Hip Makers Face FDA Questioning
Hip Makers Face FDA Questioning on Metal Levels in Patient Blood
On May 6, 2011, the Food and Drug Administration issued orders to 21 hip manufacturers, including Johnson & Johnson, Stryker Corp. and Zimmer Holdings Inc., asking them to study the effect their devices have on the level of metal in patient’s blood. The FDA’s concern is that currently is it unclear whether the levels of metal particles from hip implants are high enough to cause dangerous problems.
Release of Metal with Hip Implants
The metal ion levels of cobalt and chromium have been found to be significantly elevated in some patients with hip implants. According to recently published reports, the hip implant design may result in greater wear and metal ion release in some patients.
For example, surgeons performing revision surgeries on patients with DePuy ASR cups due to the cup loosening have noted visual evidence of metallosis, metal staining on the surround soft tissue, black tissue, and pseudo tumors around the prostheses. Adverse reactions to metal debris have been found to be associated with hip implant failure.
The FDA on Hip Implants
While some studies have shown the effects the metal particles may have on a patient, the FDA does not feel that enough research has been done to know exactly how harmful the metal ions may be. Karen Riley, an FDA spokeswoman, stated, “The agency is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems. There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”
Experienced Defective Hip Implant Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.
If you or a loved one have been injured by a defective hip or have developed serious side effects from the use of a defective hip, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.