British Medical Journal---Safety of Metal on Metal Hip Implants Questioned

New hip (Photo credit: okadots)

February 28, 2012

The British Medical Journal reported today that a million or more Americans have had metal on metal orthopedic implants installed since 2003.  That number continues to climb as as manufacturers continue to promote metal on metal devices.  This, despite the recall of devices (Depuy ASR), growing evidence of exposure to toxic and potentially carcinogenic metal ions, and the unprecedented requirement by the FDA that manufacturers conduct post-marketing studies.

Startling Highlights Contained in the Report Include the Following:

*Failure rates for all metal on metal hip implants is currently 13.6% as opposed to 3.3% for implants made of other materials.

*Multiple studies and research organizations have warned about the carcinogenic potential of metal-on-metal hip implants.

*Internal Depuy memos from July 2005 identify potential immune function changes and carcinogenic concern.

*Because of concerns, Depuy sales representatives were given paper entitled "Setting the record straight on metal hypersensitivity" written by Dr. Thomas Schmalzried (Depuy's hired consultant, stooge, or whatever you want to call him).

*In 2006, based on concerns, the MHRA (Medicines and Healthcare Products Regulatory Agency) committtee concluded that "there is evidence to suggest that some metal-on-metal hip replacements may be associated with increased DNA changes.

*Data showed raised metal ion levels in the Depuy Pinnacle were available since 2008, yet the device was promoted as the alternative for the subsequently recalled Depuy ASR.

*Speaking of the lax regulatory environment, one Depuy product manager responded to an email stating that "you could literally implant a tent rod if you wanted!"

Unfortunately for those with MOM implants, I fear that the news is only going to get worse.  The revision rate on our Depuy ASR clients is currently 46% and climbing.

If you have a MOM hip implant, it is imperative that you have regular blood tests for cobalt and chromium.

For additional information, feel free to contact me at Chrish@PittmanDutton.com

Related articles

• Serious concerns over Metal on Metal Hips - British Medical Journal (earlsview.com)
• Metal scare over hip replacement joints (guardian.co.uk)
• Jeremy Laurance: The regulator needs to recover its grip, fast (independent.co.uk)
• Hip implant fiasco highlights regulatory failings in Europe (guardian.co.uk)
• Thouands with metal-on-metal hip implants will need annual checks - WalesOnline (walesonline.co.uk)
• Metal Hip Implant Concerns - Potentially Bigger Scandal Than Breast Implants (medicalnewstoday.com)

What did Johnson & Johnson know about their hips and when did they know it?

According to the New York Times, a year before Johnson & Johnson's Depuy division recalled their ASR hip systems, Pamela Plouhar, vice president of Depuy Orthopedics, reported privately to top executives that the FDA was going to refuse to approve the device after data showed it failed prematurely in "significant" numbers.  The device was on the market overseas starting in 2003 and was marketed in the United States in 2005 under a loophole in the law.

This, of course, is in direct conflict with public statements by Johnson & Johnson which insisted that its internal studies refuted complaints by surgeons and regulators in other companies. Johnson & Johnson maintained that the failures were the result of improper placement of the implants by physicians--a position I continue to hear parroted by uninformed doctors or physicians still on Johnson & Johnson's gravy train.

There is only one problem with this defense----the data came from clinical studies performed by surgeons hand picked by Depuy and who received royalties and consulting fees associated with it.  In other words, Depuy's hand picked surgeons were seeing failures at the same rate as other Depuy surgeons who were using the product.

In addition to this email, documents filed with a Senate committee indicate knowledge of a serious problem in 2008, nearly 2 years before the hips were recalled.

Of course, lost in this discussion were the hundreds, if not thousands of people who are now suffering crippling injuries as Depuy continued to mislead both surgeons and consumers about the condition of its product.

Related articles

• Johnson & Johnson CEO resigns after series of missteps (money.cnn.com)
• Flawed DePuy Hip Implant Had Early F.D.A. Notice (nytimes.com)
• Hip Implant the FDA Rejected Was Marketed Abroad - New York Times (nytimes.com)
• Regulator dithering put hundreds of hip patients at risk (smh.com.au)
• J&J DePuy - Hip Implant that U.S. Rejected Was Sold Overseas (earlsview.com)