PENNSYLVANIA RECORD

A Delaware County woman is suing the makers and distributors of a surgical mesh device

over allegations that she suffered post-operative injuries as a result of having had the material medically inserted into her body.

Ramona Shelley, of Darby, Pa., has filed suit against Johnson & Johnson, Ethicon Inc. and American Medical Systems Inc. over claims that she became injured by the Prolene Soft Mesh, which is a thin sterile laminate mesh material designed for the repair of hernias and other fascial deficiencies.

Shelley asserts in her products liability claim, which was filed Dec. 7 at the U.S. District Court for the Eastern District of Pennsylvania, that she developed an injury from the mesh device in early December of last year, about a month-and-a-half after she underwent a ventricle hernia repair surgical procedure in which the mesh material was implanted in her body.

The plaintiff claims that she suffered an adhesion of the polypropylene side of the mesh to her bowel, deformation of the mesh, severe abdominal pain, infection, nausea, sickness, severe discomfort, permanent ugly massive scarring, and other pains and injuries to her body.

Shelley claims her injuries led her to spend money on additional medical treatment. The plaintiff also asserts that she has suffered a loss of earnings because of her injuries.

The lawsuit says that the Prolene Soft Mesh, which was manufactured by the defendants beginning in 2003, has a design defect that can cause post-operative injuries in some patients, including adhesions to tissue, post-operative infection, chronic abdominal wall inflammation, bowel obstruction, sepsis, chronic intestinal fistula, pain, overall sickness, damage to internal organs, and even possible death.

As a result of the possible dangers, the suit states, the device was the subject of numerous Class I FDA recalls, which is the highest level of recall by the Food and Drug Administration.

The complaint alleges that the defendants knew, or should have known, that the mesh patches were dangerous or defective and “predictably could cause serious health problems or death because they were not properly designed, manufactured, labeled, tested, distributed, advertised, marketed, promoted and/or sold with proper warnings, were not suitable for the purpose they were intended, and they were unreasonably likely to injure the product’s users.”

The complaint contains counts of negligence, strict liability, breach of implied and express warranties, negligent misrepresentation and fraudulent misrepresentation.

The plaintiff seeks compensatory damages in excess of $75,000, plus costs, unspecified punitive damages and other legal relief.

Shelley is being represented by attorney Gustine Pelagatti, Sr.

 

The federal case number is 2:12-cv-06862-JD.