Bladder Sling Problems

by Steve Fields on September 14th, 2012

Over the last several years, the public has learned a great deal about bladder sling problems involved with vaginal installation of pelvic mesh implants. This surgical approach is taken to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is usually effective and results in less scarring than an abdominal approach. Unfortunately, it also introduces a high risk of serious transvaginal mesh complications, some of which cannot be resolved, even after multiple corrective surgeries.

Mesh has been implanted through the wall of the vagina since the 1990s. At the time, doctors used implants designed for hernia repair, cutting and shaping them to fit the recipients’ bodies. In the early 2000s, mesh manufacturers began to sell “kits” that included the implant along with the instruments needed to install it transvaginally and instructions for doing so. Since their debut, several hundred vaginal mesh lawsuit claims have been filed against the top manufacturers.

These implants were once believed to be completely safe. Today, there is substantial evidence that some of the devices are defective, causing severe health issues for women. In fact, at least one implant currently for sale was modeled after a product withdrawn from the market years ago due to its role in causing major injuries. As we’ll show below, such injuries have become common and recently have prompted a vaginal mesh recall.

FDA Warns Of “Rare” Vaginal Mesh Complications

One of the first official signs there were issues associated with transvaginal placement of surgical mesh (sometimes called a bladder sling) surfaced in 2008. In that year, the FDA issued a safety notification to alert the public about pelvic mesh complications. It provided a general scope of the problem, describing the types of injuries implant recipients had reported between 2005 and 2007.

Among the most frequently reported issues were mesh erosion, vaginal pain, infection, and a recurrence of POP or SUI (or both). Many women had also experienced urinary dysfunction, such as an inability to fully empty their bladders. The FDA further mentioned incidents of organ and blood vessel perforations that occurred during the mesh installation procedure.

More than 1,000 reports of adverse events were received prior to the FDA issuing its safety notice. Although the agency acknowledged the problems that had been reported could lead to serious consequences, they were described as “rare.” In less than three years, the FDA would completely reverse its position.

Vaginal Mesh Failures Are Deemed “Not Rare” By The FDA

In July 2011, an update was released addressing the issue of vaginal mesh complications. The FDA had received an additional 2,874 complaints of problems between January 2008 and December 2010. The complaints were nearly evenly split between those associated with POP repair (1,503) and those stemming from SUI repair (1,371).

Several details were similar to those described in the agency’s previous safety alert. For example, mesh erosion – a problem in which the implant moves through the vaginal wall – remained the most common complication reported to the FDA. Many women had experienced such severe erosion that a piece of their mesh implants had protruded into the vaginal canal. The FDA noted that erosion of the device was often unresolvable, a circumstance that could lead to a substantially lower quality of life for some patients.

Severe vaginal pain and infection also continued to be reported by implant recipients. In some cases, these symptoms are caused by erosion. They can also be caused by a serious complication that was previously unreported: mesh contraction. This issue was discovered in scientific literature during a review following the 2008 safety announcement. Contraction of the device has been known to cause severe pain that is aggravated by simple movement. It can be debilitating.

The FDA noted that organ perforation, urinary dysfunction, and pain during sex continued to plague many women who underwent vaginal mesh surgery. Some also reported developing neuromuscular problems after the procedure.

Information that has surfaced since 2008 indicates that vaginal mesh complications are far more common than most experts had believed. To that end, the volume of adverse event reports received by the FDA spurred the agency to describe the problems as “not rare.” This marked a reversal of its previous position.

If mesh manufacturers were negligent toward ensuring the public’s safety, they should be held accountable for any injuries for which they are legally responsible. If you underwent vaginal placement of surgical mesh, and have since developed bladder sling problems, you may be eligible to receive compensation for your injuries. Contact a vaginal mesh lawsuit settlements attorney to discuss your legal options and for the latest surgery mesh recall news.

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