Pharmaceutical giant Bayer is now facing lawsuits from literally thousands of women across the United States. The majority of these plaintiffs are claiming that the intrauterine device (IUD) Mirena has significant and life-threatening side effects that Bayer intentionally declined to make public. Instead of advising doctors of these risks, they allege, the company remained silent and continued to profit from a defective and dangerous device.
What is the Mirena IUD?
IUDs, in general, are plastic T-shaped devices that release hormones after being inserted into the uterus. The Mirena model features a low-dose hormone and can be left in place for five years, which is one of the reasons for its popularity. Another reason has always been lack of uncomfortable side effects compared to birth control pills, but as more adverse event reports come in, this advantage is becoming less apparent.
The women who have filed lawsuits against Bayer allege that in addition to downplaying the potential risks of the IUD, the company misrepresented its benefits and persisted in making a defective product available to the public. Although publicized side effects include nausea and vomiting, back pain, and irregular menstrual periods, some of the more alarming risks that have come to light include:
- Heavy menstrual bleeding
- Perforated organs
- Intestinal obstruction
- Internal scarring
- Adhesions and abscesses
- Vaginal infection and erosion
- Pelvic inflammatory disease
- Ectopic pregnancy
- Infertility and miscarriage
Major complications tend to occur when the IUD becomes dislodged and migrates from its position, damaging the uterus. In some cases the damage can be so extensive that a hysterectomy becomes necessary. Recent lawsuits also argue that the Mirena device can lead to pseudo tumor cerebri, a rare condition that causes the brain to swell, damaging the optic nerve and potentially leading to total blindness.
The FDA steps in
In or around 1997, the Food and Drug Administration (FDA) began receiving reports of both medical complications and injuries from Mirena IUD patients. By 2012, the volume of complaints reached nearly 50,000. Of these, 36% arose from expulsion of the device, 10% were due to IUD migration, and 8% involved heavy vaginal bleeding. Additionally, an estimated 50 deaths were alleged to have resulted from using the device. The FDA issued a warning to the company for intentionally misleading consumers and over-generalizing when it came to the IUD’s possible uses, but for many women, any corrective action came too late.
If you have been injured as the direct result of having a Mirena IUD inserted, contact a New York personal injury attorney who can help you seek damages from Bayer. When a company appears to value profit over public safety, causing you to be hurt in the process, you deserve to be compensated. Jayson Lutzky handles accident and personal injury cases. Those who were hurt due to an improperly designed product, may be entitled to compensation for their injuries and pain and suffering. Call 718-514-6619 to set up a free in-person consultation with Mr. Lutzky or visit www.MyNewYorkCityLawyer.com to learn more.