Medical knowledge · Legal judgment · Human agency

Active Medical Device Litigation

Paragard IUD Breakage & Removal Lawsuits

Patients have filed lawsuits alleging that the Paragard copper IUD can break during insertion, become embedded in the uterus, migrate, or require complicated removal procedures. MD Law evaluates Paragard claims with rigorous medical and legal analysis.

These allegations are subject to ongoing litigation. No determination of liability or causation has been made. This page provides information about the device and current claims — not legal advice.

Confidential review. No fee unless there is a recovery.

What Is the Paragard IUD?

Paragard is a copper intrauterine device (IUD) manufactured by CooperSurgical. It is a small, T-shaped device inserted into the uterus to prevent pregnancy. Approved by the FDA in 1984, Paragard is a non-hormonal contraceptive option that is designed to remain in place for up to 12 years.

Unlike hormonal IUDs (such as Mirena or Kyleena), Paragard works through copper's spermicidal and inflammatory effects. The device consists of a plastic frame with copper wire wrapped around the stem. Insertion is performed by a healthcare provider in a clinical setting, typically during an office visit.

Paragard is a popular contraceptive choice because it is highly effective (over 99%), long-acting, and does not involve systemic hormones. However, plaintiffs in ongoing litigation have alleged that the device can fracture or break during insertion or over time, can become embedded in the uterine wall, can migrate, and can cause complicated removal procedures.

Paragard Device Specifications

ManufacturerCooperSurgical, Inc.
Device TypeNon-hormonal copper IUD
Frame MaterialPlastic (polyethylene)
Copper ElementCopper wire wrapped around the stem
Approved Since1984
Duration of UseUp to 12 years

Paragard is widely used as a contraceptive. The vast majority of devices are inserted and removed without complications. However, cases involving breakage, embedding, migration, or difficult removal have resulted in litigation.

Alleged Defects and Failure Modes

Plaintiffs have alleged that Paragard is prone to certain mechanical failures. The following are the primary categories of alleged defects:

Breakage or Fracture

Plaintiffs allege that the Paragard frame can break or fracture during insertion or over time, with fragments remaining in the uterus. This can cause pain, infection, and require additional procedures to retrieve the fragments.

Uterine Embedding

Plaintiffs allege that the device can become embedded in the uterine wall, making removal difficult or requiring surgical intervention. This differs from the device simply being retained — embedding causes the copper frame or arms to penetrate tissue.

Device Migration

Plaintiffs allege that Paragard can move from its intended position in the uterus, potentially migrating into adjacent organs such as the bladder or bowel, causing pain, infection, or requiring surgery.

Arm Breakage Specific

Some allegations focus specifically on breakage of the device's arms (the horizontal extensions), which can lead to partial expulsion, incomplete contraceptive protection, or difficulty with removal.

Important: These are allegations in pending litigation. No court has determined that Paragard is defective or that any particular design feature is at fault. CooperSurgical maintains that Paragard is a safe and effective device when used as directed.

Associated Injuries

Plaintiffs in Paragard litigation have alleged the following injuries related to device complications:

01

Severe Abdominal and Pelvic Pain

Patients have reported debilitating pain in the abdomen and pelvis, which can be persistent and require ongoing pain management or medical treatment.

02

Infection and Sepsis

Device migration, embedding, or fragmentation can lead to pelvic infections, potentially progressing to serious conditions requiring hospitalization and antibiotics.

03

Uterine Perforation

In some cases, the device or fragments can perforate the uterus, potentially damaging other organs and requiring surgical repair.

04

Organ Injury

Migration or perforation can result in injury to adjacent organs such as the bladder or bowel, requiring surgical intervention.

05

Complicated Removal Procedures

When the device becomes embedded or fractured, removal often requires hysteroscopic procedures, laparoscopic surgery, or laparotomy (abdominal surgery) rather than simple office removal.

06

Loss of Fertility

Severe infection, perforation, or surgery related to device complications can result in scarring, adhesions, or other complications affecting future fertility.

Who May Qualify for a Claim?

While Paragard is widely used without serious complications, those who experienced device failure with resulting injury may be eligible to pursue a claim. The following factors suggest potential eligibility:

You had a Paragard IUD inserted and experienced complications such as breakage, embedding, migration, or difficult removal.

You required additional medical procedures — such as hysteroscopy, laparoscopy, or laparotomy — to address device-related complications.

You experienced serious complications including infection, organ perforation, or injury.

Your complications occurred during or after use of the Paragard device.

You have medical records documenting the device placement, complications, and treatment.

The statute of limitations has not expired in your state (typically 2–4 years from discovery of injury).

You did not sign a waiver of liability before insertion, or any liability waiver may be unenforceable.

Note: Not every case of device removal or discomfort constitutes a viable claim. A claim typically requires evidence that the device was defectively designed or manufactured, failed in a manner that was foreseeable and preventable, and that the failure caused serious, documented harm. A confidential evaluation of your medical records and history is the appropriate first step.

Current Litigation Status

Paragard lawsuits are currently subject to active, multi-jurisdictional litigation. Here is the current status as of [DATE]:

Multi-District Litigation (MDL)

Paragard cases have been consolidated into a federal MDL, allowing coordinated discovery and motion practice.

Estimated Plaintiff Count

Over 5,000 plaintiffs have filed lawsuits alleging serious complications from Paragard IUD.

Discovery Phase

The litigation is in the discovery phase, with parties exchanging design documents, internal communications, complaint data, and expert reports.

Ongoing Settlement Discussions

Parties are engaged in settlement negotiations. However, no global settlement has been finalized to date.

Litigation timelines can extend 2–4 years or more from filing to final resolution. Cases may settle or proceed to trial at various points in the process. For the most current updates, view the litigation tracker.

Evidence to Preserve

If you believe you have a potential claim, gathering and preserving evidence is critical. Here is what you should collect:

Insertion and Removal Records

Documentation of when the device was inserted, by whom, and the method and date of removal.

Medical Records

All records related to the device: office visit notes, ultrasound or imaging reports, operative reports from removal procedures, and pathology reports if fragments were examined.

Imaging Studies

Copies of all imaging (ultrasound, CT scans, X-rays) that documented device position, fracture, migration, or other abnormalities.

Operative and Pathology Reports

If surgery was performed to remove the device or fragments, preserve the surgical report and any pathology findings.

Correspondence and Test Results

Emails, messages, or notes from discussions with healthcare providers about device complications. Lab results and culture reports if infection was suspected.

Device Packaging and Serial Number

If available, information about the device batch number, serial number, and insertion date.

Hospital and Pharmacy Records

Bills, discharge summaries, and records of any emergency department visits or hospitalizations related to device complications.

Documentation of Impact

Records of time away from work, lost wages, ongoing pain or symptoms, and impact on fertility or future family planning.

Request Records Immediately: Medical records can be lost or purged over time. Request copies of all relevant records from your provider and hospital as soon as possible. If you believe a claim may exist, do not delay — contact MD Law for a confidential review.

How Paragard Claims Work

Paragard claims are based on product liability law. Here are the primary legal theories:

Design Defect

Plaintiffs allege that the Paragard design is inherently prone to breakage or migration due to the materials used, the device geometry, or lack of adequate safeguards. A design defect claim argues the device should have been designed differently to prevent the harm.

Manufacturing Defect

Plaintiffs allege that specific devices departed from the intended design, resulting in weaker materials, improper assembly, or other deviations that caused failure.

Failure to Warn

Plaintiffs allege that CooperSurgical failed to adequately warn patients and healthcare providers about the risks of breakage, embedding, or migration. A strong warning claim requires evidence that the manufacturer knew of the risk and failed to disclose it.

Fraudulent Concealment

In some cases, plaintiffs allege that the manufacturer concealed knowledge of device failures or misrepresented the safety profile.

Key Elements of a Viable Product Liability Claim:

01

The plaintiff used the Paragard IUD.

02

The device was defectively designed, manufactured, or inadequately labeled.

03

The plaintiff was injured as a result of the defect.

04

The defect was the proximate cause of the injury.

05

The plaintiff incurred damages (medical expenses, lost wages, pain and suffering).

Product liability law varies by state. The burden of proving each element is on the plaintiff. Expert testimony regarding device design, standards, and causation is typically essential.

Frequently Asked Questions

Answers to common questions about Paragard litigation and potential claims.

If Paragard Caused Serious Injury, a Claim May Exist

Device breakage, embedding, migration, or complications requiring surgery warrant careful legal evaluation. MD Law evaluates Paragard IUD claims with engineering and medical expertise combined with rigorous product liability analysis. There is no fee unless there is recovery.

Confidential review. No fee unless there is a recovery. Nationwide case evaluation.