Surgery Mesh Recall
Hundreds of vaginal mesh lawsuit claims were filed against various mesh manufacturers after the FDA issued an alert in July 2011 about the medical devices. Recently, the first major surgery mesh recall was announced by Johnson and Johnson and it is expected that other manufacturers may also announce recalls for their products. The agency disclosed that it had received thousands of adverse event reports highlighting a range of serious – and in some cases, life-threatening – complications. Some women have experienced vaginal pain and bleeding. Others have encountered more serious issues, such as erosion of the device. These and other pelvic mesh complications have spurred many women to explore their legal options.
The first group of lawsuits against one of the manufacturers, Ethicon, a subsidiary of Johnson & Johnson, is scheduled to be presented to a jury in November 2012. It is worth reviewing some of the reasons such cases are being pursued in the first place. Below, we’ll explain the purpose of transvaginal placement of mesh, and describe in more detail some of the problems women have suffered as a result of the procedure. You’ll also learn about two rare, but particularly serious, surgical mesh complications.
Expectations For Vaginal Placement Of Mesh For POP Repair
Mesh is surgically implanted to repair stress urinary incontinence (SUI) and various forms of pelvic organ prolapse (POP). It can be placed abdominally or vaginally. The latter approach is less-invasive, and thus more popular. In order to understand how the device is used for POP repair, it is useful to be familiar with the circumstances surrounding prolapse.
The pelvic organs are held in place by a network of muscles, ligaments, and tissues. Due to many potential causes, such as multiple vaginal childbirths, obesity, or repeated heavy lifting, this support structure can weaken or become stretched. As this occurs, the level of support it offers to the pelvic organs decreases. This can cause one or more organs to fall from their positions, and bulge into the vaginal wall.
Depending on the type of prolapse (i.e. which organ has fallen), the condition may cause persistent discomfort, urinary and bowel dysfunction, and a sensation of fullness. Thus, many women seek treatment for relief.
Transvaginal placement of mesh is designed to achieve two goals. First, the medical device provides support for the vaginal tissue into which the prolapsed organ has bulged. Second, it helps to return the affected organ (or organs) to its correct place. Women understandably expect relief from the symptoms associated with POP. Unfortunately, there have been thousands of cases of surgical mesh failure.
Common Pelvic Mesh Complications Following The Procedure
The FDA first alerted the public about problems associated with the medical devices in October 2008. At the time, complications were believed to be rare, a position based on limited details provided by nine mesh manufacturers. The FDA indicated that placing mesh through the vaginal wall could result in persistent vaginal pain and recurring infection. They also noted that women may experience pain during sexual intercourse (dyspareunia), urinary problems, and erosion of the device through the wall of the vagina.
In July 2011, the FDA issued a second alert, this time revealing a marked change in their position regarding surgical mesh placed through the vagina. Transvaginal mesh complications were now believed to be “not rare.” The agency mentioned the same problems noted in 2008 with the addition of mesh contraction. This latter issue is associated with vaginal tightening and chronic pain.
Mesh Erosion Into The Bladder And Rectum
Erosion of mesh through the wall of the vagina is serious, particularly because the device is often irretrievable. On rare occasions, mesh can also erode through the wall of the bladder or rectum. Both circumstances present serious complications. The former can cause urinary tract infection and urine drainage into the vaginal canal. The latter may also cause infection, and allow stool to drain into the vagina. Invasive surgery is required to retrieve the failed device, and repair the damaged tissue.
Many women who have undergone vaginal mesh placement for pelvic organ prolapse, and developed serious complications afterward, were unaware the two circumstances were linked. The FDA’s 2011 announcement informed them, prompting many to file lawsuits. Though hundreds of pelvic mesh lawsuit claims have been filed, experts expect the number to grow substantially.
If you received a transvaginal mesh implant and have experienced mesh erosion or suffered any other complications, you may be eligible to file a claim for compensation. Contact a vaginal mesh lawsuit settlements lawyer to discuss your case and for the latest surgical mesh recall news.