Pharmaceutical

More than 800 Physiomesh Incidents Reported to FDA

physiomesh More than 800 Physiomesh Incidents Reported to FDAAccording to the U.S. Food and Drug Administration (FDA) website, there are more than 800 negatively reported incidents associated with Physiomesh, including injuries and death.

The FDA’s MAUDE reporting system allows doctors and hospitals to submit adverse event reports regarding various medical devices and products. Physiomesh yielded 839 results from 2010 to present, most of which reported incidents that resulted in injuries, and many of which resulted in deaths.

The number of adverse incident reports have increased significantly every two years. From 2010-2012, only 95 incidents were reported. From 2012-2014, 293 incidents were reported. From 2014-present, 451 incidents were reported. At least nine deaths were linked to the device.

Physiomesh, a hernia repair mesh made by Ethicon, a subsidiary of Johnson & Johnson, is designed to bridge the gap of a hernia to promote healing. Physiomesh has a unique five-layer design with knitted filaments of polypropylene at its center. Two layers of film coat each side, which has been the source of many complaints.

According to multiple lawsuits, the coating used in the mesh device doesn’t allow the material to incorporate into the human body effectively. The multiple layers discourage adequate fluid drainage, which leads to a buildup of infection-causing bacteria, lawsuits allege. Lawsuits also claim the mesh is unable to sustain normal abdominal forces.

A MAUDE Report dated July 13, 2017, said the patient’s mesh “had become infected and necessitated additional surgical repair to remove the mesh. He had abdominal wall cellulitis due to the hernia infection, exploratory laparotomy with excision of the infected hernia mesh. ”

A MAUDE Report dated July 10, 2017, said, “patient underwent a hernia repair surgery on [undisclosed date 2013] and mesh was implanted. It was reported that the patient had a surgical excision of the mesh on [undisclosed date 2016] due to complications. The patient continues to experience pain.”

Another MAUDE Report dated July 10, 2017, said, “the patient underwent a laparoscopic assisted repair on an incarcerated incisional hernia … and mesh was implanted.” The patient developed tumors in the peritoneum and returned to have them surgically removed. “Upon entering the abdominal cavity, her physicians encountered extensive adhesions of the mesh to her bowel and abdominal wall. On [undisclosed date 2015] she underwent another invasive and extensive surgical procedure to take down adhesions, repair recurrent hernias and remove the mesh in its entirety.”

A MAUDE Report dated July 3, 2017, said of a patient who had received Physiomesh in 2015, “Following the surgery, the patient experienced persistent abdominal pain, diminished bowel motility and bowel obstruction. She was re-admitted to hospital with severe nausea, vomiting, abdominal cramping and abdominal distention on [undisclosed date 2015]. Medical imaging scans taken revealed hernia recurrence, specifically a paraumbilical hernia containing soft tissue, possibly bowel, and it was noted that free fluid was seen within her pelvis in addition to seroma. On [undisclosed date 2016], the patient underwent surgery at hospital for severe hernia recurrence and mesh removal, it was noted that the mesh had not completely incorporated into the abdominal wall and had begun to disintegrate, with a recurrent hernia noted in areas where the mesh had torn and disintegrated and she had an intestinal obstruction.”