Last week, a Senate committee gathered to understand how medical devices are approved by the U.S. Food and Drug Administration (FDA). Senators heard medical device makers accuse the FDA of a slow approval process for devices which they claim costs money and jobs. Manufacturers are in favor of pushing for a streamlined process to get devices to the market faster, although about 90 percent of new medical devices are already fast-tracked through the FDA’s little-known 510(k) process that is basically an exchange of paperwork to assure regulators that the device is similar enough to one that was grandfathered in the 1970s.
Now, Consumers Union, the advocacy arm of Consumer Reports, has added its voice to the few who were present to remind the FDA that it cannot serve two masters – the medical device manufacturers and the public who it is supposed to protect. Consumers Union is in favor of strengthening the federal regulation of medical devices.
“You have been hearing that the medical device industry faces onerous regulation by FDA. But in many respects, the device industry is far less regulated than the drug industry. For example, the standards for the fuller premarket approval of devices that require clinical trials are weaker than are used for drug approval. Drugs must show substantial evidence of safety and effectiveness where devices must merely show reasonable assurance of safety and efficacy,” said Lisa McGiffert, the Director of the Safe Patient Project.
Consumers Union wants medical devices such as surgical mesh to undergo premarket approval for safety by the FDA as well as implementing a post-market surveillance of the devices so patients can be followed and alerted when there is a problem with a device.
A product liability action is filed when a device is defective in its design or manufacture and/or when the manufacturer fails to adequately warn the public about the defective nature and complications associated with a medical device. Without a warning, a patient cannot make an informed decision on whether or not he or she wants the product.
So many women who have synthetic surgical mesh implanted had no idea whatsoever what was being used to treat their pelvic organ prolapsed or incontinence, nor were they warned about the injuries associated with this defective device. If you have been injured by a synthetic surgical mesh, the experienced Florida transvaginal mesh attorneys at Farah & Farah are ready to listen to you and help. Call (800) 533-3555.
Source: http://news.consumerreports.org/health/2011/11/lax-oversight-of-medical-devices-puts-patients-at-risk-consumers-union-says.html; http://www.consumersunion.org/pub/core_health_care/018231.html
