The big pharmaceutical company Bayer is currently facing lawsuits filed across the country by thousands of women for various health allegations. Most of the women claim that Mirena, an intrauterine device (IUD) used for birth control, has serious and dangerous side effects that Bayer intentionally concealed and failed to warn consumers.
IUD’s are small, T-shaped plastic devices that release hormones after being inserted into a woman’s uterus. They are typically quick to insert and do not require any major medications or hospital visits. Many women opt for IUD’s because they last a long time – anywhere between 3 and 6 years and they require minimal maintenance.
Mirena is usually known for its less serious side effects, such as nausea, vomiting, breast tenderness, back pain, irregular menstrual periods and breakthrough bleeding. However, women across the country who have initiated lawsuits against Bayer allege that the birth control can migrate after implantation and tear the uterus or other internal organs. If the IUD does this, it requires surgery to repair.
Not only can the IUD move, but more recent lawsuits argue that Mirena causes a rare condition called pseudo tumor cerebri. This condition presents like a brain tumor, causing the brain to swell. If it remains untreated or undiagnosed, it can cause irreversible damage to the optic nerve, and result in complete blindness. If pseudo tumor cerebri is caught in time, surgery is necessary to relieve the swelling and protect the optic nerve.
Other serious risks that accompany the Mirena IUD are intestinal perforations, obstructions, adhesions, or abscesses, which can be caused by IUD migration. Infection is also a major risk, and can sometimes cause such severe scarring that it can lead to infertility. Many of the potential side effects can be serious enough to be fatal.
As if that wasn’t enough, many of the plaintiffs are also claiming that Bayer knew that Mirena was defective and dangerous. Instead of telling doctors about its risks, Bayer concealed them and continued to profit from a product that had been designed in a defective and unsafe manner.
Mirena’s label only warns consumers that uterine perforation is possible during IUD-insertion, not afterwards or spontaneously. This is contrary to what many women say they’ve experienced, which are internal damages caused months or years after they received their IUDs.
Between 1997 and 2012, the Food and Drug Administration (FDA) received almost 50,000 consumer reports of injury or medical complications from Mirena IUDs. According to the complaints, most of the injuries caused were from the IUD migrating, being expelled from women’s bodies or inflicting vaginal hemorrhages. The FDA issued Bayer a warning for overstating the device’s possible uses as well as for misleading consumers intentionally.
From all this information, three things are clear: thousands of women across the country have legal claims against Bayer for different types of medical injuries, Bayer has a history of inappropriate marketing behavior, and the FDA has received an overwhelming number of complaints regarding Mirena. All of this information is certainly enough to warrant serious concerns over the product’s safety.
As with all medical products, if you have any questions or concerns about having a Mirena IUD it is recommended that you contact a doctor directly. The upcoming lawsuits against Bayer will determine whether the company has continued to mislead consumers and place value on profit instead of safety.
If you or a loved one has been injured by a defective product, at Galfand Berger we are happy to answer your questions and review your case for free. With offices located in Philadelphia, Bethlehem, Reading and Lancaster, our product liability lawyers in Philadelphia serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.