When first introduced to the world of birth control options, you may decide that you don't want to experiment with any methods susceptible to human error. Thus, in the end, the search for a hormone-free birth-control option may lead you to the copper ParaGard IUD.
When you choose the copper IUD, the device would be implanted in your uterus and stay there for many years, reliably blocking the fertilization of eggs without any further work on your end. The ParaGard contraceptive agent is the thin copper coil wrapped around the device and offers contraception for up to 10 years.
According to medical professionals, once you and your partner decide you're ready to remove the Paragard and embrace motherhood, it should be as easy as contacting your OB/GYN to have the IUD removed.
However, while for some women, Paragard removal is a simple and straightforward procedure, it proves to be an ordeal of epic proportions for many others.
According to Paragard manufacturers, the IUD removal should be performed by a healthcare professional. As such, you would need to make an appointment with your OB-GYN. Then, in a simple, non-surgical procedure, your doctor or nurse will find the IUD strings located in the cervix. Next, your doctor will gently pull on them until the IUD slides out. The process should be quick and require no anesthesia or extra preparation.
However, for some women, the Paragard does not come out quickly and easily. In one of the worst scenarios, the T-shaped device broke during removal. As a result, many women had to live with broken pieces from the Paragard IUD inside their bodies until removal through an expensive and traumatic procedure.
Eventually, some required surgery to get out the missing fragments. As for side effects, some women suffered permanent injuries and could not go back to their regular routines immediately.
Because Paragard IUD removal is a highly individual experience, you won't know what you're getting into until you experience the actual procedure.
Paragard IUD breakage is a well-documented yet little-publicized problem. According to the voluntary reports filed with FAERS - The FDA Adverse Events Reporting System database since 2013 to date regarding Paragard - which tracks problems reported by individuals and health care providers - there have been 3,290 reports of device breakage, out of which:
● 2,009 events deemed serious
● 180 related reports of hospitalization
● 181 reports of life-threatening complications
● 190 reports of related disability
● 121 cases when the device breakage required intervention
Since they represent only those women that took the time to file a report in a government system that is not well known to the public, these figures may be just the tip of the iceberg. There are also some problems with voluntary reporting because it's hard to tell:
● How often device breakage happens
● Which specific lot numbers these devices are tied to
● If the complication is related to the device
Despite this documented potential for being a dangerous contraceptive device, Paragard manufacturers - Teva Pharmaceuticals and CooperCompanies - have not recalled it. Instead, they removed one batch of Paragard IUDs from the market in 2019 due to sterility issues, not breakage issues.
Unfortunately, the U.S. Food and Drug Administration (FDA) does not currently require any new studies of the Paragard IUD. And companies are not required to look at complications following FDA approval. Therefore it's challenging to get answers about the source of device breakage after Paragard hit the market. Generally, companies don't act or voluntarily choose to conduct a study.
But with more than 3,000 Paragard IUD breakage reports, The FDA should now step in to take a closer look. The agency could use its authority and investigate. For example, it could potentially require a study so that women can make an informed choice.
The most critical issue is that, although IUDs are a safe & effective birth control method for many women, potential complications need to be brought to light. And healthcare providers never warn that Paragard could potentially break because this complication is not included in the list of warnings of health problems it could cause.
For now, many impacted women are discussing their experience with Paragard on social media pages. Others are filing complaints and lawsuits over concerns the device can break, leaving them facing surgery and other complications. Many women have shared experiences discussing Paragard IUD breakage. These collective experiences can prove decisive. For example, previously, after a grassroots campaign on social media compelled FDA to look closer at complications on another birth control device, Essure, the agency took action.
As a result, after advocates spent years highlighting problems with the device, Essure is no longer on the market. Now, the FDA is called to step in and investigate Paragard breakage problems so women can have more information about the device.
In conclusion, for many women, alleged defective design, manufacturing problems, and negligence made the ParaGard IUD prone to break during removal. In turn, this resulted in the need to undergo surgery or additional procedures to remove fragments left in their bodies. In addition, some had to go through a total hysterectomy that impacted their ability to have children in the future.
About the Author:
Hilda Mateiu works as a case manager for Atraxia Law, supporting women injured by the ParaGard IUD. Hilda helps injured women gather and organize relevant information to evaluate if they are eligible to recover compensation for medical expenses, as well as pain and suffering.
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