Earlier this week, WJLA News 7, an ABC affiliate station in Los Angeles, released an investigative spotlight story on the hidden problems with a popular birth control device called Paragard IUD. Earlier this year the station reported finding over 3,200 women who had their Paragard IUD fracture during removal, often leaving sharp pieces inside their bodies.
Reporters for the station continued their investigation and uncovered evidence that the manufacturer of Paragard knew about the problems and may not have done enough to inform consumers.
There is now a Paragard class action lawsuit because of the problems women have experienced with Paragard.
A Typical Paragard IUD Story
The WJLA story featured the experience of Ashlie Gilbert, one of the many thousands of women who experienced the shock of having part of their IUD break off inside them when it was removed. Ashlie had the Paragard IUD implanted at the base of her uterus when she was 18. She was attracted to the Paragard because it offered non-hormone birth control on a long-term basis.
After having the Paragard implanted for almost 10 years (which is the maximum FDA-approved lifespan of the device) Ashlie made an appointment with her OB/GYN to have the IUD removed. What was supposed to be a simple 5-min process turned into a nightmare. Ashlie told WJLA that after the doctor pulled the Paragard out, she said that part of the IUD had broken off and was “missing” somewhere inside Ashlie’s uterus. Ashlie was shocked and extremely upset.
Ashlie explained that until she showed up at her doctor’s office for the removal appointment, she never had any idea that the Paragard was prone to break during removal. Had Ashlie been aware of this potential defect, she says she would never have chosen the Paragard IUD for birth control.
The Maker of Paragard Was Aware of the Breakage Problem
The Paragard IUD is a small, T-shaped device about the size of a quarter. The flexible arms of the Paragard are designed to hold the device in place during use and then flex upward to allow removal. Unfortunately, a design defect in the Paragard caused these arms to become brittle and lose their flexibility over time. This often caused the arms to fracture during removal and break off inside the body.
As of July 2021, the FDA had received 3,290 adverse event reports involving Paragard breakage during removal. At least 2,000 of these events were classified as involving serious health consequences.
The maker of Paragard, Teva Pharmaceuticals, was directly aware of these incidents and the general design flaw in the device since at least 2013. It was not until 2019, however, that Teva took any action in response to the problem. It was at that point that Teva added a carefully worded warning to the fine print on the label for Paragard. Under the section entitled “Warnings and Precautions,” Teva added a simple sentence stating “[b]reakage of an embedded Paragard during non-surgical removal has been reported.”
This update to the product label for Paragard was clearly designed and intended more to protect Teva from liability than to promote public awareness of the breakage problem. By the time the warning label was amended, Teva was already aware of 2,500 incidents of Paragard breakage just in the U.S. Moreover, the update to its product warning label obviously did nothing to notify the thousands of women like Ashlie Gilbert who already had the Paragard device implanted.
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Paragard Breakages Can Have Serious Health Consequences
Sometimes when the Paragard IUD breaks during removal, the doctor is able to retrieve the missing arm pieces without any physical harm to the patient. Sadly, in the majority of Paragard breakage cases, the missing pieces are not recovered and end up floating around inside the woman’s uterus where they can cause serious damage.
A public advocacy group called IUD Alert compiles reports and information from women who have experienced Paragard breaks during removal. When broken pieces of the Paragard go missing inside the woman’s body they must be removed or they can cause pelvic inflammation, infection, severe pain, and could potentially endanger any future pregnancies.
The problem is that locating and extracting tiny, fractured pieces of the Paragard inside the body can be extremely difficult. Laparoscopy is the first option, but this technique is not particularly effective at locating small plastic pieces in the uterus, particularly when they are embedded into the uterine wall. The next option is to surgically open the uterus to locate and remove the fractured Paragard pieces. Some Paragard breakage victims have even been required to undergo an emergency hysterectomy (removal of the uterus), leaving them permanently infertile.
Should Teva Be Required to Notify Existing Paragard IUD Users?
The investigative story by WJLA advocated for regulations that would obligate Teva and/or doctors to proactively notify women with existing Paragard IUDs about the potential dangers of breakage during removal. The longer the Paragard is implanted, the more likely it is to break during removal. Notifying existing users would give them the option of lower the risk of breakage by having the device removed sooner rather than later.
Currently, there are no FDA regulations that would require this type of proactive notification to existing device users. According to researchers at IUD Alert, mandatory notification requirements are necessary because neither Teva nor the doctors have any incentive to go out and inform existing Paragard users about the breakage risk.
Reporters from WJLA reached out to the FDA for comment on this issue. In response, the FDA issued a written statement stating that the current Paragard IUD warning label is adequate and that the agency has no plans to impose any further notice requirements for existing users.
Tell Us About Your Paragard Breakage Story
If you are one of the thousands of women who have experienced a Paragard IUD removal breakage contact our Paragard lawyers today to find out if you qualify to file a product liability lawsuit.