Johnson & Johnson Braces for First Vaginal Mesh Trial

Johnson & Johnson’s first vaginal mesh trial is set to begin in January 2013, according to Bloomberg. Linda Gross, a 47-year-old woman from South Dakota is alleging that the Gynecare Prolift that she had implanted in 2006 causes her severe pain and is responsible for 18 ensuing medical procedures. Gross claims that as a result of Johnson & Johnson’s faulty design of the Prolift, failure to disclose the risks associated with the Prolift, and negligence, she is unable to work or maintain a high quality of life. According to her attorneys, Gross cannot sit for more than a few minutes at a time without experiencing considerable pain, at which point she must lay on her back for relief. In order to combat her pain, she requires medication on a daily basis.

The FDA found sufficient discrepancies between the devices and required a new application.

When Johnson & Johnson introduced the Prolift in March 2005, it did so without obtaining proper FDA clearance. FDA official guidelines stipulate that health care companies must complete the 510(k) application process in order to demonstrate that the new product they intend to offer is reasonably “equivalent to a device” that has already been approved by the FDA. Johnson & Johnson began sales of the Gynecare Prolift in 2005 without completing the 510(k) application process, believing that the device was similar to the Gynecare Gynemesh, which was already approved by the FDA. The FDA found sufficient discrepancies between the devices and required a new application, which was formally requested in August 2007.

In January 2012, the FDA instructed Johnson & Johnson to conduct research into possible connections between implants and problematic organs. At the conclusion of its research in August 2012, Johnson & Johnson discontinued U.S. sales of the Gynecare Prolift, while insisting that such a decision was solely based on the product’s profitability, not safety concerns. Although Johnson & Johnson refutes the notion that sales were halted because of safety issues, there remains significant worry regarding health risks posed by products such as the Gynecare Prolift and other similar vaginal mesh devices.

Women can be treated with a vaginal mesh after experiencing stress urinary incontinence and pelvic organ prolapse, a painful condition that occurs when organs prolapse into the vagina as a result of pelvic muscles failing. While some vaginal mesh implants are successful, far too many have resulted in agonizing complications. Side effects of malfunctioning vaginal mesh implantations include erosion or protrusion of the mesh, urinary tract infections, bleeding, pain during intercourse, and general discomfort when seated or walking. Thousands of vaginal mesh lawsuits have been filed against several companies, including Johnson & Johnson, Boston Scientific, and American Medical Systems. If you or a loved one has experienced side effects from a vaginal mesh, complete the form on the right to determine whether you qualify to take legal action. You may be entitled to compensation for pain and suffering, lost wages, and medical expenses.