For women all over the country, visiting a gynecologist is a personal decision made with care and consideration. Women spend hours on the internet researching what makes a good gynecologist and what to expect at a new patient appointment. As women, seeing a doctor who must examine parts of the body that are widely considered private is not a choice made lightly. The physician must maintain an exemplary reputation within their specialty and they must abide by a stringent standard of care. This standard of care applies as well, to the prescriptions they write, the surgical procedures they perform, and the medical devices they suggest.
So why, then, are physicians still prescribing certain manufacturer’s IUDs (intrauterine devices)? This article will look at how the risks of a woman’s very personal choice to use an IUD as a form of birth control may outweigh the benefits. The Shaked Law Blog always presents the facts and allows readers to get the whole picture, without the added song and dance. The insurance companies will try to convince those injured by defective medical devices that it “may not” have been the device that caused them harm; this is simply a scare tactic. The Shaked Law Blog will delve into the truth about the Mirena IUD and the dangers it has–to the manufacturer’s knowledge–caused hundreds if not thousands of women.
Marketing marred by withheld side effects
Unlike other Class Action lawsuits, the FDA stepped in on behalf of injured women in mid-2009, when the Food and Drug Administration slapped IUD manufacturer Bayer on the wrist for the company’s misleading marketing.
The scientific and medical efficacy of the intrauterine device (known as “Mirena”) was called into question because it failed to acknowledge that the device was no longer considered an adequate form of birth control after five years of use. The marketing initially implied it was a device that could be used for an indefinite amount of time–suggesting a woman need not worry about removing the device until she chooses to become pregnant.
Furthermore, the device-maker, Bayer, never warned women that Mirena was meant for those who already had at least one child, given its high risk for causing fertility problems.
70,000 and counting
Aside from errors in marketing, Bayer has had their feet to the fire since 2000, when they introduced Mirena to the public. Over 70,000 injury reports have been filed as a result of injuries caused by the intrauterine device. These injury reports have resulted in thousands of lawsuits filed against Bayer. To add insult to injury, every lawsuit thus far has alleged that Bayer’s Mirena device failed to provide adequate warnings about the side effects posed by the device. These side effects were reported months and some even years after the device was initially placed, calling into question how safe the device was if what it was meant to do was the problem.
Dangerous side effects sideline Bayer
According to Consumer Safety, the thousands of Class Action lawsuits filed on behalf of women who fell victim to the manufacturer’s deceit that resulted in permanent pain and injury, allegations included but weren’t limited to:
- Bayer knowingly produced a product they were aware had flaws; they sold this product to the public without fixing the defects
- Withholding the dangerous side effects posed by the device–even when not a defective model
- Engaged in and disseminated marketing that was proven false and lacked the research to be considered medically accurate
- Breach of warranty
- A stark misrepresentation of the benefits of the device in question
- No recall was ever issued upon acknowledgement that the device was defective
Doctors blindsided, Bayer makes bank
Complications ranged in severity from “relieved after device was removed” to the most serious and permanently injuring such as “device migration”. This phenomenon is rare in the medical community and implanted medical devices are thoroughly researched for their safety before being deemed fit for the human body.
During manufacturing of the Mirena IUD, Bayer became aware that the device had the ability to migrate, and chose to ignore this fact, instead pushing the device to doctors’ offices across the company with falsified marketing and claims of its safety and efficacy.
Some of the worst cases of IUD complications that have come to light have been well documented across the legal sphere and consumer safety forums throughout the country.
Desaree Nicole Lee Johnson had the Mirena device placed and suffered, according to her Class Action claim, and shared in part by Consumer Safety:
“Desaree’s Mirena IUD perforated her uterus and moved to her abdomen. After undergoing surgery to remove it, she became pregnant, experienced vaginal bleeding, and had a miscarriage. Sadly, she may be infertile.”
There are thousands of stories almost identical to Mrs. Johnson’s and they don’t seem to have an end in sight. As of the publishing of this article, the Mirena device is still being prescribed by doctors as a form of long term birth control for women. The best thing a woman can do is be her own advocate and thoroughly research her options before making her educated decision as to whether the risks outweigh the benefits of such a dangerous medical device.
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