Paragard IUD Lawsuit
(Breakage During Removal)
Federal litigation alleging the Paragard copper IUD is defectively designed and prone to breaking during removal, leaving fragments in the uterus and requiring additional surgeries.
Key Takeaways
- Over 3,900 cases pending as of May 2026 with 36% growth
- Paragard is the only copper IUD available in the United States
- Allegations claim T-junction design is prone to fracture during removal
- No global settlement has been announced yet
- Cases involve retained fragments, additional surgeries, and infertility
Key Facts (May 2026)
| Pending Actions | 3,984 cases in federal MDL |
| Total Actions Filed | 4,278+ cases historically |
| Defendant | CooperSurgical, Inc. / The Cooper Companies (NYSE: COO) |
| Presiding Judge | Hon. Leigh Martin May (N.D. Georgia) |
| MDL Created | December 2020 |
| Key Allegation | T-junction design prone to fracture during removal |
| Settlement Status | No global settlement announced |
| Can You Still File? | Yes — actively recruiting cases |
Steady Case Growth
Cases continue to be filed as women report IUD breakage during removal. Case count has grown 38% in 2025 as awareness of device defects spreads.
Source: JPML MDL Statistics Reports, January 2025-May 2026
2024 Study: Paragard Generates Higher Stress During Removal
A peer-reviewed study in Contraception (2024) compared IUD designs during simulated removal:
Source: La Saponara V, et al. Contraception. 2024;133:110399 (PMID: 38369271)
1 What Is Paragard?
Paragard T 380A is the only copper-containing intrauterine device (IUD) available in the United States. It's a T-shaped device inserted into the uterus to prevent pregnancy for up to 10 years.
Unlike hormonal IUDs (Mirena, Liletta, Kyleena, Skyla), Paragard is hormone-free, making it the preferred choice for women who cannot or choose not to use hormonal contraception. It works by releasing copper ions that are toxic to sperm and create an inflammatory response that prevents fertilization.
Paragard Components
- T-shaped polyethylene frame
- Barium sulfate (for x-ray visibility)
- Copper wire wound around frame
- Monofilament removal strings
2 The Alleged Defect: Breakage During Removal
Plaintiffs allege that Paragard is prone to breaking during removal attempts, with the arms of the T-shaped device fracturing and separating from the frame. This leaves fragments inside the uterus.
T-Junction Stress Point
The junction where the horizontal arms meet the vertical stem is a stress concentration point. The 2024 study found Paragard generates 1.70 MPa of stress at this junction during removal—significantly more than other IUD designs (0.36-0.79 MPa).
Material Degradation Over Time
Plaintiffs allege the polyethylene frame degrades over the 10-year approved duration, and copper corrosion may further weaken the device structure, increasing breakage risk for devices left in place longer.
FDA MAUDE Database Reports
The FDA's adverse event database contains numerous reports of Paragard breakage during removal with problem codes for "Break" and "Entrapment of Device," resulting in "Foreign Body In Patient."
3 Alleged Injuries
Immediate Complications
- Retained device fragments in uterus
- Fragment migration through uterine wall
- Chronic pelvic pain
- Infection / sepsis
Long-Term Consequences
- Infertility
- Ectopic pregnancy
- Scarring and adhesions
- Hysterectomy (loss of fertility)
Additional Surgeries Required
- Hysteroscopy (camera-guided removal)
- Laparoscopy (small incision surgery)
- Laparotomy (open abdominal surgery)
- Hysterectomy (in severe cases)
4 FDA Label Warnings
The FDA-approved Paragard label includes warnings about several complications, though plaintiffs allege the breakage risk during removal is inadequately warned:
5 Litigation Timeline
Paragard originally approved (NDA 018680), initially for 4 years.
FDA approves extended duration, increasing time device remains in body.
The Cooper Companies acquires Paragard from Teva Pharmaceuticals.
JPML centralizes cases in Northern District of Georgia before Judge Leigh Martin May.
Peer-reviewed study in Contraception shows Paragard generates significantly higher stress during removal than other IUDs.
3,984 cases pending. No global settlement announced. Cases continue to be filed.
6 Do You Qualify?
Eligibility Requirements
- Had a Paragard IUD (the copper IUD, not Mirena or other hormonal IUDs)
- Device broke during removal — arm(s) fractured or separated from the frame
- Fragments retained — pieces of the device remained in your body
- Required additional procedure(s) — surgery to remove fragments, or other medical intervention
7 Frequently Asked Questions
Is Paragard still available?
What makes Paragard different from other IUDs?
Is there a recall on Paragard?
Has there been a settlement?
What are the legal claims?
Who are the defendants?
Sources & References
6 official sources cited• Judicial Panel on Multidistrict Litigation (JPML) — MDL Statistics Report (December 2, 2025)
• La Saponara V, et al. "Understanding the mechanical behavior of intrauterine devices during simulated removal." Contraception. 2024;133:110399 (PMID: 38369271)
• FDA Drugs@FDA Database — NDA 018680
• FDA-approved Paragard Prescribing Information (June 2024)
• FDA MAUDE Database — Adverse Event Reports
• CDC U.S. Selected Practice Recommendations for Contraceptive Use (2024)
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Every case is unique, and results depend on the specific facts and circumstances involved. Past settlement amounts and case outcomes do not guarantee similar results in your case. If you believe you have a legal claim, you should consult with a licensed attorney in your jurisdiction who can evaluate your specific situation.