Bladder Sling Recall

by Steve Fields on March 26th, 2012

Recent reports estimate that over 650 vaginal mesh lawsuit claims have been filed against several medical device manufacturers. There currently is no general bladder sling recall covering all of the different surgery mesh products from the different manufacturers. The lawsuits allege that negligence was demonstrated in a variety of ways that endangered the health and safety of women. Meanwhile, the FDA continues to assess the risk of surgical mesh complications after receiving thousands of complaints since 2005.

The number of reports describing serious pelvic mesh complications has escalated in recent years, particularly so after a warning was issued by the FDA in 2008. This has prompted the agency to not only look more closely into the risks, but to reevaluate the process by which the devices were approved. Below, we’ll explain the reasons for which mesh is implanted, and describe the most common problems reported by women. You’ll also learn about the process of filing a transvaginal mesh lawsuit claim in the event you experience complications.

Transvaginal Placement Of Mesh To Repair POP And SUI

Mesh is surgically implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The former condition occurs when muscles in the pelvic floor weaken, allowing one or more organs in the pelvis to drop from their normal positions. These organs, which may include the bladder and rectum, bulge into the vaginal wall. In the case of uterine prolapse, the uterus drops into the vaginal canal.

Stress urinary incontinence is a condition in which the muscles that control the flow of urine weaken. As a result, activity that exerts sudden pressure against the bladder (e.g. a sneeze, cough, etc.) produces an involuntary leak. SUI is often accompanied by some form of prolapse.

Pelvic mesh is implanted to provide support to the vaginal wall and prolapsed organs. Years ago, the device was placed through abdominal incisions. Today, a majority of women opt for vaginal placement; the device is implanted through incisions made into the anterior or posterior vaginal wall.

Vaginal Mesh Complications Reported By Women

From 2005 to 2007, the FDA received over 1,000 reports of problems that occurred following vaginal placement of mesh. This spurred the regulatory agency to issue a public health notification in 2008. From 2008 to 2010, they received an additional 2,874 reports describing “adverse events.” Although an increase in complaints is expected after an initial warning, the FDA admitted concern that the number was so high.

Women and their physicians reported that surgical mesh implanted transvaginally often led to urinary dysfunction, vaginal bleeding and discharge, infection, and pain during sex (known as dyspareunia). Some women suffered bladder and bowel perforations caused during surgery. Others experienced neuromuscular problems that led to muscle weakness and muscle pain.

Still other women reported that the bladder sling had begun to move through the vaginal wall, often to the point of being viewable in the vaginal canal. This problem is known as erosion, and can often cause pain that becomes debilitating. The only solution is to remove the device, which the FDA has noted is sometimes impossible.

Stages Of A Vaginal Mesh Lawsuit Claim

While each bladder mesh lawsuit is unique, most begin with a complaint made to the company that designed the device. The complaint may include a claim that the product was negligently designed; the company failed to monitor literature regarding mesh side effects; or they violated laws designed to protect the public’s safety.

If the mesh manufacturer denies its role as described in the complaint, an investigation is conducted. During this stage (called discovery), exhaustive research is performed to uncover every relevant detail about the bladder sling. This stage of the lawsuit may include interviews, depositions, and motions to induce the mesh manufacturer to provide information.

In the event that a vaginal mesh lawsuit settlement cannot be agreed upon, the case may be presented to a judge and jury. A ruling made in your favor will detail the compensation to which you are entitled for your injuries. This includes compensation for lost wages, costs related to hospitalization and treatment, and pain and suffering.

If you received a pelvic mesh implant and have suffered vaginal bleeding, pain, or other complications, you may be eligible to file a claim against the manufacturer. Contact a transvaginal mesh lawsuit lawyer to discuss your case and for the latest bladder sling recall news and information.

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