FDA Issues New Warning Concerning All-Metal Hip Implants
On January 17, the FDA issued a new safety communication regarding metal-on-metal hip implants geared to orthopedic surgeons and patients who are considering or have already received an all metal hip device. The federal agency has been analyzing the risks of these prosthetic implants for several years, following reports of Zimmer hip replacement complications and those of other devices manufactured from cobalt-chromium-molybdenum alloys that have been linked to loosening, metal grinding, and early failure fates.
According to FDA officials, “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants…. metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.”
Revised recommendations for surgeons
A ball, stem and shell make up the metal-on-metal devices, which have been associated with soft tissue damage as the components slide against each other during activity, sometimes resulting in adverse reaction to metal debris as particles shed into the surrounding tissues and bloodstream. This tissue damage is often the precursor to chronic pain, loosening of the implant, and ultimately may require revision surgery. The FDA further concluded that certain types of patient were at higher risk for complications from the all metal devices; these include:
- Female patients
- Severely overweight patients
- Patients who are very active
- Patients with bilateral implants
- Patients with resurfacing systems with small femoral heads
- Patients with evidence of renal problems
- Patients with weakened immune systems
- Patients with metal sensitivity
- Patients taking high doses of corticosteroids
Doctors are also urged to follow up with patients who report any symptoms or complications such as such as pain or swelling in the hip area, lack of mobility, or any popping noises from the hip joint more than three months after the device is surgically implanted. Those with metal-on-metal hip devices who develop any physical findings that indicate their implant may be faulty or functioning incorrectly are advised to have metal ion testing.
Injured patients seek advice from Zimmer hip lawyer
The FDA began assessing the safety and risks of all-metal implants, after receiving more than 5,000 complaints of adverse reactions, ranging from inflammation and bone fractures to dislocation and heavy metal blood poisoning. Among the devices cited was the Zimmer Durom Cup, which has been the source of increasing litigation in courtrooms across the country. Patients implanted with the Durom were often forced to undergo painful revision surgery, and seek to hold the manufacturer liable for their pain and suffering. Dozens have retained a Zimmer hip lawyer to file their claims in hopes of securing compensatory damages.
In July of 2008, the hip manufacturer temporarily suspended sales of its Durom Cup, but there has never been an official Zimmer hip replacement recall. The device was released about four weeks later, with revised instructions for orthopedic surgeons. Zimmer isn’t the only company on trial, others such as Johnson & Johnson and DePuy have been named as defendants in thousands of product liability lawsuits.