mardi 8 octobre 2013

Mirena IUD Health Concerns

Americans are generally willing to try new medical devices without much worry, trusting that for a device to make it to market, it must have undergone substantial testing. Unfortunately, it seems that the quest to profit from new devices by getting them to market may make long-term issues of safety go undetected until the device is available on the market for some time.


How else can you account for the horror stories having an effect on patients who used a Mirena IUD medical device for contraception? The names have been changed to maintain the privacy of the patients.


The Heartbreaking Narrative of Sara


Sara had her physician fit her with a Bayer Pharmaceuticals’ Mirena IUD, and she kept it for less than a year. Sara then decided to have it taken out, as she was ready to have a baby. After the IUD was removed, Sara had a difficult time getting pregnant. In an effort to strengthen her odds, she began utilizing ovulation drugs.


Although there are many problems related to Bayer Pharmaceuticals’ Mirena IUD, some of the most widespread are ectopic pregnancy and infertility. These troubles were not explained to either Sara or her medical doctor. If she had known the danger, Sara wouldn’t have selected this kind of contraception device. She was devastated to learn that her choice would likely have an impact on her plans to have kids. Sara is now litigating against Bayer.


How a Mirena IUD Ripped Through a Uterus and Caused Kidney Failure


Alexa had a Mirena IUD inserted in 2011. After her procedure, Alexa’s device dislodged and moved through her body, ripping her uterus by doing so. The IUD then embedded itself in a completely different section of her body, triggering renal failure that nearly killed her. Ever since, she is in near constant limited mobility, neck pain, cramping, stomach issues, and a heavier period. Alexa is suing Bayer.


Mirena IUD


Mirena is a birth control method that emits a small amount of a hormone called levonorgestrel into a woman’s uterus. The plastic device is inserted into a woman’s body by a physician. The Mirena IUD then releases tiny doses of a hormone which thins the uterus lining, but thickens surrounding tissue to block egg fertilization.


In 2009, the United States Food and Drug Administration also approved the Bayer Pharmaceuticals’ Mirena IUD for dealing with heavy periods.


When a woman decides she wants to have children, the IUD is taken out. The moment that takes place, the ability to get pregnant returns, according to Bayer. This is a long-term birth control tool and will last approximately five years. The product packaging indicates that this product is for use in patients who have at least one baby. The reason it is suggested for use in patients who already have a child is because the company has found out that negative result of using Bayer’s Mirena IUD is that it can produce fertility problems in women. Even so, the company continues to ignore the dangers of this device and promotes it as a “very convenient, robust, and reversible method of birth control.” The fact that patients can be left infertile after using the device is not divulged in the marketing information that hails its many benefits.


The Dangers and Difficulties Associated With Bayer Pharmaceuticals Mirena IUD


More than 50,000 claims of serious unwanted side effects have been submitted with the FDA regarding the Bayer Pharmaceuticals Mirena IUD.


These complications include: Contamination, uterine wall embedding, pelvic inflammatory disease, internal bleeding, uterine wall damage, ectopic pregnancy, perforation of the cervix, migration throughout the stomach, inability to conceive, soreness.


Surgery to remove the device or mend damage it caused is not uncommon. the company recognizes that up to one out of every 1,000 women may experience considerable complications.


Ladies who have encountered complications as a result of utilizing the are suing the company for their pain and anguish.


The FDA’s response to Bayer


In 2010, the US Food and Drug Administration issued a warning letter to the company stating that their advertising campaign was misleading. The Food and Drug Administration told the company they were understating the risks and overstating the benefits associated with utilizing the Mirena IUD. The FDA also ordered a stronger warning be added to the packaging. This warning lists comprehensive health problems that can be encountered by using the care product including: movement of device in other parts of the body, congenital anomalies, ovarian abnormal growths, expulsion, tearing of the uterus, breast cancer.


The new wording requested by the FDA contains information that if tearing occurs pregnancy may result.


Legal Status of Mirena Lawsuits


Women who believe Bayer knew of the Mirena IUD side effects and yet neglected to warn patients have filed lawsuits againstthe manufacturer. If they had known of the unwanted effects, they may not to use the product.


Forty-six lawsuits have been consolidated into a Multidistrict litigation, called an MDL. This case is designated MDL 2434 and titled In Re: Bayer Pharmaceuticals’ Mirena IUDProducts Liability Litigation. This MDL consolidates 46 lawsuits in New York Federal Court before Judge Cathy Seible.


In addition, there are 113 Mirena cases making their way through state court in New Jersey and a handful of cases in each of the following states; New York, California, Mississippi and Missouri.


What to do if you’ve been affected by a Mirena IUD product


If you’ve suffered side effects from a Mirena IUD or are aware of someone who has, it is critical to contact a law firm who specializes in such matters. Many attorneys will offer a free case evaluation.


Mirena IUD brought a lot of trouble to its consumers. Not only did it waste their money but it, endangered their life. To learn more about Mirena IUD, kindly visit the writer’s website.


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