Transvaginal Mesh FDA Warnings

Hernia Mesh Infection and FDA Warnings

The mesh implant has been used since the 1950’s, primarily in hernia surgeries. While some of the recipients of the mesh implant reported a hernia mesh infection following their surgery, the mesh implant was largely considered safe for use. The FDA approved the mesh implant specifically for use in hernia surgeries, however the current laws allow physicians to alter the use of an approved product for other uses and surgeons soon began using the mesh implant in surgeries on women, particularly for stress urinary continence or pelvic organ prolapse. The mesh implant has been used widely in these types of surgeries for the past several decades. One of the “precursors” to the idea of using the mesh implant in a transvaginal application was the ProteGen bladder sling which was a sort of prototype for the eventual approval of the newer mesh products currently on the market—however the ProteGen suffered under its own litigation over a decade ago and was eventually recalled in 1999 due to complications from the device.


Initial Concerns

Although there have been concerns regarding the safety of mesh implants for at least the past decade, the first actual FDA mesh warning came about in October of 2008, informing physicians that over 1000 reports of complications had been received. These complications were a direct result of the use of the transvaginal mesh implant during surgeries on women for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). At the time of this warning, physicians were strongly encouraged to seek specialized training for surgeries involving mesh implants and to be particularly vigilant in monitoring their patients to avoid potential complications. The problem with this FDA warning was that not only were many physicians unaware of the potential problems surrounding the mesh implant, but virtually no patients received the safety information prior to their surgery. Additionally, little was known about the potential long-term complications or even the advisability of using the mesh implant in the pelvic region.


Recent Safety Alerts

The somewhat troubled history between the FDA and vaginal mesh once more came before the public eye on July 13, 2011 when the FDA once more issued a safety alert to both patients and their healthcare providers. This particular safety warning indicated that the original concerns the FDA had reported on in 2008 had increased and that serious complications stemming directly from mesh implantation were actually far more common than previously thought—or disclosed to patients. In fact, in the period between January, 2008 and December, 2010, almost 3000 adverse event reports—which resulted in injury, death or malfunction—were received regarding the transvaginal mesh implant used in surgeries for POP and SUI. Not only had these women suffered organ perforations, infections and erosions of the mesh, they also suffered a recurrence of their original problem, vaginal scarring and shrinking and a variety of emotional problems as well.


Review of the Safety Profile

Because the FDA was receiving so many reports of mesh injuries, they instigated a more thorough review of the overall safety profile of the mesh implants used from 1996 through 2011. The conclusion was that although the mesh implants appeared to have few risks when used in other parts of the body, use of the mesh in the pelvic region posed very specific threats to patients. Further, the FDA noted that there were few benefits to using the mesh implants over other more traditional surgical methods which do not use mesh, and that using the mesh implants in a transvaginal application bring far more risks than benefits. The August issue of Obstetrics & Gynecology reported that one clinical trial involving transvaginal mesh was halted in 2009 when over 15% of the women who underwent vaginal prolapse surgery which implemented the surgical mesh suffered erosion within three months.


Most Common Complications

Although mesh erosion is the number one FDA mesh injury reported by users, many others have experienced: severe and chronic pain, pain with sexual intercourse, minor to serious infections, surrounding organ perforation, bleeding, complications of urination, a recurrence of the original prolapse treated for, vaginal scarring and emotional issues which stem directly from the physical pain and harm caused by the mesh implant. The FDA’s investigation confirmed seven fatalities—three of these deaths were directly linked to the actual procedure used with the transvaginal mesh during POP surgical procedures, while the other four deaths were associated with post-op complications of the procedure.


We Can Help

If you or a loved one have undergone POP or SUI surgeries and have had complications as a result, you may have the right to recovery for medical expenses and possible pain and suffering. Each case is unique, therefore if you have reason to believe you were harmed by the use of transvaginal mesh, the attorneys of Sullo and Sullo would like to learn about your situation and evaluate the facts of your case. Don’t suffer in silence—call an experienced, compassionate attorney who has the necessary background and knowledge to litigate such a case.


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