Mirena IUD Dangers. The popular Mirena intrauterine device (IUD) manufactured by Bayer has come under tremendous scrutiny for side effects of which Bayer failed to warn the women to whom it was prescribed. Bayer, as with all medical device manufacturers, has an obligation to inform their customers about the possible side effects using Mirena […]
Mirena IUD Dangers. The popular Mirena intrauterine device (IUD) manufactured by Bayer has come under tremendous scrutiny for side effects of which Bayer failed to warn the women to whom it was prescribed. Bayer, as with all medical device manufacturers, has an obligation to inform their customers about the possible side effects using Mirena might cause. However, scores of women have been injured when their IUDs failed to remain in place, and the synthetic hormone used in Mirena caused a serious adverse and dangerous reaction. Bayer denies any wrongdoing and has vigorously defended all lawsuits filed against them. It is clear that Bayer is protecting its brand. Notwithstanding, they might be held responsible for damages if the women injured by Mirena convince a judge or jury that the Mirena IUD inured them.
If you or someone you love suffered serious personal injuries because you used Mirena, you might be eligible for financial compensation. Parker Waichman LLP is a national law firm whose attorneys zealously represent their clients who experienced injuries caused by a faulty medical device. Parker Waichman’s Mirena products liability lawyers employ their extensive litigation experience and knowledge of the law to obtain damages for their clients. To date, Parker Waichman’s lawyers have recovered over $2 billion in damages for their clients. While every case is different, you can count on Parker Waichman LLP to exhaust their resources to vigorously pursue justice on your behalf.
Bayer designed Mirena to prevent fertilization. Bayer did not design this device for women without children. Rather, the device is ideal, according to Bayer, for women who have given birth previously. Women can. Additionally, Bayer touts Mirena as an option to relieve discomfort and pain from menstruation. Mirena is a “T” shaped device that also has strands trailing off of the end. Those strands serve two purposes. The primary purpose for those strands is to release a synthetic hormone into the uterus called levonorgestrel. Also, the strands permit the patient to feel if the device remains in the place in which the physician inserted it. Bayer claims that Mirena is the perfect option for busy mothers who want to delay having another child. The device can last for approximately five years.
A physician must insert the item into the patient’s uterus. The procedure is relatively quick. Bayer anticipates that insertion will not cause any complications, although many women reported some discomfort and pain during the installation procedure. Other women said bleeding during the insertion procedure or within a couple of months after receiving the device.
Bayer quite understates the potential side effects. The U.S. Food and Drug Administration (FDA) has received 47,000-plus complaints about Mirena. However, the FDA has not exercised its authority to issue a recall of the device as of this time. The FDA did order Bayer to issue warnings about the potential efficacy of the device and its possible severe side effects in 2009. Many women complain about excessive bleeding after insertion. Over 20,000 women have complained about the expulsion of the device. Of course, that is problematic because that could lead to an unwanted pregnancy. Partial expulsion is also a common complaint. Pain, soreness, and cramping are all signs that the uterus partially expelled the device. Partial expulsion also carries with it the possibility of unwanted pregnancy as well.
One of the most serious side effects is bleeding. Women can experience some bleeding, but in others, the problem becomes much worse and is potentially life-threatening. Some women only experience spotting occasionally, and it goes away after a while. Others suffer from massive hemorrhaging. Some patients experience irregular or the absence of their monthly period.
Low-volume bleeding might be an anticipated side effect after implantation. However, excessive bleeding could be the result of a perforated uterus, whether it gets stuck in the uterine wall or passes through into the abdominal cavity. The device can travel a long way out of the uterus and embed in the intestinal walls of the patient. This phenomenon is described as perforation and migration.
Bayer warns that perforation of the uterine wall can occur during the insertion procedure. The company claims, however, that perforation cannot happen at any other time. Bayer recommends having an ultrasound test to make sure the device is where it should be. But, thousands of patients have complained about severe damages from secondary migration. Secondary migration results in the IUD are moving out of the uterus and implanting in another organ after the insertion procedure. Bayer denies this can happen or if it does, the number of instances is statistically insignificant. The pain and discomfort of a statistically insignificant group of women may not mean much to Bayer. Notwithstanding, instances of this occurring have been documented. The Mirena devices have lodged themselves in blood vessels, bladders, stomachs, kidneys, and other organs in the abdomen.
Physicians must remove the device surgically when migration occurs. Surgery, naturally, comes with its own potential risks and complications. For example, the patient could be sensitive or have an allergy to anesthesia. Additionally, the patient could get an infection from being in the hospital. Further still, the patient might experience excessive bleeding or prolonged post-operative pain.
This issue of whether Mirena is capable of secondary migration is the subject of lengthy litigation. Many plaintiffs lost their battle when a federal judge hearing the cases ruled that the plaintiffs could not prove that the device was one that was capable of causing the damages about which the women complained. An appeals court upheld the decision. Still, the fight wages on. Some women have tried to assert their claims in state courts across the country rather than taking their case to federal court. If scientifically reliable evidence develops proving that Bayer knew or should have known about secondary migration and failed to warn patients about the risk, then the women suffering from injuries relating to secondary migration might have a viable claim for damages.
An additional side effect of Mirena is now the subject of strenuously contested court cases. Numerous women suffered from a complication called PseudotumorCerebri. This complication mimics the symptoms a person suffering from a brain tumor might exhibit. PseudotumorCerebriis also described as intracranial hypertension. The sufferer experiences painful headaches, vision loss, blurry vision, double vision, and ringing in the ears.
Studies have shown that PseudotumorCerebri can be caused by the synthetic hormone used in Mirena, levonorgestrel. Levonorgestrel causes these problems in normal, healthy patients. But, Bayer argues that this complication has more to do with the women in question than their product. Bayer claims that women who are overweight or obese are more likely to develop intracranial hypertension. Women who are overweight tend to be the better candidates for Mirena. Therefore, Bayer argues, the body composition of the women themselves cause the problem and not the hormone. These cases are still pending in court.
Parker Waichman LLP will vigorously pursue every available avenue of relief for victims of the Mirena IUD. Call Parker Waichman LLP for scheduling a free, no-obligation consultation to discuss your claim, or more convenient you can fill out our online form. Do not delay. Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) and speak with one of our Mirena IUD lawyers about your rights.
Our Mirena IUD lawsuit attorney is here to help you when you need it the most.