Today’s society has a ton of open-minded people, especially as it concerns birth control. Parents no longer want to have children they cannot care for.
Intrauterine Devices (IUDs) are one of the most standard ways of family planning and birth control. In the United States, IUDs rank as the second most reversible birth control method. The country has over 23% of females globally using IUDs as their go-to birth control method.
In the world of IUD birth control, we have the Paragard IUD, a reliable and hormone-free contraceptive. However, it has found itself entangled in a web of legal challenges.
Why? Are IUDs no longer safe?
In this article, we will explore the pain points of the legal battle and give historical context to it. We will also look at the potential repercussions for both users and birth control manufacturers.
Historical Background
Typically, there are two types of IUDs used in healthcare – copper IUDs (Paragard) and hormonal IUDs (Mirena, Skyla, Liletta, etc.). Paragard IUD includes a plastic frame in the shape of a T. It is implanted into the uterus, which triggers an inflammatory response that is poisonous to sperm and eggs.
IUDs stand as one of the best reversible contraceptive methods available. It is because they can be used to prevent pregnancy for many years. IUDs and implants are referred to as long-acting reversible contraceptives or LARCs.
IUDs have been around for many years in the United States. However, a safety controversy in the 1970s led to the withdrawal of all but one IUD from the market by 1986.
The Paragard IUD produced by Teva Women’s Health Pharmaceuticals was introduced in 1984. It was approved by the Food and Drug Administration (FDA) and gained quick popularity. The approval helped in garnering trust amongst many.
According to the Centers for Disease Control and Prevention, the prevalence of women using IUDs like Paragard IUDs to prevent pregnancy is about 10.3%. The age ranks fall between 15- 49 years. Over the years, reports of complications during removal began to surface, which gave birth to the legal battle of the Paragard lawsuit.
It led to many lawsuits against the manufacturers – Teva Pharmaceuticals and CooperSurgical. Complaints claimed that the IUD had design flaws that caused breakage during extraction.
Health Implications
According to the CDC, the failure rate for a copper IUD is 0.8%. It means that women who use the copper IUD are less likely to get pregnant.
Some benefits of copper IUDs are:
- Safe sex
- Removal of the device doesn’t cause infertility
However, the second benefit wasn’t applicable to the Paragard IUD, as noted by TorHoerman Law. While the manufacturers claimed the IUD device was safe and effective, it has several health implications.
The negative health implications of this device outweighed its health benefits. Heavy periods became one of the health implications associated with using a Paragard IUD. According to the Open Access Journal of Contraception, 4 – 15% of women remove copper IUDs due to heavy periods. It can lead to an increase in blood loss by 30 – 50%.
Other side effects might be increased period cramps, pain during sex, and backache. Complications might also happen if the IUD becomes lodged wrongly or breaks into pieces. They include:
- Vaginal bleeding
- Ectopic pregnancy
- Organ perforation
- Infection after improper insertion of the IUD
- Perforated or punctured Cervix/Uterus that might require surgery
- Pelvic Inflammatory Disease (PID) due to fractured IUD
The Legal Landscape of the Case
Amid the legal battles, personal stories of Paragard users have emerged. People have come with tales of pains and complications. These have influenced and shaped the narrative surrounding this once-trusted contraceptive.
Plaintiffs argue that the device’s flaws have not only jeopardized users’ health. The argument extends that it has also led to emotional distress and financial burdens.
The Paragard IUD lawsuit carries broader implications for the birth control manufacturing industry. If the allegations are substantiated, it could prompt a reevaluation of approval processes and post-market monitoring for medical devices.
Manufacturers may face increased pressure to prioritize safety, conduct thorough testing, and enhance communication regarding potential risks associated with their products.
The legal scrutiny surrounding the Paragard IUD has the potential to impact public trust in contraceptive methods. Users may become more discerning and demand transparency.
They would also want comprehensive information about the potential risks and benefits of various birth control options. This increased awareness may influence choices and preferences among individuals seeking reliable contraceptive measures.
The crux of the lawsuits revolves around the alleged inadequacies in the Paragard IUD’s design. It specifically pertains to its removal process.
Users contend that the device is prone to breakage. Thus, resulting in significant health consequences. Some of these consequences include injuries and the need for surgical interventions.
Legal proceedings against Teva Pharmaceuticals and CooperSurgical have garnered attention. Questions about the initial approval process and post-market surveillance have surfaced.
The outcomes of these cases may have far-reaching implications for the regulatory oversight of contraceptive devices.
Who Can Sue?
Any user of a Paragard IUD who faces complications due to the device can sue.
If, after insertion of the IUD, it fractures or breaks and causes injuries resulting in surgeries, you can sue. You can also sue the company for damages if it leads to irreversible effects. Attorneys speculate that the lawsuit settlement might range from $10,000 to $400,000.
As the Paragard IUD lawsuit unfolds, it highlights the intersection of medical innovation, regulatory oversight, and user experiences. The outcomes of these legal battles will undoubtedly shape the future of contraceptive device development and usage.
