Product News and Recalls

Mirena Label Misled Users

New evidence has been uncovered indicating that the warning label for Mirena was not sufficient to warn users of the risk of perforation. Mirena is a hormonal intrauterine device (IUD) manufactured by Bayer and used by millions of women in the United States. In recent years, consumers have filed numerous Mirena lawsuits as a result of harmful complications and side effects.

One dangerous potential complication of Mirena—and the subject of many Mirena lawsuits —is perforation of the uterus. The Mirena device can puncture or embed itself in the uterine wall, often requiring surgical procedures to remove the device or repair uterine damage.

If the perforation is not immediately discovered, a woman may become pregnant. Additionally, the device may migrate into a woman’s abdominal cavity, risking puncture of the intestines, bowels, bladder, or other organs. Uterine perforation can lead to other complications, which can be serious and even life-threatening, including:

  • Infertility;
  • Scarring;
  • Sepsis;
  • Infections;
  • Hysterectomy; and
  • Obstruction of the intestines.

Bayer has the responsibility to warn consumers of these potentially very serious complications before they choose to have Mirena inserted.

Recent Label Changes

Until last month, the Mirena warnings advised as follows: “Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until sometime later.” (emphasis added). This label led users to believe that if their Mirena device was safely inserted, they were in the clear.

However, as of May 29, 2014, Bayer issued what the company called a “major change” to the warning label regarding possible perforation. The new label will state: “Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later.”

Although subtle, the updated warning advises doctors and patients that the risks of Mirena do not end after a successful insertion. It also provides evidence that Bayer was not adequately and accurately warning women of all possible side effects and complications of Mirena.

If you have suffered injury from an injury caused by using Mirena perforating the uterus or migrating into the abdominal cavity, the Mirena lawyers at Lopez McHugh, LLP can help. Contact our office today for a free consultation.