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MIRENA IUD and Risk of Uterine Perforation
Mirena, an intrauterine device inserted directly into the uterus to prevent pregnancy, has been associated with mirena uterine perforation and other serious side effects. As of June 30, 2012, The US Food & Drug Administration (FDA) received 45,697 reports of a serious Mirena birth control side effect.
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According to AdverseEvents.com, the top three adverse events related to the use of Mirena were device expulsion, device dislocation and vaginal hemorrhage, with more than six percent of patients requiring hospitalization or surgery. Mirena birth control side effects can include:
Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
intrauterine pregnancy (a pregnancy with Mirena in place)
Group A streptococcal sepsis
Pelvic inflammatory disease (PID)
Embedment of the device in the uterine wall
Perforation of the uterine wall or cervix
Infertility, abscesses, erosion of adjacent areas such as the vagina
Mirena was approved by the FDA in 2000 as a contraceptive device and in 2009 it was approved for the treatment of heavy menstrual bleeding for women who prefer an IUD as their method of birth control.
The Mirena IUD is a T-shaped device that is implanted directly into the uterus and can remain in place for up to five years. It works by slowly releasing levonorgestrel, a synthetic “hormone” to prevent pregnancy and to treat heavy menstrual bleeding. Levonorgestrel is a hormone commonly used in combined oral contraceptives.
The FDA issued a warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. Up until the FDA’s reprimand for deceptive marketing of Mirena, Bayer held live presentations as part of its “Simple Style” program that targeted “busy moms” and claimed that the IUD would help increase libido and “look and feel great”. Instead, and included in the FDA warning letter, “at least 5 percent of Mirena IUD users reported decreased libido in clinical trials.”
Bayer Mirena Warnings
The FDA’s Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) concluded that the benefits of Mirena were overstated through this program while downplaying its side effects.
(The German pharmaceutical giant had already received a similar warning from the FDA regarding how it advertised Yasmin and Yaz products, along with a large fine against the company.)
As a probable result of Bayer’s multi-million dollar advertising campaign of its IUD directly to the consumer, by 2009 the use of IUDs implanted in American women using birth control had doubled in just two years (about 7.5 percent of all American women using birth control had IUDs).
In 2010 a joint safety information statement issued by Bayer Inc. and Health Canada stated that women in the US and Canada reported injuries related to use of Mirena. Bayer AG and Health Canada said that uterine perforation is a rare complication associated with all intrauterine contraceptive devices/systems, including Mirena. Perforation occurs at a rate between 1/1,000 and 1/10,000 insertions. The statement was issued because Bayer Inc, had received reports of uterine perforation associated with the use of its device. The statement also noted that the risk of perforation may be increased after pregnancy, during lactation, and in women with atypical uterine anatomy.
Bayer is facing a number of lawsuits by women who have suffered injuries from the Mirena IUD device. The company has petitioned that all cases be consolidated to the New Jersey Superior Court in Middlesex County, where Bayer is headquartered.
A Pennsylvania woman filed a Mirena lawsuit (Civil Action No. MRS-L-272412) against Bayer Healthcare Pharmaceuticals on November 5th, alleging numerous damages as a direct result of Mirena and Bayer’s wrongful conduct and negligence, including severe and permanent injuries and pain and suffering. Further, the lawsuit is also asking for financial compensation due to lost wages and the decreased ability to earn future wages.
According to the lawsuit, the woman had the Mirena IUD implanted in 2008 but did not experience pain until 2010. In November 2010 a CT scan revealed that Mirena was no longer inside her uterus. She underwent a subsequent laparoscopic surgery to have the device removed.
A Florida woman also claims that the Mirena IUD caused physical and emotional damages. Her complaint (also filed Nov 5th, Civil Action No. MRSL-2723-12) states that she had the Mirena IUD implanted in 2008 and in July 2010 suffered from pelvic pain. She had laparoscopic surgery in December 2010 in order to remove the IUD. The lawsuit alleges that the Mirena caused a number of damages, including severe and permanent physical injuries, pain and suffering, and economic losses in the form of medical expenses and lost wages.
According to Bayer’s petition, at least 16 Mirena IUD lawsuits are currently pending as of November 2012 against the company.
Mirena IUD Legal HelpIf you or a loved one has suffered illness or an adverse health event resulting from the use of this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Dec-16-14
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