The tone and content of the FDA’s warnings about transvaginal mesh complications changed between 2008 and 2011. In 2008, after receiving over 1,000 adverse event reports about injuries related to vaginal mesh placement, the agency announced its first safety alert regarding the issue. If you have suffered from complications, please contact us for the latest vaginal mesh lawsuit news. It noted that a small number of women had experienced vaginal pain, infection, incontinence, and migration of the mesh through the vaginal tissue (i.e. erosion). These complications were defined as rare. Within three years, however, the FDA changed its position.
In 2011, the second safety announcement was issued. Complications were now defined by the FDA as “not rare.” In addition, the agency added mesh contraction (shrinkage) to the list of problems reported by women who had received an implant. This triggered a wave of vaginal mesh lawsuit claims.
Below, we’ll focus on mesh contraction, a potentially debilitating injury, and mesh erosion, the most commonly-reported complication. You’ll learn about the side effects caused by both circumstances, along with how they are treated.
Vaginal Mesh Complications – Contraction Side Effects
The FDA admitted in its 2011 safety announcement that mesh shrinkage had been “missed” in its 2008 alert. They implied the problem had not been reported prior to that time, nor had it been listed in the published scientific literature regarding vaginal mesh injuries. One of the first studies that focused on this complication appeared in the February 2010 issue of the Journal of Obstetrics & Gynecology. The study was titled, “Vaginal Mesh Contraction: Definition, Clinical Presentation, and Management.”
The researchers noted that mesh contraction was a “serious complication after prolapse repair with armed polypropylene mesh.” They went on to remark that the contraction of the device “may cause substantial morbidity, frequently requiring surgical intervention.”
Seventeen women were identified as subjects for the study. All of them reported severe vaginal pain, and complained that moving made the pain worse. Fourteen of the subjects reported experiencing pain during sexual intercourse (dyspareunia); mesh erosion was detected in nine of the women; seven presented signs of vaginal tightness; and five subjects displayed signs of vaginal shortening.
Concluding their study, the researchers noted that surgical intervention was needed to remove the defective mesh from the patients’ bodies.
Pelvic Mesh Erosion Into The Vagina, Bladder, And Rectum
As previously noted, mesh erosion is the most common complication reported by implant recipients. The device typically migrates through the wall of the vagina, sometimes surfacing in the canal. This causes severe pain, and exposes the woman to recurring infections. If the infections are not treated, they can progress through the urinary tract to the kidneys, potentially damaging them in the process.
Mesh implants occasionally erode in the opposite direction. For example, following surgery to repair bladder prolapse, the device may migrate into, and through, the wall of the bladder. If it forms a fistula between the bladder and vagina, urine from the former will drain to the latter.
Following surgical repair of rectal prolapse, the device may move through the wall of the rectum. This is a serious complication. If the implant’s erosion causes a fistula to open between the rectum and vagina, stool will drain into the latter. This can lead to dangerous and recurring infections.
Treatment for transvaginal mesh erosion involves the surgical removal of the implant. Unfortunately, removing it may not be possible.
When Surgical Intervention For Mesh Erosion Is Ineffective
In its 2011 safety announcement, the FDA highlighted erosion as a particularly problematic issue. The agency noted that resolving it might require that the implant recipient undergo several surgeries. In cases where removal of the device was impossible, the patient might be forced to endure persistent pain for the remainder of her life. Even when the implant is successfully removed, a woman might experience a significant decrease in her quality of life.
Many of the plaintiffs who have filed vaginal mesh lawsuit claims allege the manufacturers did not adequately test their devices. As a result, their implants were unsafe for transvaginal placement.
If you received a surgical mesh implant and have suffered pain, bleeding, erosion, or contraction of the device, you may be able to file a pelvic mesh lawsuit. Contact an experienced vaginal mesh lawsuit lawyer to discuss your case.
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