Smith & Nephew ($SNN) has issued a warning on its Birmingham metal-on-metal hip implants, telling regulators that new data reveals higher rates of failure for the devices.
As MassDevice reports, the company told the Hong Kong health department that the implants had a failure rate of 1.29% based on the National Joint Registry of England and Wales, exceeding the 1% benchmark established by U.K. regulators.
But the orthopedics giant isn't recalling the devices. Instead, Smith & Nephew is changing the implant's indications, saying that as long as Birmingham is used in conjunction with the company's Synergy femoral stem, failure rates drop to within the 1% acceptable range. In a letter to customers, Smith & Nephew says that the device's inherent risks haven't changed and still warns that patients may endure pain and difficulty moving if the implant wears down.
The re-labeling doesn't affect U.S. customers, because Birmingham is not FDA-approved for primary hip-replacement surgeries, MassDevice reports.
The concern over Birmingham is the latest development in the metal-on-metal hip saga, as devicemakers around the world face recalls and lawsuits over the technology. Once touted as a more durable alternative to plastic implants, all-metal devices have been found to fret and corrode, sometimes leading to swelling and blood contamination.
Stryker ($SYK) and Johnson & Johnson ($JNJ) have recalled many of their metallic offerings, and both companies have recently landed in court, facing plaintiffs who claim the products left heavy metal toxins in their blood. Regulators have taken notice, too, and experts from the FDA and MHRA have said they see no reason to continue using metal-on-metal implants in light of their risks.
- read S&N's letter (PDF)
- check out MassDevice's report