Cincinnati Product Liability Lawyer: Safety Agency Warns of Serious Essure Implant Injury Risks
In April 2018, the Food and Drug Administration (FDA) commissioner announced that the safety agency imposed “unique” restrictions on sales of permanent contraceptive device Essure, due primarily to Essure implant injury risks, and an “unacceptable” number of women being implanted without full knowledge of Essure implant injury risks.
The FDA said in their statement that despite other efforts to alert women to the potential complications of Essure, many patients still aren’t receiving important information. Now, Bayer will only be authorized to sell the device to health-care providers that collect signatures confirming that patients have received a detailed checklist explaining known Essure implant risks. Consumer advocates, attorneys and the FDA are working to detail injury claims and make certain they are being taken seriously to protect women.
Commonly reported adverse events associated with the Essure device include device migration, allergic reactions and chronic pain. Though rare, more severe adverse events have been reported, like the perforation of the uterus, and fetal deaths.
Joe Lyon is a highly-rated Cincinnati product liability lawyer representing plaintiffs in Ohio and nationwide in a wide variety of civil litigation claims against pharmaceutical and medical device companies.
The FDA has received over 26,000 medical device reports of injuries reportedly caused by Essure implants, including life-threatening ectopic pregnancy, miscarriages, device migration, and perforated organs. A painful revision surgery is usually required to remove the device in these cases. Short-term and long-term adverse events reported by doctors and Ohio patients include:
Bayer, the device manufacturer, downplays any Essure Implant risks, and maintains the device is safe to use, despite evidence that injuries are rather common. The concerns of experts are not new, however. The FDA first added a black box warning to Essure implant labeling back in 2016. A black box warning is the safety agency’s highest warning level and indicates that a product can cause serious injuries or death.
If you or a loved one has suffered an injury due to a failure of an Essure birth control device, and have questions about the legal remedies available to improve quality of life and medical care in Cincinnati, Ohio, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding Essure implant injury Risks.