ParaGard IUD Defects – Birth Control Attorneys in Pittsburgh
Did Your ParaGard Device Migrate, Break, or Cause Other Medical Issues? Let Us Help.
Since 1988, women have had access to a non-hormonal IUD—Paragard, an implantable copper device, that’s as capable as its progestin-driven counterparts. The product was sold as an extremely effective and easy form of birth control. Initial tests showed the pregnancy rate among users was less than 1% and, unlike some other birth control options, IUD users do not have to remember follow-up treatments. Initially sold by TEVA Pharmaceuticals, the device is now marketed by CooperSurgical after a buyout.
The promises of ParaGard caught many women’s attention when it was released and continue to do so to this day. Its status as the only non-hormonal IUD available in the U.S. has drawn a large base of consumers concerned about the effects of long-term hormonal birth control as well as those looking for a method they deem more natural.
Some of these women have experienced unexpected complications. Though ParaGard is marketed as a 10-year solution, some women experienced device breakage as early as 6 years after insertion. For other patients, the IUD’s migration out of the uterus has damaged other nearby organs.
Have you experienced any unexpected side effects from your ParaGard IUD? If so, you could be able to sue for compensation.
Warnings May Have Been Insufficient
ParaGard came with a long list of warnings when it was approved by the FDA and released, but patients who chose the device found the packaging did not cover all possible side effects. In response, the FDA has asked the company to revise its labeling multiple times, so consumers are informed of the risks they incur by using ParaGard The most recent update was requested in September of 2019, and the history of changes dates back to the year the product became available.
Among the problems discovered after the product’s release was the possibility the device would not stay in the uterus. If it migrated through the abdominal cavity, its copper wire could perforate the cervix or intestines. This type of injury is very dangerous and often requires patients to undergo surgery so the device can be removed. Many women claim they were not made fully aware of this risk before choosing the product and may have selected a different IUD had they known.
Because IUDs are a long-term birth control solution, many women decide they want to try for a pregnancy and decide to get their device removed early. ParaGard was supposed to last for 10 years, and over that time, a large percentage of users reached a point in their lives where they were ready for parenthood. Despite their supposed longevity, ParaGard IUDs would break during extraction. When this happened, women often needed surgical intervention to make sure all parts of the IUD were safely removed from their bodies.
Similarly, the chance of the device being expelled from the uterus—a risk all IUDs carry—may have been understated. ParaGard’s packaging claims that only 2.3% of women would experience this problem. However, a third-party study found the risk to be 10.2%. The same study found the first-year pregnancy rate for ParaGard users at 1.6%—which contradicts the fewer than 1% rate the marketing and packaging claim. Perhaps the difference was due to the increased risk of expulsion that could leave women unprotected without their knowledge.
Was ParaGard’s Longevity Overstated?
ParaGard promises up to 10 years of protection for women, but it may not last that long in reality. Multiple case studies show device breakage during removals that took place between 6 and 8½ years after insertion. Small pieces that do not make it out with the rest of the IUD could require surgery or the use of alligator forceps, suction curettage, or other specialized equipment.
ParaGard warns there is a risk of breakage—when the device embeds itself in the myometrium, which is itself a very rare side effect. However, that was not the case in these incidents. The study authors warn that the rate of device breakage is hard to pinpoint, as it is likely underreported. They also note their experiences all featured devices that had been in use for more than 5 years. The 10-year promise of ParaGard may not be true in all cases.
Injured by ParaGard? We Can Help.
Our skilled medical device defect attorneys have helped many patients recover millions of dollars after serious injuries. We’re not afraid to take on big corporations with internal legal departments. Users of CooperSurgical’s products should know they are safe from dangerous side effects, and we will keep fighting until that is the case.
You deserve justice. That’s why we won’t back down.
If you think your ParaGard IUD caused medical complications you were not sufficiently warned of, contact Robert Peirce & Associates, P.C. for a free consultation. You can call us 24/7 at (844) 383-0565 or reach out online right now.