The Smith & Nephew Hip Replacement System have been linked to injuries like metallosis, bone damage, device failure, and other serious complications. We are now working with experienced hip implant lawyers, who can file a lawsuit on your behalf and there are no legal fees until you receive a settlement or award. Feel free to call us toll-free or submit a contact form online.
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Smith & Nephew is the largest medical device manufacturer in Europe and the fourth largest manufacturer in the United States with a 12% share of the market. In 2011, the company had annual revenue of $4.3 billion with $2.3 billion attributable to the sale of its joint products. The company has sold two allegedly defective hip implants in the United States.
The Birmingham Hip Resurfacing System (BHR) was approved in May 2006 for the treatment of degenerative joint diseases like several forms of arthritis, dysplasia, and avascular necrosis (i). Complaints about this device began even before it received approval. Wright Medical Technology petitioned the FDA to deny approval of the device because the data in support of the pre-market approval “is not scientifically valid… Smith & Nephew has not proven that the BHR is effective.” View the petition here. Later, the R3 Acetabular System was approved in November 2008. Approximately 7,700 patients received this device worldwide and up to 4,000 patients have received it in the United States (ii). Both of these implants were designed to be metal on metal joints. This means that both the ball (head) and cup (socket) are made out of metal. In recent years, medical studies have revealed the high rate of failure among these types of devices and now thousands of patients are filing lawsuits.
Complications Linked to All-Metal Hips
These hip replacements have been linked to high failure rates and potentially dangerous levels of metal in the bloodstream because the two metal components wear down quickly. “Squeaky joints,” pain, and swelling are all early warning signs that a device may be failing. A patient who experiences these side effects should talk to a doctor immediately because the joint could fracture or dislocate if it is not treated. In some cases, patients with these hip implants have had to undergo corrective surgery. You may want to talk to a hip replacement lawyer if you have suffered any of the following:
- Infection at the surgery site
- Buildup of metal debris
- High concentrations of metal in the bloodstream
- Damage to tissue or bone
- Device failure requiring surgery
Smith & Nephew Hip Recall
On June 1, 2012, the company announced a recall of the metal liners used in its R3 Acetabular System due to a higher than expected number of revision surgeries. The company based this recall on clinical results showing that 1.6% of patients needed surgery, which is higher than the 1% guideline established by the British government. The company’s chief medical officer stated that “We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component” (ii).
Medical Studies Warn About High Failure Rates
Dr. Derek McMinn is the British orthopedic surgeon who introduced metal on metal hip replacements to the market. Smith & Nephew bought Dr. McMinn’s design and renamed it the Birmingham Hip Resurfacing (BHR). In 2004, he published a paper in the Journal of Bone and Joint Surgery addressing metal-on-metal implants stating, “caution still needs to be exercised until longer term results are available” (iii). According to a study published by Clinical Orthopaedics and Related Research, doctors followed the outcomes of 537 patients who received the BHR and discovered 14 revision surgeries within the first year of implantation. Among these surgeries 10 were for device fracture, 2 for loosening, and 2 for dislocation (iv).
A 2010 study investigated the outcomes of 5,000 patients who were implanted with the Birmingham Hip. Out of the 182 patients who needed corrective surgery 56 suffered loosening, 54 suffered fractures, 17 suffered infections, and the remaining experienced pain, metallosis, dislocation, or malposition of the cup (v). Later, in a 2011 clinical trial, doctors found that a large diameter Smith & Nephew Hip Replacement caused 20% of patients who received the device to have raised concentrations of metal ions in their bloodstream. Read the trial's abstract.
In 2012, two studies were published on the BHR. In the first study, researchers stated, “We are now reluctant to undertake hip resurfacing in women with this implant.” The second study posted similar results stating “the results in women have been poor and we do not recommend metal-on-metal resurfacing in women” (vi). In May 2013, Smith & Nephew sent doctors a letter providing updated information on the safety of the Birmingham Hip. The letter stated that the revision rate of the device was 5.3% after 5 years according to the Australian Orthopeaedic Association’s National Registry and 10.7% after almost 9 years according to the National Registry of England and Wales. Read the entire letter here.
Smith & Nephew Pays Millions to Settle Illegal Marketing Claims
In 2007, Smith & Nephew was investigated by the Securities Exchange Commission (SEC) for an alleged violation of the Federal Corrupt Practices Act. Specifically, the company improperly influenced doctors to recommend its products over other products. Smith & Nephew along with other medical device manufacturers settled these federal claims for $311 million (vii). In 2010, the FDA issued a warning to the company after determining that its manufacturing practices of a R3 Acetabular System component did not meet minimum sterilization requirements. Read the FDA letter here.
Birmingham and R3 Hip Lawsuits
Many patients are now examining their legal options in order to receive compensation for the injuries that the Birmingham Hip Resurfacing System and R3 Acetabular System have caused. On September 12, 2012, William Reilly, a California man filed a Smith & Nephew lawsuit after the hip he was implanted with failed. He received the device on September 8, 2010 and underwent revision surgery on November 20, 2010 because he began experiencing pain and “hearing a grinding noise” from the implant. The plaintiff now alleges that these hip replacements cause metallosis, blood toxicity, and premature device failure. Read the complaint here.
One month later, Cheryl and Ken Elmore filed a Smith & Nephew lawsuit after she was implanted with the BHR but suffered “a tremendous amount of pain and suffering.” Within a year of receiving the device she felt “looseness,” “popping,” and “grinding” in her hip. She soon had it explanted (removed). Most recently, on January 15, 2013, Dr. David Chao, the team physician for the San Diego Chargers, filed a lawsuit against the company after he was forced to settle a BHR medical malpractice claim for $2.2 million. He alleges that the company was negligent in training him and other doctors to conduct surgery using the device (viii).
Do You Need Legal Advice Regarding Your Smith & Nephew Hip Injuries?
If you or a loved one has experienced metal on metal side effects from one of these devices, you may want to speak with an attorney about your legal options. We work with some of the more experienced hip replacement lawyers in the country who are handling these cases. There is no legal fee unless you receive a settlement or award. Feel free to fill out an online contact form in confidence or call us at 1-800-992-6878.
- (i) FDA Approval of the BHR, May 9, 2006.
- (ii) Reuters, June 1, 2012.
- (iii) The Journal of Bone and Joint Surgery (Br), March 2004.
- (iv) Clinical Orthopaedics and Related Research, January 2009.
- (v) The Journal of Bone and Joint Surgery (Br), October 2010.
- (vi) The Journal of Bone and Joint Surgery (Br), September 2012.
The Journal of Bone and Joint Surgery (Br), March 2012.
- (vii) The New York Times, September, 2007.
- (viii) California Southern District Court, January 15, 2013.