While there is no clear count of the number of women who have experienced complications from the use of a Mirena IUD, there is a significant number who associate symptoms with this device due to the fact that the potential side-effects are published by the manufacturer, Bayer, directly on the label. Cramping and infections due to the device are not unheard of, but there are those who would claim that more serious health outcomes may be taking place while using this device.
A supposed side effect of the Mirena IUD is referred to as idiopathic intracranial hypertension, or “IIH.” This is a central nervous tissue disorder that results in a pressure increase of pressure in the areas of the brain tissue and the spinal column. Unfortunately, the symptoms associated with IIH are not unlike those associated with a tumor of the brain. This condition is known as a “false tumor,” or papilledema. Headaches and blurred vision may present themselves to a patient following the insertion of this IUD. Consequently, there is the fear of a misdiagnosis that may lead to emotional distress and additional expensive tests to verify that a tumor does not actually exist. For example, if one had used a Mirena IUD even a couple of years ago, it may have resulted in the symptoms just described, is it likely that you or your physician would correlate those with the IUD? If you live in the United States, then it is not likely.
The plaintiffs in current litigation over this device, who have experienced damage to their optic nerves, are alleging that this failure to make all symptoms and side effects available to all potential users of the IUD can lead to delays in accurate diagnosis. In nations such as South Africa and Hong Kong, side-effect information published by the manufacturer reveals that papilledema is indeed a potential side-effect for the use of this device. However, that risk material was not revealed to women in America or the medical establishment in the U.S.
It is essential to ensure consistency in labeling not only medical devices, but any items used by consumers that can cause a risk of injury, or worse. Often times, these inconsistencies are not due to any desire by the manufacturer to hide known defects or turn a blind eye to possible dangers. Instead, they label risk factors in accordance with the requirements of the law. If manufacturers are not pressured to place the concerns of the consumers first and foremost in their labeling, it is a temptation to not be completely forthcoming with all possible risk issues documented during the development of a product. While this may not technically be illegal, it can be argued that it is unethical when known defects or risk issues are withheld from the public under the rationalization that they are not “significant” risks, or that very few people could realistically expect to be harmed. Full disclosure is always preferable and the consumer should be trusted to rationally evaluate risks associated with any medical device.
If you have been involved in a product liability claim then you should seek legal help as soon as possible to help get the compensation you deserve. The attorneys at Ferguson & Associates are here to help! Give us a call today.