For women looking for non-hormonal birth control with a high success rate, Paragard® is one of the few FDA-approved options. In fact, Paragard® is the only brand of copper IUD available in the United States. Unfortunately, it now appears Paragard® is not as safe as its manufacturers lead some doctors and patients to believe. One problem--the device breaks during removal and causes serious complications.
Paragard® Warnings
On its website, Paragard® warns it can cause “serious side effects.” Paragard® can cause ectopic and intrauterine pregnancies, life-threatening infections (like sepsis), pelvic inflammatory disease (PID), and endometriosis. It can also become attached to (embedded) in the wall of the uterus or go through (perforate) the wall of the uterus. Sometimes, Paragard® falls out of the uterus completely, causes significant pain and bleeding, and fails to protect its user from pregnancy.
Embedment and perforation can lead to intense pain, require invasive surgeries, result in infertility, and leave behind scarring, infection, and damage to other organs.
Aside from all these risks, many women experience heavy, painful periods and anemia after having a Paragard® inserted.
The biggest risks of all, however, appear to come during removal.
Playing Down the Problem
Although Paragard® warns of embedment and perforation, manufacturers Teva Pharmaceuticals and CooperSurgical, Inc. do not specify how often these events occur. Additionally, Paragard® is marketed as “easy to remove,” but some women experience breakage during removal and must undergo invasive surgeries to get pieces of the device out of their bodies.
Another allegation is that the unusual, T-shaped intrauterine device (IUD) is defective in design, as the IUD’s “arms” are at 90-degree angles and can easily break off, get stuck, or otherwise fail to work properly during removal.
In any case, Teva and CooperSurgical lead both doctors and patients alike to believe that Paragard® IUDs are safe – and that complications are rare. Meanwhile, studies like the one from Carlos M. Fernandez, MD suggest that clinicians should better recognize the possibility of breakage.
Like other manufacturers of drugs and medical devices, Teva and CooperSurgical have a duty to warn patients and physicians of risks and market their products truthfully.
With the Paragard® IUD, many victims and their attorneys argue that the manufacturers have failed to meet this duty.
When Should I Speak to an Attorney About Paragard®?
If Paragard® complications led you to need surgery to remove broken or fractured pieces, you should consider speaking to an attorney right away.
Examples of these surgical procedures include:
- Hysteroscopy
- Laparoscopy
- Laparotomy
- Hysterectomy
You should also talk to a lawyer if you have retained pieces of Paragard ® IUD) or difficulty getting pregnant after a Paragard® breakage. A successful legal claim may help you become compensated for your damages, for example, helping afford fertility treatments.
When defective drugs or medical devices harm you, Brett H. Oppenheimer, PLLC is here to help.
Call Brett directly at (502) 242-8877 or send a message online to get a callback and a free consultation.
We hope to help you hold Teva and CooperSurgical accountable for any injuries or losses associated with the Paragard® IUD.