Paragard lawsuits filed for women experiencing a break in the Paragard IUD birth control device during removal causing painful complications and removal surgery.
The Teva Paragard IUD birth control device has been linked to a defect which can cause the device to break during removal and embed in the uterus requiring a painful removal surgery.
Currently there are two FDA approved IUDs available in the U.S. today – the copper T-380A (Paragard) and the levonorgestrel intrauterine system (Mirena). Both are now subjects of support groups and lawsuits filed by women that believe they should be removed from the market.
Although IUDs are the most widely used method of reversible contraception in the world today, women in the U.S. use them at smaller rates because of negative repercussions that started with the Dalkon Shield in the 1970’s.
The Dalkon Shield hit the market in the late 1960s and early 1970s and became known as a “veritable instrument of torture.” The public learned very quickly that the Shield was not effective at birth control and it was dangerous. The string that was supposed to be used in removal of the medical device deteriorated inside women’s bodies resulting in infections, sometimes deadly.
Although many argue that current medical devices face more regulation since the Dalkon Shield came to market prior to the regulation of medical devices in 1976. This is simply not true. Many medical devices on the market today, including Paragard, were able to avoid extensive clinical testing because they were grandfathered in through the 510(k) Clearance process.
The FDA 510(k) clearance process “lacks the legal basis to be a reliable premarket screen of safety and effectiveness” according to the Institute of Medicine (IOM). Although IOM was appointed by the FDA in 2011 to tackle the important issue of patient safety, the recommendations that resulted have not been acted upon in any substantial way by the FDA.
For this reason, women must receive full information about the risks an IUD carries before they make important health decisions.
What is the Paragard IUD?
The Paragard IUD is marketed as a simple, safe, hormone free, and effective intrauterine device.
The T-shaped device is made of plastic and then wrapped with copper. This long-term birth control device is placed in the uterus in minutes during a regular office visit to the doctor and is supposed to last for ten years. Removal is marketed as a nonsurgical procedure done in just a few minutes during an office visit.
According to the manufacturer, the copper in Paragard interferes with sperm so that it does not reach the egg. At over 99% effective, Teva claims Paragard prevents pregnancies as well as sterilization.
But, according to a Facebook group with more than 11,000 members, complications due to copper toxicity and breakage of the device happen more frequently than Teva warns women. According to this Facebook page, the side effects of this medical product are not worth it – these prior users are warning other women, when it comes to Paragard – “Don’t get one”
Paragard Lawsuits Filed
Teva Pharmaceuticals USA Inc, the manufacturer of Paragard, is currently facing lawsuits alleging that it inadequately warned that its Paragard intrauterine contraceptive device could break during removal. According to the Paragard lawsuit, the break during removal can lead to a painful removal surgery when the device ultimately embeds in the uterus.
Paragard lawsuits allege that Teva put women at risk as a result of a defect in the device. Teva continues to risk our reproductive health by not warning women of this risk.
Was Teva Warned of the Risk of Paragard Complications?
According to Paragard lawsuits, Teva knew that Paragard can and does cause serious harm to individuals who use it through undetected breakage while implanted or breakage while being removed. Further, Teva knew of the risk from the trials they performed and post-marketing experience and complaint but took no action to adequately warn women of these dangers.
In 2015, the Open Journal of Clinical & Medical Case Reports published a study of physicians within a three-year time frame in a single gynecological practice in Chicago. This study found seven issues over the course of three years with all but one requiring hysteroscopic removal of the IUD’s arm. One 28-year old client was unable to completely remove the broken arm, despite the use of operating room procedures.
This Chicago study suggested that, while still rare, the complications from Paragard are under reported. Furthermore, this study found that broken IUDs present a unique challenge to practitioners because the blind removal anticipated by the manufacturer is not possible.
Studies and real-life events shared on the Facebook page similarly show that even when women follow all of the proper procedures, attempts to remove the IUD intact by pulling the threads, can be unsuccessful and may result in serious side-effects.