Mirena IUD Recipient Alleges Permanent Disability in New Lawsuit

An Indiana woman claims she has been left permanently physically disabled due to defects with the Mirena Intrauterine Device (IUD).

The woman has filed a lawsuit against Bayer Corp. and Berlex Laboratories, the two companies responsible with distribution and manufacture of the Mirena IUD. The suit claims those two Defendant corporations “admit they do not understand exactly how Mirena works” and that when the Plaintiff was to have it removed surgically, the IUD had moved from where it was supposed to be.

The national law firm of Parker Waichman LLP has taken the Indiana woman’s case and filed it in New Jersey Superior Court recently.

The Indiana woman claims she was implanted with the Mirena IUD in March 2009. About 18 months later, she was to have a surgery to have it removed but when an intraoperative ultrasound was performed to locate the device, it was not where it was implanted near the uterus. The Mirena IUD device had migrated to the left abdominal wall and required a laparoscopy to remove it six days after the original surgery.

The Plaintiff claims the makers of Mirena IUD do not specifically warn that the device could migrate. The only reference to device migration made in warning labels and safety information indicate that this side effect is possible when the uterus is perforated during the surgery to implant it.

Mirena is a contraceptive device and more than 15 million women in the U.S. have received the device during a surgery since it was first approved in 2000. Currently, two million women in the U.S. use Mirena. Mirena delivers the synthetic progestin, levonorgestrel, directly to the uterus. It is implanted a week before menstruation and can stay in the body for up to five years. Mirena is supposed to thicken cervical mucus, thin the uterine lining, inhibit sperm movement, and reduce sperm survival to prevent pregnancy, according to the firm’s press release announcing the lawsuit.

Both companies have been chastised by the federal Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) regarding its misleading marketing of the Mirena IUD. Bayer created in the “Simple Style Program” and targeted so-called “busy moms” with having the Mirena IUD implanted. The device is intended to serve as a contraceptive device for women who’ve had at least one child.

To market Mirena as successfully as it did, the company overstated the benefits of Mirena while neglecting to mention the potential side effects of having it implanted. In addition to potential migration of the device, the Mirena device has been linked to several other serious side effects like pelvic inflammatory disease, ovarian cysts, irregular bleeding, and a condition known as amenorrhea. Some women who’ve had Mirena implanted have suffered a miscarriage and risk losing fertility. Mirena can also cause weight gain, acne, and breast tenderness.

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