The use of transvaginal mesh to treat stress urinary incontinence (SUI) or pelvic organ prolapsed) seemed like a good idea at first. Surgical mesh has been used with much success in treating hernias, so the translation to SUI or POP support did not seem like such a long stretch. Past events prove that the pharmaceutical dangers presented by use of the mesh are nothing to laugh at.
SUI is a condition that primarily affects older women when the pelvic muscles become weaker so when they cough or laugh a little harder, a little urine squirts out. POP may also develop in older women, where the bladder, rectum, or uterus may get out of its usual position and bulge out on the vagina. These conditions are not always severe enough to require surgery, but when it is, the treatment method of choice at one point was the use of a transvaginal mesh to provide the support to prevent incontinence or slippage.
Manufacturers produced transvaginal mesh with the blessings of the Food and Drug Administration (FDA), and it was implanted in a lot of women. Because the FDA did not require clinical trials for this new use for surgical mesh, it was not until complications started to develop that the problems with this oversight surfaced.
The first problem was the risk of infection. The implantation was routinely done through the vagina, which is not ever totally sterile. A lot of women developed serious infections on the site that spread throughout their body.
The second problem was of dynamics. The vagina is designed to contract and expand as needed; the mesh is not. Over time, the mesh developed rough edges that damaged the walls of the vagina and other organs in the area, leading to painful and life-long problems for the patient. According to the website of Williams Kherkher, the health risks of the product far outweighed its benefits, especially as safer alternatives are available for SUI and POP sufferers.
Even though the FDA did not require clinical trials, the manufacturers should have carried them out to ensure the safety of the end-users. This is a duty of care that was disregarded and would cost them plenty in the end because of their civil liability. Thousands of patients have suffered from physical, emotional and financial damage because of this negligence. The only way that they can get some compensation for the manufacturers’ lack of foresight is by engaging the services of a product liability lawyer to file a suit.