Mirena IUD Attorney
The Mirena IUD (Intra-Uterine Device) was approved by the FDA in 2000 for contraception and later as a treatment for heavy bleeding in women who gave birth. The device is manufactured by Bayer HealthCare Pharmaceuticals, Inc. and is used by more than 2 million women in the United States.
An estimated 8.5 percent of American women using contraception use a long-term, reversible method such as an intrauterine device. An IUD is intended to prevent pregnancy for up to five years by emitting hormones after implantation and can be a more convenient option for women who find it difficult to take oral contraceptives on a daily basis or want to avoid getting regular contraceptive shots.
The device is implanted into a woman’s uterus, where it slowly releases levonorgestrel (a synthetic version of the hormone progestin). This hormone may thicken the cervical mucous, which prevents sperm from entering the uterus. It also makes the lining of the uterus thinner, which reduces the chances that a fertilized egg will implant and grow. Mirena is indicated for intrauterine contraception for up to 5 years, and is only recommended for women who have had at least 1 child. Although Mirena has been promoted as a safe and reversible form of birth control, many women may face an unreasonable risk of the following problems:
Perforation into Uterine or Cervix wall which may not be readily detected
Embedment in vaginal tissue that may require surgical removal
Migration of the device which can lead to adhesions, scarring or intestinal perforation
In some women, Mirena can cause serious complications, including life-threatening ectopic pregnancy (pregnancy that occurs outside the uterus), perforation of the uterine wall, and a serious condition known as pelvic inflammatory disease (PID).
Many women are contacting a Mirena IUD attorney and filing lawsuits against the drug’s manufacturer, Bayer, claiming that the product is “defective and unreasonably dangerous” and seeking compensation for medical expenses, lost wages, and pain and suffering.
Among the many claims of negligence, Bayer is accused of intentionally selling a dangerous product, deceptive advertising and concealing the risk of complications. According to FDA reports, there have been more than 45,000 adverse events reported, including device expulsion, device dislocation and vaginal hemorrhage. In reviewing the manufacturer’s script for advertising for the product, the FDA warned Bayer in a Dec. 30, 2009, letter that the company was in violation of the Federal Food, Drug, and Cosmetic Act. The agency further stated that the advertising included false or misleading presentations and misbranded the drug.
According to the FDA, Bayer made false claims that the use of Mirena will result in “increased levels of intimacy, romance and by implication emotional satisfaction” when there is no evidence for this claim. In addition, Bayer falsely insinuated that women who use Mirena will “look and feel great,” even though women using the product may experience weight gain, back pain, breast pain and acne. The advertising also omits important instructions with regard to the use of the device. Bayer has also been warned for omitting risk information for complications.
According to allegations raised by many a Mirena IUD attorney in lawsuits filed in courts throughout the United States, Bayer HealthCare Pharmaceuticals, Inc. knew or should have known about the risk of all of these Mirena problems, yet failed to provide adequate warnings for women or the medical community.
While withholding important information about the risk of devastating complications, Bayer aggressively promoted Mirena IUD systems as a convenient form of birth control, negligently and recklessly making false and misleading representations about the safety of the device.
The attorneys at Tate Law Group are investigating these injuries and currently litigating a number of cases. If you or someone you know was the recipient of a Mirena IUD, please contact a Mirena IUD attorney at Tate Law Group today toll-free at (866) 610-7107 or contact us online.