Higher Rate of Hip Implant Revisions Associated with Metal on Metal Devices

Ft. Lauderdale, FL (SANEPR) December 2, 2011.

A new study published in the British Medical Journal (BMJ) on November 29, 2011, revealed evidence of higher rates of hip implant revision associated with metal on metal (MoM) implants compared with traditional metal on polyethylene implants in the three largest national registries. “This study’s results appear to be consistent with the FDA’s Adverse Event Report filings, as well as with the complaints of my clients wherein the metal-on-metal hip implants are requiring revision surgeries much sooner than the traditional implants due to either increased cobalt and chromium levels or simply failed devices,” commented David Ennis of Ennis & Ennis, P.A.

The U.S. Food and Drug Administration (FDA) initiated this study in 2009 after BMJ called for better regulation of medical devices upon learning of the severe cases of patients with the accumulation of metal ions in their tissues from the MoM implants.

Working with the FDA, a team of researchers led by Professor Art Sedrakyan set out to compare the safety and effectiveness of hip implants with different bearing surfaces. They analyzed the results of 18 studies involving 3,139 patients and over 830,000 operations in annual reports of registries.

The researchers concluded that there was limited evidence regarding comparative effectiveness of various hip implant bearings, and the results did not indicate any advantage for MoM implants compared with traditional implants. They called for a large randomized trial of bearing surfaces before any final claims of benefit are made. "There's more work needs to be done before drawing more definitive, worldwide conclusions, but it is probably not likely to change the signal that these metal-on-metal implants are failing at a greater rate," Sedrakyan said.

In September 2011 The New York Times reported that the FDA received more than 5,000 adverse event reports in the first six months of 2011 regarding MoM hips, which was more than the agency had received in the prior four years combined. http://www.nytimes.com/2011/10/01/health/01hip.html?pagewanted=1&_r=1. Then a study in England revealed that all-metal hips were failing early at three times the rate of hips made from metal-and-plastic components, which can last 15 years or more. http://www.njrcentre.org.uk/NjrCentre/Portals/0/71381621%20BHR%20SAFETY%20AND%20EFFICACY%20OF%20LG%20DIAMETER%20MOM%20THA%20WP_R3.pdf

Some manufacturers of MoM implants have already recalled certain devices and are already the subject of a number of lawsuits. The DePuy ASR XL Acetabular System, which was voluntarily recalled last year by Johnson & Johnson, has received approximately 7,500 complaints through the FDA Adverse Event reporting system, while Zimmer’s Durom cup, which was voluntarily recalled in July 2008, has received over 1,600 complaints. Due to the increasing number of adverse events being filed, on May 6, 2011, the FDA issued orders to 21 manufacturers of MoM hip systems, including DePuy Orthopaedics, Stryker, Zimmer, Biomet and Wright Medical Technology, for postmarket surveillance studies, which required the companies to provide additional studies regarding the possible adverse health consequences of the implants.

Ennis & Ennis, P.A. recommends that anyone with a metal on metal hip implant system, who is experiencing pain in the groin, hip or leg, swelling at or near the hip joint, or a limp/change in walking ability, first seek medical attention. Then file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, consult with an experienced attorney.

Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has a metal-on-metal hip replacement system by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies, as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills and Transvaginal Mesh Devices.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.