A husband and wife from Georgia claim that problems with the design of Ethicon’s Physiomesh led to the wife’s ruptured hernia mesh, which caused her intestines to protrude through the surgical product.

In August 2016, plaintiff Connie F. underwent surgery for recurrence of her incisional hernia after receiving the Physiomesh device during a prior hernia repair surgery.

During Connie’s surgery to repair the ruptured hernia mesh, the central part of the Physiomesh device was not adequately secured into the wall of her abdomen and loops of her intestines ended up protruding through the ruptured hernia mesh, which caused her to develop an intestinal obstruction.

Despite having undergone the surgery, portions of the Physiomesh could not be removed by her surgeon and still remain in Connie’s body.

As a result of the hernia mesh rupture, the Physiomesh lawsuit states that Connie “has suffered and will continue to suffer physical pain and mental anguish” as a result of the defective nature of Ethicon’s hernia mesh device.

Connie has brought the hernia mesh lawsuit on multiple counts including defective design, failure to warn and negligence. Her husband also joins the lawsuit, bringing claims for loss of consortium (loss of intimacy with a spouse).

The couple is seeking a trial by jury and judgment against Ethicon for compensatory and punitive damages, along with attorneys’ fees, interest, or any other relief, monetary or equitable, to which they are entitled.

About Ethicon’s Physiomesh

In April 2010, Physiomesh received clearance via the FDA’s 510(k) process. The 510(k) process does not require clinical trials to be conducted on a product if it is substantially similar to a previously approved product.

Physiomesh is made of a mesh material “composed of nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh,” the FDA summary states.

However, studies have found that the polypropylene breaks down in its structure which can allow the hernia to recur or cause bacterial infections and swelling at the surgery site, requiring another surgery.

On May 25, 2016, Ethicon (a subsidiary of Johnson & Johnson) voluntarily withdrew Ethicon Physiomesh from the market.

The voluntary market withdrawal came after Ethicon analyzed data from two registries that documented hernia issues and the data indicated that the recurrence rate of hernia and rate of a second hernia operation after initial repair with Physiomesh were both higher than average.

What Do You Do If You Suffered a Ruptured Hernia Mesh?

Hernias are a relatively occurrence for many individuals and many hernia operations are routinely performed to help sufferes reduce their pain and dicomfort brought about by the condition.

Some patients who received Ethicon Physiomesh unfortunately had more issues to deal with following their surgery, with issues like ruptured hernia mesh, hernias that recurred and the need for another surgery to repair problems stemming from the original surgery.

If you or someone you know has experienced complications after the use of Ethicon Physiomesh or has required surgery because of a ruptured hernia mesh or intestinal obstruction, you may want to consider your legal options.

An experienced hernia mesh lawyer will be glad to review your case with you and answer your questions for during a free case consultatoin if you qualify.

The Ruptured Hernia Mesh Lawsuit is Case No. 4:17-cv-00031-CDL, in the U.S. District Court for the Middle District of Georgia.