The FDA is requiring hip implant manufacturer DePuy to conduct an explant study protocol as part of its post-market surveillance study of the metal-on-metal Pinnacle hip replacements. An agreement has now been reached between attorneys for Plaintiffs and Defendants in the consolidated DePuy Pinnacle Hip Implant litigation regarding the contents of a notice that DePuy must send to hospital and surgeons regarding the explant protocol established in conjunction with a U.S. Food & Drug Administration-mandated metal-on-metal hip implant study.
According to the FDA, metal particles shed by metal-on-metal hip implants can cause damage to bone and tissue surrounding the device and joint, resulting in adverse local tissue reactions. The FDA is also concerned that some studies have found that high levels of metal ions shed from metal-on-metal hip implants into the blood stream may cause symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.
Women and Many Men Are Advised Against Hip Resurfacing
Hip resurfacing surgery is an alternative to standard hip replacements for patients with severe arthritis. In a hip resurfacing surgery, the implant is smaller, and less normal bone is removed. During the hip resurfacing procedure, only a small amount of bone is removed from the ball-and-socket hip joint, and a metal cap is placed on top of the ball. A metal socket is placed in the pelvis, similar to the hip replacement procedure. This hip resurfacing preserves much more normal bone than a standard hip replacement.
However, a new study recently published in the medical journal The Lancet* found that hip resurfacing is prone to early failure and shouldn’t be used in women. The researchers found that metal resurfacing implants fail more quickly than total hip replacements made of other materials, with the failure rate as much as five times higher for women.
The researchers, headed by Dr. Ashley W. Blom of the University of Bristol, concluded that resurfacing had an “unacceptably high” early failure rate in women when compared with traditional hip replacement. The early failure rate was also higher in smaller men.
Traditional hip implants are supposed to last 10 years or more before requiring replacement. But the only class of patients in which the durability of a resurfacing was on par with a traditional plastic-and-metal implant was middle-aged men of larger stature, the study found.
The researchers reviewed the National Joint Registry for England and Wales, which has data on 434,650 hip operations. In September 2011, the registry said the ASR Acetabular hip replacement, made by Johnson & Johnson’s DePuy Orthopedics Inc., was removed or replaced 29 percent of the time after six years, compared with a 9.5 percent failure rate for all metal- on-metal implants. J&J issued a recall of the devices in 2010. The registry also found the metal-on-metal hip implants needed to be replaced more often than their counterparts.
HO&P & Defective Hip Implant Lawsuits
Heygood, Orr & Pearson is actively representing clients who have been injured as a result of defective hip implants. We have been and will be dedicating all resources necessary to pursuing these cases.
If you have been injured by a defective artificial hip implant, contact Heygood, Orr & Pearson for a free case evaluation. You can reach us by calling toll-free at 1-877-446-9001, or by filling out the free case evaluation form on this site.