On February 24, 2012 the Food and Drug Administration (FDA) announced a nationwide recall of RegenErect, which was produced by Regeneca, Inc., previously known at Ethos Environmental, Inc. This product was marketed as a male enhancement pill. According to the company, RegenErect contains Tadalafil, which is an approved drug to treat male Erectile Dysfunction (ED). Unlike Tadalafil, RegenErect has been distributed over the internet and given as samples at public events in the United States and in Puerto Rico.
Posts tagged "FDA"
According to a recent Food and Drug Administration (FDA) warning, transvaginal placement of surgical mesh might not be the best treatment option in patients suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Transvaginal mesh is a type of surgical mesh that is permanently implanted in patients suffering from POP or SUI to strengthen the weakened vaginal wall. Although doctors routinely use transvaginal mesh to treat such conditions, the FDA warns that thousands of women are at risk of developing serious health complications despite the fact that much safer and similarly effective alternatives exist.
Women who have undergone certain surgical procedures involving the placement of surgical mesh are being warned by the Food and Drug Administration that the added risk associated with the surgical mesh may outweigh the intended benefit. Earlier this month, the FDA released an updated safety bulletin warning health care providers and patients that this product (commonly used in surgery to treat pelvic prolapse) may increase the risk of pain, bleeding and infection in women - as compared to women who have traditional surgery with stitches.