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ParaGard Lawsuit

Multiple means have been created over the years to give women the ability to prevent pregnancy. Of these, a popular one is the intrauterine device (IUD), having an effective rate of nearly 100%. Its popularity has greatly increased over the past 20 years. Finding a spot near the top of the popularity list is the Paragard IUD (models Tcu380A, T380A, and T380) manufactured by Teva Pharmaceuticals.

Paragard was first approved by the Food and Drug Administration (FDA) in 1984. In the early days of IUD use, the devices were not recommended for women who had never given birth to a child. That restriction was removed, however, and women of all ages use the device whether they have or have not birthed children.

The increase in the number of women using IUD devices has been followed by an increase in the number of reports of unexpected side effects and complications. Women have encountered problems with their IUDs migrating inside their bodies or breaking. Additionally, parts of the IUD have unknowingly been left in women’s bodies after the devices broke apart while being removed. Such occurrences can lead to perforation of organs and the need for surgery.

What is the Paragard IUD?

Birth control pills and hormonal methods of birth control were used by many women before IUDs were introduced as an alternative type of contraceptive. An IUD is a small device, shaped like the letter T and merely an inch and a half tall and similarly wide. The tiny frame is made of flexible soft plastic, and the unit is wrapped with copper wire on the stem. According to Planned Parenthood, the device can even be used as emergency contraception if placed intrauterine within five days of unprotected sex.

Surgery is not required to place Paragard in the uterus, and the procedure can be performed by a physician or a nurse. A special inserter allows the IUD to go through the cervix and into the uterus. The whole procedure only takes minutes to complete. The insertion may be followed by cramping or other pains.

While IUDs are effective at preventing pregnancy, they do not protect against sexually transmitted diseases. The Paragard unit has an expected life of approximately ten years and then needs replacement. It can be removed at any time by a medical professional.

Other IUDs use hormones to prevent pregnancy. Paragard is the only IUD to effectively stop pregnancy without the use of hormones. According to the manufacturer, Teva Pharmaceuticals, the device is 99 percent effective. The copper on the unit creates an inflammatory response in the uterus that is toxic to sperm and eggs.

History of Paragard

1984 – Teva Pharmaceuticals’ Paragard IUD was approved by the FDA.

2013 – A report was sent to the FDA’s Medical Product Safety Network about a patient who had her Paragard IUD removed and experienced moderate traction and some bleeding. The removed IUD was also reported to be missing an arm, which suggests the arm broke off during the removal process.

2015 – A report was sent to the FDA’s Medical Product Safety Network about a patient who had a Paragard IUD implanted for about 8.5 years and when it was removed, part of the copper coil was missing. Doctors later found that the piece remained in her body and had to remove it.

2017 – Researchers evaluated IUD devices that release levonorgestrel in patients with PTC (pseudotumor cerebri). They found that women using these devices were over seven times more likely to develop PTC.

How is Mirena Different From Paragard?

Another IUD on the market is called Mirena. The contraceptive device uses the hormone levonorgestrel contained in a reservoir to help stop pregnancy from occurring, and is expected to last approximately 5 years.

A low dose of the hormone (20 micrograms daily) is released to keep the endometrial lining inside the uterus from thickening. During a normal menstrual cycle, this thickening occurs right before the lining is dispelled and is the ideal condition for a fertilized egg to implant. Thus, by creating an inhospitable environment, Mirena helps prevent implantation and pregnancy. Another contraceptive quality of the hormone levonorgestrel is that it thickens cervical mucus, making it more difficult for sperm to migrate.

Removal Complications With Paragard

According to a report given to the Medical Product Safety Network of the Food and Drug Administration, one woman had her Paragard IUD removed at a clinic eight years after implantation. Surprisingly, when the device was removed, it was missing the copper coil from the stem of the unit. The copper on the arms of the device was still intact, but no copper whatsoever remained on the stem.

According to the website for Paragard, removal of a unit could become difficult “because it is stuck in the uterus.” Additionally, further information on the site informs readers that, “Surgery may sometimes be needed to remove Paragard.”

Other Complications

Further complications from Paragard include the propensity for some units to break apart upon extraction from the uterus, thus leaving pieces inside the patient’s body. Surgery to remove the broken pieces is typically necessary, and in some cases, a woman may require a full hysterectomy, removing any possibility of future pregnancies she may have desired.

Another potential complication involves perforation of the uterus wall upon implantation. This penetration of the uterine wall can lead to infection, damage to other organs nearby, and scarring. Again, surgery is often the only recourse to help rectify the problem.

Lastly, if a woman does become pregnant with a Paragard IUD in place, the risk is higher that she will experience an ectopic or tubal pregnancy with the baby developing outside the uterus. This emergency situation can be life-threatening for the woman, and she needs immediate medical care, often surgery. Ectopic pregnancies can produce internal bleeding and result in infertility or, tragically, death.

Pseudotumor Cerebri Linked to Paragard

A condition called pseudotumor cerebri (PTC) happens when symptoms of a brain tumor exhibit in a person, but there is no actual tumor. The affected individual’s pressure in the skull rises, and other physical symptoms of a brain tumor manifest. Studies have been conducted that demonstrate a link between PTC and the use of a Paragard IUD.

Symptoms of PTC include:

  • Intense headaches that begin behind the eyes
  • Vision problems and/or blindness
  • Dizziness, nausea, vomiting
  • Back, neck or shoulder pain
  • Whooshing sound in the head that pulses with the heartbeat
  • Light flashes
  • Ringing in the ears

Lawsuits Claim Manufacturer Knew Risks

Lawsuits have been filed against Paragard, claiming that the manufacturer, Teva Pharmaceuticals, was aware of the serious injuries possible from breakage of the device either in the uterus or upon removal. In addition, the lawsuits claim that the trials Teva Pharmaceuticals performed, plus the experiences and complaints that came to the manufacturer after marketing the IUD, clearly alerted the manufacturer to the serious risks of the product, but the company chose not to warn women of the impending dangers.

One woman filed a lawsuit against Teva Pharmaceuticals, claiming that the manufacturer failed to properly warn her that the Paragard IUD could break during removal. The plaintiff had Paragard implanted in 2010 and in 2014 when she got the device removed, a piece of the IUD broke off and was then embedded in her uterus. Due to the Paragrad breaking, the woman required additional surgery and was put at risk for other health issues.

Social media carries stories from patients who followed the exact procedures given for removing a Paragard, but still could not successfully remove the device. Severe side effects resulted in some cases.

Broken Paragard Lawsuit

A number of women have been safely using Paragard IUDs for years. However, reports have surfaced from others using the device that they have suffered serious complications. Some of the most painful issues surfacing include pelvic inflammatory disease and perforations requiring expensive surgeries. Lawsuits are being filed against the manufacturer by patients who have experienced broken or migrating units and are seeking compensation.

Many women have sought legal counsel from attorneys to determine whether Paragard’s manufacturer produced an unsafe product and failed to notify patients of the potentially dangerous effects like brain injury. Legal representatives are investigating allegations that:

  • The manufacturer did not adequately warn doctors, medical providers, and consumers about the possible risks involved.
  • The manufacturers knew about the risks, but did nothing about redesigning the Paragard to make it safer.
  • The manufacturer marketed and distributed the device as a safe and effective birth control.

Do You Have a Paragard IUD Lawsuit Claim?

Have you had a Paragard device implanted? Have you suffered any of the complications below? If so, you may have the right to file a claim for compensation.

  • Paragard IUD migrated and caused injury
  • Paragard IUD broke and caused injury
  • Paragard IUD complications required surgery
  • Ectopic pregnancy
  • Unable to remove or retrieve Paragard IUD

Contact an Experienced Paragard Lawyer

Victims need legal counsel who will hold “big pharma” and negligent medical manufacturers accountable for the damage and injury they’ve caused to consumers. Here at The Eichholz Law Firm, we want to find out what happened to you, so we can help reverse the negative, and get you on the path to recovery through financial compensation. 

Victims who have suffered injuries and required corrective surgery after their Paragard IUD broke should seek legal advice immediately. Our experienced Paragard lawyers have looked into the details of the Paragard lawsuit and are prepared to represent victims who may be eligible for recovery.

To speak with one of our experienced and compassionate attorneys, contact us today. Call (855) 551-1019, or complete an online form. Our team is available to answer all of your questions and begin the process of getting you the compensation you deserve.

References

Please seek the advice of a medical professional before making health care decisions.
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