Transvaginal mesh failure complications stemming from surgery to correct pelvic organ prolapse (POP) prompted the Food and Drug Administration to issue a public health notification in 2008, however there as not been any vaginal mesh recall. If you suffer from complications following surgery, please contact us for the latest vaginal mesh lawsuit news. The agency reported that it had received more than 1,000 adverse event reports from nine mesh manufacturers. These adverse events included mesh erosion, infection, vaginal scarring, and organ perforation. They were reported to be serious, but rare. On July 13, 2011, an update was issued. The FDA found that vaginal mesh complications were, in fact, not rare, despite what was originally believed.
Since 2008, thousands of additional reports have been filed with the FDA regarding complications from transvaginal placement of surgical mesh. While no pelvic mesh class action lawsuit has been filed in the U.S., nearly 500 individual cases are pending.
Potential Vaginal Mesh Side Effects
Pelvic organ prolapse is a condition in which one or more pelvic organs fall into the vaginal opening, or bulge against its wall. Mesh is used to hold these organs in their proper positions. Transvaginal mesh products were designed to be implanted through the vaginal wall as a minimally-invasive alternative to other methods of POP repair.
Women have reported numerous health problems following installation of these products. These include vaginal bleeding and drainage, chronic constipation, pain during sexual intercourse, and recurring vaginal infections. Many patients have also experienced lower back pain, neuro-muscular problems, and vaginal shrinkage.
According to the FDA, the most common complication, and the one most “consistently reported,” was mesh erosion through the vagina. The medical device – often made of a polymer, such as Gore-Tex or Teflon – has been known to erode into the vaginal wall. In some cases, it erodes into the wall of the bladder, uterus, or other prolapsed organ.
In addition to the discomfort and pain that accompany these side effects, some women have reported a recurrence of POP, the condition for which surgical mesh was originally installed.
Higher Risk Of Complications With Surgical Mesh Placement
Scientific literature reviewed by the FDA following the 2008 public health notification acknowledged that vaginal placement of mesh posed a higher rate of complications than abdominal placement. The August 2010 issue of Obstetrics & Gynecology included a study that produced similar findings.
In the study, researchers were forced to abandon a clinical trial of transvaginal mesh due to a higher-than-expected rate of mesh erosion through the vaginal wall. Over 15 percent of the women who underwent the surgical procedure developed signs of erosion a few months after therapy. The researchers also voiced their doubts regarding the value of bladder sling placement of surgical mesh; there was no evidence that the procedure was more effective than traditional non-mesh repair. The FDA’s ongoing analysis of reported adverse events suggests a similar position.
Some Pelvic Mesh Complications May Be Permanent
Recall from earlier that mesh erosion, namely through the vaginal wall, has proven to be the most common complication posed by transvaginal placement of the device. While other side effects, such as infections, bleeding, and pain during intercourse, can be treated, mesh erosion is more complicated.
Once the device has eroded, it must be removed from the woman’s body; there is no way to repair it. Extraction is not always possible in a single surgery. In some cases, a surgeon must perform multiple surgeries in order to separate the mesh from the wall of the organ into which it has eroded. The FDA reported in its July 2011 update on complications surrounding transvaginal placement of surgical mesh that erosion is sometimes unresolvable. Even after multiple surgeries, the mesh cannot be withdrawn. The patient is forced to endure the consequent pain of the defective device.
According to a recent report by Bloomberg News, 75,000 women underwent vaginal placement of mesh for pelvic organ prolapse in 2010. The exposure, especially given the high rate of complications, is substantial.
Bladder Sling Lawsuits Help
If you underwent transvaginal placement of pelvic mesh, and have suffered vaginal bleeding, infection, pain, and other side effects, you may be eligible to file a claim for compensation. Contact an experienced vaginal mesh lawsuit lawyer to discuss your case.
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