Consumers Union strongly supports the FDA’s proposed order to change the classification for surgical mesh used to repair transvaginal Pelvic Organ Prolapse (POP) from Class II to Class III. This change will require any future mesh product for POP to provide much needed clinical evidence demonstrating it is a safe and effective device before it is marketed for use in patients.
Consumers Union’s Safe Patient Project submitted comments to FDA about a proposed rule to study limiting the list of drug side effects in a TV drug ad. We have concerns about the possibility of limiting major drug side effects in drug ads, and believe the FDA proposed study has design flaws.
A Boston couple behind a campaign to stop doctors from performing a risky surgical procedure is applauding a new U.S. Food and Drug Administration warning against doctors performing the procedure called laparoscopic power morcellation. The FDA warned doctors that this procedure to uterus or uterine fibroids poses a risk of spreading unsuspected cancerous tissue beyond the uterus.
The FDA has been criticized for approving medical devices through the 510K (fast track) approval requiring no clinical trials. But there’s another way-read on.
“The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade. Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday.”
“The FDA may have gone too far and violated federal law when it chose to monitor 6 scientists who made public their safety concerns about medical devices approved at the agency, a congressional investigation has concluded.”
Seattle Times series on marketing of orphan drugs for off label use
ISSUE: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall.
FDA has created a new form for consumers to report adverse events with drugs or devices. This less technical form is part of larger FDA effort to encourage consumers to submit quality reports.
Washington Post reports: “The Food and Drug Administration is tightening standards for a wide range of medical devices — from fetal monitors used in hospitals to pacemakers implanted in people — because of escalating concerns that the gadgets are vulnerable to cybersecurity breaches that could harm patients.”