The researchers said that the failure rate seen in women was “unacceptably high” and “recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men.”
(PRWEB) October 05, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is warning the public about the potential dangers of undergoing hip resurfacing and other surgical procedures involving metal-on-metal prostheses. After assessing some 434,000 hip replacement patients, a newly published study in The Lancet concluded that metal-on-metal hip resurfacing is linked to poor survivorship, especially in women and men of smaller stature.
The study, which was published on October 2nd, used the National Joint Registry of England and Wales to assess data from 434,560 total hip replacement (THR) procedures performed between 2003 and 2011; 31,932 of these patients underwent hip resurfacing. Essentially, the researchers found that resurfacing was associated with high rates of early revision compared to patients who were implanted with a traditional stemmed metal-on-plastic implant. Women are observed to have the highest risk, with a predicted revision rate of 8.3 and 6.1 percent after five years for those implanted with 42 mm and 46 mm diameter heads, respectively. Comparatively, females who received a stemmed metal-on-polyethylene THR with a 28 mm head showed a revision of 1.5 percent at five years. Men who underwent resurfacing with smaller diameter heads also experienced poor implant survival rates. At five years, predicted revision rates were 4.1 percent for 46 mm heads and 2.6 percent for 54 mm heads versus 1.9 percent for those with a 28 mm metal-on-polyethylene THR. The researchers said that the failure rate seen in women was “unacceptably high” and “recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men.”
A traditional THR involves a metal stem being inserted into the femur bone. This femoral component interacts with a cup or shell, which is placed into the acetabulum of the hip. When both the femoral stem and acetabular cup are made of metal, it is referred to as a metal-on-metal hip replacement. Hip resurfacing is a type of metal-on-metal hip replacement that is an alternative to conventional THR and which is used to conserve more bone. Instead of using a metal stem, a metal cap is placed over the top of the thighbone.
According to an article in The New York Times, use of all-metal hip replacements has declined in the past two years over concerns that the devices cause serious health problems associated with the shedding of metallic debris. Concerns reached international proportions in August 2010, when DePuy Orthopaedics globally recalled its ASR Hip Resurfacing and Acetabular Systems due to a high rate of revision.
In June, the U.S. Food and Drug Administration (FDA) gathered a panel of experts to discuss the risks and benefits of all-metal hips. In making recommendations for patients implanted with metal-on-metal hips, the panel advised yearly physicals and imaging techniques such as X-rays and CT scans. The follow-up recommendations are intended to detect any potential metallosis, bone damage, pseudotumors, soft tissue reactions and other reported complications that have been linked to the devices.
Parker Waichman LLP continues to offer free legal consultations to victims of defective medical devices, including DePuy ASR and other metal-on-metal hip implants. If you or a loved one experienced premature failure of your implant or other health problems associated with a recalled DePuy ASR Hip Implant or other metal-on-metal hip replacement device, please contact their office by visiting the firm's metal-on-metal hip implant injury page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1-800 LAW-INFO (800 529-4636)