Posts in:February, 2015

How the FDA Pregnancy Labeling Rule Affects Patients

Posted February 20, 2015 by admin

Recently, the American College of Obstetricians and Gynecologists (ACOG) released a statement concerning the FDA’s updated product labeling for pregnant users. The changes were widely applauded as an advancement for women’s health but, before diving into the specifics, it is important to know exactly what’s new. The Pregnancy and Lactation Rule The Pregnancy and Lactation Rule, or PLLR (sometimes called "the final rule"), required new changes to the labeling of prescription drugs where pregnancies are concerned. The most important changes Continue reading…

A Statement on Power Morcellation

Posted February 16, 2015 by admin

Power morcellation, a procedure that uses a morcellator to break up large uterine fibroids or an enlarged uterus before removing them through small incisions, was used on 50,000 women each year until just a few months ago. Since December 2013, the FDA has seen over two dozen incidences of cancer being spread by using the powerful medical device. These reports feature women who have no previous history of the disease, and the results may have revealed a serious threat to Continue reading…