When it comes to birth control, women face the decision between hormonal and non-hormonal contraceptive methods. Many women are opposed to hormonal contraceptive methods due to side effects they may have faced, or a general distaste toward altering their hormone levels. Unfortunately, the options for non-hormonal birth control are extremely limited, with only one approved form of non-hormonal birth control currently on the market: the Paragard IUD.
Paragard has been on the market since 1988, approved by the FDA in 1984. The t-shaped IUD is implanted in the uterus and can stay there for up to 10 years, giving it a reputation as a low-maintenance method of birth control for women avoidant of hormonal methods. One woman who was drawn to the Paragard IUD because of its non-hormonal, low maintenance nature was Anna Speaks.
Issues with the Paragard IUD
Anna, like many IUD users, opted for self-removal when it came time to remove her Paragard IUD. Experts are not in agreement on the safety of self-removal, but women without access to insurance or adequate care often choose to remove them on their own. When Anna removed her IUD, she immediately realized something was not right. A piece of the IUD was still left inside her body, which eventually required medical care and surgery.
Anna is not alone in her negative experience with the Paragard IUD. The FDA Adverse Events Reporting System (FAERS) tracks problems reported by health care providers and individuals. Spotlight on America sorted through thousands of these adverse events, uncovering the following numbers on Paragard:
- 3,186 reports of device breakage
- 1,910 of these events deemed as serious
- 102 related reports of hospitalization or life-threatening complications
These uncovered statistics have caught the attention of leaders in the field of women’s health, specifically Cindy Pearson, the Executive Director of the National Women’s Health Network, an organization that works to empower women and promote equity in healthcare. However, Pearson explains that these complaints are few among many, given that filing a report with FAERS is taxing and not publicly well-known. Pearson also notes that the 3,000+ number for Paragard device breakage is concerning and requires further investigation.
FDA Response to Breakage Reports
The FDA is not currently requiring or requesting any studies or follow-up research on the adverse effects of the Paragard IUD. The FDA also noted in a Q&A with Spotlight on America that FAERS data alone has limitations and cannot necessarily prove causation, indicate the safety of a drug, or establish rates of occurrence. FAERS data is also not medically verified, given that it is self-reported.
While the FDA is not taking action, many IUD users are. Over 55 recent lawsuits have been filed against Paragard, claiming the product has a propensity to break upon removal, and that it causes complications and injury. Women have also banded together on social media, bonding over negative experiences with Paragard. One Facebook group has over 8,000 members where they share stories and support one another through collective experiences.
Grassroots groups like these can cause big waves, says Pearson. Essure, another birth control device, has been removed from the market after campaign members pushed the FDA to look into complications resulting from the device. For those who have experienced the adverse effects of Paragard, successes like this may serve as a beacon of hope for their continued efforts.
Let an Attorney Help With Your Case Against Paragard
Having a defective Paragard IUD break inside your body could come with life-altering consequences. Fortunately, a qualified attorney could assist you in getting the financial compensation you deserve while you recover physically and emotionally. Call our firm today to schedule a consultation.