Modern medicine provides many benefits that improve the lives of millions of people. For all of the advancements and breakthroughs in medicine, however, there are occasional instances in which a device, drug, or other product ends up causing more harm than good. Recently, many women have come forward reporting adverse health consequences associated with the Essure device, with several patients requiring revision and removal surgeries to address their conditions. The device is marketed as a less invasive, permanent sterilization procedure for females. Developed by Conceptus, which is a company owned by Bayer AG, it features flexible coils inserted in the fallopian tubes. Roughly three months after insertion, tissue forms around the coils, which prevents sperm from reaching an egg and achieving fertilization. The device is not intended to be removed and is seen as a permanent measure.
According to some reports, over 9,000 removal procedures have occurred since 2009 as results of punctures in fallopian tubes or the uterus and shifting of the coils. Some of the adverse health events identified in the U.S. Food and Drug Administration’s adverse events database include reports of fetal death, miscarriages, and other issues. Other women have required hysterectomy procedures in order to remove the broken fragments from the device. So far, 15,500 adverse event reports associated with Essure have been filed.
Although the device received FDA approval, the FDA cautions women to consider permanent birth control carefully and has required the maker of Essure to revise the label to include a boxed warning and decision checklist for patients. Since 2013, at least one public interest group has pressured the FDA to revoke approval of Essure and to require it to be removed from the market. Instead, the FDA invoked a label change that now requires the packaging to state that the device can cause a number of conditions, including organ perforation, chronic pain, and allergic reactions. In the meantime, the agency has indicated that it will continue to examine the risks and dangers associated with Essure.
If you or someone you love has suffered injuries as a result of a dangerous device or product, you can bring a product liability action against the developer, manufacturer, or marketer of the device to seek compensation for your injuries. Some product liability cases can be complicated, requiring a number of skilled experts to explain how the device caused your injuries to occur. This type of action requires the plaintiff to show that the product was unreasonably dangerous as a result of a design defect, manufacturing defect, or marketing defect. A design defect occurs when the product was designed in a dangerous manner. A manufacturing defect occurs when one unit suffers from a mistake or flaw in the manufacturing process that renders it unreasonably dangerous. A marketing mistake is when the device lacks adequate warnings or instructions.
At Therman Law Offices, our Illinois product liability lawyers have assisted numerous victims with seeking justice after suffering an unexpected and unnecessary injury. We understand how confusing and daunting the legal system can be. We will provide you with the personal, diligent, and compassionate legal counsel that you and your family require during this stressful time. To schedule your free consultation, call us now at 312-588-1900 or contact us online.
Related Posts: