Consumer Reports concludes that however shocking it may sound, most implanted medical devices are never tested for efficacy and the few that are do not undergo stringent testing.
Consumer Reports interviewed three people who were injured from different implants that the FDA grandfathered onto the market.
Metal-on-Metal Hips
Dr. Stephen Tower, an orthopedic surgeon in Alaska, who has written articles about cobalt toxicity from metal-on-metal hips after he suffered from side effects of a metal-on-metal hip replacement. The DePuy Orhopaedics ASR XL (chromium and cobalt metal hip replacement) was substantially equivalent to its predecessors and was grandfathered onto the market without clinical testing. Althuogh Dr. Tower experienced great short term results, after a year he began to experience detrimental heart, brain and thyroid problems. He noted the product of his metal on metal hip implant as "profound poisoning".
New studies have revealed metal-on-metal hips fail prematurely and at a higher rate than conventional hip implants with a plastic liner. Many patients with metal-on-metal hips are experiencing pain, popping/click, high cobalt levels (referred to as cobaltism/metallosis), and pseudotumors, which necessitates a revision surgery.
Vaginal Mesh
Surgical Vaginal Mesh is often used to for prolapse repair and bladder support. However, women are experiencing complications that include: chronic pain, hemorrhage, infection, urinary problems and even recurrence of prolapse. These complications require another surgery to remove and replace the mesh.
This month, Johnson & Johnson notified the FDA it wishes to discontinue sales of vaginal mesh implants in 2013 - read more about this here: http://faultyimplants.blogspot.com/2012/06/j-to-stop-sales-of-vaginal-implants-in.html.
Cardiac Devices
Other dangerous findings in the article discuss implantable cardioverter-defibrillators. Consumer Reports says "since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to our analysis of the FDA’s database of adverse events." More than 500,000 people abnormal rhythms have defibrillators implants that administer shocks to correct the abnormal rhythm. Two recalls related to defibrillators involved component parts called leads, which are the wires that connect the defibrillator to the heart.
In 2007, Medtronic recalled the Sprint Fidelis and in 2011 St. Jude recalled the Riata/Riata ST lead. Patients with the leads require close monitoring and potentially may have to have them surgically removed.
I highly recommend you read the article "Consumer Reports Investigates Dangerous Medical Devices" and watch the CBS report above.
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