In a startling revelation, an investigation has uncovered that the U.S. Food and Drug Administration (FDA) raised significant concerns about the Paragard intrauterine device (IUD) in 2022. This scrutiny was prompted by ongoing safety issues, particularly related to the device breaking inside women's bodies. 

Are you also wondering how the famous birth control device is causing concerning health issues? Then, read on to know more in detail. 

How Effective Are IUDs?

Intrauterine devices (IUDs) are highly effective forms of long-acting reversible contraception. According to WebMD, along with hormonal implants, they are among the most reliable methods for preventing pregnancy, with a success rate exceeding 99%. 
Key advantages of IUDs include:

• Long-term effectiveness

• Low maintenance

• One-time cost

• Safe for use during breastfeeding

IUDs are suitable for most healthy individuals, including those who are transgender or nonbinary. They're particularly appropriate for people in monogamous relationships with low STD risk. Nevertheless, IUDs are not a sexually transmitted disease prevention device.

IUDs may not be suitable for those who:

• Have an active STD or a recent pelvic infection.

• Are pregnant.

• Have cervical or uterine cancer.

• Experience inexplicable vaginal bleeding.

Specific contraindications:

• Copper IUDs: Not for those with copper allergies or Wilson's disease

• Hormonal IUDs: May be unsuitable for individuals with liver disease, breast cancer, or high breast cancer risk

FDA Expressed Concerns About Breakage of Paragard IUD in 2022 

The Food and Drug Administration (FDA) inspected the plant that manufactures the Paragard IUD. They found issues with how the company handled complaint reports of the IUD breaking inside women's bodies.

The FDA visited the CooperSurgical plant in New York. This came after a years-long investigation by the news program Spotlight on America into growing reports of Paragard breakage. Thousands of women said their Paragard broke inside them during removal or afterward. In some cases, pieces lodged in painful spots that required surgery.

In its inspection report, the FDA said CooperSurgical failed to look into the breakage complaints fully. According to the report, the company failed to take appropriate action to avert further issues. The FDA also did not follow up to make sure issues were fixed.

Despite more breakage reports than ever before in 2023, neither CooperSurgical nor the FDA have warned the public more about the risk. 

One woman told her story of suffering for months after her Paragard broke, including enduring a hysterectomy operation. She wishes she had known about reports of breakage before using Paragard. She wants CooperSurgical and the FDA to do more to acknowledge the problem and ensure safety.

The Rise of Paragard IUD Lawsuits

Based on the FDA's adverse event database, approximately 38,000 reports of problems with the Paragard IUD have been received in the last ten years. According to JD Supra, around 9,000 of these reports describe injuries from implantation or removal. This is nearly double the reports for hormonal IUDs.

Broken Paragard pieces can have serious health impacts. These fragments can migrate to other areas or become embedded in the uterine wall. In severe instances, the damage necessitates a hysterectomy to completely remove the uterus.

According to TorHoerman Law, more lawsuits have been filed against the Paragard IUD manufacturer in response to reported injuries. These cases are part of multidistrict litigation (MDL) consolidated in federal court rather than a class action.

In an MDL, individual cases are settled separately based on their specific facts and damages. This contrasts with class actions, which distribute one settlement amount evenly among plaintiffs. Experts estimate MDL settlements for Paragard IUD lawsuit settlement amounts could range from $10,000 to $400,000. This depends on the case details and prior similar lawsuit outcomes, though compensation amounts may vary.

Paragard Lawsuit Update: Over 2,700 Cases Now Filed

As of July 2024, over 2,700 pending legal cases have been consolidated in multidistrict litigation (MDL 2974) against the Paragard IUD. The presiding judge is Leigh Martin May in the Northern District of Georgia federal court.  In the lawsuits, plaintiffs seek damages for injuries allegedly caused by Paragard's copper intrauterine device. 

FAQs

1. Are there specific individuals who should avoid using Paragard?

A: Paragard IUDs may not be suitable for everyone. Healthcare providers typically advise against their use in individuals with significant uterine abnormalities like large fibroids, which can interfere with proper placement or retention. Those with current pelvic infections, including pelvic inflammatory disease, or diagnosed with uterine or cervical cancer are also generally discouraged from using Paragard.

2. What is considered the most significant potential complication of IUD use?

A: The most serious potential complication associated with IUDs is infection. The infections typically stem from the insertion procedure. It's crucial to remember that there is barely any chance of infection. In the unlikely event that an infection does arise, it is frequently treatable without requiring IUD removal.

3. Has there been an official recall of the Paragard IUD?

A: As of now, despite ongoing concerns, no official recall has been issued for the Paragard IUD. The U.S. Food and Drug Administration (FDA) has not mandated any product recalls for this device. Consequently, there is continued potential for women to experience injuries related to Paragard IUD breakage, fracture, or migration.

Many women report serious health issues from Paragard IUD breakage. The manufacturer failed to address safety concerns raised by regulators. This controversial birth control device may face its day of reckoning soon. 

While IUDs can be effective when well-designed and monitored, no contraceptive should risk a woman's health. Ongoing litigation may decide justice for injured Paragard users. It could ensure women's voices are heard in matters affecting their bodies directly.