Failed metal-on-metal hip replacements and the ‘C’ word

As if metallosis and other adverse tissue reactions were not enough woes for many metal-on-metal hip replacement recipients, some scientists believe that there should be further examination of a potential increased risk of cancer.

This is a conclusion of a study reported in the April 2 online edition of the British Journal of Cancer, in which researchers poured over a National Health Service cohort of nearly 72,000 hip implant patients derived from a “linked database of hospital discharge, cancer registration, and mortality records.”

“With follow-up to the end of 2010,” these monitored patients underwent either a total hip arthroplasty from 1990 through 2009 or a primary resurfacing arthroplasty from 2000 through 2009 in Scotland.

An article published in the British Medical Journal on April 19, 2012, contrasted the procedures: “In total hip arthroplasty, the patient’s femoral head and neck are removed and replaced. Resurfacing arthroplasty is an alternative technique that preserves the neck of the patient’s femur. The femoral head is then resurfaced with a cap rather than replaced. The concept of resurfacing arthroplasty has been around for many years, but early implant designs failed owing to limitations in the materials available and the accuracy of the production processes.”

The Scotland “results imply an overall excess risk of cancer of 5 percent,” according to the British Journal of Cancer article, in which researchers conceded that the validity of their undertaking would be strengthened by the creation of a joint registry in Scotland. (Researchers could document rather than infer the metal-on-metal procedures, for example.)

Researchers observed prostate cancer, basal cell carcinomas of the skin, and cutaneous melanoma. The authors delved into this research enough to know that it would be scientifically imprudent to dismiss entirely cancer risks among metal-on-metal hip implant recipients.

Reasoning that the current absence of a smoking gun does not presuppose nothing is behind the red flag, the study’s architects wrote, “[F]ollow-up of individuals operated on most recently, who are more likely to have been exposed to new-generation metal-on-metal prostheses, is necessarily limited and it will be important to re-assess the risk of cancer among this group after a further period of follow-up has accrued.”

Some of the science suggests that their concern is just. The cancer journal writers pointed it out empirically. For instance, several studies published from the mid-1990s to 2012 “have reported excess risks of melanoma of the skin, prostate cancer, kidney cancer, and basal cell carcinoma of the skin, specifically in patients with modern generation metal-on-metal hip replacements. … Recent meta-analyses and reviews of studies of cancer risk following THA (as well as, in some cases, total knee arthroplasty) have also identified increased risks of skin melanoma, prostate cancer, cancer of the endometrium, and cancers of the urinary tract and mouth/pharynx.”

Cancer risks notwithstanding, excessive device failures have left thousands of metallic hip implant recipients in a heck of a bind — apparently the result of an unfortunately defective product that posed an unreasonable risk of injury.

In regard to all large-diameter metal-on-metal total hip replacements, the British Hip Society and the British Orthopaedic Association released in March 2011 the conclusions of their self-proclaimed “well researched and audited results of these devices.”

Those groups wrote, “The presented results show a higher than anticipated early failure rate. These range from 21 percent revision rate at 4 years (potentially rising to 35 percent if all currently known painful implants progress to revision) to 49 percent at 6 years for the ASR XL device. Other devices have a revision or impending revision rate of 12-15 percent at 5 years.”

Metal-on-metal hip implant lawsuits have been filed by injured patients seeking to recover their damages, which have included soaring medical costs related to the treatment of adverse reactions. Such treatment may necessitate revision surgeries.

The U.S. Food and Drug Administration alerted physicians and patients about the nature of these awry potentialities, explaining, “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect.” The agency described some of what could go horribly wrong as follows:

• “Improper design or inadequate mechanical properties of the device, such as its lack of strength and resistance to wear, may result in the loss or reduction of joint function…”

• “Adverse tissue reaction,” to include “the release of materials from the device to the surrounding tissues and the systemic circulation.”

• “Elevated adverse event rates for these devices may lead to an increased risk of premature revision.”

• “Infection … These adverse tissue reactions include metallosis, hypersensitivity/allergy, tumor (pseudo) or aseptic lymphocyte dominated vasculitis associated lesion (ALVAL).”

Anyone who has suffered complications related to the failure of any of the following metal-on-metal hip replacements may be entitled to compensation:

• Biomet M2a Hip Implants
• Biomet M2a-Magnum
• Biomet Regenerex
• Birmingham Hip Replacement
• Birmingham Hip Resurfacing (BHR) system
• DePuy ASR XL Acetabular System
• DePuy ASR Hip Resurfacing System
• DePuy Pinnacle Acetabular Cup System
• DePuy PINNACLE ULTAMET Metal Liner
• Portland Orthopaedics Ltd. M-COR Modular Hip System
• RingLoc + Modular Acetabular System
• Stryker Hip Implants
• Wright CONSERVE Total Resurfacing Hip System
• Wright PROFEMUR Hip Implant
• Zimmer Durom Cup
• Zimmer Continuum Acetabular System

At no charge, one of the experienced product liability attorneys at Reich & Binstock can examine a patient’s circumstances and determine whether there is an entitlement to compensation. For a free consultation, one may call Reich & Binstock toll-free at 1-866-LAW-2400 or visit www.reichandbinstock.com to submit an electronic request for a case evaluation.