Product News and Recalls

Smith & Nephew Receives FDA Warning Letter

smith and nephew warned by fdaAccording to FierceMedicalDevices, the U.S. Food and Drug Administration (FDA) has issued a warning letter to medical device manufacturer Smith & Nephew over quality-control violations at the company’s facility in Andover, MA. The letter outlines problems related to some of Smith & Nephew’s mechanical morcellators, which are used in surgeries to remove intrauterine tissue. FierceMedicalDevices reports that among the violations mentioned in the FDA’s letter is “failure to establish and maintain procedures for verifying or validating corrective and preventive actions.” The agency claims that Smith & Nephew provided insufficient evidence that it had resolved issues of loss of visualization resulting from use of its Truclear Ultra Reciprocating Morcellator 4.0.

The morcellators in question do not belong to the group of powered laparoscopic tools currently under investigation by the FBI. However, Smith & Nephew is still facing its share of legal troubles over its problematic hip implants. The British-based company has recently come under fire for its defective Birmingham Hip Resurfacing System. Approved by the FDA in 2006, the Birmingham Hip Resurfacing System was hailed as a safer, easier alternative to traditional total hip replacement systems. It was marketed as a top-of-the-line product that would last for 15 to 20 years. But less than a decade after it was introduced to the market, Smith & Nephew hip resurfacing lawsuits began piling up.

smith and nephew hip resurfacing systems under firePlaintiffs in Smith & Nephew hip resurfacing lawsuits claim that they were injured when their Birmingham Hip Resurfacing System implants began to erode inside of them. As with several other metal-on-metal hip implants, such as those produced by DePuy, Stryker, and Zimmer, when the metal components of the Birmingham Hip Resurfacing System abrade against one another, toxic metal ions are released into the bloodstream. This can result in a putative condition known as metallosis. Metallosis has been associated with extreme pain, dizziness, and fatigue, and can lead to loosening or dislocation of the implant, requiring painful and costly revision surgery.

In additional to its hip resurfacing implants, Smith & Nephew has also had problems with its total hip replacement products. In June 2012, Smith & Nephew recalled the optional metal liner component of its total hip replacement device, the R3 Acetabular System, due to unreasonably high rates of failure. The R3 metal liner, which is inserted into the device’s metal pelvic socket, was originally designed for use with the Birmingham Hip Resurfacing System. According to the FDA, the R3 Acetabular System was never approved for use with the R3 metal liner. Plaintiffs in Smith & Nephew hip replacement lawsuits claim that the combination of these devices led to serious health problems, including fractures, dislocation of the implant, and infection of the tissue around the hip joint.

The hip implant lawyers at Lopez McHugh know how painful and costly revision surgery can be. If you or a loved one was injured by a failed Smith & Nephew hip resurfacing or replacement implant, contact our attorneys today for a free legal consultation. You may qualify to receive compensation through a Smith & Nephew hip resurfacing or hip replacement lawsuit.