Smith & Nephew is announcing a recall of a metal lining product used in metal-on-metal hip implants. The company estimates that nearly 8,000 people have already been implanted with the defective device. Although the company officials declined to state exactly why they were initiating the recall, metal-on-metal hip implants have been plagued with safety issues — early device failure, corrosion, shedding metal particles into the body, and more.
Smith & Nephew Hip Recall
June 1, 2012 — Smith & Nephew, PLC announced the recall of a metal liner that is used in metal-on-metal hip implants. The product is intended to be used in the R3 Acetabular System hip replacement. When asked why the company was recalling the liner, they only said that they were “not satisfied with the clinical results.” The company officials did not say exactly what results prompted the recall.
The metal liner has been produced since 2009. The company estimates that it is a component of hip replacements in 7,700 people.
Metal-on-Metal Hip Replacements
The Smith & Nephew hip recall is just the latest problem associated with metal-on-metal hip implants. Experts have recently called for a ban of the devices, citing numerous safety concerns that are greater for the metal-on-metal design than for ceramic or plastic devices. In 2010, DePuy issued a massive recall of defective hip replacements. Since then, multiple scientific studies have linked the products to high rates of corrosion, failure, metal poisoning, and more.
Metal-on-metal hip replacements are associated with the following side effects:
- Metallosis, Cobalt Poisoning, and Toxicity: These severe side effects are due to the grinding of metal-on-metal parts of the hip implant. Over time, the device may shed particles of cobalt and chromium into the surrounding tissue and bone.
- Corrosion: A recent study has linked the metal on metal hip replacements to corrosion that is more severe and appears more quickly than other hip replacement designs
- Pseudotumors: Another recent study has found that pseudotumors are 10-times more likely to occur in people with metal-on-metal hip implants. A pseudotumor is a 2-cm growth of abnormal tissue.
- Device failure
- Hip dislocation, misalignment
- Damage to the bone and tissue surrounding the device
- Chronic pain
- Swelling in the hip
- And more