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What's Paragard?

Paragard is a non-hormonal intrauterine device (IUD) made of copper. It is a long-term contraceptive method that can prevent pregnancy for up to 10 years. Unlike hormonal IUDs, which release progesterone, Paragard works by releasing copper ions, creating a hostile environment for sperm and preventing fertilization.

What are the risks?

1. Increased Menstrual Flow and Cramps

  • Many users report that their periods become heavier, longer, and more painful, especially in the first few months after insertion.

  • It may not be the best option for those who already experience heavy periods or severe cramps.

2. IUD Expulsion

  • In about 2 to 10% of cases, the IUD may partially or completely come out of the uterus, especially within the first few months of use or during menstruation.

  • If the IUD is expelled, it is no longer effective and needs to be replaced.

3. Uterine Perforation (Rare)

  • In rare cases (less than 0.1%), the IUD may perforate the uterine wall during insertion.

  • If this occurs, a surgical procedure may be required to remove the device.

4. Pelvic Infection (Pelvic Inflammatory Disease - PID)

  • There is a small risk of pelvic infection, particularly within the first three weeks after insertion, if bacteria are present.

  • Women with a history of sexually transmitted infections (STIs) may have a slightly higher risk.

5. Ectopic Pregnancy (Rare but Serious)

  • Although Paragard is highly effective, if pregnancy occurs while using it, there is a higher risk of ectopic pregnancy (outside the uterus, usually in the fallopian tubes).

  • Ectopic pregnancy is a serious medical condition that requires emergency treatment.

6. Allergic Reactions or Copper Sensitivity (Rare)

  • Some women may have a reaction to copper, leading to inflammation or adverse symptoms, but this is uncommon.

  • Women with a copper allergy or Wilson’s disease (a disorder affecting copper metabolism) should not use Paragard.

7. Discomfort During Insertion

  • The insertion procedure can cause pain, dizziness, or even fainting in some women, but these symptoms usually subside within a few minutes.

​             Possible Compensation

 

Many individuals are seeking compensation in Paragard lawsuits due to complications caused by the breakage of the IUD during removal. The most common reasons include the need for additional surgeries, such as hysteroscopies or hysterectomies, to remove broken fragments, which in some cases have led to permanent infertility. Some women have also suffered uterine damage, chronic pelvic pain, and scarring, resulting in long-term discomfort.

In addition to physical injuries, claimants are pursuing compensation for emotional distress, including anxiety, depression, and PTSD, caused by unexpected medical complications. Medical expenses related to treatments, surgeries, and follow-up care, as well as lost wages due to recovery time, are also key factors in these lawsuits.

The lawsuits allege manufacturer negligence, arguing that Teva Pharmaceuticals and CooperSurgical failed to adequately warn users about the risks of the Paragard IUD breaking during removal. If you or someone you know has experienced similar complications, consulting a mass tort attorney may help determine eligibility for compensation.

Regulations and Legal Responsibilities:

Regulations and Legal Responsibilities Summary:

  1. Regulatory Oversight:

    • In the U.S., the FDA regulates medical devices, requiring rigorous testing and approval (PMA or 510(k) clearance).

    • In the EU, devices must comply with the Medical Device Regulation (MDR), including conformity assessments and post-market surveillance.

  2. Manufacturer Responsibilities:

    • Maintain quality assurance and quality management systems (QMS).

    • Provide clear labeling and warnings about risks and usage.

    • Monitor post-market performance and report adverse events.

  3. Legal Responsibilities:

    • Manufacturers can face product liability for defects (design, manufacturing, or lack of warnings).

    • Healthcare providers must ensure informed consent and adhere to a standard of care.

    • Adverse events associated with devices must be reported by both manufacturers and providers.

  4. Patient Implications:

    • Patients may pursue legal action for injuries related to medical devices based on negligence, product liability, or malpractice claims with the help of specialized legal professionals.

This framework promotes patient safety while holding manufacturers and healthcare providers accountable for their roles in medical device use.

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Cases about Paragard

The Paragard intrauterine device (IUD) has been widely used as a contraceptive method. However, in recent years, significant concerns have emerged regarding its safety, particularly during removal. Many women have reported that the device broke during the removal process, leading to serious complications, including the need for additional surgeries to remove retained fragments and, in extreme cases, permanent infertility.

As a result of these incidents, thousands of lawsuits have been filed against the manufacturers of Paragard. These lawsuits allege that the manufacturers failed to provide adequate warnings about the risk of the device breaking during removal and were negligent in its design and manufacturin

While no global settlements have been reached yet, it is speculated that payout amounts may range between $40,000 and $400,000, depending on the severity of injuries and individual circumstances

 

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A mass tort is a civil action where many people are harmed by the same act or omission. The individual victims have claims against the same defendants, and the cases can be combined in a multi-district litigation.

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