Johnson & Johnson, the world’s largest maker of health care products, announced last month that it would discontinue sales of its metal-on-metal hip replacement products. The company claims that decreased sales is the reason for its decision and not safety or effectiveness concerns. Interestingly, the company is not recalling the devices. Metal-on-metal hip sales in the United States and Europe have plunged almost 90 percent since 2007 because of widespread safety and effectiveness concerns.
Interestingly, Johnson & Johnson’s decision comes on the heels of the Food and Drug Administration’s proposed rule that would request metal-on-metal hip replacement manufacturers put metal-on-metal products through a more extensive safety review process if they want to continue selling the metal-on-metal products. Johnson & Johnson recalled the DePuy ASR Acetabular System in August of 2010 after reports worldwide indicated that the ASR device was failing at an alarming rate.
DePuy also sold and marketed the Pinnacle Acetabular Cup System, which included a line of cup inserts made of plastic, ceramic and metal. The Pinnacle System was never recalled even though there are safety and effectiveness issues concerning the Pinnacle metal liner. Johnson & Johnson’s recent decision will result in the Pinnacle metal liner being removed from the market.
Problems related to the metal-on-metal hip devices concern the accelerated wear of the articular surface, i.e., the all-metal ball and socket. This accelerated wear causes metal debris to release into the soft tissue surrounding the hip joint. Adverse reactions from this metal debris often lead to revision surgeries. These adverse reactions include metallosis, pseudotumors, bone and tissue loss and necrotic tissue. In addition to revision, major complications included dislocations, palsy of the femoral nerve and early loosening of the acetabular component.
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Source: Bloomberg
