Transvaginal Mesh Problems Discovered in Pelvic Organ Prolapse Patients
May 16th, 2012
A loophole in the FDA medical device regulation system has yet again let down the American public. The agency is intended to keep the public safe, guarding against medical devices that, while profitable for medical device companies, are risky or dangerous. But a specific classification of medical device allows for the approval of new medical products if they are essentially similar to another product that has been tested and proven safe. This is how vaginal mesh products were approved. However, a 2011 FDA Safety Alert indicates the product is not safe, causing lasting transvaginal mesh problems in a significant sampling of patients. If pre-market testing had been required for surgical mesh used in pelvic organ prolapse surgery, many women would have been saved from pain and suffering caused by the product. The benefit of this method of product approval is that new products are made available to patients sooner, and in some cases, a new and untested product can prove essential to saving patients lives. Go to http://www.pelvicmeshlawyers.com to read more.
