On October 20, 2008, the FDA reported that it had received over 1,000 reports of vaginal surgery mesh complications from nine manufacturers over the previous three-year period. Please contact us for the latest transvaginal mesh lawsuit news if you suffered from problems after surgery. The complications stemmed from surgery to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). On July 13, 2011, the agency noted it had received an additional 2,874 reports. The majority (1,503) resulted from vaginal placement of mesh for POP; the remaining reports (1,371) arose from surgical repair of SUI.
The complications reported to the FDA have been wide-ranging and serious. In some cases, they are unresolvable. While there has been no transvaginal mesh class action lawsuit filed in the U.S., hundreds of cases have been filed individually. We’ll explain some of the factors that have prompted these lawsuits below.
Broad Range Of Vaginal Mesh Failure Side Effects
Pelvic organ prolapse and stress urinary incontinence affect millions of women. Both conditions can be treated in various ways. When surgery is an option, the procedures are usually invasive. Transvaginal placement of surgical mesh was introduced as a less-invasive approach to treating POP and SUI. Patients were told they could expect a faster recovery, less postoperative pain, and less scarring. While these benefits were realized (due to the nature of minimally-invasive surgery), many women developed severe complications after the procedure.
Some patients have reported vaginal bleeding. Others have suffered from recurring vaginal infections. Still other women have experienced pain during sexual intercourse as well as intermittent pain unrelated to sexual activity. Side effects from transvaginal mesh placement also include difficult bowel movements, pain in the lower back, and a sensation that something has been pushed from the vagina.
Following the Food and Drug Administration’s 2008 safety notification about vaginal mesh complications, the agency reviewed literature involving the procedure and its effects. They noted the most common issue reported was mesh erosion. The medical device, after it had been installed transvaginally, often eroded into, and through, the wall of the vagina. The FDA also noted that surgery to address surgery mesh erosion and remove the medical device was sometimes unsuccessful. That is, the defective pelvic mesh could not be withdrawn in some cases.
High Rate Of Bladder Sling Complications
All medical devices are susceptible to possible failure. Manufacturers are expected to minimize the risk, thereby lowering the failure rates for their respective products. The failure rate that accompanies transvaginal mesh placement for POP repair is reportedly higher than average.
In August 2010, a study was published in the medical trade journal Obstetrics & Gynecology. Researchers had intended to conduct clinical trials on vaginal mesh placement for prolapse repair. They reported that they were forced to stop one trial due to the device failing in over 15 percent of cases. The main cause of failure was mesh erosion.
The FDA indicated that abdominal placement of mesh for POP repair may result in fewer complications compared to vaginal placement of mesh.
Lack Of Clinical Trials Prior To FDA Approval
Another factor that has contributed to the hundreds of pelvic mesh lawsuit claims is the manner in which the devices were approved for sale. Rather than being forced to undergo rigorous testing via clinical trials, they gained approval through the FDA’s 510(k) premarket notification process. Manufacturers such as Ethicon (a subsidiary of Johnson & Johnson) and C.R. Bard had only to prove their products were similar to those that were already approved. This is known as proving “substantial equivalence.”
The Wall Street Journal reported in September 2011 that the FDA was considering a reclassification of surgical mesh to the Class III high-risk category. This action comes on the heels of injuries and deaths stemming from complications with the product. The agency’s decision, however, does not excuse the manufacturers from responsibility for failing to ensure the public’s safety. To that end, many of the lawsuits that have been filed claim the manufacturers were negligent.
If you underwent surgery mesh placement for POP or SUI, and have suffered complications, you may be eligible for compensation for your injuries. Contact a transvaginal mesh lawsuit attorney to discuss your options and the latest vaginal mesh recall news.
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We believe that the manufacturers of transvaginal mesh products should be held accountable for any harm they are legally responsible for and people should be fairly compensated for damages caused by surgery mesh complications… find out more
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