Ethicon Inc., a subsidiary of parent company Johnson & Johnson, is being served with court papers in record numbers, as more and more women are bringing to light the adverse health effects brought by the use of their transvaginal mesh products.
The brand names affected are the Gynecare Prolift line of transvaginal mesh, as well as their Ethicon Prolene & Prolene Propylene Mesh kits. These types of transvaginal meshes are implants designed to help urinary incontinence, as well as help repair vaginal prolapse. Many women had these transvaginal meshes by Ethicon, and other manufacturers, implanted in Chicago, Illinois, among other jurisdictions, leading to many women seeking compensation in various areas. The Gynecare Prolift line has been specifically on the market since 2005.
The overwhelming number of negative reports to the FDA resulted in them releasing a press release in 2011 stating that adverse
outcomes aren’t rare for these types of devices. Since 2012, many products in the Gynecare line have been recalled.
What’s the issue with Gynecare Prolift?
The most common complications directly caused by these products include damage to the reproductive and urinary organ systems, pain during intercourse, frequently recurring infections, and pain surrounding the area the mesh was implanted. Often, a supplementary procedure is necessary to remove the mesh to reduce the amount of damage occurring.
The damage is caused by stiffening of the mesh after implantation, resulting in jagged edges that slowly erode into the vaginal lining, causing chronic pain. In some cases, pain persists long after the removal of the device due to the permanent damage caused by this dangerous product. To streamline the approval process, Ethicon used the FDA’s 501(k) approval method. This is a method in which a new product is approved and immediately put on the market without rigorous testing due to its similarity to an existing product that has already been deemed safe by the FDA. This decision has proven to not be a prudent one as over time, Ethicon, as well as other transvaginal mesh manufacturers, forwarded thousands of consumer reports to the FDA showing consistent, recurring complications among a wide subset of the population.
What’s happening now with Ethicon?
Women are now taking action against Johnson & Johnson and Ethicon on the grounds that these meshes were often installed on advice from their doctors, who weren’t advised sufficiently as to the potential risks. It can be reasonably assumed that had doctors been properly told of the risks involved with the procedure, less may have recommended it, or the women may not have agreed to the procedure in the first place. Due to this fact, over 8,700 of such claims have been filed as of July 2013, with one specific case resulting in a payment of $11 million to a single woman hurt by a Gynecare Prolift product. Attorney Tom Plouff from Chicago obtained a $35 million jury verdict in Hammond, IN on a Prolift case.
Claims are still being filed to this day, as women are just making the connection between their newly found pelvic issues and their use of Ethicon’s transvaginal mesh products. If you’ve used a Gynecare Prolift product in the last two decades, there’s a chance you’ve been affected negatively and may be eligible for compensation. Depending on what state you are in there are statutes of repose and limitations that can bar your claim if you wait too long to bring a case. Time is of the essence in getting a complaint on file if that is what you want to do.