http://badmedicaldevicesblog.com Just another WordPress weblog Thu, 02 Feb 2012 09:04:35 +0000 http://backend.userland.com/rss092 en The Food and Drug Administration and medical device industry have agreed to terms on a five-year plan to have companies partly fund agency reviews of proposed new products. According to Bloomberg, the FDA will get about $595 million annually from medical device makers to conduct expedited reviews of new devices. These ... http://badmedicaldevicesblog.com/2012/02/02/fda-device-makers-agree-to-fee-expediting-reviews-on-new-products/ Over 30,000 Britons have received metal-on-metal faulty hip implants and medical regulators are compiling new advice for them out of concern they might be even more dangerous than originally thought. Friction between the metal ball and cup causes miniscule metal filings to shave off, causing them to enter the bloodstream, ... http://badmedicaldevicesblog.com/2012/01/31/british-regulators-ready-new-metal-on-metal-hip-implant-advisory/ Authorities have caught up with the former head of a French company that manufactured faulty breast implants that sparked a panic among women around the world. Jean-Claude Mas, the founder of the now-defunct Poly Implant Prosthese, or PIP, was detained Thursday as part of a judicial investigation in Marseille into ... http://badmedicaldevicesblog.com/2012/01/26/owner-of-shady-french-breast-implant-company-arrested/ Women in the United States are being warned about cheap, faulty silicone breast implants that caused a major scare in France, where the implants were implanted into about 30,000 women. The PIP implants were produced by the now-defunct French manufacturer Poly Implant Prosthesis. They are composed of industrial grade silicone originally ... http://badmedicaldevicesblog.com/2012/01/25/us-women-warned-about-breast-implants-received-abroad/ A federal judge has asked attorneys for each side of C.R. Bard transvaginal mesh Multidistrict Litigation (MDL) to select bellwether cases to go to trial soon. According to an update from a federal court in West Virginia where more than 250 lawsuits against C.R. Bard and more than 29 varieties of ... http://badmedicaldevicesblog.com/2012/01/20/federal-judge-asks-for-transvaginal-mesh-bellwether-cases/ A new review suggests one out of every 100 people undergoing knee replacement surgery and 1 out of every 200 people having hip replacement surgery will suffer a blood clot before they are discharged from the hospital – even if preventative measures are taken. A deep vein thrombosis can form deep ... http://badmedicaldevicesblog.com/2012/01/19/dangerous-blood-clot-possible-complication-of-hip-knee-replacement-surgery/ The Food and Drug Administration has again missed a deadline to strike a deal with medical device makers to improve the speed of the agency's approval process for new products. According to a report from Bloomberg, the FDA had until Jan. 15 to draft a proposal to leading medical device makers ... http://badmedicaldevicesblog.com/2012/01/19/fda-misses-deadline-on-deal-to-fund-medical-device-approval-process/ A product liability lawsuit has been filed by a couple in Georgia against two vaginal mesh manufacturers, Caldera Medical, Inc., and American Medical Systems (AMS.) The plaintiffs allege that problems with the Caldera Desara pelvic mesh sling caused severe complications. Sherry and Reginald Wimbush filed the lawsuit last month in ... http://badmedicaldevicesblog.com/2012/01/16/ams-named-in-another-transvaginal-mesh-lawsuit/ At least 10 women from Iceland are the latest Europeans seeking to join a lawsuit over caused or potential dangers of an inferior silicone gel breast implant. According to IcelandReview.com, "around ten" women on the island nation have sought legal help in joining a lawsuit against Poly Implant Prosthese (PIP), a ... http://badmedicaldevicesblog.com/2012/01/11/10-icelandic-women-seek-to-join-lawsuit-against-maker-of-french-breast-implant/ Public safety officials and a former Food and Drug Administration official are asking the federal government to withdraw the Stryker-made Wingspan stent system because patients with the device have been found to have a 2.5-fold increased risk of stroke or death. Watchdog group Public Citizen and professor Larry Kessler want the ... http://badmedicaldevicesblog.com/2012/01/09/group-seeks-recall-of-wingpan-stent/