Maine Paragard Lawyer
The Paragard is the only nonhormonal intrauterine device (IUD) available in the United States. Because the Paragard IUD does not contain hormones, many women have preferred to use the device without having to worry about many common side effects associated with hormonal contraceptives including blood clots. However, the Paragard also poses serious risks for some patients. While the Paragard is intended to be easily removed so that women can bear children, many women have suffered significant injuries when an arm of the Paragard breaks off during removal resulting in the need for invasive surgeries to extract the retained limb and repair severe internal injuries.
How Does the Paragard IUD Work?
The Paragard IUD has a frame consisting of a stem with two attached arms that form a “T” shape. The stem and arms are constructed of polyethylene and are wrapped with a thin layer of copper. In addition, there are two monofilament polyethylene threads that are attached to the base of the stem which are intended for use when removing the device.
The Paragard is the only hormone free contraceptive device available in the U.S. and works to prevent pregnancy by mimicking a woman’s ovulation cycle. The Paragard is also the only available contraceptive device in the U.S. which utilizes copper in its design. The copper “sleeves” on the stem and arms deionize in the body which causes an inflammatory reaction and the buildup of a mucosal layer that blocks sperm from traveling to fertilize an egg. The Paragard is approved for continuous use for up to 10 years.
Since its introduction on the market, there have not been any design or material changes or improvements to the Paragard. Other IUDs have curved or articulated arms that do not easily break off during removal. However, the Paragard’s arms are perpendicular to the stem forming its “T” shaped design which, in part, makes the Paragard more prone to arm breakage.
The Paragard was originally designed and developed by Teva Pharmaceuticals USA, Inc. and Teva Women’s Health, LLC. In September 2017, Teva sold the rights to the Paragard to CooperSurgical who continues to sell the Paragard in the U.S.
Paragard IUD Injuries
Over time, the Paragard’s polyethylene frame loses its flexibility and becomes prone to breakage. In addition, the “T” shaped design of the Paragard makes it more difficult to safely remove the device without unintentionally breaking off one or more arms. What should be a routine removal can often result in an arm breaking off requiring an invasive surgery to extract the retained limb. The retained arm can have sharp edges which may rip through tissue and embed into the uterine wall or other organs complicating removal. At times, a full hysterectomy is required to safely remove the retained limb.
Although the ParaGard IUD works well for some women, many others have suffered serious complications including:
- Breakage of one or both arms during removal
- Breakage of one or both arms prior to removal
- Surgery to remove the retained arm(s) and repair internal damage
- Hysterectomy, laparotomy, laparoscopy, and hysteroscopy procedures
- Perforation of internal organs
- Pelvic pain
Injuries like these can be significant, permanent, and life-altering, including the inability to have children.
When a medical company designs and sells a product, they have a duty to produce a safe and effective device that will not cause harm to patients. When a medical device or drug has been defectively designed or manufactured or if patients and physicians are not adequately warned about the risks of the product, patients have the legal right to seek fair and reasonable compensation for their pain and suffering, medical expenses and other losses. Women who have been injured by the ParaGard should contact an experienced medical device law firm like Fitzgerald Law Group. We can help you determine whether you have a legal case and what you can expect from the process.
Paragard IUD Litigation
A growing number of Paragard lawsuits have been filed against Teva Pharmaceuticals USA, Inc., Teva Women’s Health, LLC, and CooperSurgical in courts around the U.S. Plaintiffs allege that the companies designed and manufactured a defective product and knew about the risks of arm breakage but failed to provide adequate warnings about this serious side effect. Plaintiffs also claim that the companies did not adequately test the Paragard IUD before putting it on the market.
In December 2020, federal lawsuits involving the Paragard IUD were centralized in a multi-district litigation (“MDL”) before U.S. District Court Leigh Martin May in the United States District Court for the Northern District of Georgia (MDL No. 2974). As of January 2021, there were already hundreds of cases docketed in MDL No. 2974 alleging failure of the Paragard IUD due to arm breakage.
Paragard IUD Lawsuit
If you or someone you love has been injured by the Paragard IUD, you may be entitled to significant compensation for your injuries.
To speak with an experienced, Paragard lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (207) 874-7407, or complete the Case Evaluation Form on this website for a free, confidential, case assessment.