Contraception and contraceptives have been a lively topic of debate for years. With the November 2012 election decided the debate over contraceptives and contraception will continue in many forums. Our office remains involved in representing girls and women that suffered blood clot injuries from use of a DROSPIRENONE (DRSP) containing form of birth control. The original DROSPIRENONE (DRSP) family of contraceptives is manufactured by BAYER HEALTHCARE PHARMAECEUTICALS (BAYER), which also manufacturers the MIRENA IUD (INTRAUTERINE DEVICE) or IUS (INTRAUTERINE SYSTEM). As a result, modern contraceptive litigation continues to have BAYER as a central figure over injuiries following use a product and claims they failed to warn of risks associated with a Blockbuster component of their bottom line.
IUD is simply an abbreviation for intrauterine device. BAYER has attempted to avoid the stigma, from past litigation, assoicated with the term IUD and coined the term IUS, an acronym for intrauterine system. The idea of inibiting sperm from meeting an egg in the womb dates back centuries to primitive IUD devices. The Modern IUD is most remembered, at least in the United States, by the litigation plagued and stigmatized “Dalkon Shield“. It appears that BAYER sought to distance itself from this very device in trying to brand the MIRENA as an IUS rather than an IUD.
The MIRENA IUD was approved in the U.S. by the FDA in 2001, as levonorgestrel-releasing intrauterine system. The “T” shaped device is a hormone-releasing system that is placed in the uterus by a trained professional. BAYER claims it can be left in the uterus for up to 5 years and that it also treats heavy periods from a womans menstrual cycle in those women who choose the MIRENA IUD.
The Mirena IUD is recommended for women who have had at least 1 child. This is clearly stated in the promotional materials from BAYER despite recent media reports that it is safe and effective for girls and women of any age. Efforts to promote the Mirena IUD as a ‘set and forget’ form of long term contraception fail to emphasize the serious risks of injuries, potential complications and side effects in the reproductive organs.
Surpisingly, despite FDA approval, and the existence of a number of different IUDs in the modern era, it is arguably not clear exactly how any IUD works to prevent pregnancy. Perhaps, if that was made clear to a girl or women considering the IUD they would reconsider placing the device altogether. With regard to the MIRENA IUD, BAYER provides the following graphic detail and information in certain promotional materials.
Emphasis on “may work in several different ways” is not provided in this detail taken from BAYER materials available on line. Similarly, other graphics indicate that these statements are arguably theory or theoretical which could give some pause in considering long term placement of the device.
The FDA previously warned BAYER over claims it advanced in promotional materials that it was marketing the MIRENA IUD in ways that overstated the effectiveness of the product, presented unsubstantiated claims, downplayed and minimized the risks and included false or misleading representations. The MIRENA IUD is not a carefree, or ‘set and forget’ form of contraception. It is not, as once promoted a ‘worry-free birth control’. It comes with risks and requires that a woman regularly check to confirm the device remains in place to be effective, in conjunction with risks inherent to this form of contraception.
MIRENA lawsuits involve the MIRENA IUD and serious complications, or injuries during use of the device. Our office has intiated investigations to represent girls and women that suffered injuries from use of the MIRENA IUD. Our evaluations are on a case by case basis, dependent upon a number of factors unique to each girl or woman at the time she had MIRENA placed.
At this time, we are reviewing MIRENA claims where girls or women suffered injuries that include the following:
Let us know if you need or want additional information regarding this litigation, our post or related topics. At this time, there are no MIRENA settlements, or any centralized MIRENA class action or MIRENA mass tort. It is possible that centrailzed civil litigation will lead to a MIRENA mass tort and we will provide an update on related proceedings.