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Indiana Woman Claims Bayer Understated Mirena IUD Risks

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The Mirena IUD is at the center of another lawsuit after an Indiana woman claimed that Bayer understated the device’s risks. National law firm, Parker Waichman LLP, is representing the woman.

According to Parker Waichman LLP, Bayer Corporation and Berlex Laboratories, Inc. have a history of overstating the benefits of the Mirena IUD and understating the potential complications associated with this contraceptive device. The lawsuit, which alleges that the Indiana woman suffered permanent and physical injuries due to the Mirena Intrauterine Device (IUD), was filed on July 26, 2012, in New Jersey Superior Court, Morris County (Case No. 61910-12).

The lawsuit states that the Mirena IUD was approved by the U.S. Food & Drug Administration (FDA) in 2000, and is currently used by 2 million women in the U.S.; globally, more than 15 million women have used Mirena. The Mirena IUD releases a synthetic progestin, levonorgestrel, directly into the uterus and, according to the complaint, even Bayer and Berlex admit they do not understand exactly how Mirena works, stating that it may thicken cervical mucus, thin the uterine lining, inhibit sperm movement, and reduce sperm survival to prevent pregnancy. The device is inserted into the uterus within seven days of the first day of menstruation, where it may remain for up to five years.

In 2009, the Mirena IUD was also approved to treat heavy menstrual bleeding in women who use IUDs. The Mirena device is recommended for women who have had at least one child, noted NewsInferno.

According to the complaint, the woman, now 24-years-old, received the Mirena IUD in March 2009. On September 24, 2010, she underwent a hysteroscopy to remove the Mirena IUD; however, no IUD was found in the vicinity of her uterus upon the performance of an intraoperative ultrasound. On September 30, 2010, a CT scan revealed the Mirena IUD in the left abdominal wall. The woman then underwent an operative laparoscopy on October 1, 2010 to remove the IUD.

The complaint notes that the Mirena label does not warn about spontaneous migration of the device, and only states that migration might occur if the uterus is perforated during insertion. In 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) found that claims made via Bayer’s “Simple Style Program,” which marketed Mirena to “busy moms,” were unsubstantiated, noting that the program failed to mention side effects such as weight gain, acne, and breast tenderness. NewsInferno previously wrote that The FDA said the script for the program misbranded Mirena in violation of the Federal Food, Drug, and Cosmetic Act, and the agency’s implementing regulations.

The FDA says Mirena has been associated with serious complications including ectopic pregnancy, intrauterine pregnancy, group A streptococcal sepsis, pelvic inflammatory disease (PID), device embedment in the uterine wall, and uterine wall and cervix perforation. Side effects also include bleeding and spotting at irregular intervals, headaches, ovarian cysts, vaginitis, pain during menstruation, pelvic pain, and breast tenderness. NewsInferno pointed out that Canadian health regulators reminded healthcare providers there of Mirena’s risks of uterine perforation.

In June, NewsInferno wrote that Parker Waichman LLP filed two lawsuits against Bayer Corporation, and others, on behalf of women allegedly injured by the Mirena (IUD). The first lawsuit was filed on April 12th on behalf of an Ohio woman (Case No. MRS-L 924-12); the second lawsuit was filed on May 21st on behalf of an Oklahoma woman (Case No. MRS-L 1263-12). Both complaints were filed in the Superior Court of New Jersey, Morris County. Both complaints allege that the women underwent a hysteroscopy to remove the Mirena IUD when the device was not found in its expected location.

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