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Texas Woman Says Physiomesh Design Increases Risk of Inflammation

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On October 9, 2017, a Texas woman filed a new Physiomesh lawsuit against manufacturer Ethicon and parent company Johnson & Johnson (J&J). She filed the case in the Eastern District of Texas, but it has since been transferred to the Northern District of Georgia where all federal cases have been consolidated.

The plaintiff claims that after she was implanted with Physiomesh, she suffered from serious injuries. She seeks damages in excess of $75,000.

Plaintiff Suffers Severe Adverse Reaction from Physiomesh

According to her complaint, the plaintiff had surgery on October 14, 2015, to repair an incisional hernia. An incisional hernia occurs in an area that has been weakened by a previous incision, such as one made during an abdominal surgery. The muscles may not heal correctly, leaving a gap through which tissues can later poke through and create a bulge under the skin. In minor cases, it’s usually the lining of the abdominal cavity that protrudes, but in more severe cases, more tissues or organs may be involved.

During surgery, doctors often use a product like Physiomesh, which is a net-like patch, to help shore up and support the weakened area to hold the tissues and organs in their proper place. The mesh is used as a graft to cover the hole and is supposed to be a permanent implant in the body.

The surgeon, in this case, used Physiomesh to fix the plaintiff’s incisional hernia in a minimally invasive, laparoscopic repair. Unfortunately, the plaintiff claims that it failed to perform as expected, and instead caused serious injury and a severe adverse reaction.

Plaintiff Criticizes Design of Physiomesh

The plaintiff states that at the time of the implant she and her doctors were unaware of the defects and dangers associated with Physiomesh. But they have since learned that the way it was designed can increase the risk of reactions such as the one she experienced.

She notes that the unique 5-layer design includes 2 layers of Monocryl film covering two layers of polydioxanone film, which all surround the core polypropylene mesh. The defendants advertised this design as a way to prevent or minimize adhesion and inflammation while facilitating incorporation into the body, but instead, the plaintiff claims that it prevented incorporation and caused intense inflammation.

She adds that the multi-coated surface prevented fluid escape, which led to the formation of seromas (pockets of fluid). This, in turn, increased the risk of infections and the formation of abscesses. “The multi-layer coating provides a breeding ground for bacteria,” she states in her complaint, “in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”

Ethicon Recalls Physiomesh

In May 2016, Ethicon issued a voluntary recall Physiomesh. They stated in an urgent field safety notice that the product had created higher recurrence and reoperation rates than other similar mesh products, and asked hospitals and medical centers to stop using it.

The plaintiff brings counts of defective design and manufacture, failure to warn, negligence, breach of warranties, vicarious liability, and violation of deceptive trade practices. She seeks both compensatory and punitive damages.

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