Vaginal Mesh Implants Sold by Johnson & Johnson Without FDA Approval
Johnson & Johnson is currently a defendant in more than 550 vaginal mesh lawsuits. New information reveals that J&J sold and distributed the product, known as the Gynecare Prolift, before it was ever approved by the Food and Drug Administration (“FDA”). The company says that it was acceptable to market the device before FDA approval because it was very similar to a previously approved device. However, a spokesperson with the FDA disagrees, stating that the “FDA disagreed with this assertion” and that the Prolift was distributed “without appropriate” clearance.
FDA Fast-Tracking
J&J’s decision to fast-track the product is nothing new to the medical device industry. FDA rules allow companies to introduce products without human testing if the FDA decides that there are similar devices already on the market. These are known as predicate devices. However, in the case of the vaginal mesh Prolift, J&J did not follow the proper procedures for fast-tracking the product. The FDA reports that J&J did not even inform them about the product until two years after J&J began marketing and selling the device. Why would J&J act in such a reckless manner? The answer is simple: medical device companies like J&J are driven first and foremost by profits. The quicker a product is placed on the market, the more money the company stands to make.
Vaginal Mesh Associated with an Increased Risk of Complications
The FDA reported in July 2011 that patients receiving vaginal mesh implants are five times more likely to suffer death, injury or malfunctions. The complications associated with vaginal mesh implants can be devastating. In September, the FDA was urged by an advisory panel to label vaginal mesh as “high risk.” Many European countries have already removed vaginal mesh from the market.
Legal Action for Defective Vaginal Mesh
The nationwide defective medical device attorneys at Bailey & Greer are already representing victims of trans-vaginal mesh failure. If you have a question about your legal rights, call us today at 901-680-9777 for a free consultation. We know this is a delicate matter and can be difficult or embarrassing to talk about. Our lawyers understand and care about you. We are experienced, knowledgeable, and sensitive to your concerns.
Since graduating magna cum laude in 2005 from the University of Memphis School of Law, Thomas has helped make a difference in the lives of victims of serious personal injury, wrongful death, and professional negligence. Thomas has extensive trial experience in both state and federal court. Among other victories in the courtroom, Thomas obtained several impressive jury verdicts and settlements
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