May 28, 2015 — The FDA has issued a warning letter to Signal Medical Corp. for selling a hip implant with “major changes” that were never approved.
During inspections in July and August 2014, the FDA found that Signal was selling the MicroSeal hip replacement with design modifications that had never been evaluated for safety or effectiveness.
Changes included two new hood liners that were not included on the implant’s original 510(k) approval application. Furthermore, Signal was selling several additional sizes of the MicroSeal Acetabular Liner that were not approved.
The warning was issued on December 15 and only recently released publicly. It accused Signal of insufficiently responding to the problem:
“During the close of the inspection, the investigators discussed the observed device design changes to the MicroSeal total hip acetabular system, a 510(k)-cleared device. The 510(k) changes as described above were not covered in your response letter.”
The FDA has been criticized for approving metal-on-metal hip implants through the 510(k) process, which allows manufacturers of new devices to avoid conducting new safety studies so long as their device is “substantially equivalent” to another device on the market.
The problem is that small modifications add up over time and can introduce new safety risks. Thousands of people have been seriously injured by metallosis caused by chromium and cobalt in their all-metal hip replacement.
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