IUD Breakage an Increasing ParaGard Problem

New JerseyWhen NJ gynecologist Carolyn Delucia, MD suggests to NewBeauty readers that “you can go back to your gynecologist any time to get [Paragard IUD] removed,” it makes you wonder what bubble she is living in. Since 2010, the FDA has received more than 1,600 reports of ParaGard breakage, with more than 700 classified as serious.

The ParaGard may be the most cost-effective method of contraception over a five-year period, but it isn’t the safest. Three Paragard lawsuits were filed against Teva Pharmaceuticals, one of the manufacturers of the device, in May alone. The three plaintiffs claim that the IUD is defective and causes serious complications and injuries—all three women suffered uterine pain and tried to have the intrauterine device removed, only to discover that one arm of the device was missing. When this small copper arm breaks off, it can potentially cause severe damage to the surrounding tissues and organs.

Paragard Lawsuits

At the end of September, plaintiffs’ attorneys petitioned the Judicial Panel on Multidistrict Litigation (JPML) to transfer ParaGard IUD lawsuits to the U.S. District Court for the Central District of California for pretrial consolidation and coordination. Because there are currently 55 actions pending in 29 different judicial districts, plaintiffs’ attorneys noted that the creation of a multidistrict litigation (MDL) is proper and necessary due to the similarity of the claims. The Northern District of Georgia and the Western District of Missouri were also suggested as alternatives for the MDL.

"It's not a coincidence that women nationwide are claiming their ParaGard IUD broke and caused life-changing injuries," said attorney Tim Clark with Sanders Phillips Grossman in a news release. "We expect hundreds of additional women to come forward with similar claims, which makes multidistrict litigation even more crucial."

The first lawsuit against Teva’s Paragard was filed back in 2016. While Stephanie Ideus was having the device removed it broke and imbedded in her uterus, and she required surgery to have it removed. Four years on, nothing has changed with the device design.  Ideus and the women who recently filed claims all say that Teva misrepresented the device as safe and effective even if the device was actually defective. There has been a slight change, however, with the Paragard warning. Cooper Surgical lists in its prescribing information  “device breakage” under the postmarketing adverse events section but doesn’t say how often it occurs. It does warn that “breakage of an embedded Paragard during non-surgical removal has been reported.” 

The lawsuit filed on May 11, 2020 in California comprises a ten-count complaint that includes claims for negligence, strict liability design defect, strict liability manufacturing defect, strict liability failure to warn, among others. The plaintiff says she was implanted with the IUD for approximately two years before she asked for her doctor to remove the device. When her doctor removed the IUD according to the manufacturer’s instructions, one arm of the device was missing. The doctor was eventually able to remove the stray part via a hysteroscope.

The second lawsuit filed on May 26 in the US District Court for the Southern District of New York states the same complaint and damages. The plaintiff says the defendants “knew or should have known that Paragard can and does cause serious harm to individuals who use it, due to the risk of the Paragard’s arm breaking upon removal.” Ditto for the third lawsuits, filed on May 28, in the US District Court for the Southern District of Illinois in the East St. Louis Division. The plaintiffs lists th same complaints as above, along with violation of consumer protection laws, and gross negligence. She underwent two procedures before the missing arm was found and successfully removed. The plaintiff claims that “Paragard is inherently dangerous and defective, unfit and unsafe for its intended use.”

We are hopeful that health professionals such as Dr. Delucia are aware of Paragard risks, particularly breakage.