Pharmaceutical

Patient Claims Physiomesh Multi-layer Design to Blame for Injury

physiomesh Patient Claims Physiomesh Multi layer Design to Blame for InjuryA recent lawsuit filed against Ethicon, a subsidiary of Johnson & Johnson, claims its Physiomesh hernia repair mesh is to blame for a patient’s injury and perpetual pain.

Amy Flood, a Texas resident, filed a lawsuit over the injury allegedly caused by the multi-layered design of Physiomesh, the very aspect of the device that, according to marketing promotions, sets the product apart from other hernia mesh devices available on the market at the time.

On Oct. 14, 2015, Flood underwent a surgical procedure to repair an incisional hernia, and Physiomesh was the chosen device for treatment.

After the surgery, Flood began experiencing severe pain, which continues to this day. Upon examination, the multi-layer coating of the Physiomesh was found to be degraded, which exposed the “naked” polypropylene mesh to the internal viscera and tissues. The breakdown of the coating caused an intense inflammatory and foreign body reaction.

Flood will now require an additional surgery to hopefully remove the Physiomesh before any further damage can be done.

The lawsuit claims Physiomesh is “cytotoxic, immunogenic, and not biocompatible, which causes or contributes to complications such as delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications.”

The lawsuit also states that ” … Defendants failed to issue a nationwide recall, opting instead to simply remove the product from shelves and cease further sales within the United States. This notice was not sent to patients implanted with the device, nor were physicians instructed to immediately remove the device. Instead, the recall instructed health care practitioners to ‘continue to follow those patients in the usual manner.’”