The latest in a string of reports on health care giant Johnson & Johnson (NYSE:JNJ) suggest that the FDA hinted at issues with the device maker’s metal-on-metal hip implants in 2009, a few weeks before the company began phasing out the products.
In a non-approvable letter sent to J&J in August 2009, the FDA asked the company for additional safety data about the articular surface replacement hip system and raised concerns that some patients who received the metal-on-metal implant showed a "high concentration of metal ions" in blood tests.
The federal watchdog agency also raised concerns that data from countries where the device was in use suggested a higher failure rate than the data submitted from J&J’s studies, the New York Times reported.
J&J has maintained that the decision to shift to phase out the metal-on-metal hips, which it began to do in November 2009, was "purely a business decision."
"At the same time that the company received this FDA letter, market demand for hip resurfacing was declining rapidly," J&J spokeswoman Jessica Masuga told MassDevice in an email last month. "In weighing the significant resources that would be required to produce the new clinical data-set requested by FDA against the declining market interest in resurfacing, DePuy decided to withdraw the PMA."
The FDA’s rejection letter is considered a confidential notice which isn’t generally made public. The New York Times obtained a copy under the Freedom of Information Act.
In August 2010 DePuy recalled both the ASR resurfacing implant and the related ASR cup due to a high rate of revision surgeries required to correct or remove the defective implants. The pair of implants were used on about 93,000 patients worldwide.