Pharmaceutical

FDA clears new transvaginal mesh device despite warnings, lawsuits

mesh FDA clears new transvaginal mesh device despite warnings, lawsuitsThousands of lawsuits have been waged against the makers of transvaginal mesh and the public has been warned by the Food and Drug Administration (FDA) that serious complications with these devices are “not uncommon.” However, the FDA is still clearing more pelvic mesh products for use in the treatment of pelvic organ prolapse and stress urinary incontinence.

Caldera Medical announced that it gained FDA approval for an improved Vertessa Lite mesh, which the company says is “lightweight, flexible and strong for sacrocolpopexy (pelvic organ prolapse repair) procedures.” Vertessa Lite mesh is made with larger pores and lightweight mesh designed to improve host tissue acceptance.

Pelvic organ prolapse, or POP, is a condition in which one or more of the pelvic organs bulges or protrudes out of or into the vagina. An estimated 40 percent of women have some form of prolapse, and about 250,000 women undergo surgical procedures each year to treat POP.

Transvaginal mesh is used to treat POP and, in some cases, stress urinary incontinence. However, after receiving an alarming number of reports of complications from women who had undergone procedures in which transvaginal mesh was implanted, the FDA issued a warning that the devices could cause injuries to women that in some cases could last a lifetime.

Complications from transvaginal mesh include erosion or protrusion of the mesh into tissue and/or organs, leading to symptoms such as chronic pain, infections, hemorrhages, and disability. Many women have had to undergo multiple surgeries to remove the device, and some have been left with lifelong complications.

Manufacturers of transvaginal mesh are facing thousands of lawsuits claiming the devices are defectively designed and were not adequately tested before they were marketed, resulting in serious injuries.

Source: Business Wire