In December 2005, Davol, Inc. initiated a recall of its extra-large Bard® Composix® Kugel® Mesh Patches used in the repair of incisional hernias. Since the product went on the market in 2002, Davol had received numerous reports of patient injuries occurring when a plastic ring in the device breaks. Initially believing the failures were due to doctors mishandling the device during surgery, they eventually discovered instead a faulty weld in the plastic component and issued the recall.
The recall was expanded to other large and extra-large sizes of the product in March 2006 and January 2007. However, two hospitals in Virginia Beach, Virginia did not remove the recalled product from their inventory, and mistakenly implanted the recalled patches in seven patients in the early months of 2007.
The mistake was not discovered until Judith Coyne, a patient who had hernia surgery at Sentara Virginia Beach General Hospital, contacted a local TV news station in June 2007. She had been suffering excruciating pain following her surgery and in reviewing her medical records correlated the product code and lot number of the Kugel patch she received with those in the recall. She told the reporter from station WAVY that the hospital, operated by Sentara Health Systems, did not believe her when she told them she had been implanted with a recalled patch.
In fact, a Sentara spokesperson initially denied that Coyne’s patch was among those recalled, but soon after released a retraction. Upon investigation, the hospital discovered they did indeed have recalled patches on their shelves, and that six other patients had received them in early 2007 – three at Sentara Virginia Beach General and three at sister facility Sentara Leigh Hospital.
Even though the recall had received much publicity and Davol had sent letters to all hospitals and surgeons informing them of the recall, Sentara blamed the mistake on “human error” because the product details and lot numbers listed in the rolling recalls were “confusing.”
Dr. Tom Thames, Senior Vice President of Medical Affairs contacted Mrs. Coyne’s surgeon to request a follow-up examination and evaluation so the hospital could provide any assistance possible to address her pain issues.
The problems Coyne was experiencing, however, were not due to a broken plastic ring, but rather due to complications that sometimes accompany hernia repairs. Because the mesh patch had already fused to her internal organs, doctors determined removing the patch would be a far greater risk to her life than leaving it so long as the plastic ring remained intact.
In the meantime, Mrs. Coyne and six other patients are living with a known defective device implanted in them simply because a hospital staffer couldn’t understand a series of recall notices clearly enough to identify and return the recalled patches to the manufacturer. Granted, the average person reading the recall notices might agree that the specification of product codes and lot numbers was challenging to interpret. But given the life-and-death stakes, there seems little excuse for the hospital administration not having procedures for double-checking that medical device recalls are administered to the letter.
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