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Kugel Mesh Hernia Patch Used At Virginia Hospitals Long After Recall

Jun 9, 2008 | Parker Waichman Alonso LLP

The defective Kugel Mesh Hernia Patch - recalled several years ago - was mistakenly implanted in seven patients at two Virginia hospitals.  At least one woman who received a recalled Kugel Mesh Hernia Patch at one of the two hospitals owned by Sentara Health Systems says she has been living in excruciating pain since her surgery, and is worried that the medical device might be putting her life in danger.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quit using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice - in 2006 and 2007 - to include several other sizes of the device.

Apparently, not all hospitals have gotten the word on the Kugel Mesh Hernia Patch recall - at least not in the case of Sentara Virginia Beach General Hospital and Sentara Leigh Hospital.  Officials from the Virginia health system admitted last week that four patients at the Virginia Beach location, and three others at Leigh were implanted with the dangerous hernia patch.

Sentara was first alerted to the problem when Virginia Beach's Judith Coyne, who had hernia surgery last June - six months after the final Kugel Mesh Hernia Patch recall was announced - related her story to a Virginia TV station.  Coyne said shortly after her surgery, she began having excruciating abdominal pain.  When she and her son got her medical  records, using the product code and lot number, they determined that the Kugel Mesh Hernia Patch which was implanted in her during surgery was recalled.  According to WAVY.com, Coyne says doctors now tell her that the mesh is stuck to her organs and aren't willing to operate because it could kill her. But Coyne lives in fear that the Kugel Mesh Hernia Patch inside her body will put her life in danger if it should break.

At first, Sentara insisted that Coyne's Kugel Mesh Patch was not the same lot number as the one recalled, but later released a statement conceding that the patch was, in fact, subject to recall.  The statement said that Sentara had "contacted Ms. Coyne's surgeon and requested that he conduct a follow up examination and evaluation so that we can provide any assistance possible to address her pain issues."

Late last week, Sentara announced that Coyne was not the only patient implanted with a recalled Kugel patch.  Sentara's Vice President Of Medical Affairs,  Dr. Tom Thames told Fox 43 that the recalled patches were implanted in 7 people at the hospitals "as a result of human error." While Davol did inform Sentara of the Kugel Mesh Hernia Patch recall, Dr. Thames said that because the recall occurred in stages, it was confusing.

Sentara is in the process of notifying all of the patients who received the recalled Kugel Mesh Hernia Patch, and says it will offer assistance to those patients.  Anyone with questions can call the health system at  1-800-SENTARA, weeknights until 11:30 p.m.