Thursday, June 6, 2013

How Will Manufacturers of Transvaginal Mesh Defend the Cases?

Over the past few years, literally scores of women were promised that having transvaginal mesh used in a pelvic organ prolapse or stress urinary incontinence surgery was a low-risk operation. To the contrary, it has since been found that the complications from transvaginal mesh can cause serious complications and even change the lives of women forever. Women across the United States have experienced such complications as device erosion, infection, perforation of surrounding organs, extreme pain and the inability to engage in sexual intercourse. Many women have been forced to undergo not one revision surgery but two, three, four and even in a few extreme cases, ten surgical procedures to remove the mesh from their bodies. While plaintiff’s attorneys in these cases are claiming the mesh was insufficiently tested, is potentially defective and that the manufacturers exhibited a clear failure to warn, manufacturers are gearing up with counterclaims.

 

The three primary areas the manufacturers are expected to claim in the thousands of lawsuits pending are that the manufacturers told the doctors of the potential risks, the manufacturers told the patients of the potential risks and the doctors also warned the patients of the risks involved. The manufacturers will argue that the Directions for Use with the mesh implants warned of the possibility of dyspareunia, infection and a need for future surgeries. The patient brochure, given to patients by their doctors, also state there is a risk of dyspareunia and erosion. Additionally, many patients were given individual consent forms by their doctor that detailed the risks of mesh erosion in the vagina, urethra and bladder, the possible need for future surgeries, possible fistulas and the fact that the mesh simply may not work.

 

What was not in the Directions for Use is just how often the mesh can erode into surrounding tissue and organs. A recent article published in the British Journal of Obstetrics and Gynecology places the risk of mesh erosion as high as 10% which is much higher than the statistics given by manufacturers. While the manufacturers claimed 1-2% erosion rates, their own internal data places this number as high as 15-18%.  Further, the manufacturers simply did not adequately warn women in the Directions for Use or in patient brochures about the fact that when the mesh goes wrong it can lead to intense pain, subsequent surgeries and problems that can last a lifetime. The mesh products are also being sold to doctors and patients as a primary product with no procedure or protocol for removal. Doctors are finding they must go in time after time, putting the patient through one surgery after another as they attempt to find each piece of the defective mesh.

 

Verdicts in two recent California trials placed 40% of the fault on the doctor’s technique when placing the mesh. This leaves the door wide open for manufacturers to shift the blame to the doctors during future trials. Attorneys for mesh plaintiffs will generally try to determine whether the problems began within the first month of the implant or began six months or more following the implant. Problems which began soon after the implantation could be due to surgical issues rather than mesh erosion, however in most cases where issues began at least six months following the implant then it is more likely the mesh itself is the problem.

 

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