Hip Replacement Recall on Defective Medical Devices
Brown and Crouppen Welcomes FDA Study on Potentially Defective Hip Replacement Products
Metal-on-Metal (“MoM”) hip replacements have come under scrutiny lately. On May 6, 2011, the Food and Drug Administration ordered 21 manufacturers of 145 different MoM hip replacements to study and report the outcomes of patients who have received these devices. Such a study is called a “postmarket surveillance study.”
Attorney Ron Brown, of St. Louis-based law firm Brown and Crouppen, welcomed the development saying, “I’m very glad to see the FDA’s action on this.”
Recent years have seen growing concern in both the United States and overseas about the safety of MoM implants. In August of 2010, Johnson & Johnson subsidiary, DePuy Orthopaedics, recalled both its ASR and ASR XL hip replacement systems after growing pressure from the FDA over the devices’ unusually high failure rate and DePuy’s marketing of the implants.
MoM implants were aggressively marketed as being more durable and harder to dislocate than traditional implants. Unlike traditional hip replacement systems, MoM implants do not have a plastic spacer between the ball and socket. However, the metal-on-metal design can result in increased wear and debris generation. As the metal ball-and-joint scrape against each other, tiny particles of metal debris wear off within the patient. The particles can float freely within the joint, embed into nearby tissue or even enter the bloodstream.
These tiny metal particles can wreak havoc on the body. Complications include pain, infection, tissue damage, bone loss and metal hypersensitivity. Metal hypersensitivity is very common-between 10% and 15% of the population have it. Most people know somebody who cannot wear some types of metal without breaking into a rash. But when the metal is inside the body, a tube of cortisone cream won’t help. The internal inflammation can be painful and debilitating.
In severe cases, patients require “revision” surgery to remove and replace the hip implant. “Patients who undergo revision surgery are placing themselves at risk of anesthesia complications, unexpected bleeding, blood clots, deep vein thrombosis, even death,” says Brown. He also noted that the surgery is expensive and can leave patients with a staggering medical bill. “Many hip replacement patients are elderly and live on a fixed income. They should not be stuck with the cost of a surgery caused by a defective product.”
Brown warns patients with MoM implant injuries not to wait on the outcome of the FDA study. “Strict time limits apply for injury cases. If you have been harmed, you need to speak with a qualified attorney about your rights.”
Brown & Crouppen has been in practice since 1979. The firm focuses on injury law in Missouri, Kansas and Illinois. Brown & Crouppen represents clients with claims arising from defective products, defective drugs, motor vehicle accidents, workers’ compensation, premises liability, medical malpractice and social security disability. Missouri Lawyers Weekly named Brown & Crouppen “Winningest Plaintiff Law Firm” in Missouri for 2010.
Brown & Crouppen may be reached toll-free at 877-448-5415. The firm’s website is www.getbc.com.