Medical Device Approved To Prevent Hemorrhoids After Childbirth
This week a patented device called Hem-Avert® Perianal Stabilizer was approved for use during labor and vaginal childbirth by the U.S. Food and Drug Administration (FDA). From 750,000 to 1 million women every year, in the U.S. alone, suffer from external hemorrhoids after vaginal childbirth. Soon the device will be available to hospitals and physicians nationwide.
The Hem-Avert, made by Plexus Biomedical, is the first of its kind. The device is applied externally and is designed to support the perianal region of a patient during labor and delivery. Considering the incidence of birth induced hemorrhoids, the device stands to be highly successful, and not only in the U.S.
Prior to FDA approval, Plexus conducted multicenter clinical trials in which women were randomly selected to use Hem-Avert during labor and birthing. Though 25 percent of the control group developed hemorrhoids as a direct result of childbirth, none of the women who used the Hem-Avert developed hemorrhoids as a result of vaginal delivery.
Plexus believes that better patient outcomes, cost savings, and patient demand for its use will contribute to the success of Hem-Avert.