More than 30 women have filed a product liability lawsuit in a St. Louis court against medical device manufacturer Bayer over injuries related to its Essure permanent birth control device. According to a report on Mass Device, the lawsuit filed on behalf of the women said Bayer deliberately deceived not only the U.S. Food and Drug Administration (FDA),but also physicians and patients who believed that the product was safe and effective. These and thousands of other women have alleged that the Essure device led to severe health problems and side effects such as abdominal cramping, migraines and bleeding.
Complaints and Deaths
Essure is basically a small metal coil, which is placed in a woman’s fallopian tubes using a catheter. According to the FDA, just last year, it received 5,093 complaints of the device breaking and resulting in five fetal deaths and four adult deaths caused by infection and uterine perforation. In addition, many women have also reported that the device simply does not do what it sets out to do – prevent pregnancies. The most recent lawsuit states that Bayer and the company that originally developed Essure, Conceptus Inc., knew that the device was dangerous, but intentionally misreported and hid facts and findings to keep the product on the market.
FDA’s Essure Warning
Last month, the FDA required a new clinical study and new warnings on the device based on a whopping 1400 percent increase in Essure complaints over the last three years. Bayer’s director told government officials during a hearing that the company received 17,000 adverse event reports, 15,000 of those from the United States. Also, in October, a study found that women implanted with Essure were 10 times more likely to require post-procedure surgery than those who had their tubes tied.
Understanding Your Rights
We’re seeing a new kind of uprising among women who have been affected by Essure. Thousands of these women who have suffered severe Essure side effects have joined together through the Facebook page titled “Essure Problems” where they support one another and help each other out with information about where to find help.
Consumer advocate Erin Brockovich has also been speaking out on behalf of women who have been affected by this birth control device. If you or a loved one has suffered side effects as a result of getting an Essure device, please contact an experienced product liability lawyer who can help you fight for your rights and obtain maximum compensation for your losses.