The use of contraceptives has been prevalent over time. Most women are looking for the most advanced and efficient ways of controlling birth as companies continue to reveal different ways and equipment to meet this expectation. One of the most effective contraceptives that have been used over time is the intrauterine device, commonly known as IUD. Not all IUDs are effective as expected since some can lead to complications. We at the Consumer Alert Now are at the forefront of identifying and educating contraceptive users on the risks that might come with defective Paragard IUDs and how you can join a mass tort if you are injured by these devices.

Understanding How Intrauterine Devices Work

About 15% of all women in the world within the productive age use IUD as their primary form of birth control. The wide preference for this type of birth control is its effectiveness and durability. A good copper IUD insertion can last up to ten years unless the user experiences some complications.

Intrauterine devices are also known as coils and intrauterine contraceptive devices (ICD or IUCD). It is a small t-shaped birth control device that is inserted into the uterine of a woman to prevent pregnancy. Most coils are made out of copper as a mechanism to prevent fertilization.

Types of IUDs

There are several types of IUDs available in the market. They go by different names, but in the United States, only two models are available. These types include: 

  • The non-hormonal types that contain copper. Paragard is the primary manufacturer of these types of IUDs in the United States.
  • Progestogen-releasing IUD manufactured by Mirena and other companies.

How the Non-Hormonal Intrauterine Device Works

The non-hormonal coils have a pure electrolyte copper wire wound on a T-shaped plastic device that is inserted inside the uterus. The copper works as a spermicide by increasing copper ions, white blood cells, and prostaglandins inside the tubal fluids and uterine walls. Essentially, they disrupt the motility of the sperms by preventing their joining with the egg. The copper can also alter the endometrial lining, although studies have revealed that it cannot alter an egg that has already been implanted.

Advantages of Using Copper IUDs 

There are several advantages that copper IUDs have over other types of contraceptives. These benefits are as follows:

  • Their level of effectiveness is estimated to be more than 99%
  • They are usable by breastfeeding women
  • They can last for a long duration. Paragard IUDs can last for ten years
  • No medication affects their working
  • They can allow another contraceptive choice if one finds it difficult to take the hormone estrogen.
  • Require less attention. Once it has been placed inside the uterus, the only thing that a user should do is check the thread every month after the periods to confirm whether it has moved from its position or not
  • The possibility of getting back to normality is retained after the copper coil has been removed
  • The devices can be withdrawn at any given time as long as it is done appropriately by an experienced doctor or nurse
  • There is no need to interrupt sex for contraceptives while you have an IUD
  • Usable as an emergency contraceptive if inserted within a five-day window after indulging in an unprotected sex

Paragard IUDs

Paragard is an American copper intrauterine contraceptive that is made out of soft, flexible plastic that is wrapped with a copper layer. As learned earlier, it is one of the common copper coils that is widely used in the United States. The ParaGrad T-380A is the trademark copper-containing IUD that has been approved by the Food and Drug Administration ( FDA).

As required by the FDA, every manufacturer should publish information about its products once it is released in the market. The information about ParaGrad T- 380A is as follows:

Preparing For IUD Insertion

Paragard can be used anytime during the menstrual cycle. However, women who have just gone through delivery are recommended to wait for eight weeks following the delivery.

The healthcare provider should assess your pelvic and overall health before the insertion. The healthcare provider should also do a parturiency test and screen for STIs as well. You can take a non-inflammatory medication such as Motrin IB, ibuprofen, and Advil an hour or two before the insertion to reduce cramping.

Expectations

There are a couple of experiences that come along with the IUD insertion. This is experienced during and after the procedure. These experiences are as follows:

During the Insertion

The healthcare provider will place a reflector into your vulva to clean it using an antiseptic solution. One might also use a unique instrument to align the cervical canal as well as the uterine cavity. As soon as the doctor is done with the alignment, he or she will fold the horizontal arms of the Paragard and place it inside a seamer tube.

The doctor will insert the applicator tube inside your vagina and ensure that the device is placed carefully inside the uterus. When the healthcare provider removes the applicator, the Paragard will stay in its position. The doctor will then trim the device’s string to ensure that it does not stick out too far and record its length as well.

While the device is being inserted, you might experience dizziness, hypotension, nausea, fainting, and slow heart rates. Your healthcare provider should recommend that you lay down for a couple of minutes to let the side effects pass. It is rare to experience perforation of the uterine walls during the insertion. However, if such an experience occurs, you should discuss the right management process with the doctor.

After the Insertion

In about a month following the insertion, the healthcare provider might request a re-examination of the device to check whether it is still in place and any infections. It is recommended to seek professional healthcare intervention if you experience the following: 

  • Signs and symptoms associated with pregnancy
  • Foul odor discharge from the vulva
  • Severe pelvic pain
  • Unexplained fever
  • STI exposure
  • Severe tenderness and pain in the abdomen

You should also contact your healthcare provider if you perceive that the IUD is not in place. Some of the things that should prompt you to call your healthcare provider include: 

  • The string suddenly misses or seems to be longer
  • Feel as if the device is at your cervix or vagina
  • Sex turns out to be painful for either you or your partner
  • You experience bleeding after sex or breakthrough bleeding

In such a situation, your doctor will check the position of the device and withdraw it when necessary.

Removal of Paragard IUD

ParaGrad is supposed to be withdrawn in a doctor’s office. The health practitioner will utilize forceps to get hold of the device’s string and pull it gently. This will force the device’s arm to fold upward while it is removed from the uterus.

Patients might experience light bleeding during the removal, but there are fewer chances of adverse complications after this.

Possible Side Effects and Adverse Reactions of Paragard IUD

There are several side effects and reactions that Paragard users can experience. These effects are explained below.

Intrauterine Pregnancy

Intrauterine pregnancy is a gestation sac that has the fetal pole or the yolk sac. In such a situation, the IUD should be removed immediately to avoid the risk of spontaneous pregnancy, septic shock, premature delivery, and in rare cases, death. Removal of the device will result in a pregnancy loss, but it is much safer at this point compared to having one at an adverse stage.

If the Paragard string is not visible, and the user decides to keep the pregnancy, doctors are advised to take an ultrasound on the patient. The doctor should further warn the woman about the risks that will follow and remove the IUD as soon as possible.

Ectopic Pregnancy

If a woman gets pregnant with Paragard IUD in place, one will likely experience an ectopic pregnancy. This kind of pregnancy is quite different from the normal one. However, since Paragard is meant to prevent pregnancy, the chances of having an ectopic are at the lowest rate.

Pelvic Infection

Pelvic inflammatory disease is uncommon with IUD users. However, it still stands to be a risk that should not be taken lightly. Pelvic inflammatory disease, also known as PID, usually occurs twenty days after the insertion. In that case, the first visit that you make after the menstrual insertion period should be the perfect opportunity to assess the possibility of infection. Pelvic infection is usually associated with women with a high risk of acquiring sexually transmitted infections. So, such women should avoid its usage.

There are serious consequences that result from PID. This includes tubal damage, sepsis, hysterectomy, and in rare cases, death. So, a woman should assess and treat any developing signs or symptoms of a PID as soon as possible.

Immunocompromise

Women with AIDS should not consider using IUD unless they have a stable antiretroviral treatment. Some data have shown that asymptomatic women can use the Intrauterine device despite having HIV. Also, there is little data about the illness that might lead to serious immunocompromise. Therefore, any consideration for an IUD insertion to such people should be carefully decided and given similar attention to the risk of pregnancy.

Embedment

If the IUD partially embed, it can cause difficulty during its removal. In severe situations, it might require surgical removal if found necessary to do so.

Perforation

Perforation of the cervix might happen partially or totally. It is hard to detect such instances, but it is usually detected at a later stage. There are also reports of spontaneous migration. Once perforation is confirmed, the IUD should be removed immediately since the copper winded in the T-frame can cause an intraperitoneal adhesion.

The user might end up experiencing intestinal obstruction and intestinal penetration if the IUD is left in the peritoneal cavity. In such a situation, one should undertake pre-operative imaging followed by laparotomy to remove the IUD from the peritoneal cavity.

Expulsion

An IUD patient can experience expulsion during the menses and in the first few months following the insertion. There are high chances of expulsion for nulliparous patients. If this condition is unnoticed, the user might end up pregnant.

Wilson’s Disease

Paragard can lead to Wilson’s disease, but in rare cases. This is a rare genetic disease that results from the copper excretion.

Other factors can lead to adverse reactions to the Paragard. This include: 

  • Having an abnormally shaped uterus
  • An allergy to anything in Paragard
  • Have an infection of the cervix or uterus
  • Pregnancy
  • Having unexplained bleeding in your vaginal

Complications Associated with Paragard IUD

Besides the wide preference for IUDs in birth control, there have been a couple of complications associated with its usage. The FDA had formerly warned against the use of IUDs by providing the possible risks and adverse reactions provided above. This is probably the reason why there is no major recall on the T-380A coils.

According to most reports provided about Paragard complications, women who suffered from their usage usually experienced the following during the removal of the device:

  • Broken pieces of the device lodged in the uterine cavity
  • Uterine wall perforation
  • Migration of the fractured pieces to other organs
  • Perforation of the uterine wall and lining
  • Fractured IUD
  • Pain, bleeding, and cramping that are caused by the irritation of the broken pieces

In adverse situations, the patient experiencing this kind of issue should seek surgery to correct it. The necessities that follow are:

  • The need for general anesthesia
  • Ultrasound imaging before the surgery
  • Total hysterectomy
  • Uterine incision
  • A full invasive surgery to remove the remaining parts

This usually comes with reality, such as failing to have children in the future and failure to have a vaginal delivery.

Limitation in the Usage of Paragard

It is recommended to undergo a full medical checkup to determine whether it is safe to use Paragard. The Center for Disease Control and Prevention ( CDC) restricts Paragard to people with the following conditions:

  • Cystic fibrosis
  • Breast cancer
  • Depression
  • Diabetes
  • Multiple sclerosis
  • Ovarian cyst
  • Thyroid disease
  • Liver tumors
  • Malaria
  • Valvular heart disease
  • Women with a BMI equal to or greater than 30
  • Anyone with a history of bariatric surgery

Paragard IUD Lawsuits

Several cases have been filed against Teva, which is the company responsible for the marketing of Paragard IUDs. Most lawsuits have been filed based on inadequate warning about the potential risks that result from the use of the IUDs. Paragard lawsuits have been filed in states such as Florida, Pennsylvania, and others.

Florida Lawsuit

One of the lawsuits involved a Florida woman who had an issue with the IUD. The plaintiff, Yolanda Hudson, filed a case against Teva pharmaceuticals claiming that the birth control device moved in her uterus and embedded in the colon.

According to the lawsuit, Yolanda had the implant inserted in her uterus in 2008. She started to experience complications a few years after the insertion, although the device was expected to have remained in place for ten years. However, she discovered that the device had perforated her uterus and migrated from the uterus, embedding itself in her colon. Therefore, she required surgery to remove the part removed from her colon.

The lawsuit claimed that Teva did not warn women and doctors about the risks associated with the Paragard and usually promotes it as a safe and effective long-term birth control contraceptive. Therefore, the lawsuit charged Teva with:

  • Designing a defective device
  • Failure to warn
  • Misrepresentation
  • Breach of warranty

From the lawsuit, the plaintiff was seeking a $15 million compensation for damages such as:

  • Physical impairment
  • Loss of capacity for life enjoyment
  • Disfigurement
  • Pain and suffering
  • Disability and
  • Punitive damage

Louisiana Lawsuit

Another lawsuit involves a Louisiana woman who had the coil implant and claimed that her reproductive organs had been permanently damaged when a piece of the device broke inside her uterus. She filed the case on 10th August 2018 against the Teva pharmaceuticals, Inc, of North Wales, Teva Branded Pharmaceutical Products R & D, Inc. of Frazer, Cooper Surgical, Inc. of Trumbull, Conn, among others.

According to the lawsuit, the device had been detected to have the risk of breaking inside the uterus of its user, but there were no warnings provided to the prospective users. This occurred in the wake of more than 1,600 reports of Paragard breakage.

The plaintiff, Melissa Arias, went for an implant at the Jefferson Parish Health Unit and had no complications. This happened in 2015. On 6th April 2017, the plaintiff wanted to have the coil removed at Angela Praise, M.D. Dr. Praise tried to remove the Paragard as instructed by Teva, which includes grasping the device with forceps and pulling it gently. Despite the instructions, only a portion of the device was retrieved, and one of its arms was missing. This resulted in the permanent damage of the plaintiff’s reproductive health.

The plaintiff had to undergo a trans-abdominal and transvaginal ultrasound of the pelvis to reveal the remaining Paragard fragment in the plaintiff’s uterine walls. This prompted a robotic-assisted total laparoscopic hysterectomy to remove the piece of the Paragard.

According to the lawsuit, all these events led to damages such as mental anguish, pain, suffering, loss of reproductive health, and medical expenses, which should be compensated by the at-fault parties.

The Court of Common Pleas of Philadelphia County

Two plaintiffs Kathryn Reith, a Utah resident, and Steiner Halperin, a California resident, filed two separate laws action in the Court of Common Pleas of Philadelphia County against the following defendants:

  • Teva Pharmaceuticals USA
  • Teva Women’s Health. Inc
  • Teva Branded Pharmaceuticals Product
  • The Cooper Companies
  • CooperSurgical

The plaintiffs alleged that they suffered damages as a result of the defective Paragard IUD. Therefore, the assertion of the complaint can be considered as follows:

  • Strict liability in manufacture defects
  • Strict liability due to design defects
  • Negligence
  • Failure to warn
  • Negligent misrepresentation
  • Breach of express warranty
  • Violation of consumer protection
  • Gross negligence
  • Punitive damages

Stephanie Ideus V. Teva Branded Pharmaceuticals Product R&D Inc.

In 2016, Stephanie Ideus filed a case against Teva after a piece of Paragard broke and embedded in her uterine wall. Stephanie had the coil inserted in her uterus in 2010 and experienced complications several years later. Therefore, she required to undergo surgery to have the piece removed.

According to the lawsuit, Teva failed to provide adequate warning about the risks associated with Paragard, especially the possibility of breaking and perforating the uterus. Therefore, the claims were that she could not have gotten the implant, and her physician would not have recommended it as well.

Unfortunately, in an issue provided on 19th February 2019, a motion of summary judgment was granted to Teva pharmaceuticals, which dismissed the case. The dismissal was considered on the argument that there was enough warning about the risks of Paragard, and the plaintiff would have decided on a different form of birth control. Despite the dismissal, Ideus filed an appeal of the ruling to restore her ability to pursue damages from the Paragard's manufacturer.

Although most lawsuits that are filed consider the severe injuries suffered after the migration of the Paragard inside the body, the most severe complication that would link to such a device would be the Pseudotumor Cerebri ( PTC).

This is a type of brain condition that makes the victim experience similar symptoms as a brain tumor. The condition might manifest itself as chronic headaches, migraines, disorientation, blindness, light sensitivity, and blurred vision. The condition is also referred to as intracranial hypertension (IIH).

Join a Mass Tort Near Me

 Currently, attorneys have been holding Teva Pharmaceuticals responsible for the injuries that their consumers have been experiencing through their devices. Ideally, this would prompt a mass tort against the company. We at the Consumer Alert Now understand the dangers of defective Paragard IUDs. Thus, our objective is to ensure that you understand the possible dangers associated with these IUDs and how you can get legal help if you suffer any harm as a result of these devices. Contact us today at 800-511-0747 to learn more about how you can join a mass tort today.