# Paragard Lawsuit

Paragard Fracture Can Lead to Hysterectomy & Sterility

In the U.S., Paragard is the only available non-hormonal, copper IUD on the market, FDA-approved in 1984 and launched in 1988. As of August 2022, 1,021 women have filed liability charges against makers Teva Pharmaceuticals and Cooper Companies, Inc., in a recent lawsuit that has been consolidated into a multi-district litigation, or MDL.

Plaintiffs’ primary claim alleges their Paragard broke inside them upon removal in-office. The tiny T-shaped Paragard has been known to break during removal,  sending plastic, wire, copper residue and string drifting into the uterine cavity where debris can migrate into fallopian tubes and nearby organs, disappear or, worse, become embedded in tissue. If surgery to remove the lodged shard involves hysterectomy, young women (many of them childless) are left barren in the prime childbearing stage of their life.

Plaintiffs also allege the companies knew about the defects and did nothing to inform consumers, least of all provide adequate warnings on the packaging.

Paragard History

Branded by Pharmaceuticals under the name Paragard (or ParaGard), the metallic IUD was first invented in 1929 by German physician Ernst Grafenburg using silver wrapped in silk instead of hormones to “decapitate” sperm. The metal filament concept was improved by Howard Tatum and Jamie Zipper with the first introduction of a copper IUD in 1967.

Teva sold the Paragard brand to Cooper Companies (Pleasanton, California) in 2017 for $1.1 billion. Billed as the most natural, most effective, long-term, low-maintenance contraceptive on the American market, it was considered revolutionary, boasting no notable side effects – maybe a little light bleeding or intermittent spotting –  and a greater than 99% assurance of preventing pregnancy.

Paragard’s design incorporates two T-wings (arms) attached at 90° angles to a vertical plastic stem wrapped in copper coil. At the bottom, strings are trimmed to retract just inside the vaginal entrance to assist in removal.  When pressure is gently applied with forceps, the horizontal arms theoretically fold up, enabling the device to slide down through the uterus, which is aligned with the cervix, and exit through the vagina.

Using copper filament instead of hormone solution as spermicide (sperm cells are revolted by copper), Paragard is considered the most widely used reversible contraceptive on the U.S. market.

Paragard Was Supposed to Be a Safer IUD – Except It Wasn’t.

As early as 2015, an article was published in the Open Journal of Clinical and Medical Case Reports that explored data on a series of broken IUDS – all of them involving ParaGard® 380A copper IUD. “The ‘Broken’ IUD: Its Detection and Clinical Management” notes that while IUDs are a popular form of long-term birth control and can be both safe and effective, healthcare providers should be more aware of the potential dangers of IUDs breaking (specifically ParaGard 380A).2

What Makes Paragard So Attractive to Women?

Paragard’s use of copper coiling instead of hormones is advantageous because copper doesn’t typically disrupt menstrual cycles.  Theoretically, the product also:

• Eliminates the need to interrupt sex for contraception
• Can remain in place for up to 10 years
• Can be removed at any time (in-office)
• Can be used while breastfeeding
• Doesn’t carry the risk of side effects, such as blood clots related to hormonal birth control methods
• Can be used for emergency contraception if inserted within 5 days after unprotected sex

Sadly, it doesn’t always work as advertised.

Paragard doesn’t always work according to design. The akimbo (or T-Shaped) arms have been known to break off instead of folding into mummy position for easy removal.

1/ If the device breaks in utero, copper wire, plastic and string are sent into the uterine cavity where sharp fragments may drift out of reach, migrate into fallopian tubes, collide with nearby organs, puncture or become lodged in tissue – or disappear altogether.

2/ When a Paragard fracture results in a foreign object’s embedding in uterine tissue, surgical removal is required to eliminate the piece and/or prevent internal bleeding, which is fatal if unchecked. If surgery involves hysterectomy, the young patient (statistically 15-44) is left sterile during the most fertile stage of life.

These are life-altering complications, especially when considering the context: 150 million women worldwide depend on copper IUDs for effective birth control (“set it and forget it”). ³