The Mirena Intrauterine Device was approved as a contraceptive by the Food and Drug Administration in 2000 and was approved to treat heavy menstrual bleeding in 2009.
The Mirena IUD quickly became a commercial success for its manufacturer, pharmaceutical giant Bayer, and has been the choice of contraception for millions of women in the United States and many other countries.
However, numerous adverse reactions have been reported from women using Mirena and FDA records now show that nearly 50,000 Adverse Event Reports have been filed by women and health care professionals over serious side effects, and in turn leading to lawsuits.
Call Ford & Associates Nationwide Legal Services, A.P.C. now If you are among the women who has suffered any of these injuries resulting in surgical removal of your IUD.
Our firm is investigating whether these injuries may be linked to the use of Mirena:
These injuries are serious. To find out if you may be entitled to compensation for your injury call Ford & Associates Nationwide Legal Services, A.P.C immediately.
Since winning approval for the Mirena IUD from the FDA, Bayer Pharmaceuticals successfully marketed the device as a safe, convenient alternative to birth control pills and other contraceptives.
This campaign, and the increasing number of Mirena IUD Adverse Event Reports, caught the attention of FDA officials who sent Bayer officials a warning letter in 2010, admonishing the company for overstating the benefits and understating the risks of the device.
The FDA wrote:
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act.”
The Mirena IUD is a t-shaped device placed in the uterus to prevent conception for up to five years. It blocks pregnancies by releasing the progestin levonorgestrel to prevent the release of eggs in a woman’s ovaries.
However, it was not long before serious health issues were being reported to the FDA from women suffering about dangerous complications caused by these IUDS.
Claims have been made against Bayer from an increasing number of women who are alleging that these devices were marketed with wildly false claims, that the dangerous side effects were not adequately made public and that the side effects include such serious side effects as organ damage, ectopic pregnancies and infertility.
There have been startling figures compiled by the FDA about the Mirena IUD. Nearly 50,000 Adverse Event Reports have been filed by women and health care professionals and, according to these reports, a disturbing number of women have had been hospitalized or undergone surgery to repair their organ damage.
The reports of serious health problems that have been reported to the FDA prompted the federal agency to require Bayer to provide labeling changes on the Mirena IUD warning patients of additional side effects.
A serious problem reported is that a condition known as “migration,” which occurs when the implanted Mirena IUD shifts inside the body.
The FDA Adverse Event Reports show these are among the problems that have occurred:
Our team of experienced medical device lawyers are now offering free consultations to women who may have suffered any of the serious health problems caused by side effects from the use of the Mirena IUD. If you, a relative, or a friend has suffered these problems in which medical treatment was necessary, please contact us as soon as possible for a complete analysis of the legal options that may be available.
Compensation may be available for pain and suffering, medical costs, or other expenses attributable to defined problems caused by a Mirena IUD. Be aware there may be time limits involved in the filing of a Mirena IUD lawsuits so it is recommended that you contact us as soon as possible in order to preserve all legal options in your case.
The Mirena IUD lawsuits that have been filed so far contain serious claims of health problems that victims are attributing to their use of the device. Bayer Pharmaceuticals is facing charges that company did not adequately test the devices, knew or should have known that the Mirena IUDs could cause serious health problems, and failed to adequately warn consumers and government regulators about these dangerous side effects.
The lawsuits claim that for years Bayer was generating tens of millions of dollars in sales but misleading the public about the dangers of the devices through a marketing campaign that emphasized the safety.
Millions of women chose the Mirena IUD for contraception, and many have suffered serious health complications eligible for filing a Mirena IUD lawsuit. Please contact us call Ford & Associates Nationwide Legal Services, A.P.C immediately for a free consultation.