Shares of Kips Bay Medical Inc., makers of surgical mesh used to treat pelvic floor disorders, have taken a nosedive following news that the Food and Drug Administration (FDA) may order transvaginal mesh devices to go through clinical trials to determine efficacy and safety. The Minneapolis-based company marked a 34 percent loss following the announcement, closing at $1.87. Earlier in the day, the shares hit an all-time low of $1.79.
Kips Bay Medical’s eSVS surgical mesh is just one of the transvaginal mesh products that is under review by the FDA following a staggering increase in complaints about the products. The mesh is used to repair conditions such as stress urinary incontinence (SUI) and pelvic organ prolapse (POP). SUI is caused by leakage of urine during physical exertion.
POP is a condition caused by obesity, age or childbirth that occurs when a pelvic organ drops from its normal position and pushes against the walls of the vagina. Organs involved include the bladder, bowel, and rectum. POP can cause pain or problems with the bowel or bladder functions or cause sexual intercourse to be uncomfortable or painful.
During pelvic floor repair, surgical mesh may be implanted into the vagina to hold up the prolapsed organs. More than 1,500 women who have undergone the surgery using the transvaginal mesh have reported serious complications. The most frequent problems reported include erosion of the mesh through the vagina, infection, pain, urinary incontinence, and recurrence of the organ prolapse.
Patients who experienced these problems suffered pain and disability. Many had to undergo additional surgeries. Some say their injuries are permanent. More than 500 lawsuits have been filed against the makers of transvaginal mesh.
An FDA advisory panel recently held a public forum to hear complaints about the mesh and to discuss options. While some advocacy groups pushed for banning the devices, the panel fell short of recommending such measures. Instead, the group said that to ensure safety, new transvaginal mesh products should go through clinical trials before being approved for use. The FDA does not always follow the advice of its panels, but it usually does.
Source: Mass Device