Numerous side effects are associated with transvaginal mesh placement for treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI). If you have suffered from complications after surgery, please contact us for the most recent mesh bladder sling lawsuits news and information. The Food and Drug Administration became aware of the problem in 2005, when it began to receive reports of serious complications from several mesh manufacturers. In 2008, the agency issued a public health notification to alert women of the dangers. Complications were believed to be rare at the time. In July 2011, an update was issued to inform women that problems associated with transvaginal mesh for POP repair were, in fact, not rare.
Since then, hundreds of women have filed pelvic mesh lawsuit claims against two of the most prolific mesh manufacturers: Johnson & Johnson and C.R. Baird. In addition, the FDA convened a special meeting in September 2011 with the Obstetrics & Gynecology Devices Advisory Committee. Their goal was to evaluate the need for stricter controls over premarket testing of the device. We’ll present the FDA’s findings below, beginning with the adverse event reports received by the agency over the last six years.
Overview Of FDA Adverse Event Reports
The FDA received over 1,000 medical device reports (MDRs) of surgical mesh complications between 2005 and 2007. An additional 2,874 adverse event reports were submitted between 2008 and 2010. In total, the agency identified 3,979 complaints describing mesh failures that led to injuries and in several cases, deaths. There is not currently and FDA bladder sling recall covering the different mesh repair products.
Most of the reports received between 2008 and 2010 were associated with POP repair rather than treatment for SUI (1,503 and 1,371, respectively). But it is worth noting that the number of complaints stemming from transvaginal mesh repair of POP were five times the number received during the previous period (between 2005 and 2007).
The FDA acknowledges that several factors could have contributed to the dramatic increase in MDRs related to vaginal mesh placement. For example, broader awareness of the potential complications resulting from the 2008 public health notification could be expected to generate more reports. However, even after taking such factors into account, the FDA notes that the increase poses reason for concern.
Vaginal Mesh Erosion Is The Most Common Problem
Among the adverse event reports received between 2008 and 2010, the most common issue was erosion of the device through the vaginal wall. This problem is sometimes called extrusion or exposure. It can cause chronic vaginal pain that worsens during intercourse. In severe cases, sexual intercourse may be impossible due to the pain; surgical mesh can be observed protruding through the vaginal tissue.
Complete removal of the device is the preferred treatment option for resolving mesh erosion. The procedure requires a high level of expertise from the surgeon, and even then might warrant multiple surgeries. Sometimes, removing the entire mesh is impossible due to its manner of erosion through the vaginal tissue. A partial resection may be performed. While this approach does relieve current symptoms, it does not preclude the portion of surgical mesh left intact from continued erosion.
The FDA notes that some cases of mesh extrusion may not be resolvable via surgery. The patient may be forced to live with the chronic pain and discomfort.
Safety And Effectiveness Of Transvaginal Mesh Repair Of POP
Perhaps the most dismaying of the FDA’s findings relate to details surrounding surgical mesh’s safety and effectiveness. As previously noted, the agency acknowledges that complications are not rare following transvaginal placement of the device. In addition to erosion (i.e. extrusion), patients are exposed to a risk of persistent vaginal pain, recurring infection, bleeding, and urinary and bowel dysfunction.
While surgical mesh placed transvaginally can resolve prolapsed organs, the results of the procedure are rarely better than those that follow traditional surgery. Patients who undergo abdominal surgery for POP enjoy a comparable quality of life without exposure to the numerous complications associated with bladder sling surgery.
The FDA’s findings underscore the risks involved with pelvic mesh implantation through the vagina. If you received surgical mesh for POP or SUI, and have suffered complications following the procedure, you may be eligible for compensation for your injuries. Contact a mesh bladder sling lawsuits lawyer to discuss your options. There is never any cost or obligation to speak to us regarding your legal options. There is a limited time to file a bladder sling lawsuit. Please contact us at your earliest convenience.