Mirena is a brand-name medical device known as an IUD or Intra-Uterine Device. Mirena is a form of hormonal birth control for women, typically offered as an alternative to oral contraceptives. Mirena is a small, plastic T-shaped device that is inserted into a woman’s uterus and releases low amounts of estrogen.
Mirena has been shown to be 99% effective in preventing pregnancy, while most oral contraceptives are 99.9% effective when taken properly. However, the pill must be taken daily around the same time each day. IUDs are inserted during a brief outpatient procedure and offer contraception lasting up to 5 years, without the need for daily attention.
Other types of non-hormonal IUDs do exist, such as Paraguard. However, the Mirena device has been the subject of attention in recent years due an alarming rate of reported side effects and personal injuries experienced by women using it. A rash of lawsuits and personal injury claims filed against Bayer, Mirena’s manufacturer, has brought to light numerous reports of device migration and product-related injuries.
Mirena – Problems and Complications
The chief complaint associated with the majority of Mirena injury claims is the device’s tendency to migrate through the wall of the uterus into other parts of the body in and around the abdomen. As a result, cases of reported injuries also include perforation or tearing of the uterine wall. Once the device penetrates the uterus, it may move through the abdominal cavity and damage nearby organs. Abscesses, as well as intestinal perforation and obstruction, have been reported in related claims.
Clinical studies have also revealed the tendency of the Mirena IUD to have an unacceptably high tendency to migrate toward the pelvis, thus further substantiating the early claims of product defects and resulting injuries. In such cases, many women were forced to undergo multiple surgeries in order to properly locate and remove the device.
Complaints against Bayer – Failure to Warn and False Claims
One woman filed a lawsuit against Mirena maker, Bayer, after requiring multiple surgeries to remove the device from her abdomen. Her chief complaint stated that Mirena’s product label failed to warn users against the possibility of device migration. No mention of the side effect was listed. The lawsuit also alleged false claims made about the product’s benefits, including claims of “increased desire for intimacy” with zero research or evidence in place to back it up.
Several, similar personal injury claims of product migration, where one or more surgeries were necessary to remove the device, were made by women over the past 3-4 years. Almost every case claims Bayer’s failure to warn or that Bayer knowingly released a defective, untested, and unsafe product.
Mirena, Bayer, and the FDA
The numerous claims by women suffering from device migration were not without merit. The lawsuits prompted a Food and Drug Administration (FDA) investigation into the lawsuits’ allegations as well as Bayer’s marketing tactics. An FDA letter to Bayer, dated December 30, 2009, warned the pharmaceutical giant that Mirena was in violation of the Federal Food, Drug, and Cosmetic Act in that the product’s radio and television scripts included grossly misleading representations and unsubstantiated claims.
The FDA’s warning went on to state that product labels and advertising minimized and omitted the immediate risks of using the product and failed to properly warn women. As a result, these claims have gained strength and legitimacy. Women who have been injured by the product and were not made aware of the risks may have a rightful entitlement to compensation for any damages suffered.
References:
Drugwatch – Mirena Lawsuits – https://www.drugwatch.com/mirena/lawsuit/
WebMD – IUD for Birth Control – https://www.webmd.com/sex/birth-control/intrauterine-device-iud-for-birth-control
