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New IUDs and the Failure to Warn

Are intrauterine devices (IUDs) safe for use? For a number of years, patients have filed lawsuits against Bayer, the maker of Mirena. Mirena is one of three IUDs that is currently on the U.S. market, accompanied by ParaGard and Skyla. According to an article from U.S. News & World Report, Skyla is the newest IUD available for U.S. patients. Does Skyla pose the same serious risks as Mirena? And should patients who have suffered injuries after using an IUD consider filing a product liability lawsuit?

Understanding How IUDs Work

How do IUDs work? According to Anne Burke, an assistant professor of obstetrics and gynecology at the Johns Hopkins University School of Medicine, IUDs are placed in the uterus to prevent pregnancy. When it comes to Mirena and Skyla, these devices release a hormone—levonorgestrel—that has “several contraceptive effects.” As Burke explains, “it helps thicken the cervical mucus, which creates a more impenetrable barrier for sperm,” and the hormone in the IUDs “suppresses the growth of the lining of the uterus, which also probably impacts fertilizations and enhances contraceptive effect.”

All IUDs are small T-shaped devices. Paragard, unlike Mirena and Skyla, contains no hormones. It is a small object made of copper and plastic that “creates a mild inflammatory reaction inside the uterus, which primarily helps prevent the sperm from fertilizing the egg.” A ParaGard IUD can remain inside a woman’s uterus for up to 10 years. Mirena and Skyla are a bit different. Mirena can remain inserted for up to 5 years, while Skyla can remain inserted for 3 years.

Risks of Using IUDs

Common side effects of IUDs include irregular bleeding, spotting, and cramping. However, rare but very serious risks also exist. To be sure, IUDs can result in “infections and pelvic inflammatory disease,” and in a small number of cases they can cause uterine perforation. Uterine perforation is “when the IUD works its way through the uterus and ends up in a woman’s abdomen.” While Burke emphasizes that uterine perforation is rare, occurring on only about 1 out of 1,000 insertions, it can result in serious and life-threatening injuries, and it often requires laparoscopic surgery.

Due to such injuries, numerous women have filed product liability lawsuits against Bayer Healthcare, the maker of Mirena, arguing that the manufacturer failed to warn women about the risks of the IUD migrating, puncturing organs, and causing severe injuries. Given that Skyla is a new IUD on the U.S. market, should patients be concerned about similar issues? Will this IUD result in lawsuits like those against the maker of Mirena?

New IUD Lawsuits and Product Liability Claims

Skyla is slightly smaller than Mirena, but it comes with the same risks as other IUDs. Released onto the market in 2014, this device, like Mirena and ParaGard, can migrate to other parts of the body and can cause damage to organs. According to a report from PRNewswire, a fourth IUD called Lilettawas recently approved for use in the U.S.

If you have a recently approved IUD like Skyla inserted and experience serious injuries, can you file a successful product liability claim?

It is important to remember that each case is different, and it is impossible to know, without having an experienced product liability attorney examine the facts of your situation, whether you are likely to be successful in court.  In addition to negligence claims and arguments about defective design, many women have argued that Bayer failed to warn physicians and consumers about the risks of the device.

What does the term “failure to warn” mean? Sometimes referred to as a marketing defect, this is one of three general types of claims that can be made when it comes to product liability law. If you were injured by a Skyla IUD and you file a product liability claim alleging that Bayer failed to warn consumers about the dangers associated with the product, you will need to prove the following elements:

  • Bayer manufactured Skyla;
  • Skyla had potentially serious risks that were known at the time of its manufacture and sale;
  • Those potential risks presented a danger to patients who used the IUD in a reasonably foreseeable manner;
  • You, as a typical consumer, could not recognize those risks;
  • Bayer failed to provide adequate warnings of those potential risks;
  • You sustained a serious injury; and
  • Bayer’s lack of adequate warnings about the risks played a substantial role in causing your injury.

The issues surrounding filing a product liability claim for a defective medical device are complex. If you or a loved one has suffered an injury as a result of an IUD, you should contact an experience defective medical products attorney to determine your rights.

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