These 2 medical devices have sparked controversy

Sandra Maddock, president, IMARC Research The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death. It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of these events occurred decades ago, medical devices still have the potential to cause harm. These issues are documented in the FDA’s annual list of medical device recalls and (in some rare cases) even make headlines. Here are two examples of more recent medical devices that have hurt patients. Pelvic mesh treatments Pelvic organ prolapse occurs when the tissue and muscles of the pelvic floor no longer support pelvic organs, causing them to drop. This can cause bulging, pain, urinary incontinence or sexual difficulties. Pelvic organ prolapse can be caused by childbirth or age. Many physicians have used plastic surgical mesh to treat pelvic organ prolapse. However, the FDA has identified serious complications with the use of surgical mesh for this purpose. An FDA review of adverse events from 2005 to 2010 identified at least three deaths directly associated with pelvic mesh procedures (two bowel perforations and one hemorrhage), as well as nearly 4,000 reports of injury and malfunction. The most frequent complications included: Vaginal mesh erosion Infection Urinary problems Bleeding Organ perforation...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news