A Florida woman has filed a hernia mesh lawsuit against the world’s largest medical device company, Johnson & Johnson and its Ethicon subsidiary.

In February 2016, plaintiff Sarah Ann G. had Ethicon’s Physiomesh Composite hernia mesh implanted laparoscopically to repair a ventral hernia.

However, the hernia mesh caused serious injury and Sarah was forced to have the allegedly defective Physiomesh surgically removed via invasive surgery.

During the revision surgery, Sarah Ann was found to have abdominal bulge, recurrent hernia and pain with adhesion complications, the hernia mesh lawsuit states.

According to the hernia mesh lawsuit, neither Sarah Ann nor her implanting physician were adequately warned or informed by the defendants of the risks associated with the hernia mesh.

The hernia mesh lawsuit further asserts that Sarah Ann “has suffered and will continue to suffer physical pain and mental anguish” as a result of the defective nature of Ethicon and J&J’s Physiomesh.

Sarah Ann has brought the hernia mesh lawsuit on multiple counts including defective design, failure to warn and negligence.

She is seeking a trial by jury and judgment against Johnson & Johnson and Ethicon jointly for compensatory and punitive damages, along with attorneys’ fees, interest, or any other relief, monetary or equitable, to which she is entitled.

Physiomesh Market Withdrawal

Ethicon’s Physiomesh Composite Mesh is an implantable tissue-separating mesh designed to be physiologically compatible with the abdominal wall. It is manufactured from flexible, non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated.

Physiomesh was cleared by the U.S. Food & Drug Administration (FDA) in 2010, via the agency’s 510K program.

This program does not require a device manufacturer to conduct human clinical trials, as long as it can be demonstrated that the new product is substantially equivalent to another device that was previously approved by the FDA.

Ethicon announced the worldwide market withdrawal of Physiomesh on May 25, 2016.

According to the company, unpublished data from two European registries indicated the recurrence and revision rates following laparoscopic ventral hernia pair were higher with the device than rates associated with the comparator set of mesh.

Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors.

Filing a Hernia Mesh Lawsuit

Hernias are a relatively common problem that, for many, requires surgery to alleviate daily pain, discomfort and other symptoms.

Unfortunately, some who were promised a solution with Ethicon’s Physiomesh Composite hernia mesh, instead found themselves facing potential infections, hernia recurrence and more surgeries.

In fact, Physiomesh has been associated with high rates of bowel obstructions, seromas, infections and mesh failures.

Patients who have experienced serious complications following hernia repair with Physiomesh should consider filing a hernia mesh lawsuit. An experienced medical device injury attorney can provide you with a free, no obligation case review.

The Hernia Mesh Lawsuit is Case No. 8:16-cv-03502, in the U.S. District Court for the Middle District of Florida, Tampa Division.