A common side effect of childbirth, hemorrhoids are caused by prolonged labor and increased pressure on the anus. Between 750,000 and 1 million U.S. women are affected every year. After seeing his wife go through childbirth, David Blurton developed the Hem-Avert Perianal Stabilizer, which just received FDA approval last month.
Made of medical grade polycarbonate with a cushioned pad in the center, the wedge device is applied externally to support the anal and perianal region during labor. The device works by applying counter-pressure to prevent the patient’s anus from overextending and gorging with blood – a condition that increases the susceptibility of hemorrhoids during childbirth.
The clinical study found that none of the randomly chosen participants who used the device developed hemorrhoids. However, 25 percent of the women in the control group who delivered without the device developed hemorrhoids, which is consistent with the reported incidence of external hemorrhoids caused by vaginal childbirth.
CEO David Blurton stated, ”Since there were not any competitive products or predicate devices that addressed delivery-induced hemorrhoids, the company conducted a prospective, randomized, multicenter clinical study to provide the clinical data necessary for the FDA to create a new classification for the device.”