against the manufacturers of the device. Join the Many is currently helping women facing complications like these to get help from attorneys who specialize in cases like these.
What Are the Lawsuits Based On?
Many women have filed lawsuits that claim that the product did not do as it was supposed to. While it does have a high pregnancy prevention rate and many women have not experienced complications, there are some women that claim the product failed them.
The most common noted claims in lawsuits against Paragard include the following:
- The Paragard IUD has design and manufacturing defects (that allow it to break during the removal process).
- The company did not label its product properly to discuss any breakage risks with the patient prior to the use of the product.
- The manufacturers are negligent as a result of these claims.
The lawsuits in these cases are focused on two manufacturers. The first is Cooper Surgical, which is the company that first developed the product. Later, Teva Pharmaceuticals purchased the property and continues to manufacture and sell it to the public.
Is Paragard Safe to Use?
It is hard to say that Paragard is safe for everyone as there are known complications to its use. The Cleveland Clinic provides some warnings for women considering this type of IUD. They note that the most common side effects include heavier and longer periods, more painful periods, spotting between periods, or other types of abnormal uterine bleeding.
Some women also should not use the device, they state, because of more severe side effects. That includes those who have pelvic inflammatory disease, a condition in which there is an infection of the uterus or other reproductive organs. This is a noted risk factor from Paragard as well. It is not related to any of the claims made by women filing lawsuits against this product, though.
Additionally, the Cleveland Clinic reports that there are known concerns related to the placement and removal of the IUD device. This could create health complications. These are not warnings initially provided on Paragard products.
They also know that there is a risk for pelvic or other infections to occur, some risk of cancers from the use of the device, and the risk of uterine fibroids or tumors developing in some women. More so, it is still possible for pregnancy to occur, though it is very rare for that to occur.
What Is the Outcome of the Lawsuits Against Paragard?
Paragard lawsuits are still in their early stages. There have been many women that have come forward and filed claims in circuit courts around the U.S. Many of those women have claimed product liability and negligence against the manufacturers of this product.
Because so many lawsuits have been brought against the manufacturers due to the Paragard failures and breakage concerns, a Multidistrict Litigation panel was developed. This means that the courts will compile all of the claims in the region into one larger case. In this case, in December 2020, the Judicial Panel of Multidistrict Litigation established the MDL with Judge Leigh Martin, who oversees the Northern District of Georgia.
As of this time, the process is very much in its early stages. There have been no cases that have gone to trial, though it is expected that the early cases will begin being processed within the coming year. This could set the stage for additional claims as well as settlements with the manufacturers.
No settlements have been awarded just yet, but there are numerous claims against them that could push the manufacturers to decide to settle.
What You Can Do Now
If you suffered losses like those described here, especially during the removal of the Paragard device, reach out to Join the Many.
If you have a qualifying case, we’ll handle everything from gathering medical records to matching you with the best legal care for your situation. You’ll pay no legal fees unless you’re awarded compensation.