The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring.
According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org.
Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that allows clearance for medical devices without clinical testing if they are similar to ones already on the market. While this allows medical devices to reach consumers faster and, medical device manufacturers say, speeds medical technology, consumer groups like CU argue that it puts human lives in jeopardy. As much as 90 percent of medical devices are cleared under this program.
CU has initiated the “Safe Patient Project” aimed at stepping up government oversight for medical devices. The group says that seniors are at the greatest risk since surgical complications can be more serious later in life. Seniors are also more likely to receive many of these medical devices, such as transvaginal mesh and hip implants.
“Having to do any surgery when you’re older is a dangerous endeavor, but having to do it over and over again if something goes wrong can really cause a lot of harm,” CU’s Lisa McGiffert told Fowler Tribune.
Recently, the Food and Drug Administration (FDA) addressed reports of complications with surgical mesh used to repair pelvic floor disorders such as pelvic organ prolapse and urinary incontinence. Problems with the mesh increased fivefold between 2008 and 2010, compared to 2005 to 2007. These complications included the mesh eroding, poking or migrating into the vaginal wall or other pelvic organs, causing debilitating pain and a diminished quality of life. Consumer groups pushed for a ban on the surgical mesh, but the FDA panel opted instead to recommended testing before newer devices are approved for use.
Congress is currently reviewing the Medical Device User Fee Act, which would increase the fee for manufacturers seeking device approvals. Those funds would go toward hiring more FDA employees and more oversight programs for medical devices.
Source: Fowler Tribune