When Connie Franklin underwent surgery to repair an incisional hernia with a Physiomesh implant, she probably didn’t expect the months of complications that would eventually result in severe pain, additional surgery and pieces of the mesh stuck inside her body.
But that’s exactly what happened in late 2016. Now, Franklin joins the growing number of people who are suing Johnson & Johnson and its subsidiary Ethicon over claims that the Physiomesh hernia device was defectively designed and caused a number of complications.
According to the lawsuit filed in the U.S. District Court for the Middle District of Georgia on Feb. 2, Franklin blames Johnson & Johnson for making a defective device that led to severe adverse reactions without warning of possible risks.
Connie was initially implanted with the device while undergoing a repair for an incisional hernia, a type of hernia that can occur after surgery in the abdomen, at Midtown Medical Center in Columbus, Ga. Then, in August 2016, she underwent a second surgery to repair her hernia again and was presented with pain, nausea and vomiting.
When the surgeon went to repair her hernia, part of the Physiomesh device was not incorporated into the abdominal wall and parts of her intestines were protruding through the mesh, causing intestinal obstruction.
“The mesh was densely adhered to the loops of Ms. Franklin’s intestines,” the lawsuit said. “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 [sic]. Portions of the Physiomesh could not be removed, and remain in Ms. Franklin’s body.”
The lawsuit blames the failure of the Physiomesh device on the multi-layer coating that was supposed to minimize inflammation and facilitate incorporation into the body. However, the coating was said to have contributed to an intense inflammatory response, resulting in adverse reactions such as migration and damage to the surrounding areas.
Franklin said Johnson & Johnson should have been aware of the design flaws with the coating and warned patients of the risks. On top of that, Franklin is suing for negligence because the company “knew, or in the exercise of reasonable care should have known, that Physiomesh was defectively and unreasonably designed and/or manufactured, and was unreasonably dangerous and likely to injure patients in whom Physiomesh was implanted.”
Ethicon Physiomesh has been a source of controversy the past few years. The device was first introduced in 2010 via the U.S. Food and Drug Administration’s 510(k) application, which allows a device to go to market without clinical studies as long as it is similar to another device already on the market.
In May 2016, Johnson & Johnson issued a voluntary global market withdrawal of its Ethicon Physiomesh based on an increased risk of unexpected side effects. Although there was no recall, letters were sent to healthcare providers to notify them of the market withdrawal.
Since then, hundreds of lawsuits have been filed against Johnson & Johnson over similar claims that a failure to warn about risks and negligence led to a number of complications like revision surgery and severe pain. More lawsuits related to Physiomesh are expected to be filed.