http://meshmedicaldevicenewsdesk.com/removing-mesh-and-getting-healthy/new-england-journal-of-medicine-medical-devices-balancing-regulation-and-innovation/ latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. Sun, 19 May 2013 19:38:49 +0000 hourly 1 http://wordpress.org/?v=3.5.1 http://meshmedicaldevicenewsdesk.com/removing-mesh-and-getting-healthy/new-england-journal-of-medicine-medical-devices-balancing-regulation-and-innovation/#comment-1967 DJ Tue, 31 Jan 2012 19:16:45 +0000 http://meshmedicaldevicenewsdesk.com/?p=1424#comment-1967 Thanks, Jane, for this article about the FDA’s flawed and outdated 510(k) process, a process which allows many defective medical devices on the market for use in unsuspecting patients. This nurse is appalled at the number of bad, faulty medical products that are allowed access to the market by saying they are “equivilent” to a “predicate”, even remaining on the market after the “predicate” they used has been removed by the FDA and labeled “misbranded and adulterated”. Many medical devices aren’t even that similar to the predicate device they used. An apple and orange are both fruit but are still very different. Thousands of patients have suffered severe physical harm, often permanent damage, emotional distress, and sometimes death from 510(k) products. The 510(k) process allows the medical device manufacturers to use people as guinea pigs without even needing to have the person sign a consent to be “experimented” on. Examples of faulty 510(k) medical devices are all surgical mesh, including transvaginal and hernia repair meshes, some heart stents and valves, artificial hip replacements, stents for stroke prevention, some sutures, and pacemaker wires, among others. Thank you IOM, GAO, and NEJM for taking stands for patient safety.

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