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Gynecologic Negligence Claims Related to Vaginal Mesh On the Rise

Synthetic mesh is expected to produce a high number of medical malpractice and negligence claims in the next 10 years in the field of gynecology.

Even though the procedures related to the mesh are safe and effective in the hands of qualified and trained physicians, malpractice injuries are expected to increase due to the exaggerated marketing of these techniques to novice gynecologists and general obstetrician and gynecologists.

While synthetic mesh has been used since the 1960s, its popularity increased in the late 1990’s with the introduction of a new product, tension free vaginal tape (TVT) in Europe and later in America. The introduction of mid urethral, tension free vaginal tape revolutionized the treatment of stress urinary incontinence in aging women around the globe. Its 10-year success rate of 90 percent only added to its popularity and use.

On the heels of this success, several other companies began marketing their own version of this device. To make this procedure known as cystoscopies more available to gynecologists who did not have the training to ensure safety and intactness of the bladder and urethra, companies modified the procedure’s retro pubic approach of TVT with trans-obturator and eventually single incision approaches.

Those physicians specializing in obstetrics and general gynecology find it profitable to add incontinence services too. These device companies began using the same type of mesh in a larger size in the vagina for prolapse repair even though no clinical studies had shown the benefits of mesh in treating prolapse over traditional repair.

The over-simplification of these techniques led to mass training of many physicians. This aggressive type of marketing resulted in many unqualified physicians conducting surgeries that were beyond their competence or training.

In 2008, the U.S. Food and Drug Administration released the first public health notice about transvaginal surgical mesh. The second notice was just released in July 2011. The most frequent complications are:

• Erosion of the mesh (mesh exposed, causing bleeding and discharge)
• Pelvic pain (which may be severe)
• Pain with intercourse
• Inability to have intercourse

Other warnings include:

• Additional surgeries may be required to deal with complications
• There is limited evidence to suggest that mesh surgery provides a superior result to traditional non-mesh vaginal surgeries.
• Mesh placed abdominally is associated with lower complication rates
• Surgeons should receive special training in using mesh

According to the FDA, surgeons should inform patients of the following:

• Mesh is permanent
• May cause complications requiring more surgery
• Complications may not be correctable
• Surgeons should recognize that most cases of prolapse can be treated successfully without mesh
• The complications of surgical mesh have not been linked to a single product.

For more information on medical malpractice cases visit our Daytona Beach malpractice attorney library.








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