Transvaginal mesh products find their origin in the history of surgical mesh. Once considered a revolutionary device in the treatment of abdominal hernias, surgical mesh has made the transition to transvaginal mesh. In the last decade the surgical application of transvaginal mesh has been used in the treatment of pelvic organ prolapse (POP), stress urinary incontinence (SUI) and a number of other injuries that compromise pelvic floor tissue. Unfortunately, transvaginal mesh failure may coincide with catastrophic complications. Recipients who experience transvaginal mesh failure may be subject to extreme pain and suffering, often times leading to a reoccurrence of the injury the device was intended to treat.
If you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Transvaginal Mesh Failure Lawsuit Overview
Surgical mesh is a metallic or polymeric screen intended to treat and reinforce compromised soft tissue or bone. In the 1990s, gynecologists began using surgical mesh in the treatment of POP. However, it was not until 2002 that manufacturers specifically began designing transvaginal mesh kits for the treatment of POP.
Pelvic organ prolapse, common after traumatic pelvic injuries, is the result of compromised pelvic floor tissue that is incapable of retaining the position of particular organs. Subsequently, pelvic organs may be subject to bulging or prolapsing into the vaginal recess. In severe circumstances, recipients may experience pelvic organs prolapse past the vaginal opening, causing numerous organs to prolapse at the same time. Organs commonly associated with prolapse include: the bladder, uterus, rectum, top of the vagina or the bowel. POP may not be responsible for symptoms in all women, but it may negatively impact the quality of life by causing pelvic discomfort and interfering with sexual, urinary and defecatory functions, as well as other daily activities.
Treatment of POP was traditionally accomplished by sutures restoring pelvic tissue to its original state. However, the development of transvaginal mesh gave physicians a viable option to provide support and treatment for injured pelvic tissue.
Unfortunately, the surgical application of transvaginal mesh is not without concerns. Transvaginal mesh failure has been responsible for an influx of adverse events in recent years. Numerous medical device reports indicate that transvaginal mesh may lead to erosion of the device, a complication that may be responsible for serious infections, injuries and even death. Due to the severity of transvaginal mesh failure, recipients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential transvaginal mesh lawsuit.
FDA Executive Summary on Transvaginal Mesh Failure
According to a recent Executive Summary issued by the U.S. Food and Drug Administration (FDA), concerns regarding the safety and effectiveness of transvaginal mesh device have grown exponentially. The following FDA report acknowledges the dangers associated with transvaginal mesh failure:
The FDA conducted a search of the Manufacturer and User Device Experience (MAUDE) database for medical device reports (MDRs) of adverse events associated with all transvaginal mesh products received from January 1, 2005 –
December 31, 2010. The investigation revealed 3,979 incidents of injury, death, and malfunction. Subsequently, 2,874 reports out of the 3,979 cases were received in the last 3 years. Furthermore, 1,503 of the adverse events reported were associated with the transvaginal treatment of POP.
From 2008 to 2010, the most frequently reported complications regarding the surgical application of transvaginal mesh included vaginal mesh erosion (otherwise known as exposure, extrusion or protrusion), pain (including painful sexual intercourse known as dyspareunia), infection, urinary problems, bleeding, and organ perforation. Reports also indicated incidents of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. Many of the medical device reports acknowledged the need for additional intervention, including medical or surgical treatment and hospitalization.
The years between 2008 and 2010 witnessed seven confirmed deaths that were associated with transvaginal mesh failure in POP procedures. Follow-up investigation on the death reports revealed that three of the deaths associated with POP repair were related to the mesh placement procedure (two bowel perforations, one hemorrhage). Four deaths were due to post-operative medical complications not directly related to the mesh placement procedure. Due to the severity of transvaginal mesh failure, recipients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential transvaginal mesh lawsuit.
Transvaginal Mesh Lawsuit
Suffering from stress urinary incontinence (SUI), Christine Scott received a transvaginal mesh implant approximately four years ago. Upon receiving the device, Scott was subjected to significant pain and discomfort when it began to perforate her colon. Additionally, perforation of the colon was followed by the subsequent erosion of the mesh into the organ itself. Following the onset of both pain and discomfort, Scott underwent at least eight surgeries in an attempt to correct her ailments. “I don’t know if I’ll have ten surgeries now. I don’t know if I’ll have one. I don’t know if I’ll have 100. The doctors cannot tell me,” Scott said in June.
After having suffered from both organ perforation and mesh erosion, Scott filed atransvaginal mesh lawsuit in a Kern County Superior Courthouse. Scott claimed that Bard, the makers of her implant, knew of the potential dangers surrounding the Avaulta Plus transvaginal mesh device she had received.
After a long process, a jury awarded Scott and her husband $5.5 million in compensation. According to the panel, Bard officials were negligent in their handling of the devices. Scott’s transvaginal mesh lawsuit is significant, in that it is the first of its kind to witness the makers of these devices held responsible for the damages they have caused. The outcome of Scott’s vaginal mesh lawsuit will, most likely, have an overwhelming affect on the consolidated suits that are to follow. Representatives “view this verdict s a promising outcome that underscores the compelling case against the mesh makers and promoters.”
Do I Have a Transvaginal Mesh Failure Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in transvaginal mesh lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by a transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.