Sulzer Has Ongoing Implant Problems
August 11, 2001
Nearly 10% of the American population currently has some type of medical implant. At least 25 million Americans are functioning daily with medical devices such as pacemakers, artificial eyes, hip implants and others. However, the Food & Drug Administration (FDA) does not closely monitor implants. This makes it difficult for patients to get information about recalls and other problems with their implants. In fact, until 1998, the FDA did not require implant manufacturers to report recalls.
One of the most publicized recent implant recalls involves the Sulzer hip replacement. Sulzer Orthopedics Inc., a Texas-based company, continued to sell and market its replacement hip despite an ongoing internal investigation of the implant's tendency to fail. The implant is designed to allow the bone to grow around the device, holding it in place. However, the implant is prone to breaking loose, causing the patient excruciating pain.
The problem lies with a small amount of oil left behind on the implants during the manufacturing process. The oil prevents the bone from bonding to the implant.
Gary Sabins, former president of Sulzer Orthopedics, received a letter from a senior surgeon at the Los Angeles Bone and Joint Institute in August 1999. The surgeon notified the company of several reports of loose sockets. Another letter followed in October, reporting additional failures. The sudden onset of loose sockets alarmed the surgeon, who had previously used the Sulzer implants for several years with no problems. Following these letters, Sulzer began an internal investigation into the implant failures.
Sulzer recalled the hip implants on December 8, 2000. Thousands of patients have undergone major surgical procedures in order to replace the defective implants. Replacement surgery costs between $20,000 and $50,000. Sulzer agreed to pay for the cost of revision surgery, lost wages, and pain and suffering associated with the ordeal. Nevertheless, Sulzer Orthopedics and Sulzer Medica Ltd., its parent company, are now facing more than 1,000 lawsuits.
According to FDA statistics, implant manufacturers have issued 39 artificial hip recalls since 1995. Fortunately, the majority of these recalls involved mislabed products, not actual defects. Only 13 recalls involved serious design or manufacturing problems. The Sulzer recall is the most notable, involving more than 25,000 implanted devices.
Sulzer is also in the news for its knee implants, also contaminated with oil. The company withdrew the implants from the market in March 2001 but did not issue a recall. At least one lawsuit has been filed regarding the knee implants. Approximately 1,600 knee implants were recalled. 229 of these have already been replaced.
-- Article Courtesy of InjuryBoard.com
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