Recent years have witnessed the surgical application of transvaginal mesh devices become a subject of great concern in the healthcare community. The use of these devices has become synonymous with the development of severe, life-threatening complications. As a result, recipients experiencing mesh failure have frequently sought compensation for their pain and suffering by filing their own transvaginal mesh lawsuit. The recent influx of transvaginal mesh lawsuits, combined with the impending threat of countless more, has led to the inevitable removal of these products from the U.S. market by several prominent medical device manufacturers.
As a metallic or polymeric screen, transvaginal mesh is ideal for both treating and reinforcing compromised soft tissue or bone. For decades, it has assisted in the treatment of abdominal hernia repairs. Most recently, surgical mesh has transitioned into what the healthcare community knows as transvaginal mesh. Vaginal mesh is intended to assist in the treatment of compromised vaginal tissue that has sustained a traumatic injury from a number of complications such as stress urinary incontinence (SUI), pelvic organ prolapse (POP) and childbirth.
The surgical application of transvaginal mesh acts as a reinforcement to the compromised pelvic tissue. Therefore, in being added to the damaged area, transvaginal mesh acts as a reinforcement that prevents the further displacement of tissue and organs. Of significant concern, however, is the association that has been established between transvaginal mesh and the development of serious complications. Women who experience transvaginal mesh failure may be subjected to adverse incidents such as infection, organ perforation, mesh erosion and even death.
According to the Manufacturer and User Device Experience (MAUDE) database, between 2005 and 2010, there were approximately 3,979 incidents of injury, death, and malfunctioning transvaginal mesh products. Subsequently, 2,874 were reported as recently as 2008, and included 1,503 cases related to POP repairs and 1,371 associated with SUI repairs. Frequently reported complications included references to pain, dyspareunia, infection, urinary complications, bleeding, and organ perforation. Of significant concern, however, were the deaths of seven women who had reportedly experienced transvaginal mesh failure.
The growing number of injuries soon culminated in an onslaught of transvaginal mesh lawsuits against the manufacturers. Prominent medical device manufacturers have been sued in recent years by women claiming that they were seriously injured by these products. One division in particular, Johnson & Johnson (J&J), is currently facing more than 1,000 pending transvaginal mesh lawsuits.
As a result, J&J has acknowledged that they will soon stop selling vaginal mesh implants. J&J spokesman, Matthew Johnson, said on Tuesday that the company has asked the U.S. Food and Drug Administration (FDA) for permission to discontinue the sales of four such products within the next 120 days. According to their discontinuation strategy, J&J will be halting the sales of several products on a region-by-region basis over the next three to nine months. Included in the discontinuation are Gynecare Prolift Pelvic Floor Repair Systems, Gynecare TVT Secur Systems and Gynecare Prosima Pelvic Floor Repair Systems.
According to Matthew Johnson, “This is not a recall; it’s a global discontinuation.” Johnson then continued to elaborate on the current discontinuation, suggesting that the products were being removed from the market largely due to negative publicity, not because of the 1,000 pending transvaginal mesh lawsuits.
Speculation as to why J&J has announced this discontinuation has already begun to run rampant. Subsequently, many feel that J&J’s decision to remove these products from circulation may be an attempt to prevent additional transvaginal mesh lawsuits from being filed. Regardless for their reasoning, a discontinuation such as this may have an overwhelming impact on the future of transvaginal mesh devices.