Broken Arm of ParaGard IUD Left In Woman’s Body After Removal Procedure, Due To Design Defect

A Colorado woman indicates she experienced painful complications from a ParaGard IUD, when the birth control implant broke during a routine removal procedure, leaving pieces of a broken arm inside her body.

Mishelle Garcia Tlamayo filed a complaint (PDF) in the U.S. District Court for the District of Colorado on April 7, alleging a dangerous and defective design makes the ParaGard prone to break during removal.

Paragard IUD is a T-shaped plastic device wrapped in copper, which is intended to be placed in the uterus for up to ten years, providing a reversible form of long-acting protection against pregnancy. However, the manufacturer markets the product as an alternative to birth control pills, which can easily reversible in a doctors office procedure when a woman no longer wants the birth control.

According to the lawsuit, Tlamayo was implanted with a ParaGard in June 2009, when she was 19 years old, since she wanted birth control that was reversible. However, when she went to have the device removed in April 2019, only part of the IUD was retrieved, as the other IUD arm had broken off in her body.

The lawsuit indicates Tlamayo suffered excruciating pain in her abdomen, chills, pelvic pain, cramping and other injuries. The other arm of the device is presumably migrating through her body.

“Plaintiff’s healthcare provider attempted to remove the ParaGard as instructed by Teva, by grasping the ParaGard by the forceps and pulling gently. No extra force was used,” the lawsuit notes. “Despite following the instructions provided by Teva, only a portion of the ParaGard was retrieved with the entire T-arm part broken and missing.”

Given common questions of fact and law raised in similar Paragard IUD lawsuits filed throughout the federal court system, centralized pre-trial proceedings have been established before U.S. District Judge Leigh Martin May in the Northern District of Georgia, where the lawsuit filed by Tlamayo will also be transferred in the coming weeks.

As part of the coordinated management of the litigation, Judge May is presiding over coordinated discovery and pretrial proceedings, and it is expected that a small group of representative claims will ultimately be prepared for early trial dates as part of a “bellwether” program, to help gauge how juries may respond to certain evidence and testimony that will be presented throughout the litigation.

While the outcome for these early trials would not be binding on other plaintiffs, they may facilitate ParaGard IUD settlements. which would avoid the need for dozens, or possibly hundreds, of additional trials to be scheduled throughout the federal court system.