The U.S. Food and Drug Administration announced earlier this year that it wants to reclassify the surgical mesh used in the treatment of pelvic organ prolapse as a high-risk device, as opposed to its existing classification as medium-risk. This reclassification would mean that transvaginal mesh products would have to be approved by the FDA before entering the marketplace.
Transvaginal mesh has been used as a treatment for a number of conditions that usually result from childbirth, including urinary incontinence and pelvic organ prolapse, which occurs when the internal support for the pelvic organs has become substantially weakened. This causes the organs to drop, which results in serious discomfort and problems with sex, urination and defecation.
Unfortunately, the potential complications of transvaginal mesh surgery are themselves quite serious. Urinary incontinence can actually reoccur, as can urinary tract obstruction. Bladder and bowel injury are also possible, as are infection and irritation. In some cases, the mesh can even erode within the body.
Injury is just one of the possible problems a victim might encounter. Having to return to the doctor can result in mounting medical bills, wasted time, missed work and lost wages. The potential for emotional suffering should not be discounted, either, as the stress related to a medical injury can be considerable. Furthermore, as transvaginal mesh problems can make sexual intercourse extremely painful, the loss of physical intimacy with a spouse may create additional suffering.
In any personal injury case, it is necessary to prove that the negligence of another person or party led directly to the injury. Because the status of transvaginal mesh has long been under close scrutiny, it may be possible to argue that recommending it to a patient might constitute negligence on the part of a doctor, or that complications may have resulted from defective manufacturing or design.
To learn more, consult the experienced product liability attorneys at Thorsnes Bartolotta McGuire in San Diego.