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A Georgia woman indicates that problems with the Ethicon Physiomesh design led to a rupture of the hernia mesh following surgery, causing her intestines to protrude through the central portion of the mesh, and resulting in an intestinal obstruction, severe pain and other complications.
In a lawsuit (PDF) was filed by Connie Franklin in the U.S. District Court for the Middle District of Georgia on February 2, Johnson & Johnson and it’s Ethicon subsidiary are accused of manufacturing and selling a defectively designed and unreasonably dangerous hernia repair product, which she maintains is likely to injure patients.
Franklin indicates that a 20cm by 25cm patch of Ethicon Physiomesh was implanted in her body to repair an incisional hernia. According to the complaint, she had to undergo surgery in August 2016 for hernia recurrence after she began suffering pain, nausea and vomiting. When surgeons performed the surgery, they found that the hernia mesh had failed catastrophically.
“The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of Ms. Franklin’s intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of Ms. Franklin’s intestines,” Franklin’s lawsuit states. “Ms. Franklin underwent a prolonged surgical procedure to attempt to remove the Physiomesh from her intestines and to remove the mesh that failed to incorporate into the abdominal facsia. Portions of the Physiomesh could not be removed, and remain in Ms. Franklin’s body.”
The Ethicon Physiomesh was introduced in March 2010, and has been commonly used nationwide during hernia repair surgery in recent years. However, the implant has been plagued by reports of complications, including adhesions, perforations, infections, mesh erosion and the need for hernia revision surgery.
After failing to identify a solution for these problems, an Ethicon Physiomesh recall was issued for certain products in May 2016. Although the action was classified as a “market withdrawal” in the United States, the manufacturer asked that all hospitals return unused implants and indicated that it will not be returning the device to the market.
The product liability case joins a growing number of similar Ethicon Physiomesh lawsuits filed in courts nationwide, each involving individuals who experienced severe complications following hernia repair.
Franklin presents claims against the manufacturer for defective design, failure to warn, negligence, and her husband joins in the lawsuit with a loss of consortium consortium. They are seeking both compensatory and punitive damages, which are designed to punish the manufacturer for recklessly disregarding the safety of hernia patients.