An Alabama woman and her husband have filed an abdominal mesh complications lawsuit against the manufacturer claiming that the wife’s hernia mesh was defective and has caused her unnecessary pain and suffering.

Plaintiff Patricia S. and her husband Charles S. claim that she was implanted with a Physiomesh composite mesh device to repair a hernia. Because this device was defective, this abdominal mesh complications lawsuit claims, Patricia has “suffered and will continue to suffer physical pain and mental anguish as a result of this revision.”

She claims she was forced to undergo invasive medical treatments because of abdominal mesh complications.

What is Hernia Mesh?

Patients who develop hernias often must have surgery to repair the abdominal wall that has been torn or split as a result of the hernia. A medical device known as a hernia mesh is frequently used in patients to help strengthen the muscle wall and prevent hernias from reoccurring.

Hernia mesh products are flexible screen-like devices made of varying materials including organic and nonorganic materials. The mesh is implanted at the hernia site, and over time, tissue grows over the mesh incorporating it into the muscle wall. Some hernia mesh devices dissolve over time, and others do not.

The mesh device that was implanted into Patricia is the Physiomesh composite device. It was approved by the U.S. Food and Drug Administration in 2010 through the 510(k) fast-track approval program. If a device is significantly similar to an already-approved device, the approval for the new device is much quicker and does not require the same types of clinical trials as another device might require.

This device is made of a “macroporous polypropylene that is held together by two undyed polygelcaprone-25 films.”

Abdominal Mesh Complications

This particular mesh device, however, has been connected with many abdominal mesh complications, including those that Patricia experienced. These abdominal mesh complications include hernia recurrence, removal surgery, infections, wound problems, and abdominal pain.

Patricia claims that Ethicon, the manufacturer of her hernia mesh device, is responsible for the invasive procedures she had to endure and her abdominal mesh complications because her mesh device was defective.

According to this abdominal mesh complications lawsuit, Ethicon was “responsible for the research, design, development, testing, manufacture, production, marketing, promotion, distribution and sale of Physiomesh, including providing the warnings and instructions concerning the Defective Device.”

Patricia claims that the Physiomesh composite mesh product was not reasonably safe for its intended use for hernia repair, and that the risks of the design outweigh the benefits of the design.

The severe adverse reactions that the abdominal mesh complications lawsuit mentions include chronic pain, hernia recurrence, foreign body response and rejection, infection, inadequate or failure of incorporation, devcie migration, improper wound healing, excessive and chronic inflammation, adhesions to internal organs, erosion, abscess, fistula formation, seroma formation, nerve damage, and tissue damage.

The claims brought forth in this lawsuit include negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, breach of express warranty, breach of implied warranty, fraud and loss of consortium.

This Abdominal Mesh Complications Lawsuit is Case No. 5:17-cv-02016 in the United States District Court for the Northern District of Alabama, Northeastern Division.