Vaginal Mesh Lawsuit
Tens of thousands of women undergo transvaginal placement of surgical mesh for pelvic organ prolapse (POP) repair each year. Please contact us for the latest vaginal mesh lawsuit news if you suffer from complications. It is a popular treatment option because the procedure is less invasive than installing mesh via abdominal surgery. Unfortunately, thousands of women have reported serious complications, many of which have lowered their quality of life. In September 2011, the Wall Street Journal reported that hundreds of vaginal mesh lawsuit claims had already been filed. Experts expect thousands more to follow over the next several months.
Pelvic organ prolapse occurs when the muscles and tissues in the pelvic floor weaken. This causes the organs in the pelvic region to drop from their normal positions, bulging into the vaginal wall or cavity. Most cases of POP involve the bladder. However, the uterus, rectum, small intestine, and vagina may also be involved. Surgical mesh (sometimes called a bladder sling) can be implanted through the vagina to provide support to the prolapsed organs, and repair the vaginal wall.
The FDA’s announcements regarding mesh complications indicate that problems reported thus far are not isolated events. They appear to happen frequently. We’ll detail the FDA’s comments made over the last few years below.
The FDA’s 2008 Public Health Notification On Surgical Mesh
In October 2008, the FDA issued a public safety announcement warning women and health care practitioners about problems associated with vaginal placement of pelvic mesh. From 2005 to 2007, the agency had received over 1,000 reports complaining of serious complications. Women who suffered from POP, and had undergone transvaginal mesh placement to correct the condition, reported experiencing vaginal pain, urinary and bowel dysfunction, and recurring infection.
In many women, the device had also begun to erode through the vaginal wall, causing severe pain and scarring. The FDA mentioned that mesh erosion had caused a “significant decrease in patient quality of life.”
Although these complications were considered serious – and in some cases, proved to be lifelong – they were also deemed rare. Thus, the Food and Drug Administration took no further action other than to encourage the public and medical community to continue reporting incidents of mesh failure. The agency was forced to reevaluate their position a few years later.
The FDA’s 2011 Update On Bladder Sling Problems
On July 13, 2011, the FDA issued an update on transvaginal mesh complications. Between January 2008 and December 2010, they had received 2,874 adverse event reports detailing serious problems with transvaginal placement of the device. The agency stated that it had expected to receive a higher number of reports than the previous three years, given their 2008 public health notification. But they conceded that the number received was uncomfortably high.
Women who had received the bladder sling continued to report vaginal pain and bleeding, persistent infections, and urinary issues. One of the most serious complications, erosion of the device through the vaginal wall, was also reported. Some women suffered organ perforations during the installation procedure, a problem that resulted in the deaths of at least two patients.
Particularly noteworthy was the FDA’s admission that mesh erosion through the vaginal wall was not always resolvable. That is, the patient might endure multiple operations to remove the device to no avail.
In August 2011, the consumer rights advocacy group Public Citizen issued a press release calling upon the FDA to announce a vaginal mesh recall. To date, no such recall has been issued.
New Study Reveals More Evidence Of Surgery Mesh Complications
A study published in May 2011 in the New England Journal of Medicine further demonstrated some of the serious problems associated with vaginal placement of mesh. Out of 200 women who had received the device for POP repair, 3.5 percent experienced bladder perforations. By comparison, among 189 women who underwent an alternative procedure for POP called colporrhaphy, only 0.5 percent suffered the same problem. Additionally, 3.2 percent of the former group experienced mesh erosion, and required subsequent surgeries to remove the device.
If you received a pelvic mesh implant and have suffered any of the complications described above, you may be eligible for compensation for your injuries. Contact a vaginal mesh lawsuit lawyer to discuss your options and for the latest bladder sling recall news.