The New York Times takes a hard look at Bard’s actions leading up to the recall of the Kugel hernia patches.
Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.
But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints.
And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.
Bard officials, who declined to be interviewed, said in a statement that they have since addressed the agency’s concerns, and agency officials said they are monitoring the company’s progress.
Source: History of Hernia Patch Raises Questions on Implant Recalls - New York Times