As noted previously here in the blog, there has been growing concerns regarding metal and metal hips and the various problems associated with revision surgery and metallosis. Johnson & Johnson (JNJ) and the parent company of DePuy, the world’s biggest maker of health-care products, announced it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand drops for the devices.
Metal liners in the Ultamet Metal-on-Metal Articulation and the Complete Ceramic-on-Metal Acetabular Hip System will no longer be available worldwide after August 31.
FDA Investigation of Metal Hip Manufacturers
The FDA has called for metal hip manufacturers to go through rigorous clinical trials and premarket approval processes before placing the metal on metal hip products on the market.
The FDA was dragged into action after an August 2010 recall of the DePuy ASR metal-on-metal hip implant that affected more than 93,000 patients worldwide and led to thousands of lawsuits against the company.
Earlier this year, the FDA released new guidance for metal-on-metal hip replacements that called for them to go through the PMA (Pre Market Approval) process. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market.
DePuy ASR & Pinnacle Metal Hip Debacle
The DePuy Pinnacle hip system was released for implantation in 2001. The metal-on-metal configuration was used as the basis for the approval of the DePuy ASR hip implant in 2005. Johnson & Johnson secured “fast track” 510k approval by declaring that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs.
The DePuy Pinnacle was also approved under the FDA’s 510k system as a substantial equivalent to older metal hips. This fast track 510k process is essentially a short cut for hip manufacturers to release their products rapidly into the market place without having to do significant medical testing or safety analysis of their devices.
4,000 Plus DePuy Pinnacle Lawsuits
4,000 plus DePuy Pinnacle product liability federal lawsuits have been filed and the complaints uniformly allege that metallic trash is released into the body as the metal components grind against each other. This metallic debris leads to an inflammatory and hip destructive process, which is alleged to cause the artificial hip to loosen and ultimately fail.
Biomet, Stryker, Smith & Nephew and Wright Hips Under Fire
Thousands of patients throughout the United States are pursuing product liability lawsuits against the makers of metal-on-metal hip replacement systems. There is a substantial number of lawsuits against DePuy ASR metal hip (over 10,000), Biomet M2A Magnum Hip, Stryker Rejuvenate/ABG II Hip Systems, Smith and Nephew R3 models and Wright Conserve Cup pending nationwide.
Metal on Metal Hip Sales Plunging
Metal-on-metal hip demand and sales in the U.S. plunged from 20 percent of hip market share in 2007 to less than 2 percent in 2012 as doctors challenged the safety and patients filed lawsuits claiming injuries from defective products.
“We won’t have any metal-on-metal or ceramic-on metal hips any longer,” said Mindy Tinsley, a spokeswoman for J&J’s DePuy unit, “We’ve seen, for example, a 90 percent decline in metal-on-metal sales industrywide in the U.S. and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.” According to J&J, the decision to stop selling the hips isn’t related to safety or effectiveness, and it isn’t a recall.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.