In 2005, a company called Ethicon, a subsidiary of Johnson & Johnson, made a medical device available for use. The product, which was a transvaginal mesh, was released without any testing.
This was possible under a special FDA rule called the 510(k) rule, which allows for a fast-tracked release of medical devices that are substantially similar to devices already on the market. The transvaginal mesh they released was called Gynecare Prolift propylene mesh and the prior device that it was based off of was a product called Gynecare.
Unfortunately, it would later turn out that there were significant problems with the Prolift transvaginal mesh product. Further, when Ethicon later applied for approval for a next generation product called Prolift M+, the FDA would subsequently conclude that the original Prolift Product from 2005 had never really been approved. In other words, an untested, dangerous and problematic drug was thrust upon the public in 2005 by Ethicon.
Our Boston transvaginal mesh attorneys have become very familiar with Prolift and with the stories of women who were harmed by this medical product and by other transvaginal mesh products. Now, the first trial against Ethicon has entered the courtroom. This trial is important both because it provides the opportunity for the injured patient to get justice and also because it could set the stage for subsequent legal actions.
The Transvaginal Mesh Case
Prolift, like other transvaginal mesh products, is a surgical mesh that was used to treat women with pelvic organ prolapse and with stress urinary incontinence. Women, especially those who have been through pregnancy, can suffer from pelvic organ prolapse wherein the pelvic organs (such as the bladder) drop and begin to press against or protrude into the vaginal wall.
Transvaginal mesh products are used to essentially keep the organs in place. Unfortunately, the transvaginal mesh products soon began to cause significant complications. Many women experienced pain, disintegration of the mesh products, painful sexual intercourse, contraction of the mesh and other side effects. These complications were not properly identified due to Ethicon’s insufficient and negligent testing of the product. There was also no warning of these or other potential complications for women who underwent surgical procedures with the mesh products.
Unfortunately, women may need multiple surgeries to correct the problems caused by Ethicon’s Prolift and by other transvaginal mesh products — if the problems can even be corrected. Many women who are coping with medical care costs, pain and discomfort are taking legal action against the manufacturers of transvaginal mesh products.
Many of the cases based on the transvaginal mesh products are pending, and many plaintiffs have organized into class actions. Now, however, the first case against Ethicon has gone to trial. The outcome of this trial should shed significant light on the mistakes that were made and can have a major impact on future settlements or lawsuits based on transvaginal mesh.
If you or a loved one has been harmed by transvaginal mesh, contact the Law Offices of Jeffrey S. Glassman, LLC for a free consultation. Call 1-877-617-5333.