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Ethicon Recalls Flexible Composite Mesh Product Due To Injury Risk

Patients are at risk for recurring hernias when treated with this medical device

Earlier this year, major medical device manufacturer Ethicon recalled a surgical mesh product due to concerns that it may prove ineffective, leaving patients at risk for additional surgery and further complications.

The defective medical device at the center of the recall is the ETHICON PHYSIOMESH Flexible Composite Mesh. This composite mesh is used during laparoscopic surgery to repair ventral hernias.

What is a ventral hernia?

A hernia is a medical condition that develops when part of an organ, typically the intestine or bowel, protrudes through a tear or weakness in the wall of muscles that holds organs in place. An incisional or ventral hernia is a type of hernia that arises in a place where a previous surgical incision was made, creating a weak point in the abdominal wall.

During hernia repair surgery, the surgeon must choose an incision site in order to minimize the risk of causing organ damage or running into scar tissue from the previous operation. The surgeon then uses a laparoscope - essentially a tiny telescope equipped with a television camera - to view and repair the hernia from the inside. The composite mesh is used to reinforce the weak point in the abdominal wall, preventing the hernia from recurring.

What are the injury risks due to this defective medical product?

According to Ethicon's own research, patients who have been treated with the PHYSIOMESH Flexible Composite Mesh have a significantly higher than average rate of hernia recurrence than patients treated with other mesh products. This means that patients who have already gone under the knife multiple times may need yet another surgery. That surgery will be more complex, as surgeons need to both replace the defective mesh and avoid the additional scar tissue from the previous hernia repair.

While laparoscopic surgery is a relatively minor type of surgery, there is, as with any surgery, a significant risk of infection and other complications. Moreover, the cost of follow-up surgery can be substantial, to say nothing of the pain, worry and loss of quality of life experienced by the injured patient.

If you had laparoscopic hernia repair surgery in 2011 or later and now have a recurrent hernia, you may be entitled to compensation. Medical device manufacturers such as Ethicon have a responsibility to make sure their products function properly. When they don't meet that responsibility, an experienced lawyer can hold them accountable. Contact Dean Waite & Associates for a free, confidential consultation.