Vaginal Mesh Lawsuit

by Steve Fields on October 1st, 2011

A number of serious complications have been caused by surgery mesh, prompting hundreds of women to file vaginal mesh lawsuit claims against the various manufacturers. Transvaginal mesh, sometimes called a bladder sling or pelvic mesh, is a medical device used to treat pelvic organ prolapse (POP). This is a condition in which the supportive tissues holding a woman’s uterus, rectum, bladder, and other organs, begin to stretch. This allows the organs to herniate, or bulge, into the vagina.

It is estimated that over 30 percent of women will develop POP at some point in their lives. Although there are several treatment options available, a substantial number of women undergo vaginal mesh surgery. While fatalities due to vaginal placement of pelvic mesh for POP repair are rare, several have been reported to the Food and Drug Administration. We’ll present a few details regarding these cases below. Before doing so, we’ll describe some of the surgical mesh complications reported by thousands of women to the FDA.

Common Symptoms Of Vaginal Mesh Failure Injuries

A safety communication released by the FDA on July 13, 2011 stated that serious side effects stemming from transvaginal placement of the bladder sling are not rare. Following a review of scientific literature, the agency reported that the most common complication was the erosion of the medical device into – and occasionally, through – the vaginal wall.

Mesh erosion requires surgical intervention to correct; sometimes, multiple surgeries are needed to separate the mesh from the vaginal wall. The FDA goes on to explain that even after several surgical procedures, separation of the device from the wall of the vagina may be impossible.

Another reported problem is mesh contraction, which has been known to cause vaginal tightening as well as considerable pelvic and vaginal pain. The pain often presents during sexual intercourse.

Other symptoms associated with transvaginal mesh failure include recurrent vaginal infections, pain in the lower back, urinary incontinence, and scarring in the vaginal tissue. Women may also observe vaginal drainage and bleeding. Many women experience a recurrence of organ prolapse as the mesh fails.

FDA Reports Seven Deaths Related To Surgical Mesh Placement

Although the FDA’s safety communication from July 2011 omits any mention of fatalities stemming from mesh complications, seven deaths have been reported. The details are found in the FDA Executive Summary “Surgical Mesh For Treatment Of Women With Pelvic Organ Prolapse And Stress Urinary Incontinence.” This Summary was prepared for an Obstetrics & Gynecology Devices Advisory Committee that was scheduled to convene in September 2011. The committee’s aim was to discuss the risks of vaginal mesh for POP and SUI.

The patients who died were between the ages of 62 and 80. The circumstances in each case varied. Two people died from cardiac arrest suffered after the initial implantation of the device. Another died from bowel perforation, a common complication during transvaginal placement of the bladder sling. Yet another died from blood vessel injury sustained during the operation. The remaining three deaths were due to organ perforation, pulmonary embolism, and a retained sponge.

While these fatalities are not directly associated with mesh erosion or other types of mesh failure, they highlight another serious risk of vaginal placement of the device. Organ and blood vessel perforations are common during the procedure.

Does Transvaginal Mesh For POP Repair Improve Quality Of Life?

Recall from earlier that there are several treatment options that can be used to address pelvic organ prolapse. Transvaginal placement of surgical mesh was advertised as being less invasive than other measures. As a result, it become popular very quickly. Bloomberg News reports that 75,000 women opted to undergo the procedure last year. However, according to the FDA, there is no evidence that surgical mesh implanted transvaginally offers better results than non-mesh repair of POP.

The numerous complications posed by surgical mesh have resulted in hundreds of pelvic mesh lawsuits against the manufacturers that designed the devices. If you received a vaginal mesh implant and have suffered any of the side effects mentioned earlier, you may be eligible for compensation for your injuries. Contact a vaginal mesh lawsuit lawyer to discuss your options.


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