Consumer Reports Investigates Defective Medical Devices such as Metal-on-Metal Hips, Vaginal Mesh Slings & Cardiac Defibrillators

Consumer Reports published an investigative report entitled "Dangerous Devices" in their May 2012 magazine. This article describes several medical devices such as metal-on-metal hips, vaginal mesh slings, and three cardiac devices that have failed and harmed thousands of Americans. Unfortunately, consumers were told these devices were safe when in fact they lacked proper testing.

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.

  

The article quotes Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families, a nonprofit advocacy organization saying “Standards for [medical] devices exist, they just don’t make sense.”

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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If you or someone you know has a faulty medical device, contact attorney Jon Mann by phone at 1-866-515-8880 or by email for a free case evaluation.

Smith & Nephew Withdraws Metal Liner used in Hip Replacement From Market

DO YOU HAVE A DEFECTIVE METAL-ON-METAL HIP REPLACEMENT?

Another metal-on-metal hip implant component has been withdrawn from the market due to poor clinical results. DePuy Orthopaedics recalled the ASR XL metal-on-metal hip in August 2010 due to higher than expected failure rates and patients reporting cobalt toxicity issues.

Business Week reports that Smith & Nephew PLC, a London based medical device company, announced on Friday (June 1, 2012), that it is voluntarily withdrawing a metal liner used in its R3 Acetabular Metal-on-Metal hip replacement system. This metal liner was introduced in 2009 and approximately 7,700 of the devices have been implanted. 

The company stated that it pulled the optional metal liner from the hip replacement system because it was "not satisfied with the clinical results" of the liner, and some patients needed an additional surgery to have the liner removed.  The clinical results showed "1.6% of patients with this system needed revision surgery each year, which is above the 1% guideline set by Britain's National Institute for Health and Clinical Excellence."  Patients needing hip replacement surgery will be offered the traditional plastic liner instead of the metal-on-metal configuration.

(Photo credit: okadots)

Smith & Nephew says the issues with the metal liner in the R3 Acetabular hip system are different than those seen in other all metal implants such as the recalled DePuy ASR hip. Smith & Nephew contends patients with this metal liner experienced problems including infections, fractures and dislocations, but no reports causing "metallosis" or the build up of other metallic debris in the body. Smith & Nephew claims the voluntary withdrawal of this device is a precautionary move and that patients who already have the device implanted are at low risk and do not need to have it removed. 

Metal-on-Metal hip implants generally have been linked to high rates of revision surgery and systemic complications because of component erosion and leaching of metal ions both locally and into blood circulation. In 2010, DePuy Orthopaedics issued a recall of its ASR metal-on-metal hip due to early failure rates. Problems surrounding the ASR device include increased blood levels of cobalt and chromium ions, intense hip, thigh, and groin pain, a loss in overall mobility, component misalignment and loosening,  and possible tissue and bone necrosis.

CONTACT US TODAY!

If you or someone you know suffered pain and/or had to undergo additional surgery as a result of having a metal-on-metal hip replacement, contact attorneys Jon Mann or Chris Hellums at 1-866-515-8880 so we may evaluate your potential claim. You may be entitled to financial compensation.  Don’t delay, you don't want to let your statute of limitations expire.