Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
According to allegations raised in a product liability lawsuit filed last week, problems with polypropylene mesh manufactured by Atrium Medical Corporation caused a New Mexico woman to suffer severe complications, resulting in the need for additional bowel resection surgery.
The complaint (PDF) was filed by Jesusita Aguirre in the U.S. District Court for the District of New Mexico, indicating that Atrium misrepresented that its synthetic polypropylene mesh was safe and effective, even though it has been linked to a large number of serious medical problems in recent years.
Aguirre indicates that she had the hernia mesh implanted in 1994, to treat an umbilical hernia that occurred following childbirth the year before. However, in February 2015, she went to the hospital due to extreme stomach pain, which she thought was food poisoning. Her doctors instead discovered that her Atrium hernia mesh was the cause of the problems.
“He told my daughter that the Mesh covered Hernia had embedded itself into a section of my [bowels] and had caused an obstruction and had twisted my intestines,” Aguirre said in the lawsuit. “He said that if I don’t have immediate surgery, the obstruction will burst and I would die.”
The surgery involved the removal of a portion of Aguirre’s bowels and the mesh itself, leaving her with permanent injuries and health problems.
The lawsuit joins a growing number of hernia mesh lawsuits filed in recent months against Atrium and other manufacturers, suggesting that severe complications have been caused by polypropylene material used in different products.
According to allegations raised by Aguirre and other plaintiffs, polypropylene is not suitable for implant into the human body, and never should have been used as a hernia repair mesh. The lawsuit also notes that the FDA has never fully vetted the safety of polypropylene for use in the human body, as hernia mesh products using the material were approved through the FDA’s 510(K) fast-track approval process, and only needed to be “substantially equivalent” to previous hernia mesh designs.
“Polypropylene is not biologically inert in the human body, and can cause serious injuries. A typical response to mesh implanted in the human body is inflammation, granuloma formation and a foreign body reaction,” the lawsuit states. “Scar tissue forms around the implant and causes contraction of the mesh up to 50%. This inflammation, foreign body response and scar tissue formation is a permanent condition and can result in long-term complications.”
Aguirre presents claims of negligence, design defect, manufacturing defect, failure to warn and breach of warranty. She is seeking both compensatory and punitive damages.