A woman claims that design defects in a hernia mesh sold by Johnson & Johnson and Ethicon caused her injury, requiring her to have additional surgeries to deal with problems caused by the defect. She has filed a lawsuit against Johnson & Johnson and Ethicon Inc., the makers of the device, aiming to hold them liable for her alleged injury.

According to the FDA, hernia or surgical mesh is a medical device that is inserted into the body of a patient who has a hernia, or a weakened portion of muscle or bodily structure. The hernia mesh is designed to provide support to the weakened area. 

Plaintiff Charlotte M. says that she had a 20 x 25 cm Proceed Surgical Mesh implanted into her abdomen to repair a ventral hernia. She says the surgery took place at North Florida Regional Medical Center in Gainesville, Fla. on or around Aug. 5, 2010.

Charlotte says that on or around Oct. 10, 2011, her surgeon revisited the hernia repair site because Charlotte was experiencing a recurrent incisional hernia. Allegedly, the surgeon discovered during the procedure that there was a 3 cm hernia defect. The previously placed mesh had been dislodged, according to the complaint, and the inferior edge of the mesh was located inside of the hernia.

Allegedly, the surgeon removed firm adhesions to the previously paced mesh and re-secured the mesh to the inferior abdominal wall with sutures. In this procedure, the surgeon also added an additional piece of Proceed Surgical Mesh to help repair the problem.

Charlotte goes on to say that on or around Feb. 19, 2015, she was admitted to a Florida hospital and was hospitalized again, this time due to a complete small bowel obstruction. She says that a different surgeon performed an exploratory laparotomy surgery, during which he discovered a “portion of necrotic and extremely distended cecum twisted around an internal hernia in the left upper quadrant of Charlotte’s abdomen.”

Allegedly, this occurrence was caused by “dense adhesions of a portion of small intestine to the ventral hernia mesh and to the mesentery of the right colon.” To correct this event, the surgeon allegedly “divided and removed the large polypropylene ventral mesh and eviscerated several loops of [Charlotte’s] small bowel.”

Charlotte claims that these occurrences in which the surgical mesh moved out of place an years later, caused her bowel obstruction, was caused by a design flaw in the hernia mesh that allowed it to move from the place it was inserted. Charlotte claims that Johnson & Johnson and Ethicon, the makers of the device, knew or should have known that the design of the mesh was defective and could cause injury.

She claims that the companies knowingly misrepresented the product as safe and effective. Charlotte aims to hold the makers accountable for her injury. She contends was injured by the device itself and by the surgeries she had to have to correct problems that resulted from the lack of functionality of the  mesh.

As early as 2003, says Charlotte’s lawsuit, Ethicon and Johnson & Johnson knew the materials they used in their surgical mesh could cause the device to improperly adhere to the body, making it difficult to remove. Other information available as early as 2003 indicated that the device was susceptible to shrinkage and movement from where it was implanted.

However, Charlotte’s lawsuit argues that the companies obscured this information to sell more hernia mesh products, putting patients at risk in the interest of profit.

A study in the Annals of Gastroenterology notes that mesh migration is uncommon, and Charlotte suggests that the makers of the Proceed Surgical Mesh should have exercised care necessary to ensure that their materials used in the mesh would hold up to normal functionality.

The Surgical Mesh Injury Lawsuit is Case No. 3:19-cv-00217-HES-PDB, in the U.S. District Court for the Middle District of Florida, Jacksonville Division.