May 27, 2011

Recent investigative reports from The Chicago Tribune call into question US medical device industry arguments against implementing stricter product clearance and approval processes, as well as the Food and Drug Administration’s ability to effectively regulate the industry using its current framework.

US industry trade group AdvaMed appears particularly compromised by the Tribune reports. In 1997, the organization petitioned the FDA to downgrade the classification of annuloplasty rings made by Edwards Lifesciences and used to repair faulty heart valves from Class III to Class II, contending that the devices’ safety and effectiveness had already been demonstrated and that clinical trials were not necessary. The agency ultimately did reclassify the annuloplasty rings to Class II in 2001.

In the past five years, according to the Tribune’s analysis of FDA adverse event data, annuloplasty rings have been associated with more patient deaths than any other Class II device. The report draws no clear line between these deaths and the FDA’s 2001 reclassification, but the fact that such invasive products were reclassified at AdvaMed’s behest without clinical evidence of their safety does little to enhance the images of either the regulator or the industry group.

Going forward, such revelations could and should impact the FDA 510(k) reform debate, but so far it’s not clear how. In a written response published today in the Tribune, AdvaMed president and CEO Stephen Ubl argues that the paper’s report “mischaracterizes” the FDA’s reclassification process and oversimplifies the 510(k) clearance process. Ubl makes no mention, however, of the article’s specific findings regarding annuloplasty rings, or of AdvaMed’s role in pushing the FDA to reclassify those devices.

“The American public and patients in particular need to know that FDA's regulatory processes are risk-based, science-driven and well-designed to determine the safety and effectiveness of medical devices and to protect and promote the public health,” writes Ubl.

But the facts disclosed in the Tribune article don’t quite square with that assertion.


  • Stewart Eisenhart