Why Lawyers Are Talking About the Paragard IUD

The Paragard IUD has been around since the 1980s, but the copper contraceptive is back in the news this year because of claims the device can break and become embedded in other organs.

Stephanie Ideus of Nebraska was one of the people who filed a lawsuit against Teva Pharmaceuticals, one of the manufacturers of the device, in 2016. During the Paragard IUD removal, the device broke and embedded itself in her uterus, and she had to have surgery to have it removed after her complaint.

Paragard isn’t the first IUD to hit the headlines for lawsuits. Thousands of women filed lawsuits against Bayer claiming the Mirena IUD had migrated from the uterus and perforated organs. These women had to undergo surgery to treat complications. The drug company eventually paid $ 12.2 million to settle 4,600 claims.

Paragard is one of five different IUDs available in the United States and is the only non-hormonal option. Mirena, Kyleena, Liletta and Skyla are coils that work with the hormone levonorgestrel.

“Some people prefer the copper IUD because it is not hormonal, but it is very effective in preventing pregnancy and can even be used as emergency contraception if used within five days of unprotected sex,” said Courtney Benedict, medical assistant director Standards implementation at Planned Parenthood Federation of America, Drugwatch said. “Paragard is considered the most effective form of emergency contraception because it lowers the risk of pregnancy by 99 percent for up to five days after unprotected sex and can remain in place for up to 12 years.”

The most common IUD side effects are mild, and it is the only IUD approved by the U.S. Food and Drug Administration for over 30 years.

It’s also relatively easy to paste and only takes a few minutes in a healthcare provider’s office. The doctor uses a thin plastic tube to insert the IUD into the uterus, leaving two sutures in the vagina for removal. Since no surgery is required, patients can go straight home.

Suffering After A Paragard IUD Is Broken During Surgical Removal?

Women say manufacturers haven’t warned about breakage

Ideus and other women who filed lawsuits against Teva alleged the side effect they were not properly warned about was a device breakage. They also say the company misrepresented the device as safe and effective even when the device was actually defective.

The current Prescribing information The list provided by Cooper Surgical includes “Device Breakage” in the “Post-Market Adverse Reaction” section but does not indicate how often it occurs. However, it warns that “an embedded paragard fracture has been reported during non-surgical removal”.

The instructions to health care providers on how to remove the paragard state, “The sutures can retract or break into the uterus, or paragard can break, perforate the uterus, or be expelled.”

It also warns healthcare providers, “A fracture or embedding of paragardium in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, cervical dilation, alligator forceps or another grasping device, or hysteroscopy can help remove an embedded paragard. “

There have been some reports of equipment breakage in studies. Carlos M. Fernandez and colleagues carried out such a review in 2015. They concluded: “Although the safe and effective use of IUD contraception has been demonstrated in the US, the possibility of a fracture should be recognized by doctors.”

In February 2019, the court granted Teva’s motion to summarize the judgment in Ideus’ case. In a summary judgment, one party argues that there are no important facts to dispute and this dismisses the case. The judge agreed with Teva. Ideus appealed immediately after the verdict.

That ruling has not stopped lawyers from taking cases of women alleging Paragard harmed them.

Paragard side effects

Most of the studies done with IUDs including Paragard have shown the devices to be safe and effective, but they are not completely without side effects.

“Because the copper IUD is hormone-free, there aren’t many side effects other than that some people may have longer or heavier periods, especially in the first few months after it is inserted,” said Benedict.

Another benefit is that since Paragard does not contain hormones, it does not contribute to weight gain or mood swings – two side effects that can occur with hormonal birth control.

The following Paragard side effects are listed in Cooper Surgical’s current prescribing information:

  • anemia
  • Back pain
  • Dysmenorrhea
  • Dyspareunia
  • Full or partial designation
  • Longer menstrual flow
  • Menstrual cramps
  • Pain and cramps
  • Vaginitis

Women may experience dizziness, nausea, or cramping and pinching for a few minutes after inserting the device.

Some of the more serious, rarer side effects include ectopic pregnancy, sepsis, pelvic inflammatory disease, embedding, perforation of the uterine wall or cervix during insertion, expulsion of the device, and changes in menstrual cycle pattern.

The available medical literature does not indicate that the IUD can cause copper toxicity. Few studies address this Paragard-related problem. The most frequently cited study is a study by Dr. Krishnamurthy Prema and colleagues from 1980 that found no evidence of increased copper levels in the bodies of women who wore copper IUDs for 24 months.

Some women have raised concerns that they believe they have experienced symptoms of copper toxicity after inserting the device, but the medical community’s position remains that copper levels from the IUD are not high enough to cause toxicity.

However, because Paragard is made of copper, it can worsen a rare disease that affects copper excretion called Wilson’s disease.

“IUDs, including the Paragard – or the copper IUD – are among the most effective, convenient, and long-lasting methods of contraception,” says Benedict.

But she adds, “IUDs may not be for everyone, so it is important to speak to your provider about what is best for your health needs and lifestyle.”

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