Following an expanded recall of the Kugel hernia patch, The U.S. Food and Drug Administration (FDA) has inspected the headquarters of its manufacturer, Davol, Inc., and issued the company a warning, citing serious quality control problems related to the manufacture of its surgical patch and an associated fixation device. The inspection was completed in March, 2007.
The patch, a screen-covered collapsible ring designed to resolve hernias, was manufactured in several sizes. The very largest to mid-sized versions have been recalled due to faulty metal rings, which in many instances broke, causing internal injuries and some fatalities.
The most serious FDA findings involve inadequate systems and procedures for tracking device-related complaints at Davol, Inc. Device manufacturers are required by the FDA to collect and analyze complaints, and to notify the agency of any instance where their device may have contributed to a sentinel event. However, if manufacturer investigates and determines that its product did not cause the problem, it is not required to forward the complaint to the FDA. Davol received numerous complaints concerning its patches, but after review, determined that poor outcomes were related to improper installation by physicians, rather than device construction. Consequently, the FDA was never alerted to the threat.
The episode is a reminder that complications from surgery can come as a result of faulty medical devices, as well as from medications or human error. If you have symptoms that you believe could be the result of a faulty medical device, you should consult your physician immediately.
If you or a family member believes that you have a case involving a defective medical device or medical malpractice, please contact us on-line at Regan Zambri & Long or call us at 202-753-4272 for a free consultation. If you would like to receive our complimentary electronic newsletter, please click here.